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W2.4

Title: Defining clinical important change on outcome measures for low back pain

Authors and affiliation: Raymond Ostelo, Riekie de Vet, (EMGO Institute, VU University Medical Center)

Potential co-authors: Claire Bombardier, Rick Deyo, Peter Croft, Paul Stratford, Michael von Korff, Gordon Waddell.

Introduction: In the international literature on low back pain it is agreed upon that a core set of measures would include five domains: pain intensity, low back pain specific disability, work disability, generic functional status, and patient satisfaction with the process of care as well as with the treatment outcome and for each domain specific measures were recommended (1,2). The most common reason for using these outcome measures is to assess patients’ response to treatment. However, a major challenge is estimate the minimal clinically relevant change for these measures. So far, there is no set answer to this question.

Objective: The overall objective of this workshop is to work toward consensus criteria for judging a patient ‘improved’. More specifically, as a result of this workshop, the authors would like to propose the minimal improvement that can be labelled as ‘improved’ on the widely used outcome measures in low back pain. The specific issues that will be discussed during this workshop are:

1. What is the Minimal Important Change (MIC) in order to label a patient as ‘improved’ of frequently used outcome measures in the five domains of interest,?
2. Should this MIC be stratified according to factors, such as type of low back pain, baseline scores, etc.?
3. How to express the MIC: in scale-points or in percentages improvement?

Methods / content: In preparation of this workshop the authors will depart from a preliminary review of the literature (3). Further discussion and additional analysis will result in tentative consensus criteria for judging a patient ‘improved’ for the five domains of interest. These tentative results will be presented at the beginning of the workshop. In the second part of the workshop the participants of this workshop will discuss these results in small groups in which they discus the three issues listed above. During the last part of this workshop each group will report the outcome of their discussion during the plenary session.  The outcome of this workshop will be presented in a paper.

1. Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine 2000;25:3100-3.

2. Deyo R, Battie M,  Beurskens A, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G. Outcome measures for low back pain research. A proposal for standardized use. Spine 1998:18;2003-13

3. Ostelo R, de Vet HCW. Clinically important outcome sin low back pain. Best Practice & Research Clinical Rheumatology 2005;19:593–607