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

the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

Research output: Contribution to journalArticle

5 Citations (Scopus)

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) 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.

Original languageEnglish (US)
Pages (from-to)102-113
Number of pages12
JournalNeurocritical care
Volume30
DOIs
StatePublished - Jun 16 2019

Fingerprint

Subarachnoid Hemorrhage
Observational Studies
Clinical Trials
Intracranial Aneurysm
Research
Outcome Assessment (Health Care)
Glasgow Outcome Scale
National Institute of Neurological Disorders and Stroke
National Library of Medicine (U.S.)
National Institutes of Health (U.S.)
Clinical Studies
Meta-Analysis
Common Data Elements

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Critical Care and Intensive Care Medicine

Cite this

Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies : Proposal of a Multidisciplinary Research Group. / the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators.

In: Neurocritical care, Vol. 30, 16.06.2019, p. 102-113.

Research output: Contribution to journalArticle

@article{a44350ab7203476191477ed1e212e07b,
title = "Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies: Proposal of a Multidisciplinary Research Group",
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) 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.",
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",
author = "{the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators} and Stienen, {Martin N.} and Visser-Meily, {Johanna M.} and Schweizer, {Tom A.} and Daniel H{\"a}nggi and Macdonald, {R. Loch} and Vergouwen, {Mervyn D.I.} and Suarez, {Jose I.} and Sepideh Amin-Hanjani and Brown, {Robert D Jr.} and {de Oliveira Manoel}, {Airton Leonardo} and Derdeyn, {Colin P.} and Nima Etminan and Emanuela Keller and LeRoux, {Peter D.} and Stephan Mayer and Akio Morita and Gabriel Rinkel and Daniel R{\"u}fenacht and Stienen, {Martin N.} and James Torner and Wong, {George K.C.} and Philippe Bijlenga and Nerissa Ko and McDougall, {Cameron G.} and J. Mocco and Yuuichi Murayama and Werner, {Marieke J.H.} and Rahul Damani and Joseph Broderick and Raj Dhar and Jauch, {Edward C.} and Kirkpatrick, {Peter J.} and Martin, {Renee H.} and Susanne Muehlschlegel and Tatsushi Mutoh and Paul Nyquist and Daiwai Olson and Mejia-Mantilla, {Jorge H.} and {van der Jagt}, Mathieu and Nicholas Bambakidis and Ketan Bulsara and Jan Claassen and {Sander Connolly}, E. and {Alan Hoffer}, S. and Hoh, {Brian L.} and Holloway, {Robert G.} and Adam Kelly and Peter Nakaji and Alejandro Rabinstein and Huston, {John III}",
year = "2019",
month = "6",
day = "16",
doi = "10.1007/s12028-019-00737-0",
language = "English (US)",
volume = "30",
pages = "102--113",
journal = "Neurocritical Care",
issn = "1541-6933",
publisher = "Humana Press",

}

TY - JOUR

T1 - Prioritization and Timing of Outcomes and Endpoints After Aneurysmal Subarachnoid Hemorrhage in Clinical Trials and Observational Studies

T2 - Proposal of a Multidisciplinary Research Group

AU - the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

AU - Stienen, Martin N.

AU - Visser-Meily, Johanna M.

AU - Schweizer, Tom A.

AU - Hänggi, Daniel

AU - Macdonald, R. Loch

AU - Vergouwen, Mervyn D.I.

AU - Suarez, Jose I.

AU - Amin-Hanjani, Sepideh

AU - Brown, Robert D Jr.

AU - de Oliveira Manoel, Airton Leonardo

AU - Derdeyn, Colin P.

AU - Etminan, Nima

AU - Keller, Emanuela

AU - LeRoux, Peter D.

AU - Mayer, Stephan

AU - Morita, Akio

AU - Rinkel, Gabriel

AU - Rüfenacht, Daniel

AU - Stienen, Martin N.

AU - Torner, James

AU - Wong, George K.C.

AU - Bijlenga, Philippe

AU - Ko, Nerissa

AU - McDougall, Cameron G.

AU - Mocco, J.

AU - Murayama, Yuuichi

AU - Werner, Marieke J.H.

AU - Damani, Rahul

AU - Broderick, Joseph

AU - Dhar, Raj

AU - Jauch, Edward C.

AU - Kirkpatrick, Peter J.

AU - Martin, Renee H.

AU - Muehlschlegel, Susanne

AU - Mutoh, Tatsushi

AU - Nyquist, Paul

AU - Olson, Daiwai

AU - Mejia-Mantilla, Jorge H.

AU - van der Jagt, Mathieu

AU - Bambakidis, Nicholas

AU - Bulsara, Ketan

AU - Claassen, Jan

AU - Sander Connolly, E.

AU - Alan Hoffer, S.

AU - Hoh, Brian L.

AU - Holloway, Robert G.

AU - Kelly, Adam

AU - Nakaji, Peter

AU - Rabinstein, Alejandro

AU - Huston, John III

PY - 2019/6/16

Y1 - 2019/6/16

N2 - 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.

AB - 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.

KW - Aneurysm

KW - Clinical studies

KW - Common data elements

KW - Data coding

KW - Data collection

KW - Endpoints

KW - Hemorrhagic stroke

KW - MoCA

KW - Modified Rankin Scale

KW - Montreal Cognitive Assessment

KW - mRS

KW - Outcomes

KW - Standardization

KW - Subarachnoid hemorrhage

UR - http://www.scopus.com/inward/record.url?scp=85066498216&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85066498216&partnerID=8YFLogxK

U2 - 10.1007/s12028-019-00737-0

DO - 10.1007/s12028-019-00737-0

M3 - Article

C2 - 31123994

AN - SCOPUS:85066498216

VL - 30

SP - 102

EP - 113

JO - Neurocritical Care

JF - Neurocritical Care

SN - 1541-6933

ER -