Article
The unruptured intracranial aneurysm and subarachnoid hemorrhage common data elements project: results from the unruptured intracranial aneurysms subcommittee
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Authors
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Katharina Hackenberg
- Neurochirurgische Klinik, Universitätsklinikum Mannheim, Mannheim, Deutschland
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Gabriel Rinkel
- Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands
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José Ignacio Suarez
- Division of Vascular Neurology and Neurocritical Care, Department of Neurology, Baylor College of Medicine, Houston, United States
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Loch Macdonald
- Division of Neurosurgery, Department of Surgery, St. Michael's Hospital, University of Toronto, Toronto, Canada
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Daniel Hänggi
- Neurochirurgische Klinik, Universitätsklinikum Mannheim, Mannheim, Deutschland
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Nima Etminan
- Neurochirurgische Klinik, Universitätsklinikum Mannheim, Mannheim, Deutschland
| Published: | June 9, 2017 |
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Outline
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Objective: One major limitation for pooling of data from previous studies on unruptured intracranial aneurysms or aneurysmal subarachnoid hemorrhage remains the lack of homogenous data definitions. Homogenous data definitions would facilitate pooling and thereby enable more robust estimation of effect sizes or risk ratios. The Common Data Elements (CDE) project was therefore initiated under the auspices of The National Institute of Neurological Disorders and Stroke (NINDS) to develop standardized or common data elements definitions (CDEs) for future studies on unruptured cerebral aneurysms and aneurysmal subarachnoid hemorrhage. We here present the final CDEs of the Unruptured intracranial aneurysm (UIA) subcommittee.
Methods: The total CDE group comprised 64 international and multidisciplinary cerebrovascular clinicians and scientists, 10 of which were responsible to identify or develop CDEs on UIAs. Following a systemic review of previous cohort studies on UIAs and existing CDEs, additional and potentially relevant data elements were identified, compiled and defined by means of telephone conferences, emails and face-to-face meetings. The CDEs were all defined based on existing evidence and classified into four categories: 1. core elements, which should be employed in future studies, 2. supplemental highly recommended – strongly advised to use, 3. supplemental – relevance depends on study, 4. exploratory – reasonable to use, validity is limited.
Results: A total of 92 CDEs on UIAs were compiled, 70 of which were newly created and 22 CDE were reused from the ischemic stroke CDEs. The CDE were demographics (n=3), radiological findings (n=27), clinical symptoms and assessment at baseline (n=8), risk factors (n=13), concomitant medications (n=10), concomitant diseases (n=24), reason of medical consult and diagnosis (1) as well as management (n=6) of unruptured aneurysms. Eight CDEs were defined as core, 24 as supplemental highly recommended, 25 as supplemental and 35 exploratory elements. Robust definitions of risk factors for aneurysm growth or rupture and all aneurysm locations could be established. Lastly, the working group developed a formal classification for aneurysm morphology (Type I indicates regular; Type II indicates a bleb and Type III indicates a daughter-sac or multi-lobed aneurysm.
Conclusion: The UIA CDEs developed serve to globally standardize and optimize data for future cohort studies, to ultimately facilitate pooling and comparison of different study populations.
