The Spine Journal
Volume 10, Issue 6 , Pages 507-509 , June 2010

Methodological problems associated with the present conceptualization of the minimum clinically important difference and substantial clinical benefit

  • Brian R. Theodore, PhD

      Affiliations

    • Corresponding Author InformationCorresponding author. Department of Anesthesiology & Pain Medicine, University of Washington, PO Box 356540, Seattle, WA 98195, USA. Tel.: (206) 616-0158; fax: (206) 543-2958.

Received 29 March 2010 ,Accepted 7 April 2010.

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; 2009;
  2. Carreon LY, Glassman SD, Campbell MJ, Anderson PA. Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J. 2010;10:469–474
  3. 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
  4. 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
  5. 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
  6. Dersh J, Polatin PB, Leeman G, Gatchel RJ. The management of secondary gain and loss in medicolegal settings: strengths and weaknesses. J Occup Rehabil. 2004;14:267–279

 FDA device/drug status: not applicable.

 Author disclosures: none.

PII: S1529-9430(10)00299-8

doi: 10.1016/j.spinee.2010.04.003

The Spine Journal
Volume 10, Issue 6 , Pages 507-509 , June 2010

Article Tools