PMID- 25510192 OWN - NLM STAT- MEDLINE DCOM- 20151026 LR - 20220129 IS - 1476-5624 (Electronic) IS - 1362-4393 (Linking) VI - 53 IP - 2 DP - 2015 Feb TI - Challenges for defining minimal clinically important difference (MCID) after spinal cord injury. PG - 84-91 LID - 10.1038/sc.2014.232 [doi] AB - 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. FAU - Wu, X AU - Wu X AD - 1] ICORD, Blusson Spinal Cord Centre, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada [2] Department of Spinal Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Liu, J AU - Liu J AD - ICORD, Blusson Spinal Cord Centre, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada. FAU - Tanadini, L G AU - Tanadini LG AD - 1] Spinal Cord Injury Center, University Hospital Balgrist, University of Zurich, Zurich, Switzerland [2] Epidemiology, Biostatistics and Prevention Institute, University Zurich, Zurich, Switzerland. FAU - Lammertse, D P AU - Lammertse DP AD - Craig Hospital, Englewood, CO, USA. FAU - Blight, A R AU - Blight AR AD - Acorda Therapeutics Inc. Hawthorne, NY, USA. FAU - Kramer, John L K AU - Kramer JL AD - 1] ICORD, Blusson Spinal Cord Centre, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada [2] Shepherd Center, Crawford Research Institute, Atlanta, GA, USA. FAU - Scivoletto, G AU - Scivoletto G AD - Spinal Unit, IRCCS Fondazione S. Lucia, Rome, Italy. FAU - Jones, L AU - Jones L AD - Craig H. Neilsen Foundation, Encino, CA, USA. FAU - Kirshblum, S AU - Kirshblum S AD - Kessler Institute for Rehabilitation, West Orange, NJ, USA. FAU - Abel, R AU - Abel R AD - Trauma Center Bayreuth, Bayreuth, Germany. FAU - Fawcett, J AU - Fawcett J AD - John van Geest Centre for Brain Repair, University of Cambridge, Cambridge, UK. FAU - Field-Fote, E AU - Field-Fote E AD - Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, FL, USA. FAU - Guest, J AU - Guest J AD - Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, FL, USA. FAU - Levinson, B AU - Levinson B AD - Asubio Pharmaceuticals Inc. Edison, NJ, USA. FAU - Maier, D AU - Maier D AD - Trauma Center Murnau, Murnau, Germany. FAU - Tansey, K AU - Tansey K AD - Departments of Neurology and Physiology, Emory University and VA Medical Center, Atlanta, GA, USA. FAU - Weidner, N AU - Weidner N AD - Spinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany. FAU - Tetzlaff, W G AU - Tetzlaff WG AD - ICORD, Blusson Spinal Cord Centre, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada. FAU - Hothorn, T AU - Hothorn T AD - Epidemiology, Biostatistics and Prevention Institute, University Zurich, Zurich, Switzerland. FAU - Curt, A AU - Curt A AD - Spinal Cord Injury Center, University Hospital Balgrist, University of Zurich, Zurich, Switzerland. FAU - Steeves, J D AU - Steeves JD AD - ICORD, Blusson Spinal Cord Centre, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada. LA - eng GR - G1000864/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Review DEP - 20141216 PL - England TA - Spinal Cord JT - Spinal cord JID - 9609749 SB - IM MH - Acute Disease MH - Chronic Disease MH - Humans MH - Outcome Assessment, Health Care/*methods MH - Severity of Illness Index MH - Spinal Cord Injuries/*diagnosis/*therapy EDAT- 2014/12/17 06:00 MHDA- 2015/10/27 06:00 CRDT- 2014/12/17 06:00 PHST- 2014/08/11 00:00 [received] PHST- 2014/11/16 00:00 [revised] PHST- 2014/11/19 00:00 [accepted] PHST- 2014/12/17 06:00 [entrez] PHST- 2014/12/17 06:00 [pubmed] PHST- 2015/10/27 06:00 [medline] AID - sc2014232 [pii] AID - 10.1038/sc.2014.232 [doi] PST - ppublish SO - Spinal Cord. 2015 Feb;53(2):84-91. doi: 10.1038/sc.2014.232. Epub 2014 Dec 16.