TY - JOUR
T1 - A common data language for clinical research studies
T2 - the National Institute of Neurological Disorders and Stroke and American Academy for Cerebral Palsy and Developmental Medicine Cerebral Palsy Common Data Elements Version 1.0 recommendations
AU - Schiariti, Verónica
AU - Fowler, Eileen
AU - Brandenburg, Joline E.
AU - Levey, Eric
AU - Mcintyre, Sarah
AU - Sukal-Moulton, Theresa
AU - Ramey, Sharon L.
AU - Rose, Jessica
AU - Sienko, Susan
AU - Stashinko, Elaine
AU - Vogtle, Laura
AU - Feldman, Robin S.
AU - Koenig, James I.
N1 - Funding Information:
The views expressed here are those of the authors and do not represent those of the National Institutes of Health, the National Institute of Neurological Disorders and Stroke (NINDS), or the US Government. Logistics support for this project was provided, in part, through National Institutes of Health contract HHSN271201200034C. The development of the NINDS CP CDEs was made possible thanks to the great investment of time and effort of working group members and the members of the NINDS Common Data Elements Project team participating from 2015 to present. Dr. Verónica Schiariti was the recipient of a NeuroDevNet & Child and Family Research Institute Postdoctoral Fellowship Award (2014-2016), supporting this study
Publisher Copyright:
© 2018 Mac Keith Press
PY - 2018/10
Y1 - 2018/10
N2 - To increase the efficiency and effectiveness of clinical research studies, cerebral palsy (CP) specific Common Data Elements (CDEs) were developed through a partnership between the National Institute of Neurological Disorders and Stroke (NINDS) and the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM). International experts reviewed existing NINDS CDEs and tools used in studies of children and young people with CP. CDEs were compiled, subjected to internal review, and posted online for external public comment in September 2016. Guided by the International Classification of Functioning, Disability and Health framework, CDEs were categorized into six domains: (1) participant characteristics; (2) health, growth, and genetics; (3) neuroimaging; (4) neuromotor skills and functional assessments; (5) neurocognitive, social, and emotional assessments; and (6) engagement and quality of life. Version 1.0 of the NINDS/AACPDM CDEs for CP is publicly available on the NINDS CDE and AACPDM websites. Global use of CDEs for CP will standardize data collection, improve data quality, and facilitate comparisons across studies. Ongoing collaboration with international colleagues, industry, and people with CP and their families will provide meaningful feedback and updates as additional evidence is obtained. These CDEs are recommended for NINDS-funded research for CP. What this paper adds: This is the first comprehensive Common Data Elements (CDEs) for children and young people with CP for clinical research. The CDEs for children and young people with CP include common definitions, the standardization of case report forms, and measures. The CDE guides the standardization for data collection and outcome evaluation in all types of studies with children and young people with CP. The CDE ultimately improves data quality and data sharing.
AB - To increase the efficiency and effectiveness of clinical research studies, cerebral palsy (CP) specific Common Data Elements (CDEs) were developed through a partnership between the National Institute of Neurological Disorders and Stroke (NINDS) and the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM). International experts reviewed existing NINDS CDEs and tools used in studies of children and young people with CP. CDEs were compiled, subjected to internal review, and posted online for external public comment in September 2016. Guided by the International Classification of Functioning, Disability and Health framework, CDEs were categorized into six domains: (1) participant characteristics; (2) health, growth, and genetics; (3) neuroimaging; (4) neuromotor skills and functional assessments; (5) neurocognitive, social, and emotional assessments; and (6) engagement and quality of life. Version 1.0 of the NINDS/AACPDM CDEs for CP is publicly available on the NINDS CDE and AACPDM websites. Global use of CDEs for CP will standardize data collection, improve data quality, and facilitate comparisons across studies. Ongoing collaboration with international colleagues, industry, and people with CP and their families will provide meaningful feedback and updates as additional evidence is obtained. These CDEs are recommended for NINDS-funded research for CP. What this paper adds: This is the first comprehensive Common Data Elements (CDEs) for children and young people with CP for clinical research. The CDEs for children and young people with CP include common definitions, the standardization of case report forms, and measures. The CDE guides the standardization for data collection and outcome evaluation in all types of studies with children and young people with CP. The CDE ultimately improves data quality and data sharing.
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U2 - 10.1111/dmcn.13723
DO - 10.1111/dmcn.13723
M3 - Review article
C2 - 29542813
AN - SCOPUS:85052819639
SN - 0012-1622
VL - 60
SP - 976
EP - 986
JO - Developmental medicine and child neurology
JF - Developmental medicine and child neurology
IS - 10
ER -