Cargando…
Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials
STUDY DESIGN: This is a focused review article. OBJECTIVES: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presente...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5951792/ https://www.ncbi.nlm.nih.gov/pubmed/29284795 http://dx.doi.org/10.1038/s41393-017-0015-5 |
_version_ | 1783323069477027840 |
---|---|
author | Jones, Linda A. T. Bryden, Anne Wheeler, Tracey L. Tansey, Keith E. Anderson, Kim D. Beattie, Michael S. Blight, Andrew Curt, Armin Field-Fote, Edelle Guest, James D. Hseih, Jane Jakeman, Lyn B. Kalsi-Ryan, Sukhvinder Krisa, Laura Lammertse, Daniel P. Leiby, Benjamin Marino, Ralph Schwab, Jan M. Scivoletto, Giorgio Tulsky, David S. Wirth, Ed Zariffa, José Kleitman, Naomi Mulcahey, Mary Jane Steeves, John D. |
author_facet | Jones, Linda A. T. Bryden, Anne Wheeler, Tracey L. Tansey, Keith E. Anderson, Kim D. Beattie, Michael S. Blight, Andrew Curt, Armin Field-Fote, Edelle Guest, James D. Hseih, Jane Jakeman, Lyn B. Kalsi-Ryan, Sukhvinder Krisa, Laura Lammertse, Daniel P. Leiby, Benjamin Marino, Ralph Schwab, Jan M. Scivoletto, Giorgio Tulsky, David S. Wirth, Ed Zariffa, José Kleitman, Naomi Mulcahey, Mary Jane Steeves, John D. |
author_sort | Jones, Linda A. T. |
collection | PubMed |
description | STUDY DESIGN: This is a focused review article. OBJECTIVES: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified. METHODS: The methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review. RESULTS: COAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered. CONCLUSIONS: With an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA. SPONSORS: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor. |
format | Online Article Text |
id | pubmed-5951792 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-59517922018-05-16 Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials Jones, Linda A. T. Bryden, Anne Wheeler, Tracey L. Tansey, Keith E. Anderson, Kim D. Beattie, Michael S. Blight, Andrew Curt, Armin Field-Fote, Edelle Guest, James D. Hseih, Jane Jakeman, Lyn B. Kalsi-Ryan, Sukhvinder Krisa, Laura Lammertse, Daniel P. Leiby, Benjamin Marino, Ralph Schwab, Jan M. Scivoletto, Giorgio Tulsky, David S. Wirth, Ed Zariffa, José Kleitman, Naomi Mulcahey, Mary Jane Steeves, John D. Spinal Cord Review Article STUDY DESIGN: This is a focused review article. OBJECTIVES: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified. METHODS: The methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review. RESULTS: COAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered. CONCLUSIONS: With an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA. SPONSORS: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor. Nature Publishing Group UK 2017-12-28 2018 /pmc/articles/PMC5951792/ /pubmed/29284795 http://dx.doi.org/10.1038/s41393-017-0015-5 Text en © The Author(s) 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits use, duplication, adaptation, distribution, and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Review Article Jones, Linda A. T. Bryden, Anne Wheeler, Tracey L. Tansey, Keith E. Anderson, Kim D. Beattie, Michael S. Blight, Andrew Curt, Armin Field-Fote, Edelle Guest, James D. Hseih, Jane Jakeman, Lyn B. Kalsi-Ryan, Sukhvinder Krisa, Laura Lammertse, Daniel P. Leiby, Benjamin Marino, Ralph Schwab, Jan M. Scivoletto, Giorgio Tulsky, David S. Wirth, Ed Zariffa, José Kleitman, Naomi Mulcahey, Mary Jane Steeves, John D. Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
title | Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
title_full | Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
title_fullStr | Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
title_full_unstemmed | Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
title_short | Considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
title_sort | considerations and recommendations for selection and utilization of upper extremity clinical outcome assessments in human spinal cord injury trials |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5951792/ https://www.ncbi.nlm.nih.gov/pubmed/29284795 http://dx.doi.org/10.1038/s41393-017-0015-5 |
work_keys_str_mv | AT joneslindaat considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT brydenanne considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT wheelertraceyl considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT tanseykeithe considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT andersonkimd considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT beattiemichaels considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT blightandrew considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT curtarmin considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT fieldfoteedelle considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT guestjamesd considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT hseihjane considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT jakemanlynb considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT kalsiryansukhvinder considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT krisalaura considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT lammertsedanielp considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT leibybenjamin considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT marinoralph considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT schwabjanm considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT scivolettogiorgio considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT tulskydavids considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT wirthed considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT zariffajose considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT kleitmannaomi considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT mulcaheymaryjane considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials AT steevesjohnd considerationsandrecommendationsforselectionandutilizationofupperextremityclinicaloutcomeassessmentsinhumanspinalcordinjurytrials |