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VA HSR&D Stroke QUERI Center Project

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VETERAN-CENTERED OUTCOMES USING QUALITATIVE AND QUANTITATIVE METHODS

Elizabeth M. Hannold, PhD, Co-Investigator
Maude R. Rittman, PhD, Project Consultant

Project Number O4052I funded by RR&D.
March 1, 2006 - February 28, 2008


Project Background

Existing clinically-generated measures, in general, have been developed independent of input from veterans. The purpose of this collaborative grant is to take advantage of qualitative and quantitative expertise from the Gainesville, FL Rehabilitation Outcomes Research Center (RORC) with state-of-the-art gait intervention research being conducted at the Gainesville Brain Rehabilitation Research Center (BRRC) and the Cleveland Functional Electrical Stimulation Center (FESC). Three interventions have received considerable attention for their demonstrated promise in improving gait and mobility in individuals with spinal cord injury and stroke: 1) manually assisted locomotor training (MLT), 2) robotic assisted locomotor training (RLT), and 3) functional electrical stimulation assisted gait training (FES-GT). These interventions will be the basis for improving existing outcome measures and developing new outcome measures.

Project Objectives

The objective of this study is to modify and develop measures that reflect outcomes that are relevant to recovering veterans and are sensitive to the improvements resulting from innovative gait interventions. The specific objectives of the proposal are to: 1) Define/describe experiences of veterans during MLT, RLT, and FES-GT treatment, 2) Generate new items that will improve e3xisting outcome measures and identify new veteran-centered outcomes, 3) Develop item banks for new veteran-centered outcomes using an IRT measurement framework. The major goal of the proposed project is to combine qualitative research methods and IRT to enhance existing measures and develop new outcome measures for veterans receiving innovative forms of gait rehabilitation.

Project Methods

The process of developing and evaluating valid outcome measures requires four phases of development. The funding requested in the proposal encompasses Phases I and II. Phase I (Year 1 of the grant) will involve completing qualitative research studies to identify constructs reflecting the impact of MLT, RLT and FES-GT on veterans. Data will be systematically collected using ethnographic field observations and in depth, semi-structured interviews. This multi-method approach will reveal the patients' perspectives of treatment outcomes via a dynamic, person-centered process that captures patients' treatment experiences, and the impact of treatments on patients' ability to participate in their home/community environments. Each of the 20 participants will be interviewed and observed three times - once at the beginning, mid-point, and end of treatment (total of 60 observations). Phase II (Year 2) will involve using the identified constructs to develop item banks for veteran-centered outcome measures. Transcripts of interviews and field notes, coded by research investigators, will be used to identify consistent themes and patterns that define and describe participant/patient experiences of activities performed in treatment, home and community settings. Researchers from the collaborative centers (teleconferenced bi-weekly meetings) will identify themes that are consistent with existing instruments (e.g., gait and balance) and three to five new themes that will be used to create new outcome measures. The Item Response Theory (IRT), Rasch measurement model will serve as the framework to enhance existing measures to build new measures. The qualitative themes expressed by participants will be elaborated into measurement "variables" reflecting a hierarchical continuum of difficulty, e.g., "unstable walking on a flat surface," "unstable climbing up steps," "unstable when attempting to jog."

Project Findings

No findings to report at this time.

Project Status

Data collection.

Project Impact

Dr. Velozo and colleagues have shown that the above process results in measures that match patient ability well (i.e. avoids ceiling and floor effects) and are effective in separating patients into statistically significant ability levels. The work accomplished through this collaboration will establish the foundation for future research proposals directed at Phase III - administering a paper-and-pencil version of the instrument for Rasch analysis to determine item level psychometrics and concurrent validity of these new measures against existing outcome measures (e.g., the Functional Independence Measure and Dynamic Gait Index), and Phase IV - developing a computerized adaptive test (CAT) version of the measure and conducting prospective cohort studies to determine the responsiveness of the CAT to recovery and clinical interventions.