Zachary M Grinspan1, Anup D Patel2, Renée A Shellhaas3, Anne T Berg4,5, Erika T Axeen6, Jeffrey Bolton7,8, David F Clarke9, Jason Coryell10, William D Gaillard11, Howard P Goodkin6, Sookyong Koh12, Alison Kukla13, Juma S Mbwana11, Lindsey A Morgan14,15, Nilika S Singhal16, Margaret M Storey17, Elissa G Yozawitz18, Nicholas S Abend19,20, Mark P Fitzgerald19,20, Sara E Fridinger19,20, Ingo Helbig19,20,21,22, Shavonne L Massey19,20, Marisa S Prelack19,20, Jeffrey Buchhalter23. 1. Departments of Population Health Sciences and Pediatrics, Weill Cornell Medicine, New York, NY, USA. 2. Division of Neurology, Nationwide Children's Hospital, Columbus, OH, USA. 3. Department of Pediatrics (Pediatric Neurology), Michigan Medicine, University of Michigan, Ann Arbor, MI, USA. 4. Division of Neurology, Epilepsy Center, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA. 5. Department of Pediatrics, Northwestern Feinberg School of Medicine, Chicago, IL, USA. 6. Department of Neurology, University of Virginia, Charlottesville, VA, USA. 7. Harvard Medical School, Boston, MA, USA. 8. Division of Epilepsy and Clinical Neurophysiology, Department of Neurology, Boston Children's Hospital, Boston, MA, USA. 9. Division of Pediatric Neurology, Department of Neurology, Dell Medical School, University of Texas at Austin, Austin, TX, USA. 10. Departments of Pediatrics and Neurology, Oregon Health and Sciences University, Portland, OR, USA. 11. Department of Neurology, Children's National Health System and School of Medicine, George Washington University, Washington, DC, USA. 12. Department of Pediatrics, Emory Children's Center, Emory University School of Medicine, Atlanta, GA, USA. 13. Epilepsy Foundation, Landover, MD, USA. 14. Center for Integrative Brain Research, Seattle Children's Research Institute, Seattle, WA, USA. 15. Departments of Pediatrics and Neurology, Seattle Children's Hospital, University of Washington, Washington, DC, USA. 16. Departments of Neurology and Pediatrics, UCSF Benioff Children's Hospital, University of California, San Francisco, CA, USA. 17. Department of History, College of Liberal Arts and Social Sciences, DePaul University, Chicago, IL, USA. 18. Saul Korey Department of Neurology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA. 19. Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA, USA. 20. Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 21. Epilepsy NeuroGenetics Initiative, Children's Hospital of Philadelphia, Philadelphia, PA, USA. 22. Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, PA, USA. 23. Department of Neurology, St Joseph's Hospital and Medical Center, Phoenix, AZ, USA.
Abstract
OBJECTIVE: Common 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. METHODS: A 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. RESULTS: Common 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. SIGNIFICANCE: We created, piloted, refined, finalized, and implemented a novel set of clinical CDEs for pediatric epilepsy.
OBJECTIVE: Common 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. METHODS: A 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. RESULTS: Common 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. SIGNIFICANCE: We created, piloted, refined, finalized, and implemented a novel set of clinical CDEs for pediatric epilepsy.
Authors: Juliet K Knowles; Ingo Helbig; Cameron S Metcalf; Laura S Lubbers; Lori L Isom; Scott Demarest; Ethan M Goldberg; Alfred L George; Holger Lerche; Sarah Weckhuysen; Vicky Whittemore; Samuel F Berkovic; Daniel H Lowenstein Journal: Epilepsia Date: 2022-07-17 Impact factor: 6.740
Authors: David Lewis-Smith; Shridhar Parthasarathy; Julie Xian; Michael C Kaufman; Shiva Ganesan; Peter D Galer; Rhys H Thomas; Ingo Helbig Journal: Hum Mutat Date: 2022-05-22 Impact factor: 4.700
Authors: Julie Xian; Shridhar Parthasarathy; Sarah M Ruggiero; Ganna Balagura; Eryn Fitch; Katherine Helbig; Jing Gan; Shiva Ganesan; Michael C Kaufman; Colin A Ellis; David Lewis-Smith; Peter Galer; Kristin Cunningham; Margaret O'Brien; Mahgenn Cosico; Kate Baker; Alejandra Darling; Fernanda Veiga de Goes; Christelle M El Achkar; Jan Henje Doering; Francesca Furia; Ángeles García-Cazorla; Elena Gardella; Lisa Geertjens; Courtney Klein; Anna Kolesnik-Taylor; Hanna Lammertse; Jeehun Lee; Alexandra Mackie; Mala Misra-Isrie; Heather Olson; Emma Sexton; Beth Sheidley; Lacey Smith; Luiza Sotero; Hannah Stamberger; Steffen Syrbe; Kim Marie Thalwitzer; Annemiek van Berkel; Mieke van Haelst; Christopher Yuskaitis; Sarah Weckhuysen; Ben Prosser; Charlene Son Rigby; Scott Demarest; Samuel Pierce; Yuehua Zhang; Rikke S Møller; Hilgo Bruining; Annapurna Poduri; Federico Zara; Matthijs Verhage; Pasquale Striano; Ingo Helbig Journal: Brain Date: 2022-06-03 Impact factor: 15.255
Authors: Mark P Fitzgerald; Michael C Kaufman; Shavonne L Massey; Sara Fridinger; Marisa Prelack; Colin Ellis; Xilma Ortiz-Gonzalez; Lawrence E Fried; Marissa P DiGiovine; Susan Melamed; Marissa Malcolm; Brenda Banwell; Donna Stephenson; Stephanie M Witzman; Alexander Gonzalez; Dennis Dlugos; Sudha Kilaru Kessler; Ethan M Goldberg; Nicholas S Abend; Ingo Helbig Journal: Epilepsia Date: 2021-06-02 Impact factor: 5.864