Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute TherapiesProposal of a Multidisciplinary Research Group

被引:16
|
作者
Manoel, Airton Leonardo de Oliveira [1 ,2 ,25 ,45 ]
van der Jagt, Mathieu [3 ,46 ]
Amin-Hanjani, Sepideh [4 ,23 ,44 ]
Bambakidis, Nicholas C. [5 ]
Brophy, Gretchen M. [6 ]
Bulsara, Ketan [7 ]
Claassen, Jan [8 ]
Connolly, E. Sander [8 ]
Hoffer, S. Alan [5 ]
Hoh, Brian L. [9 ]
Holloway, Robert G. [10 ]
Kelly, Adam G. [10 ]
Mayer, Stephan A. [11 ]
Nakaji, Peter [12 ]
Rabinstein, Alejandro A. [13 ]
Vajkoczy, Peter [14 ]
Vergouwen, Mervyn D. I. [15 ,36 ,58 ]
Woo, Henry [16 ]
Zipfel, Gregory J. [17 ]
Suarez, Jose I. [18 ,19 ,20 ,21 ,42 ]
Macdonald, R. Loch [22 ,48 ]
Amin-Hanjani, Sepideh [4 ,23 ,44 ]
Brown, Robert D., Jr. [24 ,38 ]
Derdeyn, Colin P. [26 ,49 ]
Etminan, Nima [27 ,50 ,54 ]
Keller, Emanuela [28 ,47 ]
LeRoux, Peter D. [29 ]
Mayer, Stephan [30 ,41 ]
Morita, Akio [31 ,39 ]
Rinkel, Gabriel [32 ,55 ]
Rufennacht, Daniel [33 ]
Stienen, Martin N. [34 ,57 ]
Torner, James [35 ,52 ]
Vergouwen, Mervyn D. I. [15 ,36 ,58 ]
Wong, George K. C. [37 ,53 ]
Bijlenga, Philippe [40 ]
Ko, Nerissa
McDougall, Cameron G.
Mocco, J.
Murayama, Yuuichi
Werner, Marieke J. H.
Mayer, Stephan [30 ,41 ]
Suarez, Jose I. [18 ,19 ,20 ,21 ,42 ]
Damani, Rahul [43 ]
Broderick, Joseph
Dhar, Raj
Jauch, Edward C.
Kirkpatrick, Peter J.
Martin, Renee H.
Mocco, J.
机构
[1] Univ Toronto, St Michaels Hosp, Keenan Res Ctr Biomed Sci, Neurosci Res Program, Toronto, ON, Canada
[2] Hosp Paulistano, UnitedHlth Grp Brazil, Dept Crit Care Med, Adult Crit Care Unit, Rua Martiniano de Carvalho 741, BR-01321001 Sao Paulo, SP, Brazil
[3] Univ Med Ctr Rotterdam, Erasmus MC, Dept Intens Care Adults, Rotterdam, Netherlands
[4] Univ Illinois, Dept Neurosurg, Chicago, IL USA
[5] Case Western Reserve Univ, UH Cleveland Med Ctr, Dept Neurol Surg, Cleveland, OH 44106 USA
[6] Sch Pharm, Dept Pharmacotherapy & Outcomes Sci, Richmond, VA USA
[7] Univ Connecticut, Dept Neurosurg, Farmington, CT USA
[8] Columbia Univ, New York, NY USA
[9] Univ Florida, Dept Neurosurg, Gainesville, FL USA
[10] Univ Rochester, Dept Neurol, Rochester, NY USA
[11] Henry Ford Hlth Syst, Dept Neurol, Detroit, MI USA
[12] Barrow Neurol Inst, Dept Neurosurg, Phoenix, AZ 85013 USA
[13] Mayo Clin, Dept Neurol, Rochester, MN USA
[14] Univ Med, Charite Hosp, Dept Neurosurg, Berlin, Germany
[15] Univ Utrecht, Univ Med Ctr Utrecht, Dept Neurol & Neurosurg, Brain Ctr Rudolf Magnus, Utrecht, Netherlands
[16] Hofstra Northwell Hlth, Zucker Sch Med, Dept Neurosurg & Radiol, New York, NY USA
[17] Washington Univ, St Louis, MO 63110 USA
[18] Johns Hopkins Univ, Sch Med, Dept Anesthesiol & Crit Care Med, Baltimore, MD 21205 USA
[19] Johns Hopkins Univ, Sch Med, Dept Neurol, Baltimore, MD 21205 USA
[20] Johns Hopkins Univ, Sch Med, Dept Neurosurg, Baltimore, MD 21205 USA
[21] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[22] Univ Toronto, Toronto, ON, Canada
[23] Univ Illinois, Chicago, IL USA
[24] Mayo Clin, Rochester, MN USA
[25] Univ Toronto, Toronto, ON, Canada
[26] Univ Iowa, Carver Coll Med, Iowa City, IA USA
[27] Univ Hosp Mannheim, Mannheim, Germany
[28] Univ Zurich, Zurich, Switzerland
[29] Main Line Hlth, Wynnewood, PA USA
[30] Henry Ford Hosp, Detroit, MI 48202 USA
[31] Nippon Med Sch, Tokyo, Japan
[32] Univ Med Ctr, Utrecht, Netherlands
[33] Klin Hirslanden, Zurich, Switzerland
[34] Univ Zurich, Zurich, Switzerland
[35] Univ Iowa, Iowa City, IA USA
[36] Univ Med Ctr, Utrecht, Netherlands
[37] Chinese Univ Hong Kong, Shatin, Hong Kong, Peoples R China
[38] Mayo Clin, Rochester, MN USA
[39] Nippon Med Sch, Tokyo, Japan
[40] Geneva Univ Hosp, Geneva, Switzerland
[41] Henry Ford Hosp, Detroit, MI 48202 USA
[42] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[43] Baylor Coll Med, Houston, TX 77030 USA
[44] Univ Illinois, Chicago, IL USA
[45] Univ Toronto, Toronto, ON, Canada
[46] Erasmus MC, Rotterdam, Netherlands
[47] Univ Zurich, Zurich, Switzerland
[48] Univ Toronto, Toronto, ON, Canada
[49] Univ Iowa, Carver Coll Med, Iowa City, IA USA
[50] Univ Hosp Mannheim, Mannheim, Germany
关键词
Clinical studies; Common Data Elements; Data coding; Data collection; Standardization; Subarachnoid hemorrhage; Aneurysm; MANAGEMENT; BRAIN; TRIAL; DEFINITION; RATIONALE; PRESSURE; ALBUMIN; TBI;
D O I
10.1007/s12028-019-00726-3
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
IntroductionThe 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.MethodsThis 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, supplementalhighly recommended, supplemental and exploratory.ResultsWe 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.ConclusionMost 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.
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页码:36 / 45
页数:10
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