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The Spine Journal
Volume 7, Issue 5
, Pages 541-546
, September 2007
Understanding the minimum clinically important difference: a review of concepts and methods
References
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Rockville, MD: U.S. Department of Health and Human Services; 2006;
- . Defining the clinically important difference in pain outcome measures. Pain. 2000;88:287–294
- . Lumbar fusion versus nonsurgical treatment for chronic low back pain. A multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine. 2001;26:2521–2534
- . Low-back pain after lumbar fusion. Spine. 1989;14:210–213
- . Understanding the relevance of measured change through studies of responsiveness. Spine. 2000;25:3192–3199
- . Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415
- . Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 1. Phys Ther. 1998;78:1186–1196
- . Interactive textbook on clinical research, ch 23. Dyspnea: NIH. 2003;http://symptomresearch.nih.gov/chapter_23/sec29/cahs29pg1.htmAccessed June 14, 2006
- Looking for important change/differences in studies of responsiveness. J Rheumatol. 2001;28:400–405
- . Methods to explain the clinical significance of health status. Mayo Clin Proc. 2002;77:371–383
- . Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J Clin Epidemiol. 1997;50:869–879
- . Simplifying outcome measurement. Evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain. Spine. 2002;27:1213–1222
- . Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Owestry Disability Index, MODEMS, and the SF-36. Spine. 2003;28:607–615
- . Sensitivity to change of the Roland-Morris Back Pain Questionnaire: Part 2. Phys Ther. 1998;78:1197–1207
- . Methods to explain the clinical significance of health status measures. Mayo ClinProc. 2002;77:371–383
- . Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol. 1994;47:81–87
- . Minimally clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine. 2006;31:578–582
- . Distribution-based and anchor-based approaches provided different interpretability estimates for the Hydrocephalus Outcome Questionnaire. J Clin Epidemiol. 2006;59:176–184
- . The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12:12–20
- . Users' guides to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients?. JAMA. 1994;271:703–707
- . Applied logistic regression. New York: Wiley, Inc; 2000;
- . Assessing the minimal important difference in symptoms: a comparison of two techniques. J Clin Epidemiol. 1996;49:1215–1219
- . Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care. 1999;37:469–478
- . Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol. 1999;52:861–873
- . SF-36 physical and mental health summaries scales: a user's manual. Boston, MA: The Health Institute; 1994;
- . Sensitivity and specificity of outcome measures in patients with neck pain: detecting clinically significant improvement. Spine. 2004;29:2410–2417
- . Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12–19
- . Interpretation of changes in health-related quality of life. The remarkable universality of half a standard deviation. Med Care. 2003;41:582–592
- . Statistical power: analysis for the behavioural sciences. New York: Academic Press; 1977;
- . Responsiveness of common outcome measures for patients with low back pain. Spine. 1999;24:1805–1812
- . Determining clinically important differences in health status measures. A general approach with illustration to the Health Utilities index Mark II. Pharmacoeconomics. 1999;15:141–155
- . The concept of clinically meaningful difference in health-related quality-of-life research. Pharmacoeconomics. 2000;18:419–423
- . Minimum clinically important difference: the crock of gold at the end of the rainbow?. J Rheumatol. 2001;28:439–444
- . Dealing with baseline differences: two principles and two dilemmas. Int J Psychophysiol. 1999;31:155–161
- . Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opinion Rheumatol. 2002;14:109–114
FDA device/drug status: not applicable.Authors acknowledge a financial relationship (Medtronic), which may indirectly relate to the subject of this research.
PII: S1529-9430(07)00052-6
doi: 10.1016/j.spinee.2007.01.008
© 2007 Elsevier Inc. All rights reserved.
« Previous
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The Spine Journal
Volume 7, Issue 5
, Pages 541-546
, September 2007
