Premium
A common data language for clinical research studies: 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
Author(s) -
Schiariti Verónica,
Fowler Eileen,
Brandenburg Joline E,
Levey Eric,
Mcintyre Sarah,
SukalMoulton Theresa,
Ramey Sharon L,
Rose Jessica,
Sienko Susan,
Stashinko Elaine,
Vogtle Laura,
Feldman Robin S,
Koenig James I
Publication year - 2018
Publication title -
developmental medicine and child neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.658
H-Index - 143
eISSN - 1469-8749
pISSN - 0012-1622
DOI - 10.1111/dmcn.13723
Subject(s) - cerebral palsy , international classification of functioning, disability and health , medicine , standardization , data collection , neurocognitive , general partnership , quality of life (healthcare) , family medicine , psychiatry , physical therapy , cognition , nursing , rehabilitation , statistics , mathematics , finance , political science , law , economics
To increase the efficiency and effectiveness of clinical research studies, cerebral palsy ( CP ) specific Common Data Elements ( CDE s) 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 CDE s and tools used in studies of children and young people with CP . CDE s 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, CDE s 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 CDE s for CP is publicly available on the NINDS CDE and AACPDM websites. Global use of CDE s 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 CDE s 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.