Outcome measures in spinal cord injury: recent assessments and recommendations for future directions.
STUDY DESIGN: Review by the spinal cord outcomes partnership endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. OBJECTIVES: Assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. METHODS: a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. RESULTS: Imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain and psychosocial tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. CONCLUSION: Significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial.
Alexander, MS; Anderson, KD; Biering-Sorensen, F; Blight, AR; Brannon, R; Bryce, TN; Creasey, G; Catz, A; Curt, A; Donovan, W; Ditunno, J; Ellaway, P; Finnerup, NB; Graves, DE; Haynes, BA; Heinemann, AW; Jackson, AB; Johnston, MV; Kalpakjian, CZ; Kleitman, N; Krassioukov, A; Krogh, K; Lammertse, D; Magasi, S; Mulcahey, MJ; Schurch, B; Sherwood, A; Steeves, JD; Stiens, S; Tulsky, DS; van Hedel, HJA; Whiteneck, G
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