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Introduction: Lack of homogeneous definitions for imaging data and consensus on their relevance in the setting of subarachnoid hemorrhage and unruptured intracranial aneurysms lead to a difficulty of data pooling and lack of robust data. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke, Unruptured Intracranial Aneurysm (UIA) and Subarachnoid Hemorrhage (SAH) Common Data Elements (CDE) Project was to standardize data elements to ultimately facilitate data pooling and establish a more robust data quality in future neurovascular research on UIA and SAH. Methods: For the subcommittee ‘Radiological imaging of SAH,’ international cerebrovascular specialists with imaging expertise in the setting of SAH were selected by the steering committee. CDEs were developed after reviewing the literature on neuroradiology and already existing CDEs for other neurological diseases. For prioritization, the CDEs were classified into ‘Core,’ ‘Supplemental—Highly Recommended,’ ‘Supplemental’ and ‘Exploratory.’ Results: The subcommittee compiled 136 CDEs, 100 out of which were derived from previously established CDEs on ischemic stroke and 36 were newly created. The CDEs were assigned to four main categories (several CDEs were assigned to more than one category): ‘Parenchymal imaging’ with 42 CDEs, ‘Angiography’ with 49 CDEs, ‘Perfusion imaging’ with 20 CDEs, and ‘Transcranial doppler’ with 55 CDEs. The CDEs were classified into core, supplemental highly recommended, supplemental and exploratory elements. The core CDEs were imaging modality, imaging modality type, imaging modality vessel, angiography type, vessel angiography arterial anatomic site and imaging vessel angiography arterial result. Conclusions: The CDEs were established based on the current literature and consensus across cerebrovascular specialists. The use of these CDEs will facilitate standardization and aggregation of imaging data in the setting of SAH. However, the CDEs may require reevaluation and periodic adjustment based on current research and improved imaging quality and novel modalities.

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.

INTRODUCTION: Development of clinical biomarkers to guide therapy is an important unmet need in aneurysmal subarachnoid hemorrhage (SAH). A wide spectrum of plausible biomarkers has been reported for SAH, but none have been validated due to significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints. METHODS: A systematic review of SAH biomarkers was performed per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The panel’s recommendations focused on harmonization of (1) target cellular and molecular biomarkers for future investigation in SAH, (2) standardization of best-practice procedures in biospecimen and biomarker studies, and (3) experimental method reporting requirements to facilitate meta-analyses and future validation of putative biomarkers. RESULTS: No cellular or molecular biomarker has been validated for inclusion as “core” recommendation. Fifty-four studies met inclusion criteria and generated 33 supplemental and emerging biomarker targets. Core recommendations include best-practice protocols for biospecimen collection and handling as well as standardized reporting guidelines to capture the heterogeneity and variabilities in experimental methodologies and biomarker analyses platforms. CONCLUSION: Significant variabilities in study design, methodology, laboratory techniques, and outcome endpoints exist in SAH biomarker studies and present significant barriers toward validation and translation of putative bio-markers to clinical use. Adaptation of common data elements, recommended biospecimen protocols, and reporting guidelines will reduce heterogeneity and facilitate future meta-analyses and development of validated clinical biomarkers in SAH.

The goal for the long-term therapies (LTT) working group (WG) of the Unruptured Intracranial Aneurysm (UIA) and Subarachnoid Hemorrhage (SAH) common data elements (CDEs) was to develop a comprehensive set of CDEs, data definitions, case report forms, and guidelines for use in UIA and SAH LTT clinical research, as part of a new joint effort between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine of the US National Institutes of Health. These UIA and SAH CDEs will join other neurological disease-specific CDEs already developed and available for use by research investigators. The eight LTT WG members comprised international UIA, and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed, and provided recommendations for future LTT clinical research. The recommendations were compiled, internally reviewed by the all UIA and SAH WGs and steering committee members. The NINDS CDE team also reviewed the final version before posting the SAH Version 1.0 CDE recommendations on the NINDS CDE website. The NINDS UIA and SAH LTT CDEs and supporting documents are publicly available on the NINDS CDE ( https://www.commondataelements.ninds.nih.gov/#page=Default ) and NIH Repository ( https://cde.nlm.nih.gov/home ) websites. The subcommittee members discussed and reviewed various parameters, outcomes, and endpoints in UIA and SAH LTT studies. The following meetings with WG members, the LTT WG’s recommendations are incorporated into the disease/injury-related events, assessments and examinations, and treatment/intervention data domains. Noting gaps in the literature regarding medication and rehabilitation parameters in UIA and SAH clinical studies, the current CDE recommendations aim to arouse interest to explore the impact of medication and rehabilitation treatments and therapies and encourage the convergence of LTT clinical study parameters to develop a harmonized standard.

INTRODUCTION: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs. METHODS: This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into "core", "supplemental-highly recommended", "supplemental" and "exploratory". RESULTS: We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs. CONCLUSION: Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.

The goal for this project was to develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in unruptured intracranial aneurysm (UIA) and subarachnoid hemorrhage (SAH) clinical research, as part of a new joint effort between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine of the US National Institutes of Health. These UIA and SAH CDEs will join several other neurological disease-specific CDEs that have already been developed and are available for use by research investigators. A Working Group (WG) divided into eight sub-groups and a Steering Committee comprised of international UIA and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed and provided recommendations for UIA and SAH clinical research. The recommendations were compiled, internally reviewed by the entire UIA and SAH WG and posted online for 6 weeks for external public comments. The UIA and SAH WG and the NINDS CDE team reviewed the final version before posting the SAH Version 1.0 CDE recommendations. The NINDS UIA and SAH CDEs and supporting documents are publicly available on the NINDS CDE ( https://www.commondataelements.ninds.nih.gov/#page=Default ) and NIH Repository ( https://cde.nlm.nih.gov/home ) websites. The recommendations are organized into domains including Participant Characteristics and Outcomes and Endpoints. Dissemination and widespread use of CDEs can facilitate UIA and SAH clinical research and clinical trial design, data sharing, and analyses of observational retrospective and prospective data. It is vital to maintain an international and multidisciplinary collaboration to ensure that these CDEs are implemented and updated when new information becomes available.

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.