Date Presented 04/21/21
Most spinal cord injury (SCI) clinical trial measures do not have the capability to accurately measure recovery of movement, which creates serious problems for SCI clinical trials that have motor recovery or repair as an endpoint. Work is underway to develop a clinical trial outcome measure that is intended to evaluate recovery of neurotypical movement within the context of function. This poster presents the iterative development process of the fine motor item pool for this outcome measure.
Primary Author and Speaker: Rachel Kim
Additional Authors and Speakers: William Conrad, Dianna Lunsford, Kristin Valdes
INTRODUCTION: The primary endpoint of SCI clinical trials is recovery of movement to physically perform meaningful activities needed and wanted for daily life (Steeves et al., 2007). Most clinical measures do not have the capability to accurately measure recovery of movement, which creates serious problems for spinal cord injury (SCI) clinical trials and the SCI population it seeks to serve. In response to the need for a clinical trial outcome measure that is standardized, administered by observation, and disallows substitutions and accounts for compensation in scoring, work is underway to develop a clinical trial outcome measure that is intended to evaluate recovery of neurotypical movement within the context of function. We describe the methods used to develop the fine motor item pool of the Spinal Cord Injury Movement Index (SCI-MI) and report the results of initial beta-testing.
DESIGN & METHODS: Mixed methods were used to identify, refine and test the administration and scoring of items for the SCI-MI fine motor item pool. Consensus meetings (N = 10) were conducted iteratively to identify candidate items from the Spinal Cord Injury-Functional Index (SCI-FI) that were amenable to administration and scoring by observation of performance. Of the 36 SCI-FI items, 9 were considered not amenable for a performance-based measure or beyond the scope of fine motor (e.g., removing something from back pocket). The remaining 27 SCI-FI items were retained for the SCI-MI and examined against an item map that was developed using the SCI-FI calibration study data. The item map provided reference for the hierarchy of items based on difficulty and discrimination. Items from other existing SCI measures were considered candidates based on item intent. Administration guidelines and scoring procedures for each item were developed through an iterative process of focus groups (N = 2), beta-testing sessions with individuals with SCI (N = 6), and input from experts in SCI rehabilitation. All focus group and beta testing sessions were IRB-approved, recorded, transcribed, and reviewed to inform iterative revisions of the items and scoring procedures. Bi-weekly study team meetings further contributed to the iterative process used to refine the procedural guidelines for administration and scoring.
RESULTS: The SCI-MI fine motor item pool consists of 40 unimanual and 16 bimanual items. Of the 56 items, 34 were modified from SCI-FI items and 22 were newly developed. Standardized administration procedures have been developed and beta-tested, including specifications about item intent. The Scoring algorithm is a 5-point scale where a score of ‘5’ reflects neurotypical movement, ‘4’ neurotypical movement with decreased quality, ‘3’ and ‘2’, movement using some and all compensatory strategies, respectively, and ‘1’ unable to do.
CONCLUSIONS: Optimizing mobility and upper extremity function is essential to enhancing independence and quality of life for individuals with SCI (Jones et al., 2018; Simpson et al., 2012). Given our expertise in activity analysis and function, occupational therapists can emerge as a key profession in developing an appropriate outcome measure for SCI clinical trials. We have created an item pool for evaluating movement within the context of fine motor function. The items are designed for administration-by-observation and use in clinical trial programs. We are confirming accuracy of administration and scoring, as a precursor to a calibration study. A future calibration study will determine if the item pool meets the assumptions necessary for computer adaptive testing.
References
Steeves, J.D., Lammertse, D., Curt, A., Fawcett, J.W., Tuszynski, M.H., Ditunno, J.F.,...Privat, A. (2007). Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures. Spinal Cord. 45(3), 206-221.
Jones, L.A.T., Bryden, A., Wheeler, T.L., Tansey, K.E., Anderson, K.D., Beattie, M.S., & Steeves, J.D. (2018). Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injuy trials. Spinal Cord, 56(5), 414-425. https://doi.org/10.1038/s41393-017-0015-5
Simpson, L.A., Eng, J.J., Hsieh, J.T.C., Wolfe., D.L., & Spinal Cord Injury Rehabilitation Evidence Research Team. (2012). The health and life priorities of individuals with spinal cord injury: A systematic review. Journal of Neurotrauma, 29, 1548-1555. https://doi.org/10.1089/neu.2011.2226
