Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group

Abstract

Introduction: Variability in usage and definition of data characteristics in previous cohort studies on unruptured intracranial aneurysms (UIA) complicated pooling and proper interpretation of these data. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke UIA and Subarachnoid Hemorrhage (SAH) Common Data Elements (CDE) Project was to provide a common structure for data collection in future research on UIA and SAH. Methods: This paper describes the development and summarization of the recommendations of the working groups (WGs) on UIAs, which consisted of an international and multidisciplinary panel of cerebrovascular specialists on research and treatment of UIAs. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the literature on UIAs. Recommendations for CDEs were classified by priority into 'Core, ' 'Supplemental-Highly Recommended, ' 'Supplemental, ' and 'Exploratory. ' Results: Ninety-one CDEs were compiled; 69 were newly created and 22 were existing CDEs. The CDEs were assigned to eight subcategories and were classified as Core (8), Supplemental-Highly Recommended (23), Supplemental (25), and Exploratory (35) elements. Additionally, the WG developed and agreed on a classification for aneurysm morphology. Conclusion: The proposed CDEs have been distilled from a broad pool of characteristics, measures, or outcomes. The usage of these CDEs will facilitate pooling of data from cohort studies or clinical trials on patients with UIAs.

Relationship between 3D Morphologic Change and 2D and 3D Growth of Unruptured Intracranial Aneurysms

“…[5][6][7] Generally, the definition of growth includes a certain increase in aneurysm size and/or any morphologic change. 8 Currently, it remains unclear which definition is most relevant and how morphologic changes relate to any change in aneurysmal size. UIA size and morphology are currently assessed with caliper measurements and visual classification by human observers, which can be prone to measurement errors and poor reproducibility.…”

“…Growing UIAs were defined according to the clinical definition of 2D growth of $1-mm increase in any direction between the baseline and follow-up scan. 8 All other UIAs were categorized as nongrowing. The difference in morphology measurements between baseline and follow-up scans was determined for each UIA (morphologic change) and compared between the populations of growing and nongrowing UIAs.…”

Scoring of Growth of Unruptured Intracranial Aneurysms

“…Core and most highly recommended supplementary variables for the study of UIA were available for the present purpose [ 22 ], and the ELAPSS score [ 16 ] was recorded for each patient from variables at the baseline. Hypertension at baseline was defined as a systolic pressure repeatedly >140 mm Hg, a diastolic pressure >90 mm Hg, or use of antihypertensive medication.…”

Intracranial aneurysm wall (in)stability–current state of knowledge and clinical perspectives

“…The goal of this project was to elaborate common definitions concerning IA and SAH, and to create data sets to capture and record information consistently across hospitals and research teams. In 2019, 8 articles describing more than 1300 CDEs about unruptured IAs and SAH have been published to define (1) subject characteristics [ 5 ], (2) assessments and examinations [ 12 ], (3) hospital course and acute therapies [ 13 ], (4) biospecimens and biomarkers [ 11 ], (5) imaging [ 30 ], (6) long-term therapies [ 103 ], (7) cohort studies and clinical trials [ 29 ], and (8) outcomes and endpoints [ 90 ]. The process of selection of each CDE was based on CDEs previously defined in the field of neurovascular diseases, on literature, on experience of group members and experts, on observational studies, and on clinical trials.…”