Hostname: page-component-586b7cd67f-g8jcs Total loading time: 0 Render date: 2024-11-24T07:02:32.124Z Has data issue: false hasContentIssue false
  • English
  • Français

Longitudinal Changes in Disability Rating Scale Scores: A Secondary Analysis Among Patients With Severe TBI Enrolled in the Epo Clinical Trial

Published online by Cambridge University Press:  13 March 2019

Julia S. Benoit ,
H. Julia Hannay ,
Jose-Miguel Yamal ,
David J. Francis ,
Imoigele Aisiku  and
Claudia Robertson
Julia S. Benoit*
Affiliation:
Texas Institute for Measurement Evaluation and Statistics (TIMES) and the Department of Basic Vision Sciences, University of Houston, Houston, Texas
H. Julia Hannay
Affiliation:
Department of Psychology, TIMES, University of Houston, Houston, Texas
Jose-Miguel Yamal
Affiliation:
Department of Biostatistics and Data Science, University of Texas School of Public Health, Houston, Texas
David J. Francis
Affiliation:
Department of Psychology, TIMES, University of Houston, Houston, Texas
Imoigele Aisiku
Affiliation:
Department of Emergency Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
Claudia Robertson
Affiliation:
Department of Neurosurgery, Baylor College of Medicine, Houston, Texas
*
Correspondence and reprint requests to: Julia S. Benoit, Texas Institute for Measurement Evaluation and Statistics (TIMES) and the Department of Basic Vision Sciences, University of Houston, 4849 Calhoun Road, STE 373, Houston, TX 77204-6022. E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: Long-term neurological response to treatment after a severe traumatic brain injury (sTBI) is a dynamic process. Failure to capture individual heterogeneity in recovery may impact findings from single endpoint sTBI randomized controlled trials (RCT). The present study re-examined the efficacy of erythropoietin (Epo) and transfusion thresholds through longitudinal modeling of sTBI recovery as measured by the Disability Rating Scale (DRS). This study complements the report of primary outcomes in the Epo sTBI RCT, which failed to detect significant effects of acute treatment at 6 months post-injury. Methods: We implemented mixed effects models to characterize the recovery time-course and to examine treatment efficacy as a function of time post-injury and injury severity. Results: The inter-quartile range (25th–75th percentile) of DRS scores was 20–28 at week1; 8–24 at week 4; and 3–17 at 6 months. TBI severity group was found to significantly interact with Epo randomization group on mean DRS recovery curves. No significant differences in DRS recovery were found in transfusion threshold groups. Conclusions: This study demonstrated the value of taking a comprehensive view of recovery from sTBI in the Epo RCT as a temporally dynamic process that is shaped by both treatment and injury severity, and highlights the importance of the timing of primary outcome measurement. Effects of Epo treatment varied as a function of injury severity and time. Future studies are warranted to understand the possible moderating influence of injury severity on treatment effects pertaining to sTBI recovery. (JINS, 2019, 25, 293–301)

Keywords

Randomized clinical trialTreatment profilesNeurotraumaFunctional outcomeDRSLong-term functional recoveryInjury severityLongitudinal data analysis
Type
Special Section: Traumatic Brain Injury
Information
Journal of the International Neuropsychological Society , Volume 25 , Issue 3 , March 2019 , pp. 293 - 301
Copyright
Copyright © The International Neuropsychological Society 2019 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

Bryk, A.S., & Raudenbush, S.W. (1987). Application of hierarchical linear models to assessing change. Psychological Bulletin, 101(1), 147–158.Google Scholar
Burchinal, M., & Appelbaum, M.I. (1991). Estimating individual developmental functions: Methods and their assumptions. Child Development, 62(1), 23–43.Google Scholar
Chua, K.S., Ng, Y.S., Yap, S.G., & Bok, C.W. (2007). A brief review of traumatic brain injury rehabilitation. Annals of the Academy of Medicine, Singapore, 36, 31–42.Google Scholar
Dams-O’Connor, K., Pretz, C., Billah, T., Hammond, F.M., & Harrison-Felix, C. (2015). Global outcome trajectories after TBI among survivors and non-survivors: a national institute on disability and rehabilitation research traumatic brain injury model systems study. Journal of Head Trauma Rehabilitation, 30, e1–e10.Google Scholar
Davis, R.A., & Cunningham, P.S. (1984). Prognostic factors in severe head injury. Surgery, Gynecology & Obstetrics, 159, 597–604.Google Scholar
Englander, J., Cifu, D.X., Wright, J.M., & Black, K. (2003). The association of early computed tomography scan findings and ambulation, self-care, and supervision needs at rehabilitation discharge and at 1 year after traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 84, 214–220.Google Scholar
Ewing-Cobbs, L., Barnes, M., Fletcher, J.M., Levin, H.S., Swank, P.R., & Song, J. (2004). Modeling of longitudinal academic achievement scores after pediatric traumatic brain injury. Developmental Neuropsychology, 25, 107–133.Google Scholar
Francis, D.J., Fletcher, J.M., Stuebing, K.K., Davidson, K.C., & Thompson, N.R. (1991). Analysis of change: Modeling individual growth. Journal of Consulting and Clinical Psychology, 59, 27–37.Google Scholar
Fleming, J., and Maas, F. (1994). Prognosis of rehabilitation outcome in head injury using the Disability Rating Scale. Archives of Physical Medicine and Rehabilitation, 75, 156–163.Google Scholar
Giacino, J.T., Whyte, J., Bagiella, E., Kalmar, K., Childs, N., Khademi, A., & Sherer, M. (2012). Placebo-controlled trial of amantadine for severe traumatic brain injury. New England Journal of Medicine, 366, 819–826.Google Scholar
Gouvier, W.D., Blanton, P.D., LaPorte, K.K., & Nepomuceno, C. (1987). Reliability and validity of the Disability Rating Scale and the Levels of Cognitive Functioning Scale in monitoring recovery from severe head injury. Archives of Physical Medicine and Rehabilitation, 68, 94–97.Google Scholar
Hall, K.M., Bushnik, T., Lakisic-Kazazic, B., Wright, J., & Cantagallo, A. (2001). Assessing traumatic brain injury outcome measures for long-term follow-up of community-based individuals. Archives of Physical Medicine and Rehabilitation, 82, 367–374.Google Scholar
Hall, K., Cope, D.N., & Rappaport, M. (1985). Glasgow Outcome Scale and Disability Rating Scale: Comparative usefulness in following recovery in traumatic head injury. Archives of Physical Medicine and Rehabilitation, 66, 35–37.Google Scholar
Hall, K.M., Mann, N., High, W.M., Wright, J.M., Kreutzer, J.S., & Wood, D. (1996). Functional measures after traumatic brain injury: Ceiling effects of FIM, FIM+FAM, DRS, and CIQ. The Journal of Head Trauma Rehabilitation, 11(5), 27–39.Google Scholar
Janowitz, T., & Menon, D.K. (2010). Exploring new routes for neuroprotective drug development in traumatic brain injury. Science Translational Medicine, 2, 27rv1.Google Scholar
Laird, N.M. & Ware, J.H. (1982) Random-effects models for longitudinal data. Biometrics, 38(4), 963–974.Google Scholar
Lingsma, H.F., Roozenbeek, B., Steyerberg, E.W., Murray, G.D., & Maas, A.I. (2010). Early prognosis in traumatic brain injury: From prophecies to predictions. The Lancet Neurology, 9, 543–554.Google Scholar
Marshall, L.F., Marshall, S.B., Klauber, M.R., Van Berkum, C.M., Eisenberg, H., Jane, J.A., & Foulkes, M.A. (1992). The diagnosis of head injury requires a classification based on computed axial tomography. Journal of Neurotrauma, 9(Suppl.), S287–S292.Google Scholar
McCauley, S.R., Hannay, H.J., & Swank, P.R. (2001). Use of the Disability Rating Scale recovery curve as a predictor of psychosocial outcome following closed-head injury. Journal of the International Neuropsychological Society, 7, 457–467.Google Scholar
Menon, D.K., & Maas, A.I. (2015). Traumatic brain injury in 2014: Progress, failures and new approaches for TBI research. Nature Reviews Neurology, 11, 71–72.Google Scholar
Perel, P., Edwards, P., Wentz, R., & Roberts, I. (2006). Systematic review of prognostic models in traumatic brain injury. BMC Medical Informatics and Decision Making, 6, 38.Google Scholar
Rappaport, M., Hopkins, H.K., Hall, K., & Belleza, T. (1981). Evoked potentials and head injury. 2. Clinical applications. Clinical Electroencephalography, 12, 167–176.Google Scholar
Rappaport, M., Hall, K.M., Hopkins, K, Belleza, T., & Cope, D.N. (1982). Disability rating scale for severe head trauma: Coma to community. Archives of Physical Medicine and Rehabilitation, 63, 118–123.Google Scholar
Robertson, C.S., Hannay, H.J., Yamal, J.M., Shankar, G., Goodman, J.C., Tilley, B.C., & the Epo severe TBI trial investigators. (2014). Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury. Journal of the American Medical Association, 312, 36–47.Google Scholar
Roozenbeek, B., Lingsma, H.F., & Maas, A.I. (2012). New considerations in the design of clinical trials for traumatic brain injury. Clinical Investigation Journal (London), 2, 153–162.Google Scholar
Steyerberg, E.W., Mushkudiani, N., Perel, P., Butcher, I., Lu, J., McHugh, G.S., & Maas, A.I. (2008). Predicting outcome after traumatic brain injury: Development and international validation of prognostic scores based on admission characteristics. PLoS Medicine, 5, 1251–1260.Google Scholar
Struchen, M.A., Hannay, H.J., Contant, C.F., & Robertson, C.S. (2001). The relation between acute physiological variables and outcome on the Glasgow Outcome Scale and Disability Rating Scale following severe traumatic brain injury. Journal of Neurotrauma, 18, 115–125.Google Scholar
Thompson, N.M., Francis, D.J., Stuebing, K.K., Fletcher, J.M., Ewing-Cobbs, L., Miner, M.E., & Eisenberg, H.M. (1994). Motor, visual-spatial, and somatosensory skills after traumatic brain injury in children and adolescents: A study of change. Neuropsychology, 8, 333–342.Google Scholar
Vanderploeg, R.D., Schwab, K., Walker, W.C., Fraser, J.A., Sigford, B.J., Date, E.S., & Defense and Veterans Brain Injury Center Study Group. (2008). Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. Archives of Physical Medicine and Rehabilitation, 89, 2227–2238.Google Scholar
Wright, D.W., Yeatts, S.D., Silbergleit, R., Palesch, Y.Y., Hertzberg, V.S., Frankel, M., & the NETT Investigators. (2014). Very early administration of progesterone for acute traumatic brain injury. New England Journal of Medicine, 371, 2457–2466.Google Scholar
Zhao, H., Ding, X., Want, Q., Gan, Q., You, C., & Yang, C. (2016). Prospective randomized evaluation of therapeutic decompressive craniectomy in severe traumatic brain injury with mass lesions (PRECIS): Study protocol for a controlled trial. BMC Neurology, 16, 1.Google Scholar
Supplementary material: File

Benoit et al. supplementary material

Benoit et al. supplementary material 1

Download Benoit et al. supplementary material(File)
File 1.5 MB