Cerebral Palsy Research Network Clinical Registry: Methodology and Baseline Report

Abstract

Objective To apply practice-based evidence to clinical management of cerebral palsy (CP). The process of establishing purpose, structure, logistics, and elements of a multi-institutional registry and the baseline characteristics of initial enrollees are reported. Design A consensus-building process among consumers, clinicians, and researchers used a participatory action process. Setting Community, hospitals, and universities. Participants More than 100 clinicians, researchers, and consumers and more than 1858 enrollees in the registry. Main Outcome Measures Not applicable. Results Consensus was that the purpose of registry was to (1) quantify practice variation, (2) facilitate quality improvement (QI), and (3) perform comparative effectiveness research (CER). Collecting data during routine clinical care using the electronic medical record was determined to be a sustainable plan for data acquisition and management. Clinicians from multiple disciplines defined salient characteristics of individuals and interventions for the registry elements. The registry was central to the clinical research network, and a leadership structure was created. A leading electronic health record platform adopted the registry elements. Twenty-four sites have initiated the data collection process and agreed to export data to the registry. Currently 12 are collecting data. Number of enrollees and characteristics were similar to other population registers. Conclusions This is the first multi-institutional CP registry that contains the patient and treatment characteristics needed for QI and CER. The Cerebral Palsy Research Network registry elements are implemented in a versatile electronic platform and minimize burden to clinicians. The resultant registry is available for any institution to participate and is growing rapidly.

Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies

“…Clinical phenotypic data is entered by clinicians caring for patients in real time, and data is captured and securely transferred to the data coordinating center at the University of Pittsburgh. 32 Participation in the CPRN clinical registry thus provides crucial phenotypic data. Privacy-preserving records linkage may then be used to link the clinical and genomic sequencing datasets, effectively connecting phenotype with genotype.…”

Epilepsy and proxy‐reported health‐related quality of life in children and young people with non‐ambulatory cerebral palsy

“…Provider‐entered data were obtained during the clinical visit utilizing data elements embedded in forms built for the Cerebral Palsy Research Network clinical registry 12 and an epilepsy‐specific form utilized by Nationwide Children's Hospital within the Epic electronic health record (Epic Systems Corp, Verona, WI, USA). Epilepsy type was determined by the neurology provider caring for the patient based on seizure semiology, electroencephalogram findings, and other clinical features according to the standard terminology 13 .…”

“…Data were summarized using frequency (percent) for categorical variables and median (interquartile range [IQR]) for continuous variables. While the number of days with seizures and side effects in the last 28 days were collected at a more granular level (1 day, 2–3 days, 4–14 days, 15–27 days, all 28 days, uncertain), aggregated categories of no days, some days ( 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 ), all 28 days, or uncertain were used for modeling because of small numbers in several categories. A composite variable was created using information about vagus nerve stimulation (VNS) and epilepsy surgery data, grouping participants into having had no surgery for epilepsy, VNS, or intracranial epilepsy surgeries (‘non‐VNS surgery’).…”

Lessons learned in the development of a nurse‐led family centered approach to developing a holistic comprehensive clinic and integrative holistic care plan for children with cerebral palsy

“…Along with the clinical restructuring of care, the electronic medical record was utilized to capture data that could be analyzed to improve clinical care through a Learning Health System model (Gross et al, 2020; Lowes et al, 2016).…”