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

Introduction In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurologi...

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Published in:Neurocritical care Vol. 30; no. Suppl 1; pp. 102 - 113
Main Authors: Stienen, Martin N., Visser-Meily, Johanna M., Schweizer, Tom A., Hänggi, Daniel, Macdonald, R. Loch, Vergouwen, Mervyn D. I.
Format: Journal Article
Language:English
Published: New York Springer US 01.06.2019
Springer Nature B.V
Subjects:
Aneurysm, Ruptured - therapy
Aneurysms
Biomedical Research
Classification
Clinical trials
Clinical Trials as Topic
Common Data Elements
Critical Care Medicine
Disease
Fatalities
Generalized anxiety disorder
Humans
Intensive
Internal Medicine
Intracranial Aneurysm - therapy
Medical prognosis
Medicine
Medicine & Public Health
Memory
National Institute of Neurological Disorders and Stroke (U.S.)
National Library of Medicine (U.S.)
Neurological disorders
Neurology
Neuropsychology
Observational studies
Observational Studies as Topic
Outcome Assessment, Health Care
Post traumatic stress disorder
Quality of life
Questionnaires
Special Article
Stroke
Subarachnoid Hemorrhage - therapy
Time Factors
United States
United States
Montreal Cognitive Assessment
MoCA
Subarachnoid hemorrhage
Hemorrhagic stroke
Aneurysm
Standardization
Data coding
Outcomes
mRS
Endpoints
Common data elements
Modified Rankin Scale
Data collection
Clinical studies
ISSN:1541-6933, 1556-0961, 1556-0961
Online Access:Get full text
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Summary:Introduction In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research. Methods This article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into “Core,” “Supplemental—Highly Recommended,” “Supplemental,” and “Exploratory.” Results The subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as “Core”. The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental—Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as “Exploratory”. We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization. Conclusion The recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data.
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ISSN:1541-6933
1556-0961
1556-0961
DOI:10.1007/s12028-019-00737-0