Challenges for defining minimal clinically important difference (MCID) after spinal cord injury

被引：81

作者：

Wu, X. ^{[1
,2
]}

Liu, J. ^{[1
]}

Tanadini, L. G. ^{[3
,4
]}

Lammertse, D. P. ^{[5
]}

Blight, A. R. ^{[6
]}

Kramer, John L. K. ^{[1
,7
]}

Scivoletto, G. ^{[8
]}

Jones, L. ^{[9
]}

Kirshblum, S. ^{[10
]}

Abel, R. ^{[11
]}

Fawcett, J. ^{[12
]}

Field-Fote, E. ^{[13
]}

Guest, J. ^{[13
]}

Levinson, B. ^{[14
]}

Maier, D. ^{[15
]}

Tansey, K. ^{[16
,17
,18
]}

Weidner, N. ^{[19
]}

Tetzlaff, W. G. ^{[1
]}

Hothorn, T. ^{[4
]}

Curt, A. ^{[3
]}

Steeves, J. D. ^{[1
]}

机构：

[1] Univ British Columbia, Vancouver Gen Hosp, Blusson Spinal Cord Ctr, ICORD, Vancouver, BC V5Z 1M9, Canada

[2] Southern Med Univ, Nanfang Hosp, Dept Spinal Surg, Guangzhou, Guangdong, Peoples R China

[3] Univ Zurich, Univ Hosp Balgrist, Spinal Cord Injury Ctr, Zurich, Switzerland

[4] Univ Zurich, Epidemiol Biostat & Prevent Inst, Zurich, Switzerland

[5] Craig Hosp, Englewood, CO USA

[6] Acorda Therapeut Inc, Hawthorne, NY USA

[7] Crawford Res Inst, Shepherd Ctr, Atlanta, GA USA

[8] IRCCS Fdn S Lucia, Spinal Unit, Rome, Italy

[9] Craig H Neilsen Fdn, Encino, CA USA

[10] Kessler Inst Rehabil, W Orange, NJ USA

[11] Trauma Ctr Bayreuth, Bayreuth, Germany

[12] Univ Cambridge, John van Geest Ctr Brain Repair, Cambridge, England

[13] Univ Miami, Miller Sch Med, Miami Project Cure Paralysis, Miami, FL 33136 USA

[14] Asubio Pharmaceut Inc, Edison, NJ USA

[15] Trauma Ctr Murnau, Murnau, Germany

[16] Emory Univ, Dept Neurol, Atlanta, GA 30322 USA

[17] Emory Univ, Dept Physiol, Atlanta, GA 30322 USA

[18] VA Med Ctr, Atlanta, GA USA

[19] Univ Heidelberg Hosp, Spinal Cord Injury Ctr, Heidelberg, Germany

来源：

SPINAL CORD | 2015年 / 53卷 / 02期

关键词：

QUALITY-OF-LIFE; SMALLEST REAL DIFFERENCE; INDEPENDENCE MEASURE; ICCP PANEL; OUTCOME MEASURES; HEALTH-STATUS; NEUROLOGICAL CLASSIFICATION; INTERNATIONAL STANDARDS; MEANINGFUL CHANGE; NEUROPATHIC PAIN;

D O I：

10.1038/sc.2014.232

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Study design: This is a review article. Objectives: This study discusses the following: (1) concepts and constraints for the determination of minimal clinically important difference (MCID), (2) the contrasts between MCID and minimal detectable difference (MDD), (3) MCID within the different domains of International Classification of Functioning, disability and health, (4) the roles of clinical investigators and clinical participants in defining MCID and (5) the implementation of MCID in acute versus chronic spinal cord injury (SCI) studies. Methods: The methods include narrative reviews of SCI outcomes, a 2-day meeting of the authors and statistical methods of analysis representing MDD. Results: The data from SCI study outcomes are dependent on many elements, including the following: the level and severity of SCI, the heterogeneity within each study cohort, the therapeutic target, the nature of the therapy, any confounding influences or comorbidities, the assessment times relative to the date of injury, the outcome measurement instrument and the clinical end-point threshold used to determine a treatment effect. Even if statistically significant differences can be established, this finding does not guarantee that the experimental therapeutic provides a person living with SCI an improved capacity for functional independence and/or an increased quality of life. The MDD statistical concept describes the smallest real change in the specified outcome, beyond measurement error, and it should not be confused with the minimum threshold for demonstrating a clinical benefit or MCID. Unfortunately, MCID and MDD are not uncomplicated estimations; nevertheless, any MCID should exceed the expected MDD plus any probable spontaneous recovery. Conclusion: Estimation of an MCID for SCI remains elusive. In the interim, if the target of a therapeutic is the injured spinal cord, it is most desirable that any improvement in neurological status be correlated with a functional (meaningful) benefit.

引用

页码：84 / 91

页数：8

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