Design and implementation of electronic health record common data elements for pediatric epilepsy: Foundations for a learning health care system

Abstract

ObjectiveCommon data elements (CDEs) are standardized questions and answer choices that allow aggregation, analysis, and comparison of observations from multiple sources. Clinical CDEs are foundational for learning health care systems, a data‐driven approach to health care focused on continuous improvement of outcomes. We aimed to create clinical CDEs for pediatric epilepsy.MethodsA multiple stakeholder group (clinicians, researchers, parents, caregivers, advocates, and electronic health record [EHR] vendors) developed clinical CDEs for routine care of children with epilepsy. Initial drafts drew from clinical epilepsy note templates, CDEs created for clinical research, items in existing registries, consensus documents and guidelines, quality metrics, and outcomes needed for demonstration projects. The CDEs were refined through discussion and field testing. We describe the development process, rationale for CDE selection, findings from piloting, and the CDEs themselves. We also describe early implementation, including experience with EHR systems and compatibility with the International League Against Epilepsy classification of seizure types.ResultsCommon data elements were drafted in August 2017 and finalized in January 2020. Prioritized outcomes included seizure control, seizure freedom, American Academy of Neurology quality measures, presence of common comorbidities, and quality of life. The CDEs were piloted at 224 visits at 10 centers. The final CDEs included 36 questions in nine sections (number of questions): diagnosis (1), seizure frequency (9), quality of life (2), epilepsy history (6), etiology (8), comorbidities (2), treatment (2), process measures (5), and longitudinal history notes (1). Seizures are categorized as generalized tonic‐clonic (regardless of onset), motor, nonmotor, and epileptic spasms. Focality is collected as epilepsy type rather than seizure type. Seizure frequency is measured in nine levels (all used during piloting). The CDEs were implemented in three vendor systems. Early clinical adoption included 1294 encounters at one center.SignificanceWe created, piloted, refined, finalized, and implemented a novel set of clinical CDEs for pediatric epilepsy.

Assessing seizure burden in pediatric epilepsy using an electronic medical record–based tool through a common data element approach

“…We created an epilepsy history form within the Epic EMR at our institution that completed clinical documentation while recording standardized data by utilizing CDE that aligned with frameworks recommended by epilepsy learning health systems. 10 We demonstrate that such a documentation tool can be deployed at scale in a large pediatric epilepsy center and that it allows for assessment of seizure frequency and improvement in specific patient cohorts. We observe that seizure frequency and seizure improvement are stable over time in our overall patient cohort, with specific patient groups experiencing high seizure burden with limited improvement (LGS) and others experiencing more modest seizure burden with more substantial improvement (CECTS).…”

“…Herein, we report on the implementation of standardized documentation of seizure frequency in >1000 individuals with pediatric epilepsies who received care at a large pediatric health network over a 12‐month period. We created an epilepsy history form within the Epic EMR at our institution that completed clinical documentation while recording standardized data by utilizing CDE that aligned with frameworks recommended by epilepsy learning health systems 10 . We demonstrate that such a documentation tool can be deployed at scale in a large pediatric epilepsy center and that it allows for assessment of seizure frequency and improvement in specific patient cohorts.…”

“…The form was designed by a panel of epileptologists at our institution through group consensus. The EHF contains fields for site‐level work and also fields that were chosen intentionally because they are aligned with or could be mapped to fields required for multi‐center initiatives including the PELHS and the ELHS 10 . The EHF contained a total of 26 main items and additional sub‐categories.…”

“…The EHF contains fields for site-level work and also fields that were chosen intentionally because they are aligned with or could be mapped to fields required for multicenter initiatives including the PELHS and the ELHS. 10 The EHF contained a total of 26 main items and additional subcategories. It assessed details of epilepsy history including seizure semiology, overall seizure frequency, epilepsy type and syndrome, medication side effects, common epilepsy comorbidities, and important counseling topics such as sudden unexplained death in epilepsy (SUDEP) and folate supplementation for women with epilepsy (Figure 1 and Table S1).…”

“…Our EEG CDEs have been in use for several years and are well accepted by clinicians 9 . Several national and international initiatives, including the Epilepsy Learning Health System (ELHS) supported by the Epilepsy Foundation and the Pediatric Epilepsy Learning Health System (PELHS), have also developed CDEs to facilitate collection of large‐scale data during routine clinical encounters 10 . Interoperable EMR‐based tools have been established for both learning health systems; however, it is not established whether such tools can be deployed successfully across entire health systems at large scale.…”