Lauridsen Henrik Hein, Hartvigsen Jan, Manniche Claus, Korsholm Lars, Grunnet-Nilsson Niels
Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
Eur Spine J. 2006 Nov;15(11):1717-28. doi: 10.1007/s00586-006-0128-6. Epub 2006 May 31.
In studies evaluating the efficacy of clinical interventions, it is of paramount importance that the functional outcome measures are responsive to clinically relevant change. Knowledge thereof is in fact essential for the choice of instrument in clinical trials and for clinical decision-making. This article endeavours to investigate the sensitivity, specificity and clinically significant improvement (responsiveness) of the Danish version of the Oswestry disability index (ODI) in two back pain populations. Two hundred and thirty three patients with low back pain (LBP) and/or leg pain completed a questionnaire booklet at baseline and 8 weeks follow-up. Half of the patients were seen in the primary (PrS) and half in the secondary sectors (SeS) of the Danish Health Care System. The booklet contained the Danish version of the ODI, along with the Roland Morris Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. At follow-up, a 7-point transition question (TQ) of patient perceived change and a numeric rating scale relating to the importance of the change were included. Responsiveness was operationalised using three strategies: change scores, standardised response means (SRM) and receiver operating characteristic (ROC) analyses. All methods revealed acceptable responsiveness of the ODI in the two patient populations which was comparable to the external instruments. SRM of the ODI change scores at 2 months follow-up was 1.0 for PrS patients and 0.3 for SeS (raw and percentage). A minimum clinically important change (MCID) from baseline score was established at 9 points (71%) for PrS patients and 8 points (27%) for SeS patients using ROC analyses. This was dependable on the baseline entry score with the MCID increasing with 5 points for every 10 points increase in the baseline score. We conclude that the Danish version of the ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in low back pain patients receiving conservative care in both the primary and secondary sector.
在评估临床干预效果的研究中，功能结局指标对临床相关变化具有响应性至关重要。事实上，了解这一点对于临床试验中工具的选择和临床决策至关重要。本文旨在研究丹麦版奥斯维斯特残疾指数（ODI）在两个背痛人群中的敏感性、特异性和临床显著改善（响应性）。233例腰痛（LBP）和/或腿痛患者在基线和随访8周时完成了一本问卷手册。一半患者在丹麦医疗保健系统的初级（PrS）部门就诊，另一半在二级（SeS）部门就诊。手册包含丹麦版ODI，以及罗兰·莫里斯问卷、LBP评分量表、SF36（身体功能和身体疼痛量表）和总体疼痛评分。在随访时，纳入了一个关于患者感知变化的7分过渡问题（TQ）和一个与变化重要性相关的数字评分量表。使用三种策略实现响应性：变化分数、标准化反应均值（SRM）和受试者操作特征（ROC）分析。所有方法均显示ODI在两个患者群体中具有可接受的响应性，这与外部工具相当。PrS患者在随访2个月时ODI变化分数的SRM为1.0，SeS患者为0.3（原始分数和百分比）。使用ROC分析确定，PrS患者从基线分数的最小临床重要变化（MCID）为9分（71%），SeS患者为8分（27%）。这取决于基线进入分数，MCID随基线分数每增加10分增加5分。我们得出结论，丹麦版ODI与其他常用的功能状态测量方法具有相当的响应性，适用于在初级和二级部门接受保守治疗的腰痛患者。
