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

Martin N Stienen; Johanna M Visser-Meily; Tom A Schweizer; Daniel Hänggi; R Loch Macdonald; Mervyn D I Vergouwen; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

doi:10.1007/s12028-019-00737-0

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

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

Martin N Stienen, Johanna M Visser-Meily, Tom A Schweizer, Daniel Hänggi, R Loch Macdonald, Mervyn D I Vergouwen and Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

Neurocritical care, Vol.30(Suppl 1), pp.102-113

06/2019

DOI: 10.1007/s12028-019-00737-0

PMID: 31123994

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https://pure.amsterdamumc.nl/ws/files/156926971/Prioritization-and-timing-of-outcomes-and-endpoints-after-aneurysmal-subarachnoid-hemorrhage-in-clinical-trials-and-obse.pdfView

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Abstract

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. 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." 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. 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.

United States

National Library of Medicine (U.S.)

Subarachnoid Hemorrhage - therapy

Humans

Clinical Trials as Topic

National Institute of Neurological Disorders and Stroke (U.S.)

Intracranial Aneurysm - therapy

Time Factors

Aneurysm, Ruptured - therapy

Observational Studies as Topic

Biomedical Research

Outcome Assessment, Health Care

Common Data Elements

Details

Title: Subtitle: Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group
Creators: Martin N Stienen - Department of Neurosurgery, UniversitätsSpital Zürich, Clinical Neuroscience Center, University of Zurich, Frauenklinikstrasse 10, 8091, Zurich, Switzerland. mnstienen@gmail.com
Johanna M Visser-Meily - Department of Rehabilitation, Physical Therapy Science and Sports, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands
Tom A Schweizer - Division of Neurosurgery, Department of Surgery, St. Michael's Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre for Biomedical Research and Li Ka Shing Knowledge Institute, University of Toronto, Toronto, Canada
Daniel Hänggi - Department of Neurosurgery, University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg, Heidelberg, Germany
R Loch Macdonald - Division of Neurosurgery, Department of Surgery, St. Michael's Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre for Biomedical Research and Li Ka Shing Knowledge Institute, University of Toronto, Toronto, Canada
Mervyn D I Vergouwen - Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands
Unruptured Intracranial Aneurysms and SAH CDE Project Investigators
Contributors: Colin P Derdeyn (Contributor) - University of Iowa, Radiology
Resource Type: Journal article
Publication Details: Neurocritical care, Vol.30(Suppl 1), pp.102-113
DOI: 10.1007/s12028-019-00737-0
PMID: 31123994
NLM abbreviation: Neurocrit Care
ISSN: 1541-6933
eISSN: 1556-0961
Publisher: United States
Grant note: HHSN271201200034C / NINDS NIH HHS
Language: English
Date published: 06/2019
Academic Unit: Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
Record Identifier: 9984070644502771

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