Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Neurocritical Care
Published in: Neurocritical Care 1/2019

01-06-2019 | Intracranial Aneurysm | Special Article

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

Authors: Katharina A. M. Hackenberg, Ale Algra, Rustam Al-Shahi Salman, Juhana Frösen, David Hasan, Seppo Juvela, David Langer, Philip Meyers, Akio Morita, Gabriel Rinkel, Nima Etminan, the Unruptured Aneurysms and SAH CDE Project Investigators

Published in: Neurocritical Care | Special Issue 1/2019

Login to get access

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.
Literature
1.
Vlak MH, Rinkel GJ, Greebe P, Algra A. Risk of rupture of an intracranial aneurysm based on patient characteristics: a case–control study. Stroke. 2013;44(5):1256–9.CrossRef
2.
Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009;8(7):635–42.CrossRef
3.
Lovelock CE, Rinkel GJ, Rothwell PM. Time trends in outcome of subarachnoid hemorrhage: population-based study and systematic review. Neurology. 2010;74(19):1494–501.CrossRef
4.
Feigin VL, Rinkel GJ, Lawes CM, Algra A, Bennett DA, van Gijn J, et al. Risk factors for subarachnoid hemorrhage: an updated systematic review of epidemiological studies. Stroke. 2005;36(12):2773–80.CrossRef
5.
Greving JP, Wermer MJ, Brown RD Jr., Morita A, Juvela S, Yonekura M, et al. Development of the PHASES score for prediction of risk of rupture of intracranial aneurysms: a pooled analysis of six prospective cohort studies. Lancet Neurol. 2014;13(1):59–66.CrossRef
6.
Backes D, Rinkel GJE, Greving JP, Velthuis BK, Murayama Y, Takao H, et al. ELAPSS score for prediction of risk of growth of unruptured intracranial aneurysms. Neurology. 2017;88(17):1600–6.CrossRef
7.
8.
Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010;41(9):1969–77.CrossRef
9.
Juvela S, Poussa K, Lehto H, Porras M. Natural history of unruptured intracranial aneurysms: a long-term follow-up study. Stroke. 2013;44(9):2414–21.CrossRef
10.
Lindgren AE, Raisanen S, Bjorkman J, Tattari H, Huttunen J, Huttunen T, et al. De novo aneurysm formation in carriers of saccular intracranial aneurysm disease in eastern Finland. Stroke. 2016;47(5):1213–8.CrossRef
11.
Vlak MH, Rinkel GJ, Greebe P, Algra A. Independent risk factors for intracranial aneurysms and their joint effect: a case-control study. Stroke. 2013;44(4):984–7.CrossRef
12.
Wermer MJ, van der Schaaf IC, Velthuis BK, Algra A, Buskens E, Rinkel GJ. Follow-up screening after subarachnoid haemorrhage: frequency and determinants of new aneurysms and enlargement of existing aneurysms. Brain. 2005;128(Pt 10):2421–9.CrossRef
13.
Etminan N, Beseoglu K, Steiger HJ, Hanggi D. The impact of hypertension and nicotine on the size of ruptured intracranial aneurysms. J Neurol Neurosurg Psychiatry. 2011;82(1):4–7.CrossRef
14.
Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011;10(7):626–36.CrossRef
15.
Juvela S, Poussa K, Porras M. Factors affecting formation and growth of intracranial aneurysms: a long-term follow-up study. Stroke. 2001;32(2):485–91.CrossRef
16.
Korja M, Lehto H, Juvela S. Lifelong rupture risk of intracranial aneurysms depends on risk factors: a prospective Finnish cohort study. Stroke. 2014;45(7):1958–63.CrossRef
17.
Igase M, Igase K, Kohara K, Yamashita S, Fujisawa M, Katagi R, et al. Visit-to-visit variability in systolic blood pressure is a novel risk factor for the growth of intracranial aneurysms. Cerebrovasc Dis. 2013;36(5–6):401–6.CrossRef
18.
Juvela S, Korja M. Intracranial aneurysm parameters for predicting a future subarachnoid hemorrhage: a long-term follow-up study. Neurosurgery. 2017;81(3):432–40.CrossRef
19.
Wiebers DO, Whisnant JP, Huston J III, Meissner I, Brown RD Jr, Piepgras DG, et al. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003;362(9378):103–10.CrossRef
20.
Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, et al. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012;366(26):2474–82.CrossRef
21.
Schneiders JJ, Marquering HA, van Ooij P, van den Berg R, Nederveen AJ, Verbaan D, et al. Additional value of intra-aneurysmal hemodynamics in discriminating ruptured versus unruptured intracranial aneurysms. AJNR Am J Neuroradiol. 2015;36(10):1920–6.CrossRef
22.
Backes D, Rinkel GJ, Laban KG, Algra A, Vergouwen MD. Patient- and aneurysm-specific risk factors for intracranial aneurysm growth: a systematic review and meta-analysis. Stroke. 2016;47(4):951–7.CrossRef
23.
Murayama Y, Takao H, Ishibashi T, Saguchi T, Ebara M, Yuki I, et al. Risk analysis of unruptured intracranial aneurysms: prospective 10-year cohort study. Stroke. 2016;47(2):365–71.CrossRef
24.
Ishibashi T, Murayama Y, Urashima M, Saguchi T, Ebara M, Arakawa H, et al. Unruptured intracranial aneurysms: incidence of rupture and risk factors. Stroke. 2009;40(1):313–6.CrossRef
25.
Matsubara S, Hadeishi H, Suzuki A, Yasui N, Nishimura H. Incidence and risk factors for the growth of unruptured cerebral aneurysms: observation using serial computerized tomography angiography. J Neurosurg. 2004;101(6):908–14.CrossRef
26.
Miyazawa N, Akiyama I, Yamagata Z. Risk factors for growth of unruptured intracranial aneurysms: follow-up study by serial 0.5-T magnetic resonance angiography. Neurosurgery. 2006;58(6):1047–53 (discussion -53).CrossRef
27.
Jing L, Fan J, Wang Y, Li H, Wang S, Yang X, et al. Morphologic and hemodynamic analysis in the patients with multiple intracranial aneurysms: ruptured versus unruptured. PLoS ONE. 2015;10(7):e0132494.CrossRef
28.
Kashiwazaki D, Kuroda S. Size ratio can highly predict rupture risk in intracranial small (< 5 mm) aneurysms. Stroke. 2013;44(8):2169–73.CrossRef
29.
Burns JD, Huston J III, Layton KF, Piepgras DG, Brown RD Jr. Intracranial aneurysm enlargement on serial magnetic resonance angiography: frequency and risk factors. Stroke. 2009;40(2):406–11.CrossRef
30.
Bor AS, Tiel Groenestege AT, terBrugge KG, Agid R, Velthuis BK, Rinkel GJ, et al. Clinical, radiological, and flow-related risk factors for growth of untreated, unruptured intracranial aneurysms. Stroke. 2015;46(1):42–8.CrossRef
31.
de Rooij NK, Velthuis BK, Algra A, Rinkel GJ. Configuration of the circle of Willis, direction of flow, and shape of the aneurysm as risk factors for rupture of intracranial aneurysms. J Neurol. 2009;256(1):45–50.CrossRef
32.
Lindgren AE, Koivisto T, Bjorkman J, von Und Zu Fraunberg M, Helin K, Jaaskelainen JE, et al. Irregular shape of intracranial aneurysm indicates rupture risk irrespective of size in a population-based cohort. Stroke. 2016;47(5):1219–26.CrossRef
33.
Backes D, Vergouwen MD, Velthuis BK, van der Schaaf IC, Bor AS, Algra A, et al. Difference in aneurysm characteristics between ruptured and unruptured aneurysms in patients with multiple intracranial aneurysms. Stroke. 2014;45(5):1299–303.CrossRef
Metadata
Title
Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group
Authors
Katharina A. M. Hackenberg
Ale Algra
Rustam Al-Shahi Salman
Juhana Frösen
David Hasan
Seppo Juvela
David Langer
Philip Meyers
Akio Morita
Gabriel Rinkel
Nima Etminan
the Unruptured Aneurysms and SAH CDE Project Investigators
Publication date
01-06-2019
Publisher
Springer US
Published in
Neurocritical Care / Issue Special Issue 1/2019
Print ISSN: 1541-6933
Electronic ISSN: 1556-0961
DOI
https://doi.org/10.1007/s12028-019-00729-0

Other articles of this Special Issue 1/2019

Neurocritical Care 1/2019 Go to the issue

Special Article

Common Data Elements for Subarachnoid Hemorrhage and Unruptured Intracranial Aneurysms: Recommendations from the Working Group on Subject Characteristics

Special Article

Common Data Element for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage: Recommendations from Assessments and Clinical Examination Workgroup/Subcommittee

Special Article

Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research: Recommendations from the Working Group on Long-Term Therapies

Special Article

Biospecimens and Molecular and Cellular Biomarkers in Aneurysmal Subarachnoid Hemorrhage Studies: Common Data Elements and Standard Reporting Recommendations

Introduction

The End of the Tower of Babel in Subarachnoid Hemorrhage: Common Data Elements at Last

Special Article

Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group