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. published online 02 April 2007.

Abstract 

Background context

The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment.

Purpose

Our goal is to review the various definitions of MCID and the methods available to determine MCID.

Study design

The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail.

Methods

The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail.

Results

Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores.

Conclusions

An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated.

Keywords: Outcomes measures, Metrics, Minimum clinically important difference, Disability, Functional assessment

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 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