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Project

Validation of the Spinal Cord Injury Functional Index (SCI-FI) Performance-By-Observation Measure

Funder: Craig H Neilsen Foundation

Funding period
USD 600 K
Funding amount
Abstract
One of the most important endpoint of spinal cord injury (SCI) clinical trials is recovery of function to physically perform activities that are desired and required for daily living. The “ideal” clinical trial outcome measure is a performance measure on an interval scale that evaluates one trait with the difference between scale scores being linear. However, most measures of physical function are multidimensional ordinal scales that were developed to categorize function in the clinical setting. The Spinal Cord Injury Functional Index (SCI-FI) is a series of patient-reported outcome measures (PRO) that were developed using item response theory and the Rasch measurement model to assess patient reported outcomes of basic mobility, fine motor function, self-care, ambulation and wheelchair mobility; the scales are built upon large calibrated item banks and are unidimensional, linear and interval. Given the strong methodological procedures that were used to develop the SCI-FI PRO as a series of unidimensional linear measures, and the availability of large calibrated item banks that contain hundreds of well-defined and relevant items that measure physical function, we will build upon the SCI-FI PRO to develop a SCI-FI Performance-by-Observation measure. Specifically, Iterative focus groups and pre-testing items will identify candidate SCI-FI Performance-by-Observation items from the SCI-FI PRO calibrated item banks. A single site repeated measures design will enroll up to 25 participants with SCI and 10 trained raters to establish reliability. Measurement properties and validity will be examined through the analysis of data collected in a multi-center study using a cross-sectional design, that will enroll at least 250 persons with SCI who will complete a one-time administration of the SCI-FI Performance-by-Observation, Spinal Cord Independence Measure (SCIM-III) and the SCI-FI PRO. Intraclass correlation coefficients with 95% confidence intervals will be used to examine reliability. Measurement properties, including linearity, item fit, differential item functioning, will be examined using a combination of statistical procedures from the Rasch measurement model. Item-person maps will be constructed and used to examine and compare the means and standard deviations of the distributions of the item difficulty and person ability, and to examine the gap between those two distributions. INFIT and OUTFIT mean square residual statistics will be used to test item fit and unidimensionality. Differential item functioning will be examined for age, gender, time since injury and type and severity of injury. Differences in mean scores between groups with known differences will be determined using the t-test and analysis of variance (ANOVA); statistical significance will be set at .05. A series of correlation statistics will be used to establish construct validity. (CHN: SCIRTS chn:wdg)
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System

Categories
  • FOR (ANZSRC)

    0104 Statistics

  • RCDC

    Injury (total) Accidents/Adverse Effects

  • RCDC

    Injury - Trauma - (Head and Spine)

  • RCDC

    Neurosciences

  • RCDC

    Rehabilitation

  • RCDC

    Spinal Cord Injury

  • RCDC

    Clinical Research

  • RCDC

    Neurodegenerative

  • HRCS HC

    Neurological

  • Health Research Areas

    Clinical