Interpreting Change in Disorders of Consciousness using the Coma Recovery Scale-Revised

Jennifer A. Weaver, Colorado State University, 3447, Department of Occupational Therapy, Fort Collins, Colorado, United States; jen.weaver@colostate.edu.
Alison Cogan, University of Southern California, 5116, Mrs. T. H. Chan Division of Occupational Science & Occupational Therapy, Los Angeles, California, United States; alison.cogan@chan.usc.edu.
Allan Kozlowski, Mary Free Bed Rehabilitation Hospital, 143308, 235 Wealthy Street SE, Grand Rapids, Michigan, United States, 49503; Allan.Kozlowski@maryfreebed.com.
Patricia Grady-Dominguez, Colorado State University, 3447, Department of Occupational Therapy, Fort Collins, Colorado, United States; patricia.grady@colostate.edu.
Katherine A. O'Brien, Memorial Hermann Health System, 23458, Houston, Texas, United States; katherine.obrien@memorialhermann.org.
Yelena G. Bodien, Massachusetts General Hospital, 2348, Department of Neurology, Boston, Massachusetts, United States.
James Graham, Colorado State University, 3447, Department of Occupational Therapy, Fort Collins, Colorado, United States; JEGraham@colostate.edu.
Stephen Aichele, Colorado State University, 3447, Department of Human Development and Family Studies, Fort Collins, Colorado, United States.
Paige Ford, Colorado State University, 3447, Department of Occupational Therapy, Fort Collins, Colorado, United States; paigeford2011@yahoo.com.
Trisha Kot, Colorado State University, 3447, Department of Occupational Therapy, Fort Collins, Colorado, United States; beekae@aol.com.
Theresa L. Bender Pape, Northwestern University, 3270, Department of Physical Medicine and Rehabilitation, Evanston, Illinois, United States; t-pape@northwestern.edu.
Trudy Mallinson, The George Washington University School of Medicine and Health Sciences, 43989, Department of Clinical Research and Leadership, Washington, District of Columbia, United States; trudy@gwu.edu.
Joseph Giacino, Spaulding Rehabilitation Hospital, 24498, PM&R, Charlestown, Massachusetts, United States.

Document Type

Journal Article

Publication Date

4-13-2024

Journal

Journal of neurotrauma

DOI

10.1089/neu.2023.0567

Keywords

ASSESSMENT TOOLS; OUTCOME MEASURES; TRAUMATIC BRAIN INJURY

Abstract

The purpose of this study was to differentiate clinically meaningful improvement or deterioration from normal fluctuations in patients with disorders of consciousness (DoC) following severe brain injury. We computed indices of responsiveness for the Coma Recovery Scale-Revised (CRS-R) using data from a clinical trial of 180 participants with DoC. We used CRS-R scores from baseline (enrollment in a clinical trial) and a four-week follow-up assessment period for these calculations. To improve precision, we transformed ordinal CRS-R total scores (0 to 23 points) to equal-interval measures on a 0-to-100-unit scale using Rasch Measurement theory. Using the 0-to-100 unit total Rasch measures, we calculated distribution-based 0.5 standard deviation (SD) minimal clinically important difference, minimal detectable change using 95% confidence intervals, and conditional minimal detectable change using 95% confidence intervals. The distribution-based minimal clinically important difference evaluates group-level changes, whereas the minimal detectable change values evaluate individual-level changes. The minimal clinically important difference and minimal detectable change are derived using the overall variability across total measures at baseline and four weeks. The conditional minimal detectable change is generated for each possible pair of CRS-R Rasch person measures and accounts for variation in standard error across the scale. We applied these indices to determine the proportions of participants who made a change beyond measurement error within each of the two sub-groups, based on treatment arm (amantadine hydrochloride or placebo) or categorization of baseline Rasch person measure to states of consciousness (i.e., unresponsive wakefulness syndrome and minimally conscious state). We compared the proportion of participants in each treatment arm who made a change according to the minimal detectable change and determined whether they also changed to another state of consciousness. CRS-R indices of responsiveness (using the 0-100 transformed scale) were as follows: 0.5SD minimal clinically important difference = 9 units, minimal detectable change = 11 units, and the conditional minimal detectable change ranged from 11 to 42 units. For the amantadine and placebo groups, 67% and 58% of participants showed change beyond measurement error using the minimal detectable change, respectively. For the unresponsive wakefulness syndrome and minimally conscious state groups, 52% and 67% of participants changed beyond measurement error using the minimal detectable change, respectively. Among 115 participants (64% of the total sample) who made a change beyond measurement error, 29 participants (25%) did not change state of consciousness. CRS-R indices of responsiveness can support clinicians and researchers in discerning when behavioral changes in patients with DoC exceed measurement error. Notably, the minimal detectable change can support the detection of patients who make a 'true' change within or across states of consciousness. Our findings highlight that continued use of ordinal scores may result in incorrect inferences about the degree and relevance of a change score.

Department

Clinical Research and Leadership

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