Validation of the NIH Toolbox in Rehabilitation Populations

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1 NIH Toolbox Assessment of Neurological and Behavioral Function Validation of the NIH Toolbox in Rehabilitation Populations David Tulsky, PhD Supported by Unveiling the NIH Toolbox Bethesda, MD September 10, 2012 This project is funded in whole or in part with Federal funds from the Blueprint for Neuroscience Research and the Office of Behavioral and Social Sciences Research, National Institutes of Health, under Contract No. HHS-N C and the National Institute on Disability and Rehabilitation Research, Grant No. H133B

2 I am a faculty member at the University of Michigan and member of the NIH Toolbox Steering Committee and Cognition Team. I have no conflicts of interest to disclose University of Michigan Medical School

3 1. New studies that will validate the NIH Toolbox in individuals with physical and cognitive deficits. 2. Individuals with Traumatic Brain Injury, Spinal Cord Injury, and Stroke. 3

4 Sample of 52 individuals with TBI completed two of the NIH Toolbox cognition tests (processing speed and working memory). Severe TBI - N=34 Moderate/Complicated Mild TBI N=18. Sample of 52 individuals were extracted from the Toolbox cognition validation data set. Serves as a control sample Participants were matched on age group, education level, ethnicity, and gender. 4

5 Variable TBI (N=52) Control (N=52) Age (years) M SD Ethnicity (%) Caucasian African American Other Multiple Education (%) Less than HS HS or Some College College or graduate degree Gender (%) Male Female

6 Group Differences NIH Toolbox Subtest TBI Mean (SD) Control Mean (SD) List Sorting (3.00) (2.94) Pattern Comparison (7.40) (6.37) 6

7 Allen Heinemann (PI) - Rehabilitation Institute of Chicago David Tulsky (study PI) University of Michigan Carolyn Baum Washington University Noelle Carlozzi University of Michigan David Gray Washington University Susan Magasi Northwestern University Anne Deutsch - Rehabilitation Institute of Chicago Elizabeth Hahn Northwestern University Jin-Shei Lai Northwestern University Sofia Garcia Northwestern University Holly Hollingsworth Washington University Pamela Kisala University of Michigan Richard Gershon Northwestern University

8 NIDRR has made the development of measures of cognitive function a priority because adequate measures have not been developed for systemic application in the field of medical rehabilitation. Cognition is both a rehabilitation outcome and a factor related to broader functional and community outcomes for individuals with a wide variety of disabling conditions.

9 Objective 1: Evaluate the sensitivity of the NIH Toolbox, the EFTP, TBI-QOL, and Neuro-QOL in patients with SCI, TBI, and stroke vs. previously collected normative data from a non-injury comparison sample (see R1 for a description of this sample) Objective 2: Evaluate the sensitivity of the NIH Toolbox and gold standard neuropsychological instruments to severity of injury within diagnostic category Objective 3: Determine the convergent and discriminant validity of the NIH Toolbox and gold standard neuropsychological instruments 9

10 Objective 4: Determine the ecological validity of the NIH Toolbox (e.g., how well it relates to measures of applied function and employment status) Objective 5: Describe the relationship between the NIH Toolbox and self-reported cognition (Neuro-QOL/SCI- QOL/SCI-CAT/TBI-QOL) and physical functioning/activity limitations (EFPT) 10

11 Sample: 200 persons with Stroke 200 with TBI 200 with SCI 11

12 R2 Data Collection NIH Toolbox (2.5 Hours) Executive Function Performance Test (45 minutes) Gold Standard tests (2 hours) Neuro-QOL/TBI-QOL (15 minutes) R3 Data Collection Self-Report measures (~ 3.5 hours) COMBINED TESTING = 10 hours over 2 days 12

13 In person training was conducted at RIC, Washington University, and University Michigan. NIH Toolbox Executive Function Performance Test Gold Standard Neuropsychological Measures Assessment Center (via webex) 9 examiners trained and practiced administering battery on 5 individuals. In person certification was performed. Plans are being made for annual recertification to 13 prevent examiner drift.

14 September-October, 2011 at RIC N=9 (3 Stroke, 3 SCI, 3 TBI) Goals of pilot were to test administration, get time estimates of battery, and foreshadow questions that might arise when study launches. 14

15 Lessons Learned: Necessary to switch order of tasks to avoid participant fatigue (computer tasks vs. interactive tasks) Testing can be accomplished. Session tends to be shorter for SCI than for TBI or stroke. However, all participants completed sessions. Examiner training is critical. Practice improves testing procedures. Launched study January,

16 Study Totals Total to Date SCI TBI Stroke Paraplegia Incomplete 5 Complete 11 Tetraplegia Incomplete 15 Complete 4 Complicated Mild 39 Moderate 4 Severe 55 Unknown 0 Mild 24 Moderate 15 Severe 16 Unknown Totals: 192

17 Lessons learned: Testing sessions are feasible. Participants are able to tolerate long sessions. Greater than 95% of participants have completed the battery. 17

18 NIH Toolbox Assessment of Neurological and Behavioral Function For more information visit Supported by This project is funded in whole or in part with Federal funds from the Blueprint for Neuroscience Research and the Office of Behavioral and Social Sciences Research, National Institutes of Health, under Contract No. HHS-N C and the National Institute on Disability and Rehabilitation Research, Grant No. H133B

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