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哪些功能结果可以在腰痛试验和治疗中测量?:一项前瞻性的 2 年因素、聚类和可靠性多中心分析,涉及 1049 人 42 个变量。

Which Functional Outcomes Can be Measured in Low Back Pain Trials and Therapies?: A Prospective 2-Year Factor-, Cluster-, and Reliability-Multicenter Analysis on 42 Variables in 1049 Individuals.

机构信息

Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt, Frankfurt am Main, Germany.

University Outpatient Clinic, Centre of Sports Medicine, University of Potsdam, Potsdam, Germany.

出版信息

Spine (Phila Pa 1976). 2021 Nov 1;46(21):1495-1508. doi: 10.1097/BRS.0000000000004028.

DOI:10.1097/BRS.0000000000004028
PMID:33731576
Abstract

STUDY DESIGN

Prospective 2-year factor-, cluster-, and reliability-multicenter analysis.

OBJECTIVE

To provide evidence on the uniqueness and usefulness of a set of potential relevant functional outcomes.

SUMMARY OF BACKGROUND DATA

A very high number of functional outcomes that can be utilized as variables in low back pain (LBP) trials exists.

METHODS

Participants (n = 1049) with and without current LBP were included. At 7 visits (baseline, 4 wk, 3 mo, 6 mo, 9 mo, 1 yr, and 2 yr), 42 different functional outcomes were assessed. Two exploratory factor analyses (for baseline-values and for changes scores to 3 mo post-baseline) were calculated (maximum likelihood extraction, varimax factor rotation). The strongest factor-loading outcomes were selected for the following hierarchical cluster analyses (average linkage, Euclidean distance measure). For each cluster, time point, and outcome, reliability analyses were subsequently calculated using intraclass correlation coefficients, standard error of measurements and coefficients of variation.

RESULTS

The factor analysis for the cross-sectional values revealed 9 factors with a cumulative variance explanation of 61.7% and 13 unique ones. The change-score factor analysis revealed nine factors with a total variance explanation of 61.8%, seven outcomes were unique. Ten outcomes were important for both cross-sectional and change-score analyses, 11 were most valuable for cross-sectional and four for the change scores. Patients with pain grades 1 to 3 show comparable patterns (cluster 2). Grade 0 (cluster 1) and grade 4 (cluster 3) are unique and cannot be cumulated with other grades. Most biomechanical outcomes were highly reliable and display low measurement errors.

CONCLUSION

We found 25 potentially meaningful functional outcomes in the context of objective functional measurements (such as trunk range of motion, dynamic and static balance, strength, and muscle fatigue resistance) and body characteristics. The present framework may help to select appropriate functional outcomes and rate effects beyond the known core set of outcomes.Level of Evidence: 1.

摘要

研究设计

前瞻性 2 年的因素、聚类和可靠性多中心分析。

目的

为一组潜在相关功能结果的独特性和有用性提供证据。

背景数据概要

在低背痛 (LBP) 试验中,可以用作变量的功能结果数量非常多。

方法

纳入了有和无当前 LBP 的参与者。在 7 次就诊(基线、4 周、3 个月、6 个月、9 个月、1 年和 2 年)时,评估了 42 种不同的功能结果。进行了两次探索性因素分析(基线值和至基线后 3 个月的变化分数)(最大似然提取、方差极大因子旋转)。选择最强的因子负荷结果进行以下层次聚类分析(平均链接、欧几里得距离度量)。对于每个聚类、时间点和结果,随后使用组内相关系数、测量标准误差和变异系数计算可靠性分析。

结果

横断面值的因子分析揭示了 9 个具有 61.7%累积方差解释的因子和 13 个独特因子。变化分数因子分析揭示了 9 个具有 61.8%总方差解释的因子,7 个结果是独特的。10 个结果对横断面和变化分数分析都很重要,11 个对横断面最有价值,4 个对变化分数最有价值。疼痛等级 1 到 3 的患者表现出相似的模式(聚类 2)。等级 0(聚类 1)和等级 4(聚类 3)是独特的,不能与其他等级累积。大多数生物力学结果具有高度可靠性且显示出较低的测量误差。

结论

我们在客观功能测量(如躯干活动范围、动态和静态平衡、力量和肌肉疲劳阻力)和身体特征的背景下发现了 25 个潜在有意义的功能结果。该框架可以帮助选择适当的功能结果,并评估超出已知核心功能结果集的效果。

证据水平

1。

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