The Spine Journal
Volume 10, Issue 4 , Pages 321-327 , April 2010

Testing minimal clinically important difference: consensus or conundrum?

  • Robert J. Gatchel, PhD, ABPP

      Affiliations

    • Department of Psychology, College of Science, The University of Texas at Arlington, 313 Life Science Building, Arlington, TX 76019, USA
    • PRIDE Research Foundation, 5701 Maple Ave., Suite 100, Dallas, TX 75235, USA
  • ,
  • Tom G. Mayer, MD

      Affiliations

    • PRIDE Research Foundation, 5701 Maple Ave., Suite 100, Dallas, TX 75235, USA
    • Department of Orthopedic Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, TX, 75235, USA
    • Corresponding Author InformationCorresponding author. PRIDE Research Foundation, 5701 Maple Ave., Suite 100, Dallas, TX 75235, USA. Tel.: (214) 351-6600; fax: (214) 351-6958.

Received 4 February 2009 ,Revised 23 September 2009 ,Accepted 20 October 2009.

References 

  1. Jaeschke R, Singer J, Guyatt G. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415
  2. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395–407
  3. Copay AG, Subach BR, Glassman SD, et al. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7:541–546
  4. Glassman SD, Copay AG, Berven SH, et al. Defining substantial clinical benefit following lumbar spine arthrodesis. J Bone Joint Surg Am. 2008;90:1839–1847
  5. Spratt KE. Minimal clinically important difference based on clinical judgment and minimally detectable measurement difference: a rationale for the SF-36 physical function scale in the SPOT interventional disc herniation cohort. Spine. In press.
  6. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19
  7. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33:90–94
  8. Nunnally JC, Bernstein IH. Psychometric theory. 3rd ed.. New York, NY: McGraw-Hill; 1994;
  9. Domino G, Domino ML. Psychological testing: an introduction. 2nd ed.. New York, NY: Cambridge University Press; 2006;
  10. Shultz KS, Whitney DJ. Measurement theory in action: case studies and exercises. London, UK: Sage Publications; 2005;
  11. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66:271–273
  12. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 health survey: manual and interpretation guide. Boston, MA: The Health Institute, New England Medical Center; 1993;
  13. Mayer TG, Gatchel RJ. Functional restoration for spinal disorders: the sports medicine approach. Philadelphia, PA: Lea & Febiger; 1988;
  14. Turk DC, Monarch ES. Biopsychosocial perspective on chronic pain. In:  Turk DC,  Gatchel RJ editor. Psychological approaches to pain management: a practitioner's handbook. 2nd ed.. New York, NY: Guilford; 2002;
  15. Hazard R. Spine update: functional restoration. Spine. 1995;20:2345–2348
  16. Jordan KD, Mayer TG, Gatchel RJ. Should extended disability be an exclusion criterion for tertiary rehabilitation? Socioeconomic outcomes of early versus late functional restoration in compensation spinal disorders. Spine. 1998;23:2110–2116discussion 2117
  17. Mayer TG, Gatchel RJ, Kishino N, et al. Objective assessment of spine function following industrial injury: a prospective study with comparison group and one-year follow-up. Volvo Award in Clinical Sciences, 1985. Spine. 1985;10:482–493
  18. Mayer TG, Gatchel RJ, Mayer H, et al. A prospective two-year study of functional restoration in industrial low back injury. An objective assessment procedure. JAMA. 1987;258:1763–1767
  19. Mayer T, McMahon MJ, Gatchel RJ, et al. Socioeconomic outcomes of combined spine surgery and functional restoration in workers' compensation spinal disorders with matched controls. Spine. 1998;23:598–605discussion 606
  20. Wright A, Mayer TG, Gatchel RJ. Outcomes of disabling cervical spine disorders in compensation injuries. A prospective comparison to tertiary rehabilitation response for chronic lumbar spinal disorders. Spine. 1999;24:178–183
  21. McGeary DD, Mayer TG, Gatchel RJ. High pain ratings predict treatment failure in chronic occupational musculoskeletal disorders. J Bone Joint Surg Am. 2006;88:317–325
  22. Proctor T, Mayer T, Gatchel R, McGeary D. Unremitting health-care utilization outcomes of tertiary rehabilitation of chronic musculoskeletal disorders. J Bone Joint Surg Am. 2004;86:62–69
  23. Proctor TJ, Mayer TG, Theodore B, Gatchel RJ. Failure to complete a functional restoration program for chronic musculoskeletal disorders: a prospective 1-year outcome study. Arch Phys Med Rehabil. 2005;8:1509–1515
  24. Rainville J, Kim RS, Katz JN. A review of 1985 Volvo Award winner in clinical science: objective assessment of spine function following industrial injury: a prospective study with comparison group and 1-year follow-up. Spine. 2007;32:2031–2034
  25. Mayer TG, Prescott M, Gatchel RJ. Objective outcomes evaluation: methods and evidence. In:  Mayer TG,  Polatin PB,  Gatchel RJ editor. Occupational musculoskeletal disorders: function, outcomes and evidence. Philadelphia, PA: Lippincott Williams & Wilkins; 2000;p. 651–667
  26. Dersh J, Mayer TG, Gatchel RJ, et al. Psychiatric comorbidity in chronic disabling occupational spinal disorders has minimal impact on functional restoration socioeconomic outcomes. Spine. 2007;32:1917–1925
  27. Gatchel RJ, Mayer TG, Theodore B. The Pain Disability Questionnaire: relationship to one-year functional and psychosocial rehabilitation outcomes. J Occup Rehabil. 2006;16:75–94
  28. Elfering A. Work-related outcome assessment instruments. Eur Spine J. 2006;15:S32–S43
  29. Vetter TR. The application of economic evaluation methods in the chronic pain medicine literature. Anesth Analg. 2007;105:114–118
  30. 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

 FDA device/drug status: not applicable.

 Author disclosures: RJG (royalties, Guilford Press, APA Press; consulting, PRIDE, Dallas, Palladian Health Care, Medical Technologies; scientific advisory board, Palladian Health Care; endowments, Nancy P. & John G. Penson Endowed Professorship; research: investigator salary, NIH; research: staff/materials, NIH, DOD).

PII: S1529-9430(09)01057-2

doi: 10.1016/j.spinee.2009.10.015

The Spine Journal
Volume 10, Issue 4 , Pages 321-327 , April 2010