Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and Pain Scales

被引:900
作者
Copay, Anne G. [1 ]
Glassman, Steven D. [3 ,4 ]
Subach, Brian R. [1 ,2 ]
Berven, Sigurd [5 ]
Schuler, Thomas C. [1 ,2 ]
Carreon, Leah Y. [3 ,4 ]
机构
[1] Spinal Res Fdn, Reston, VA 20190 USA
[2] Virginia Spine Inst, Reston, VA 20190 USA
[3] Univ Louisville, Sch Med, Dept Orthopaed Surg, Louisville, KY 40202 USA
[4] Kenton D Leatherman Spine Ctr, Louisville, KY 40202 USA
[5] Univ Calif San Francisco, Dept Orthopaed Surg, San Francisco, CA 94143 USA
关键词
Outcome measures; Lumbar fusion; SF-36; Oswestry Disability Index; Pain scales; Spinal surgery;
D O I
10.1016/j.spinee.2007.11.006
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCs) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important: difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCs, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCs were included in the study. OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCs, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. METHODS: ODI, SF-36, and pain scales were administered before and I year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCs, 1.2 points for back pain, and 1.6 points for leg pain. (C) 2008 Elsevier Inc. All rights reserved.
引用
收藏
页码:968 / 974
页数:7
相关论文
共 29 条
[1]   Simple as possible? Or too simple? - Possible limits to the universality of the one half standard deviation [J].
Beaton, DE .
MEDICAL CARE, 2003, 41 (05) :593-596
[2]  
Beaton DE, 2001, J RHEUMATOL, V28, P400
[3]   Understanding the minimum clinically important difference: a review of concepts and methods [J].
Copay, Anne G. ;
Subach, Brian R. ;
Glassman, Steven D. ;
Polly, David W., Jr. ;
Schuler, Thomas C. .
SPINE JOURNAL, 2007, 7 (05) :541-546
[4]  
DEYO RA, 1984, HEALTH SERV RES, V19, P275
[5]  
Fairbank J C, 1980, Physiotherapy, V66, P271
[6]   The Oswestry Disability Index [J].
Fairbank, JCT ;
Pynsent, PB .
SPINE, 2000, 25 (22) :2940-2952
[7]   The clinical importance of changes in outcome scores after treatment for chronic low back pain [J].
Hägg, O ;
Fritzell, P ;
Nordwall, A .
EUROPEAN SPINE JOURNAL, 2003, 12 (01) :12-20
[8]   Simplifying outcome measurement -: Evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain [J].
Hägg, O ;
Fritzell, P ;
Odén, A ;
Nordwall, A .
SPINE, 2002, 27 (11) :1213-1222
[9]   The concept of clinically meaningful difference in health-related quality-of-life research - How meaningful is it? [J].
Hays, RD ;
Woolley, JM .
PHARMACOECONOMICS, 2000, 18 (05) :419-423
[10]   MEASUREMENT OF HEALTH-STATUS - ASCERTAINING THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE [J].
JAESCHKE, R ;
SINGER, J ;
GUYATT, GH .
CONTROLLED CLINICAL TRIALS, 1989, 10 (04) :407-415