Airton Leonardo de Oliveira Manoel1,2, Mathieu van der Jagt3, Sepideh Amin-Hanjani4, Nicholas C Bambakidis5, Gretchen M Brophy6, Ketan Bulsara7, Jan Claassen8, E Sander Connolly8, S Alan Hoffer5, Brian L Hoh9, Robert G Holloway10, Adam G Kelly10, Stephan A Mayer11, Peter Nakaji12, Alejandro A Rabinstein13, Peter Vajkoczy14, Mervyn D I Vergouwen15, Henry Woo16, Gregory J Zipfel17, Jose I Suarez18. 1. Neuroscience Research Program in the Keenan Research Centre for Biomedical Science of St. Michael's Hospital, University of Toronto, Toronto, Canada. airtonleo.manoel@gmail.com. 2. Adult Critical Care Unit, Department of Critical Care Medicine, Hospital Paulistano - UnitedHealth Group Brazil, Rua Martiniano de Carvalho, 741, Bela Vista, São Paulo, SP, 01321-001, Brazil. airtonleo.manoel@gmail.com. 3. Department of Intensive Care Adults, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. 4. Department of Neurosurgery, University of Illinois at Chicago, Chicago, USA. 5. Department of Neurological Surgery, UH Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. 6. Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Richmond, VA, USA. 7. Department of Neurosurgery, University of Connecticut, Farmington, CT, USA. 8. Columbia University, New York, NY, USA. 9. Department of Neurosurgery, University of Florida, Gainesville, FL, USA. 10. Department of Neurology, University of Rochester, Rochester, NY, USA. 11. Department of Neurology, Henry Ford Health System, Detroit, MI, USA. 12. Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA. 13. Department of Neurology, Mayo Clinic, Rochester, MN, USA. 14. Department of Neurosurgery, Charite Hospital, Universitatsmedizin, Berlin, Germany. 15. Brain Center Rudolf Magnus, Department of Neurology and Neurosurgery, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. 16. Department of Neurosurgery and Radiology, Zucker School of Medicine at Hofstra/Northwell Health, New York, NY, USA. 17. Washington University in St Louis, St. Louis, MO, USA. 18. Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, USA.
Abstract
INTRODUCTION: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs. METHODS: This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into "core", "supplemental-highly recommended", "supplemental" and "exploratory". RESULTS: We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs. CONCLUSION: Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.
INTRODUCTION: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs. METHODS: This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into "core", "supplemental-highly recommended", "supplemental" and "exploratory". RESULTS: We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs. CONCLUSION: Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.
Entities:
Keywords:
Aneurysm; Clinical studies; Common Data Elements; Data coding; Data collection; Standardization; Subarachnoid hemorrhage
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