Outcome measures in spinal cord injury: recent assessments and recommendations for future directions
- PMID: 19381157
- PMCID: PMC2722687
- DOI: 10.1038/sc.2009.18
Outcome measures in spinal cord injury: recent assessments and recommendations for future directions
Abstract
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.
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References
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- Fawcett JW, Curt A, Steeves JD, Coleman WP, Tuszynski MH, et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: spontaneous recovery after spinal cord injury and statistical power needed for therapeutic clinical trials. Spinal Cord. 2007;45:190–205. - PubMed
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- Steeves JD, Lammertse D, Curt A, Fawcett JW, Tuszynski MH, et al. Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures. Spinal Cord. 2007;45:206–21. - PubMed
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- Tuszynski MH, Steeves JD, Fawcett JW, Lammertse D, Kalichman M, et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Panel: clinical trial inclusion/exclusion criteria and ethics. Spinal Cord. 2007;45:222–31. - PubMed
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