The Cerebral Palsy (CP) Common Data Elements (CDE) Working Groups and the National Institute of Neurological Disorders and Stroke (NINDS) CDE Team developed Version 1.0 of the CP CDEs in 2015 through a partnership between NINDS and the American Academy of Cerebral Palsy and Developmental Medicine (AACPDM).
To develop the Cerebral Palsy CDEs, the Cerebral Palsy CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:
- Engagement and Quality of Life Assessments/Data
- Health, Growth, Genetics, Comorbidities and Labs
- Neurocognitive, Social, and Emotional Assessments
- Neuroimaging Diagnostics
- Neuromotor Skills and Functional Assessments
- Participant Characteristics and Disease/Injury Related Events
Data standards include CDEs as well as case report form (CRF) Modules, Guidance documents and Instrument Notice of Copyright (NOC) documents. The CRF Modules logically organize the CDEs for data collection, the Guidance documents provide further information about the CDE, and the NOC documents include perinent information on recommended instruments. The CDE, CRF Modules, Guidance documents and NOCs presented are organized into domains which are intuitive and common in clinical research studies. Version 1.0 of the Cerebral Palsy CDEs were released in 2016.
The Cerebral Palsy CDE Oversight Committee (OC) was created in 2017 to periodically review, direct the updating, and advance the development of the CP CDEs.
Since 2017 the CP OC has convened regularly to develop CDEs beyond the defined data elements in the CP Version 1.0 domains. In 2018 the CP OC developed and posted the External Device – CP CRF, and in 2020 developed and posted the Participant Condition Characteristics CRF on the Cerebral Palsy data standards page.
In 2019 the CP OC convened to review validated instruments in the domain of chronic pain, and research standardized orthopedic surgeries and assessments for new CP CDEs. During this process, the CP OC formed two subgroups. The CP Pain subgroup recommended 15 Pain Instruments to assess chronic pain and the CP Orthopedic Surgery subgroup developed six CRFs and associated CDE data dictionaries for lower extremities.
After a public review period of the draft CP CDEs, from April 27, 2022 to June 1, 2022, the CP OC recommended 15 Pain Instruments and six Orthopedic Surgical CRFs and CDE Data Dictionaries were posted on the CP data standards page in August 2022. In September 2022, the CP Pain and CP Orthopedic Surgery subgroups presented the development of their respective CDEs and recommendations for pain instruments at the 76th Annual AACPDM Meeting in Las Vegas, NV.