The Spine Journal
Volume 7, Issue 5 , Pages 541-546 , September 2007

Understanding the minimum clinically important difference: a review of concepts and methods

  • Anne G. Copay, PhD

      Affiliations

    • The Spinal Research Foundation, 1831 Wiehle Avenue, Suite 200, Reston, VA 20190, USA
    • Corresponding Author InformationCorresponding author. Virginia Spine Institute, 1831 Wiehle Avenue, Suite 200, Reston, VA 20190. Tel.: (703) 709-1114; fax: (703) 709-1117.
  • ,
  • Brian R. Subach, MD

      Affiliations

    • The Spinal Research Foundation, 1831 Wiehle Avenue, Suite 200, Reston, VA 20190, USA
    • Virginia Spine Institute, 1831 Wiehle Avenue, Suite 200, Reston, VA 20190, USA
  • ,
  • Steven D. Glassman, MD

      Affiliations

    • Department of Orthopaedic Surgery, University of Louisville School of Medicine and the Kenton D. Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202, USA
  • ,
  • David W. Polly Jr., MD

      Affiliations

    • Department of Orthopaedics, University of Minnesota, 2450 Riverside Avenue, SR 200, Minneapolis, MN 55454, USA
  • ,
  • Thomas C. Schuler, MD

      Affiliations

    • The Spinal Research Foundation, 1831 Wiehle Avenue, Suite 200, Reston, VA 20190, USA
    • Virginia Spine Institute, 1831 Wiehle Avenue, Suite 200, Reston, VA 20190, USA

Received 7 September 2006 ,Accepted 24 January 2007.

References 

  1. 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;
  2. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain. 2000;88:287–294
  3. Fritzell P, Hägg O, Wessberg P, Nordwall A, TSLSSG . 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
  4. Laasonen EM, Soini J. Low-back pain after lumbar fusion. Spine. 1989;14:210–213
  5. Beaton DE. Understanding the relevance of measured change through studies of responsiveness. Spine. 2000;25:3192–3199
  6. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415
  7. Stratford PW, Binkley JM, Riddle DL, Guyatt GH. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 1. Phys Ther. 1998;78:1186–1196
  8. Schwartzstein RM, Harver A. Interactive textbook on clinical research, ch 23. Dyspnea: NIH. 2003;http://symptomresearch.nih.gov/chapter_23/sec29/cahs29pg1.htmAccessed June 14, 2006
  9. Beaton DE, Bombardier C, Katz JN, et al. Looking for important change/differences in studies of responsiveness. J Rheumatol. 2001;28:400–405
  10. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status. Mayo Clin Proc. 2002;77:371–383
  11. Norman GR, Stratford P, Regehr G. Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J Clin Epidemiol. 1997;50:869–879
  12. Hagg O, Fritzell P, Oden A, Nordwall A, the Swedish Lumbar Spine Study Group . Simplifying outcome measurement. Evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain. Spine. 2002;27:1213–1222
  13. Walsh TL, Hanscom B, Lurie JD, Weinstein JN. 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
  14. Riddle DL, Stratford PW, Binkley JM. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: Part 2. Phys Ther. 1998;78:1197–1207
  15. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, the Clinical Significance Consensus Meeting Group . Methods to explain the clinical significance of health status measures. Mayo ClinProc. 2002;77:371–383
  16. Juniper EF, Guyatt GH, Willan A, Griffith L. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol. 1994;47:81–87
  17. van der Roer N, Ostelo RWJG, Bekkering GE, van Tulder MW, de Vet HCW. 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
  18. Kulkarni AV. Distribution-based and anchor-based approaches provided different interpretability estimates for the Hydrocephalus Outcome Questionnaire. J Clin Epidemiol. 2006;59:176–184
  19. Hägg O, Fritzell P, Nordwall A. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12:12–20
  20. Jaeschke R, Guyatt GH, Sackett DL. 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
  21. Hosmer DW, Lemeshow S. Applied logistic regression. New York: Wiley, Inc; 2000;
  22. Redelmeier DA, Guyatt GH, Goldstein RS. Assessing the minimal important difference in symptoms: a comparison of two techniques. J Clin Epidemiol. 1996;49:1215–1219
  23. Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky F. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care. 1999;37:469–478
  24. Wyrwich KW, Tierney WM, Wolinsky F. 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
  25. Ware JE, Kosinski M, Keller SK. SF-36 physical and mental health summaries scales: a user's manual. Boston, MA: The Health Institute; 1994;
  26. Bolton JE. Sensitivity and specificity of outcome measures in patients with neck pain: detecting clinically significant improvement. Spine. 2004;29:2410–2417
  27. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12–19
  28. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life. The remarkable universality of half a standard deviation. Med Care. 2003;41:582–592
  29. Cohen J. Statistical power: analysis for the behavioural sciences. New York: Academic Press; 1977;
  30. Taylor SJ, Taylor AE, Foy MA, Fogg AJB. Responsiveness of common outcome measures for patients with low back pain. Spine. 1999;24:1805–1812
  31. Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. 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
  32. Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. Pharmacoeconomics. 2000;18:419–423
  33. Kirwan JR. Minimum clinically important difference: the crock of gold at the end of the rainbow?. J Rheumatol. 2001;28:439–444
  34. Jamieson J. Dealing with baseline differences: two principles and two dilemmas. Int J Psychophysiol. 1999;31:155–161
  35. Beaton DE, Boers M, Wells G. 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

The Spine Journal
Volume 7, Issue 5 , Pages 541-546 , September 2007