Bendebba Mohammed, Dizerega Gere S, Long Donlin M
Department of Neurosurgery, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
Spine J. 2007 Jan-Feb;7(1):118-32. doi: 10.1016/j.spinee.2006.06.382. Epub 2006 Nov 20.
There are currently a number of generic and disease-specific instruments for assessing complaints of low back pain (LBP). None provide the comprehensive coverage of the wide range of factors that are considered essential in evaluating treatment outcomes.
To develop and evaluate the psychometric properties of a comprehensive, disease-specific questionnaire for characterizing complaints of LBP and evaluating the outcomes of treatments for these complaints.
A clinical-cohort study of a large, convenience sample of LBP patients.
We have developed a comprehensive, disease-specific questionnaire for characterizing complaints of LBP and evaluating the outcomes of treatments for these complaints. A large group of patients who sought treatment for LBP (n=2539) completed the Lumbar Spine Outcomes Questionnaire (LSOQ) before treatment, and at 12 and 24 months after treatment. For each subject and for each evaluation period, scores on six composite measures were derived from the subjects' responses to the questionnaire: a LBP severity score, a leg pain severity score, a functional disability score, a psychological distress score, a physical symptoms score, and a health-care utilization score. These scores were used to evaluate the reliability, validity, and responsiveness of the questionnaire.
Test-retest reliability of the LSOQ was evaluated by correlating the subject's 12-month scores on each composite measure with the corresponding 24-month scores. Intraclass coefficients of correlation were used. The obtained coefficients of correlation [(a) LBP severity, 0.87; (b) leg pain severity, 0.85; (c) functional disability, 0.87; (d) psychological distress, 0.88; (e) physical symptoms other than pain, 0.82; and (f) health-care utilization, 0.76] indicate good test-retest reliability for the LSOQ. Construct validity was evaluated by correlating scores on the composite measures derived from the LSOQ with scores on measures of the same constructs derived from the Oswestry Low Back Pain Disability Questionnaire and the Short Form 36-Item Health Survey. The coefficients of correlation were relatively high (mostly between .7 and .9), indicating good construct validity. Construct validity was also evaluated by comparing the scores of groups of subjects who were known to differ or not to differ on the composite measures, using multivariate analyses of variance. Significant multivariate and univariate differences were obtained between groups who were expected to differ (ie, surgically and nonsurgically treated patients). No significant differences were found for groups who were not expected to differ (ie, patients with similar diagnosis, but different surgical treatments). Responsiveness was assessed by evaluating differences in the 24-month change scores between improved and unimproved subjects. Large and significant differences were obtained between improved and unimproved subjects for all composite measures derived from the LSOQ. The observed effect sizes ranged from .68 to 1.17 indicating that the LSOQ is highly responsive.
The LSOQ appears to be acceptable to patients, easy to administer, highly reliable, valid, and responsive. It provides information on demographics, pain severity, functional disability, psychological distress, physical symptoms, health-care utilization, and satisfaction. It should be considered for use in both clinical and research applications as well as regulatory review involving patients with LBP complaints.
目前有多种通用的和针对特定疾病的工具用于评估腰痛（LBP）主诉。但没有一种工具能全面涵盖在评估治疗效果时被认为至关重要的广泛因素。
开发并评估一份全面的、针对特定疾病的问卷，用于描述腰痛主诉并评估针对这些主诉的治疗效果。
对一大组方便选取的腰痛患者进行临床队列研究。
我们开发了一份全面的、针对特定疾病的问卷，用于描述腰痛主诉并评估针对这些主诉的治疗效果。一大群因腰痛寻求治疗的患者（n = 2539）在治疗前、治疗后12个月和24个月完成了腰椎脊柱结局问卷（LSOQ）。对于每个受试者和每个评估期，从受试者对问卷的回答中得出六个综合指标的得分：腰痛严重程度得分、腿痛严重程度得分、功能障碍得分、心理困扰得分、身体症状得分和医疗保健利用得分。这些得分用于评估问卷的信度、效度和反应度。
通过将受试者在每个综合指标上的12个月得分与相应的24个月得分进行相关性分析，评估LSOQ的重测信度。使用组内相关系数。得到的相关系数[（a）腰痛严重程度，0.87；（b）腿痛严重程度，0.85；（c）功能障碍，0.87；（d）心理困扰，0.88；（e）除疼痛外的身体症状，0.82；（f）医疗保健利用，0.76]表明LSOQ具有良好的重测信度。通过将从LSOQ得出的综合指标得分与从奥斯威斯腰痛残疾问卷和简短36项健康调查得出的相同结构指标得分进行相关性分析，评估结构效度。相关系数相对较高（大多在0.7至0.9之间），表明具有良好的结构效度。还通过使用多变量方差分析比较已知在综合指标上存在差异或不存在差异的受试者组的得分，来评估结构效度。在预期会有差异的组（即手术治疗和非手术治疗的患者）之间获得了显著的多变量和单变量差异。在预期不会有差异的组（即诊断相似但手术治疗不同的患者）之间未发现显著差异。通过评估改善组和未改善组之间24个月变化得分的差异来评估反应度。从LSOQ得出的所有综合指标在改善组和未改善组之间都获得了大且显著的差异。观察到的效应大小范围为0.68至1.17，表明LSOQ具有高度反应度。
LSOQ似乎为患者所接受，易于实施，具有高度可靠性、效度和反应度。它提供了关于人口统计学、疼痛严重程度、功能障碍、心理困扰、身体症状、医疗保健利用和满意度的信息。在涉及腰痛主诉患者的临床和研究应用以及监管审查中都应考虑使用它。
