The Influence of ICF and ICF Core Sets in Selecting the NINDS Cerebral Palsy Common Data Element Outcome Measures

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Brandenburg, Joline; Schiariti, Verónica; Mendoza-Puccini, M Carolina; Feldman, Robin; Joseph, Kristen; Esterlitz, Joy on behalf of the Cerebral Palsy CDE Oversight Committee and Working Group
Cerebral Palsy Common Data Element Outcome Measures.; Influence of ICF and ICF Core Sets; NINDS
Background: 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). Version 1.0 of the CDEs for CP is publicly available on the NINDS CDE and AACPDM websites. The CDEs are content standards that can be applied to various data collection models, are intended to be dynamic, and may evolve over time. Objective(s): To highlight the ongoing application of the International Classification of Functioning, Disability, and Health (ICF) and ICF Core Sets for CP as theoretical frameworks for outcome measures selection during the development of the NINDS version 1.0 CP CDE. Study Design: Guided by the ICF framework, international experts reviewed existing NINDS CDEs and tools used in studies of children and young people with CP. Tools include multiple-item measures, single-item measures, classifications systems, a score obtained through physical examination, a laboratory measurement, or a score obtained through observation of an image. (Figure 1) Figure 1. National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) for Cerebral Palsy (CP) Project: workflow and conceptual framework Materials/Methods: The CP CDE working groups (WG) applied the following selection criteria: (1) applicable to children and young people aged 0 to 18 years; (2) represents relevant areas of study in CP; and (3) has documented validity and reliability to select CDEs and outcome measures for the version 1.0 CP CDE recommendations. Once outcome measures were selected, they were classified as Core, Supplemental – Highly Recommended, Supplemental, or Exploratory. Results: NINDS domains were populated with the most appropriate CDEs and outcome measures incorporating the ICF components and chapters. Outcome measures included in Version 1.0 recommended as ‘Supplemental – Highly Recommended’ primarily represented the ICF component body functions but also included some domains of the component activities and participation. Many measures covered areas of neuromusculoskeletal and movement-related functions, intellectual functions, general tasks and demands, and mobility. However, when comparing the main content of selected CDE tools to the content of the ICF Core Sets for CP, some relevant areas are under-represented by the current version of the CDEs, for example sensation of pain, sensory functions, sleep functions, support and attitude of peers, role of products and technology – including assistive devices for daily living, education, and recreation. Conclusions/Significance: The ICF and ICF Core Sets for CP provided useful guidelines for the NINDS CP CDE WG to identify gaps and overlaps in content of outcome measures included in current CDEs. The CP CDEs are an evolving resource, and the ICF and ICF Core Sets for CP will continue to be considered as research progresses and the CP CDEs are updated.