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Detecting Behavioral Deficits in Rats After Traumatic Brain Injury
Published on: January 30, 2018
Determining minimally clinically important differences for outcome measures in patients with chronic motor deficits
Michael A McCrea1, Steven C Cramer2, David O Okonkwo3
1Co-Director, Center For Neurotrauma Research; And Professor, Department Of Neurosurgery, Medical College Of Wisconsin, Milwaukee, USA.
Objective:
To determine minimally clinically important differences (MCIDs) for Disability Rating Scale (DRS), Fugl-Meyer Upper Extremity Subscale (FM-UE), Fugl-Meyer Lower Extremity Subscale (FM-LE), and Fugl-Meyer Motor Scale (FMMS) in patients with chronic motor deficits secondary to traumatic brain injury (TBI).
Methods:
Retrospective analysis from the 1-year, double-blind, randomized, surgical sham-controlled, Phase 2 STEMTRA trial (NCT02416492), in which patients with chronic motor deficits secondary to TBI (N = 61) underwent intracerebral stereotactic implantation of modified bone marrow-derived mesenchymal stromal (SB623) cells. MCIDs for DRS, FM-UE, FM-LE, and FMMS were triangulated with distribution-based, anchor-based, and Delphi panel estimates.
Results:
Triangulated MCIDs were: 1) -1.5 points for the Disability Rating Scale; 2) 6.2 points for the Fugl-Meyer Upper Extremity Subscale; 3) 3.2 points for the Fugl-Meyer Lower Extremity Subscale; and 4) 8.4 points for the Fugl-Meyer Motor Scale.
Conclusions:
For the first time in the setting of patients with chronic motor deficits secondary to TBI, this study reports triangulated MCIDs for: 1) DRS, a measure of global outcome; and 2) Fugl-Meyer Scales, measures of motor impairment. These findings guide the use of DRS and Fugl-Meyer Scales in the assessment of global disability outcome and motor impairment in future TBI clinical trials.
Insights
This study determined minimally clinically important differences (MCIDs) for key outcome measures in patients with chronic motor deficits after traumatic brain injury (TBI). The findings provide crucial benchmarks for assessing treatment efficacy in future TBI clinical trials.
Area of Science:
- Neuroscience
- Clinical Trials
- Rehabilitation Medicine
Background:
- Chronic motor deficits are a significant challenge following traumatic brain injury (TBI).
- Accurate assessment of treatment efficacy in TBI requires reliable outcome measures.
- Minimally clinically important differences (MCIDs) are essential for interpreting the clinical significance of changes in patient outcomes.
Purpose of the Study:
- To establish minimally clinically important differences (MCIDs) for the Disability Rating Scale (DRS) and Fugl-Meyer Scales (FM-UE, FM-LE, FMMS).
- To provide benchmarks for evaluating motor function and global disability in patients with chronic TBI.
- To inform the design and interpretation of future clinical trials for TBI.
Main Methods:
- Retrospective analysis of data from the Phase 2 STEMTRA trial (NCT02416492).
- Inclusion of 61 patients with chronic motor deficits secondary to TBI.
- Triangulation of MCID estimates using distribution-based, anchor-based, and Delphi panel methods.
Main Results:
- Triangulated MCIDs were determined for the first time in this patient population.
- MCIDs established: -1.5 points for DRS, 6.2 points for FM-UE, 3.2 points for FM-LE, and 8.4 points for FMMS.
- These values represent the smallest change in score indicative of a meaningful clinical improvement.
Conclusions:
- This study reports the first triangulated MCIDs for the DRS and Fugl-Meyer Scales in patients with chronic TBI-related motor deficits.
- These MCIDs will enhance the assessment of global disability and motor impairment in future TBI research.
- The findings facilitate a more precise evaluation of therapeutic interventions for TBI recovery.
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