Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group
Stienen, Martin N; Visser-Meily, Johanna M; Schweizer, Tom A; Hänggi, Daniel; Macdonald, R Loch; Vergouwen, Mervyn D I; Unruptured Intracranial Aneurysms and SAH CDE Project Investigators
(2019) Neurocritical Care, volume 30, issue Suppl 1, pp. 102 - 113
(Article)
Abstract
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)
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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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Keywords: Aneurysm, Clinical studies, Common data elements, Data coding, Data collection, Endpoints, Hemorrhagic stroke, MoCA, Modified Rankin Scale, Montreal Cognitive Assessment, mRS, Outcomes, Standardization, Subarachnoid hemorrhage, Clinical Neurology, Critical Care and Intensive Care Medicine, Research Support, Non-U.S. Gov't, Research Support, N.I.H., Intramural, Journal Article
ISSN: 1541-6933
Publisher: Humana Press
Note: Funding Information: Dr Macdonald reports personal fees from Edge Therapeutics and grants from Brain Aneurysm Foundation, outside the submitted work. Dr Stienen reports grants from Fujirebio Europe and Actelion/Idorsia, outside of the submitted work. Dr Vergouwen, Dr Visser‑Meily, Dr Schweizer, and Dr Hänggi have noth‑ ing to disclose. Funding Information: The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS), or the US Government. Funding Information: The aim of the National Institute of Health (NIH)/ National Institute of Neurological Disorders and Stroke (NINDS)/National Library of Medicine (NLM) Unruptured Intracranial Aneurysms (UIA) and SAH Common Data Elements (CDE) Project was to provide a common structure for future UIA and SAH research. This paper describes the recommendations from the SAH Outcomes and Endpoints subgroup of the overall UIA and SAH CDE Working Group (WG). Funding Information: Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society, and the CHI Baylor St Luke’s Medical Center in Houston, TX. The development of the NINDS SAH CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE Project teams participating from 2015 to 2017. Publisher Copyright: © 2019, Neurocritical Care Society.
(Non peer reviewed)