Journal ArticleDOI
The clinical importance of changes in outcome scores after treatment for chronic low back pain
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The VAS of back pain is responsive enough to detect the minimal clinically important difference, whereas the smallest acceptable score changes of the Oswestry Disability Index, the General Function Score and the Zung Depression Scale may require an increase to exceed the 95% tolerance interval when used for clinical decision making and for power calculation.Abstract:
When measuring treatment effect in chronic low back pain with multi-item outcome instruments, it is necessary, both for clinical decision-making and research purposes, to understand the clinical importance of the outcome scores. The aims of the present study were three-fold. Firstly, it aimed to estimate the minimal clinically important difference of three multi-item outcome instruments (the Oswestry Disability Index, the General Function Score and the Zung Depression Scale) and of the visual analogue scale (VAS) of back pain. Secondly, it aimed to estimate the error of measurement of these instruments; and its third aim was to describe the clinical meaning of score change. The study population consisted of 289 patients treated surgically or non-surgically in a randomised controlled trial. The minimal clinically important difference was estimated with patient global assessment as the external criterion. It was compared with the standard error of measurement of the instruments. The individual items of the instruments were compared for score changes related to improvement and deterioration. The standard error of measurement of the Oswestry Disability Index, the General Function Score and the Zung Depression Scale was 4, 6 and 3 units, respectively. The 95% tolerance interval was 10, 16 and 8 units, respectively. The minimal clinically important difference was 10, 12 and 8–9 units, respectively, thus not significantly exceeding the tolerance interval. The minimal clinically important difference of VAS back pain was 18–19 units, well exceeding the 95% tolerance interval, which was 15 units. Improvement after treatment for chronic low back pain tends to occur to a greater extent in sleep disturbance, ability to do usual things and psychological irritability, but to a lesser extent in the ability to sit, stand and lift. We conclude that the VAS of back pain is responsive enough to detect the minimal clinically important difference, whereas the smallest acceptable score changes of the Oswestry Disability Index, the General Function Score and the Zung Depression Scale may require an increase to exceed the 95% tolerance interval when used for clinical decision making and for power calculation. Despite improvement after treatment, the ability to sit, stand and lift, remain notable problems.read more
Citations
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Journal ArticleDOI
Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.
Dennis C. Turk,Robert H. Dworkin,Robert R. Allen,Nicholas Bellamy,Nancy A. Brandenburg,Daniel B. Carr,Charles S. Cleeland,Raymond A. Dionne,John T. Farrar,Bradley S. Galer,David J. Hewitt,Alejandro R. Jadad,Nathaniel P. Katz,Lynn D. Kramer,Donald C. Manning,Cynthia McCormick,Michael P. McDermott,Patrick J. McGrath,Steve Quessy,Bob A. Rappaport,James P. Robinson,Mike A. Royal,Lee S. Simon,Joseph W. Stauffer,Wendy M. Stein,Jane Tollett,James Witter +26 more
TL;DR: In this article, the authors provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain, and develop a core set of outcome domains would facilitate comparison and pooling of d
Journal ArticleDOI
Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations
Robert H. Dworkin,Dennis C. Turk,Kathleen W. Wyrwich,Dorcas E. Beaton,Charles S. Cleeland,John T. Farrar,Jennifer A. Haythornthwaite,Mark P. Jensen,Robert D. Kerns,Deborah N. Ader,Nancy A. Brandenburg,Laurie B. Burke,David Cella,Julie Chandler,Penny Cowan,Rozalina Dimitrova,Raymond A. Dionne,Sharon Hertz,Alejandro R. Jadad,Nathaniel P. Katz,Henrik Kehlet,Lynn D. Kramer,Donald C. Manning,Cynthia McCormick,Michael P. McDermott,Henry J McQuay,Sanjay Patel,Linda Porter,Steve Quessy,Bob A. Rappaport,Christine Rauschkolb,Dennis A. Revicki,Margaret Rothman,Kenneth E. Schmader,Brett R. Stacey,Joseph W. Stauffer,Thorsten von Stein,Richard E. White,James Witter,Stojan Zavisic +39 more
TL;DR: A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments as discussed by the authors.
Journal ArticleDOI
Topical Review and RecommendationsCore outcome measures for chronic pain clinical trials: IMMPACT recommendations
Robert H. Dworkin,Dennis C. Turk,John T. Farrar,Jennifer A. Haythornthwaite,Mark P. Jensen,Nathaniel P. Katz,Robert D. Kerns,Gerold Stucki,Robert R. Allen,Nicholas Bellamy,Daniel B. Carr,Julie Chandler,Penney Cowan,Raymond A. Dionne,Bradley S. Galer,Sharon Hertz,Alejandro R. Jadad,Lynn D. Kramer,James Witter +18 more
Journal ArticleDOI
Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change.
Raymond W. J. G. Ostelo,Richard A. Deyo,Paul W. Stratford,Gordon Waddell,Peter Croft,Michael Von Korff,Lex M. Bouter,Henrica C.W. de Vet +7 more
TL;DR: Proposed MIC values are not the final answer but offer a common starting point for future research and facilitate the use of these measures in clinical practice and the comparability of future studies.
Journal ArticleDOI
Understanding the minimum clinically important difference: a review of concepts and methods.
TL;DR: An ideal means of determining the MCID for a given intervention is yet to be determined and it is possible to develop a useful method provided that the assumptions and methodology are initially declared.
References
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Journal Article
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Journal ArticleDOI
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