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Spontaneous subarachnoid hemorrhage (SAH) is a neurological emergency associated with high morbidity and mortality rates and represents 27% of all stroke-related years of potential life lost before the age of 65 [1,2,3,4,5]. In addition, in the case of aneurysmal SAH (the predominant cause), aneurysm rupture leads to major detrimental events which have a significant impact on outcome [6,7,8,9,10,11]. It also has been estimated that approximately 3% of the adult global population harbors an unruptured intracranial aneurysm (UIA) [12]. The increased availability and usage of high-quality imaging have led to a higher detection rate of these lesions. Several clinical trials investigating neuroprotective measures in SAH have shown neutral results. Multiple reasons have been proposed to explain this failure including inadequate preclinical models and data, underpowered studies, and lack of selection of appropriate patients among others. However, one of the major limitations in UIA and SAH research is the lack of standardized definitions to be able to compare results across observational studies and randomized controlled trials. Thus, investigators are limited in their efforts to reduce the uncertainty regarding the appropriate management of patients with UIA and also management of complications from SAH.
The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, is spearheading the effort to harmonize and standardize data collected for clinical studies in neuroscience. To achieve this, NINDS has created and supported the Common Data Elements (CDEs) Project [13, 14]. The aim of the NINDS CDE Project specifically is to develop data standards for clinical research within the neuroscience community. Central to this project is the creation of common definitions and data sets so that information is consistently captured and recorded across studies in case report forms (CRFs). NINDS first developed a set of general CDEs commonly collected in all clinical studies regardless of the type of study or therapeutic area, such as medical history data; scores on neurological assessments; and demographic information. In addition to the general elements, NINDS has also developed sets of CDEs tailored to research involving specific diseases or disorders [15, 16]. The latest addition has been the UIA and SAH CDE Project. The NINDS, in collaboration with the Neurocritical Care Society and the National Library of Medicine convened a group of diverse and multi-professional international experts to create the UIA and SAH CDEs. We had the privilege to co-chair this endeavor and collaborate with a great group of colleagues and investigators from all over the world. Participants were tasked with developing a comprehensive set of CDEs with data definitions, CRFs, and guidelines for use in UIA and SAH clinical research. The results of this project are compiled in 9 manuscripts included in this Supplement of Neurocritical Care [17,18,19,20,21,22,23,24,25].
We strongly encourage every investigator planning a study on UIA and SAH to use these recommended CDEs. If we speak a similar language, then and only then will we be able to facilitate UIA and SAH clinical research and trial design, data sharing, and analyses of observational retrospective and prospective data. Equally important, it is our strong believe that to ensure that these recommended CDEs are disseminated, implemented, and updated, we must maintain an international and multidisciplinary collaboration. The publication of these CDEs is just the first step. The hard work is still ahead of us.
References
Connolly ES, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson G, Vespa P. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2012;43:1711–37.
Diringer MN, Bleck TP, Hemphill JC III, Menon D, Shutter L, Vespa P, Bruder N, Connolly ES Jr, Citerio G, Gress D, Hänggi D, Hoh BL, Lanzino G, Le Roux P, Rabinstein A, Schmutzhard E, Stocchetti N, Suarez JI, Treggiari M, Tseng MY, Vergouwen MD, Wolf S, Zipfel G, Neurocritical Care Society. Critical care management of patients following subarachnoid hemorrhage: recommendations from the Neurocritical Care Society’s multidisciplinary consensus conference. Neurocrit Care. 2011;15:211–40.
Sudlow CLM, Warlow CP. Comparable studies of the incidence of stroke and its pathological types. Results from an international collaboration. Stroke. 1997;28:491–9.
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee, et al. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation. 2014;129:e-29–-292.
van Gijn J, Rinkel JE. Subarachnoid haemorrhage: diagnosis, causes and management. Brain. 2001;124:249–78.
Rinkel GJ, Djibuti M, Algra A, van Gijn J. Prevalence and risk of rupture of intracranial aneurysms: a systematic review. Stroke. 1998;29:251–6.
Turan N, Heider RA, Zaharieva D, Ahmad FU, Barrow DL, Pradilla G. Sex differences in the formation of intracranial aneurysms and incidence and outcome of subarachnoid hemorrhage: review of experimental and human studies. Transl Stroke Res. 2016;7:12–9.
Hop JW, Rinkel GJ, Algra A, van Gijn J. Case-fatality rates and functional outcome after subarachnoid hemorrhage: a systematic review. Stroke. 1997;28:660–4.
Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998;50:1413–8.
Roos YBWEM, Dijkgraaf MGW, Albrecht KW, Beenen LFM, Groen RJM, de Haan RJ, Vermeulen M. Direct costs of modern treatment of aneurysmal subarachnoid hemorrhage in the first year after diagnosis. Stroke. 2002;33:1595–9.
Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006;354:387–96.
Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011;10(7):626–36.
National Institute of Neurological Disorders and Stroke. NINDS Common Data Elements 2018 (cited 2019 April 24). https://www.commondataelements.ninds.nih.gov/#page=Default.
National Library of Medicine. NIH CDE Repository Bethesda, MD: National Institutes of Health; 2019 (cited 2019 April 26). https://cde.nlm.nih.gov/home.
Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, et al. Standardizing data collection in traumatic brain injury. J Neurotrauma. 2011;28(2):177–87.
Loring DW, Lowenstein DH, Barbaro NM, Fureman BE, Odenkirchen J, Jacobs MP, et al. Common data elements in epilepsy research: development and implementation of the NINDS epilepsy CDE project. Epilepsia. 2011;52(6):1186–91.
Suarez JI, Sheikh MK, Macdonald RL, Amin-Hanjani S, Brown RD, de Oliveira Manoel AL, Derdeyn CP, Etminan N, Keller E, Leroux PD, Mayer SA, Morita A, Rinkel G, Rufennacht D, Stienen MN, Torner J, Vergouwen MDI, Wong GKC. Common data elements for unruptured intracranial aneurysms and subarachnoid hemorrhage clinical research: a national institute for neurological disorders and stroke and national library of medicine project. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00723-6.
Bijlenga P, Morita A, Ko NU, Mocco J, Morel S, Murayama Y, et al. Common data elements for subarachnoid hemorrhage and unruptured intracranial aneurysms: recommendations from the working group on subject characteristics. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00724-5.
Damani R, Mayer S, Dhar R, Martin RH, Nyquist P, Olson DWM, et al. Common data element for unruptured intracranial aneurysm and subarachnoid hemorrhage: recommendations from assessments and clinical examination workgroup/subcommittee. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00736-1.
De Oliveira Manoel AL, Van der Jagt M, Amin-Hanjani S, Bambakidis N, Brophy G, Bulsara K, et al. Common data elements for unruptured Intracranial aneurysms and aneurysmal subarachnoid hemorrhage: recommendations from the working group on hospital course and acute therapies—Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00726-3.
Chou SHY, Macdonald RL, Keller E. Biospecimens and molecular and cellular biomarkers in aneurysmal subarachnoid hemorrhage studies—common data elements and standard reporting recommendations. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00725-4.
Hackenberg KAM, Etminan N, Wintermark M, Meyers PM, Lanzino G, Rüfenacht D, et al. Common data elements for radiological imaging of patients with subarachnoid hemorrhage—Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00728-1
Wong GKC, Daly JJ, Rhoney DH, Boroderick J, Ogilvy C, Roos YB, et al. Common data elements for unruptured intracranial aneurysm and subarachnoid hemorrhage clinical research: recommendations from the working group on long-term therapies. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00727-2
Hackenberg KAM, Algra A, Al-Shahi Salman R, Frösen J, Hasan D, Juvela S, et al. Definition and prioritization of data elements for cohort studies and clinical trials on patients with unruptured intracranial aneurysms—Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00729-0
Stienen MN, Visser-Meily A, Schweizer TA, Hänggi D, Macdonald RL, Vergouwen MD. Prioritization and timing of outcomes and endpoints after aneurysmal subarachnoid hemorrhage in clinical trials and observational studies—Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019. https://doi.org/10.1007/s12028-019-00737-0
Funding
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.
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JIS and RLM protocol development, and manuscript writing/editing. The corresponding author confirms that authorship requirements have been met, the final manuscript was approved by all authors.
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Dr Suarez reports being President of the Neurocritical Care Society, a member of the Editorial Board of Stroke Journal, and Chair of the DSMB for the INTREPID Study sponsored by BARD, outside of the submitted work. Dr Macdonald reports personal fees from Edge Therapeutics, and grants from Brain Aneurysm Foundation, outside the submitted work.
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The UIA and SAH CDEs project adhered to ethical guidelines.
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Suarez, J.I., Macdonald, R.L. The End of the Tower of Babel in Subarachnoid Hemorrhage: Common Data Elements at Last. Neurocrit Care 30 (Suppl 1), 1–3 (2019). https://doi.org/10.1007/s12028-019-00751-2
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DOI: https://doi.org/10.1007/s12028-019-00751-2