Mannion Anne F, Elfering Achim, Staerkle Ralph, Junge Astrid, Grob Dieter, Semmer Norbert K, Jacobshagen Nicola, Dvorak Jiri, Boos Norbert
Spine Unit, Schulthess Klinik, Lengghalde 2, 8008, Zürich, Switzerland.
Eur Spine J. 2005 Dec;14(10):1014-26. doi: 10.1007/s00586-005-0911-9. Epub 2005 Jun 4.
The present study examined the psychometric characteristics of a "core-set" of six individual questions (on pain, function, symptom-specific well-being, work disability, social disability and satisfaction) for use in low back pain (LBP) outcome assessment. A questionnaire booklet was administered to 277 German-speaking LBP patients with a range of common diagnoses, before and 6 months after surgical (N=187) or conservative (N=90) treatment. The core-set items were embedded in the booklet alongside validated 'reference' questionnaires: Likert scales for back/leg pain; Roland and Morris disability scale; WHO Quality of Life scale; Psychological General Well-Being Index. A further 45 patients with chronic LBP completed the booklet twice in 1-2 weeks. The minimal reliability (similar to Cronbach's alpha) for each core item was 0.42-0.78, increasing to 0.84 for a composite index score comprising all items plus an additional question on general well-being ('quality of life'). Floor or ceiling effects of 20-50% were observed for some items before surgery (function, symptom-specific well-being) and some items after it (disability, function). The intraclass correlation coefficient (ICC) ("test-retest reliability") was moderate to excellent (ICC, 0.67-0.95) for the individual core items and excellent (ICC, 0.91) for the composite index score. With the exception of "symptom-specific well-being", the correlations between each core item and its corresponding reference questionnaire ("validity") were between 0.61 and 0.79. Both the composite index and the individual items differentiated (P<0.001) between the severity of the back problem in surgical and conservative patients (validity). The composite index score had an effect size (sensitivity to change) of 0.95, which was larger than most of the reference questionnaires (0.47-1.01); for individual core items, the effect sizes were 0.52-0.87. The core items provide a simple, practical, reliable, valid and sensitive assessment of outcome in LBP patients. We recommend the widespread and consistent use of the core-set items and their composite score index to promote standardisation of outcome measurements in clinical trials, multicentre studies, routine quality management and surgical registry systems.
本研究考察了用于评估腰痛（LBP）患者治疗效果的六个单项问题（关于疼痛、功能、特定症状的健康状况、工作能力丧失、社交能力丧失和满意度）“核心集”的心理测量学特征。向277名患有一系列常见诊断的德语LBP患者发放了一本问卷手册，这些患者在接受手术治疗（N = 187）或保守治疗（N = 90）之前及之后6个月填写。核心集项目与经过验证的“参考”问卷一同编入手册：背部/腿部疼痛的李克特量表；罗兰和莫里斯残疾量表；世界卫生组织生活质量量表；心理综合幸福感指数。另外45名慢性LBP患者在1 - 2周内两次填写该手册。每个核心项目的最低信度（类似于克朗巴哈系数）为0.42 - 0.78，包含所有项目以及一个关于总体健康状况（“生活质量”）的附加问题的综合指数得分的信度提高到0.84。在手术前，部分项目（功能、特定症状的健康状况）以及手术后部分项目（残疾、功能）出现了20% - 50%的地板效应或天花板效应。单个核心项目的组内相关系数（ICC）（“重测信度”）为中等至优秀（ICC，0.67 - 0.95），综合指数得分的ICC为优秀（ICC，0.91）。除“特定症状的健康状况”外，每个核心项目与其相应参考问卷之间的相关性（“效度”）在0.61至0.79之间。综合指数和各个单项均能区分手术患者和保守治疗患者背部问题的严重程度（效度，P < 0.001）。综合指数得分的效应量（对变化的敏感度）为0.95，大于大多数参考问卷（0.47 - 1.01）；对于单个核心项目，效应量为0.52 - 0.87。这些核心项目为LBP患者的治疗效果提供了一种简单、实用、可靠、有效且敏感的评估方法。我们建议广泛且一致地使用核心集项目及其综合得分指数，以促进临床试验、多中心研究、常规质量管理和手术登记系统中治疗效果测量的标准化。
