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common data elements Regarding Social Determinants of Health in Pediatric Epilepsy Research: A Concept Mapping Study

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PEDIATRIC NEUROLOGY 2025年 165卷 87-95页

作者： Kirkpatrick, Laura Rao, Chethan K. Beatty, Christopher W. Bhatia, Sonal Joshi, Charuta Julich, Kristina Patel, Shital H. Patil, Rachit Wagner, Janelle L. Abath, Christina Briscoe Melendez-Zaidi, Alexandria Baumann, Sara E. Burke, Jessica G. Yang, Qian-Zhou JoJo Univ Pittsburgh Sch Med Dept Pediat 4401 Penn Ave Pittsburgh PA 15224 USA Univ Maryland Sch Med Dept Pediat Baltimore MD USA Ohio State Univ Dept Pediat Columbus OH USA Nationwide Childrens Hosp Columbus OH USA Med Univ South Carolina Dept Pediat Charleston SC USA UT Southwestern Med Ctr Childrens Med Ctr Dept Pediat Dallas TX USA Univ Texas Austin Med Sch Dept Neurol Austin TX USA Duke Univ Dept Pediat Durham NC USA Brown Univ Dept Pediat Hasbro Childrens Hosp Alpert Med Sch Providence RI 02912 USA Med Univ South Carolina Coll Nursing Charleston SC USA Med Univ South Carolina Comprehens Epilepsy Ctr Charleston SC USA Boston Childrens Hosp Dept Neurol Boston MA USA Univ Pittsburgh Sch Publ Hlth Pittsburgh PA USA Univ North Carolina Chapel Hill Dept Neurol Chapel Hill NC USA

Background: The Pediatric Epilepsy Research Consortium (PERC) Health Equity Special Interest Group (SIG) used Concept Mapping to begin developing common data elements (CDE) about social determinants of health to standardize data collection and facilitate robust evaluation of health disparities in pediatric epilepsy research. Methods: Concept Mapping is a structured participatory mixed method suited for developing group consensus. PERC members (1) identified social factors that are important to measure in pediatric epilepsy research, (2) sorted factors into meaningful categories, and (3) rated the factors on importance and ease of measurement. The authors applied multidimensional scaling to the sorting data, created spatial point maps, and used hierarchical cluster analysis to define concepts. A bivariate scatterplot was used to explore importance versus ease of measurement to prioritize factors for inclusion. The PERC Health Equity SIG met on three occasions to interpret research findings and finalize a CDE set. Results: Eighty-one PERC members generated 110 candidate factors. Thirty PERC members completed sorting, and 48 completed rating. The factors grouped into a five-cluster solution: "Household and Neighborhood Resources," "Family Context," "Individual Demographics," "Healthcare Experiences," and "School." Sixty-two items were rated with high importance, of which 34 were rated with high ease. The PERC Health Equity SIG decided by consensus to include most items with high importance and high ease ratings, plus selected additional items. The final CDE set consists of 42 items. Conclusions: Inclusion of CDE in future pediatric epilepsy research will enable researchers to undertake systematic analyses of health disparities. (c) 2025 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://***/licenses/by/4.0/).

关键词： Epilepsy common data elements Health equity Health disparities Pediatric epilepsy Social determinants of health

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Automated Integration of AI Results into Radiology Reports Using common data elements

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JOURNAL OF IMAGING INFORMATICS IN MEDICINE 2025年 1-7页

作者： Mehdiratta, Garv Duda, Jeffrey T. Elahi, Ameena Borthakur, Arijitt Chatterjee, Neil Gee, James Sagreiya, Hersh Witschey, Walter R. T. Kahn Jr, Charles E. Univ Penn Perelman Sch Med Dept Radiol 3400 Spruce St Philadelphia PA 19104 USA Univ Penn Hlth Syst Informat Serv Philadelphia PA USA Univ Penn Leonard Davis Inst Hlth Econ Philadelphia PA 19104 USA Northwestern Univ Dept Radiol Chicago IL USA Univ Penn Inst Biomed Informat Philadelphia PA 19104 USA

Integration of artificial intelligence (AI) into radiology practice can create opportunities to improve diagnostic accuracy, workflow efficiency, and patient outcomes. Integration demands the ability to seamlessly incorporate AI-derived measurements into radiology reports. common data elements (CDEs) define standardized, interoperable units of information. This article describes the application of CDEs as a standardized framework to embed AI-derived results into radiology reports. The authors defined a set of CDEs for measurements of the volume and attenuation of the liver and spleen. An AI system segmented the liver and spleen on non-contrast CT images of the abdomen and pelvis, and it recorded their measurements as CDEs using the Digital Imaging and Communications in Medicine Structured Reporting (DICOM-SR) framework to express the corresponding labels and values. The AI system successfully segmented the liver and spleen in non-contrast CT images and generated measurements of organ volume and attenuation. Automated systems extracted corresponding CDE labels and values from the AI-generated data, incorporated CDE values into the radiology report, and transmitted the generated image series to the Picture Archiving and Communication System (PACS) for storage and display. This study demonstrates the use of radiology CDEs in clinical practice to record and transfer AI-generated data. This approach can improve communication among radiologists and referring providers, harmonize data to enable large-scale research efforts, and enhance the performance of decision support systems. CDEs ensure consistency, interoperability, and clarity in reporting AI findings across diverse healthcare systems.

关键词： Radiology Reporting common data elements Standards Artificial intelligence Interoperability

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common data elements for preclinical epilepsy research: Standards for data collection and reporting. A TASK3 report of the AES/ILAE Translational Task Force of the ILAE

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EPILEPSIA 2017年第Sup4期58卷 78-86页

作者： Harte-Hargrove, Lauren C. French, Jacqueline A. Pitkanen, Asla Galanopoulou, Aristea S. Whittemore, Vicky Scharfman, Helen E. ILAE AES ILAE Translat Task Force Hartford CT USA NYU Langone Med Ctr Comprehens Epilepsy Ctr New York NY USA Univ Eastern Finland AI Virtanen Inst Mol Sci Epilepsy Res Lab Kuopio Finland Albert Einstein Coll Med Montefiore Einstein Epilepsy Ctr Saul R Korey Dept Neurol Lab Dev EpilepsyDominick P Purpura Dept Neurosci Bronx NY 10467 USA NINDS NIH Bldg 36Rm 4D04 Bethesda MD 20892 USA Nathan S Kline Inst Psychiat Res 140 Old Orangeburg Rd Orangeburg NY 10962 USA NYU Sch Med Dept Neurol New York NY USA

The major objective of preclinical translational epilepsy research is to advance laboratory findings toward clinical application by testing potential treatments in animal models of seizures and epilepsy. Recently there has been a focus on the failure of preclinical discoveries to translate reliably, or even to be reproduced in different laboratories. One potential cause is a lack of standardization in preclinical data collection. The resulting difficulties in comparing data across studies have led to high cost and missed opportunity, which in turn impede clinical trials and advances in medical care. Preclinical epilepsy research has successfully brought numerous antiseizure treatments into the clinical practice, yet the unmet clinical needs have prompted the reconsideration of research strategies to optimize epilepsy therapy development. In the field of clinical epilepsy there have been successful steps to improve such problems, such as generation of common data elements (CDEs) and case report forms (CRFs and standards of data collection and reporting) by a team of leaders in the field. Therefore, the Translational Task Force was appointed by the International League Against Epilepsy (ILAE) and the American Epilepsy Society (AES), in partnership with the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institutes of Health (NIH) to define CDEs for animal epilepsy research studies and prepare guidelines for data collection and experimental procedures. If adopted, the preclinical CDEs could facilitate collaborative epilepsy research, comparisons of data across different laboratories, and promote rigor, transparency, and impact, particularly in therapy development.

关键词： common data elements Preclinical Epilepsy Standardization Guidelines

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common data elements for Disorders of Consciousness: Recommendations from the Working Group on Biospecimens and Biomarkers

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NEUROCRITICAL CARE 2023年第1期40卷 58-64页

作者： Shah, Vishank A. Hinson, H. E. Reznik, Michael E. Hahn, Cecil D. Alexander, Sheila Elmer, Jonathan Chou, Sherry H. Y. Johns Hopkins Univ Sch Med Dept Anesthesiol & Crit Care Med Baltimore MD USA Univ Calif San Francisco Dept Neurol San Francisco CA USA Univ Pittsburgh Sch Med Dept Crit Care Med Pittsburgh PA USA Univ Pittsburgh Sch Med Dept Neurol Pittsburgh PA USA Univ Toronto Hosp Sick Children Dept Paediat Div Neurol Toronto ON Canada Univ Pittsburgh Sch Nursing Pittsburgh PA USA Univ Pittsburgh Sch Med Dept Emergency Med Pittsburgh PA USA Northwestern Univ Feinberg Sch Med Dept Neurol Chicago IL 60611 USA

BackgroundIn patients with disorders of consciousness (DoC), laboratory and molecular biomarkers may help define endotypes, identify therapeutic targets, prognosticate outcomes, and guide patient selection in clinical trials. We performed a systematic review to identify common data elements (CDEs) and key design elements (KDEs) for future coma and DoC *** Curing Coma Campaign Biospecimens and Biomarkers work group, composed of seven invited members, reviewed existing biomarker and biospecimens CDEs and conducted a systematic literature review for laboratory and molecular biomarkers using predetermined search words and standardized methodology. Identified CDEs and KDEs were adjudicated into core, basic, supplemental, or experimental CDEs per National Institutes of Health classification based on level of evidence, reproducibility, and generalizability across different diseases through a consensus *** existing National Institutes of Health CDEs, those developed for ischemic stroke, traumatic brain injury, and subarachnoid hemorrhage were most relevant to DoC and included. KDEs were common to all disease states and included biospecimen collection time points, baseline indicator, biological source, anatomical location of collection, collection method, and processing and storage methodology. Additionally, two disease core, nine basic, 24 supplemental, and 59 exploratory biomarker CDEs were identified. Results were summarized and generated into a Laboratory data and Biospecimens Case Report Form (CRF) and underwent public review. A final CRF version 1.0 is reported *** growth in biomarkers development has generated a growing number of potential experimental biomarkers associated with DoC, but few meet the quality, reproducibility, and generalizability criteria to be classified as core and basic biomarker and biospecimen CDEs. Identification and adaptation of KDEs, however, contribute to standardizing methodology to p

关键词： Coma Consciousness common data elements Biomarker

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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

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NEUROCRITICAL CARE 2019年第1-Sup期30卷 4-19页

作者： Suarez, Jose I. Sheikh, Muniza K. Macdonald, R. Loch Amin-Hanjani, Sepideh Brown, Robert D., Jr. Manoel, Airton Leonardo de Oliveira Derdeyn, Colin P. Etminan, Nima Keller, Emanuela Leroux, Peter D. Mayer, Stephan A. Morita, Akio Rinkel, Gabriel Rufennacht, Daniel Stienen, Martin N. Torner, James Vergouwen, Mervyn D. I. Wong, George K. C. Bijlenga, Philippe Ko, Nerissa McDougall, Cameron G. Mocco, J. Murayama, Yuuichi Werner, Marieke J. H. Damani, Rahul Broderick, Joseph Dhar, Raj Jauch, Edward C. Kirkpatrick, Peter J. Martin, Renee H. Mocco, J. Muehlschlegel, Susanne Mutoh, Tatsushi Nyquist, Paul Olson, Daiwai Mejia-Mantilla, Jorge H. Manoel, Airton Leonardo de Oliveira van der Jagt, Mathieu Bambakidis, Nicholas C. Brophy, Gretchen Bulsara, Ketan Claassen, Jan Connolly, E. Sander Hoffer, S. Alan Hoh, Brian L. Holloway, Robert G. Kelly, Adam Mayer, Stephan Nakaji, Peter Rabinstein, Alejandro Suarez, Jose I. Vajkoczy, Peter Vergouwen, Mervyn D. I. Woo, Henry Zipfel, Gregory J. Keller, Emanuela Chou, Sherry Dore, Sylvain Dumont, Aaron S. Gunel, Murat Kasuya, Hidetoshi Roederer, Alexander Ruigrok, Ynte Vespa, Paul M. Sarrafzadeh-Khorrasani, Asita Simone Huston, John, III Krings, Timo Lanzino, Giuseppe Meyers, Philip M. Rinkel, Gabriel Rufennacht, Daniel Wintermark, Max Torner, James Wong, George K. C. Broderick, Joseph Daly, Janis Ogilvy, Christopher Rhoney, Denise H. Roos, Y. B. Siddiqui, Adnan Etminan, Nima Rinkel, Gabriel Hackenberg, Katharina Algra, Ale Frosen, Juhanna Hasan, David Juvela, Seppo Langer, David J. Meyers, Philip M. Morita, Akio Salman, Rustam Al-Shahi Stienen, Martin N. Vergouwen, Mervyn D. I. Hanggi, Daniel Schweizer, Tom Visser-Meily, Johanna Amos, Liz Ludet, Christophe Moy, Claudia Odenkirchen, Joanne Ala'i, Sherita Esterlitz, Joy Joseph, Kristen Sheikh, Muniza Johns Hopkins Univ Sch Med Div Neurosci Crit Care 1800 Orleans StSheikh Zayed Bldg3014C Baltimore MD 21287 USA Emmes Corp Rockville MD USA Univ Toronto Toronto ON Canada Univ Illinois Chicago IL USA Mayo Clin Rochester MN USA Univ Iowa Iowa City IA USA Univ Duesseldorf Dusseldorf Germany Univ Zurich Zurich Switzerland Main Line Hlth Care Wynnewood PA USA Henry Ford Hosp Detroit MI 48202 USA Nippon Med Sch Tokyo Japan Univ Utrecht Univ Med Ctr Utrecht Utrecht Netherlands Klin Hirslanden Zurich Switzerland Chinese Univ Hong Kong Shatin Hong Kong Peoples R China Johns Hopkins Univ Sch Med Baltimore MD USA Univ Toronto Toronto ON Canada Univ Illinois Chicago IL USA Mayo Clin Rochester MN USA Univ Toronto Toronto ON Canada Univ Iowa Carver Coll Med Iowa City IA USA Univ Hosp Mannheim Mannheim Germany Univ Zurich Zurich Switzerland Main Line Hlth Wynnewood PA USA Henry Ford Hosp Detroit MI 48202 USA Nippon Med Sch Tokyo Japan Univ Med Ctr Utrecht Netherlands Klin Hirslanden Zurich Switzerland Univ Zurich Zurich Switzerland Univ Iowa Iowa City IA USA Univ Med Ctr Utrecht Netherlands Chinese Univ Hong Kong Shatin Hong Kong Peoples R China Mayo Clin Rochester MN USA Nippon Med Sch Tokyo Japan Geneva Univ Hosp Geneva Switzerland Henry Ford Hosp Detroit MI USA Johns Hopkins Univ Sch Med Baltimore MD USA Baylor Coll Med Houston TX 77030 USA Univ Illinois Chicago IL USA Univ Toronto Toronto ON Canada Erasmus MC Rotterdam Netherlands Univ Zurich Zurich Switzerland Univ Toronto Toronto ON Canada Univ Iowa Carver Coll Med Iowa City IA USA Univ Hosp Mannheim Mannheim Germany Univ Hosp Mannheim Mannheim Germany Univ Iowa Iowa City IA USA Chinese Univ Hong Kong Shatin Hong Kong Peoples R China Univ Hosp Mannheim Mannheim Germany Univ Med Ctr Utrecht Netherlands Univ Hosp Mannheim Mannheim Germany Univ Zurich FEBNS Zurich Switzerland Univ Med Ctr Utrecht Netherlands Natl Lib Med Natl Informat Ctr Hlth Serv Res

ObjectivesThe 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 *** 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 6weeks 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 *** NINDS UIA and SAH CDEs and supporting documents are publicly available on the NINDS CDE (https://***/#page=Default) and NIH Repository (https://***/home) websites. The recommendations are organized into domains including Participant Characteristics and Outcomes and *** 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.

关键词： Subarachnoid hemorrhage Unruptured intracranial aneurysms common data elements Clinical trials Observational studies Outcomes

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common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

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BMC MEDICAL RESEARCH METHODOLOGY 2016年第1期16卷 1-10页

作者： Bruland, Philipp McGilchrist, Mark Zapletal, Eric Acosta, Dionisio Proeve, Johann Askin, Scott Ganslandt, Thomas Doods, Justin Dugas, Martin Univ Munster Inst Med Informat D-48149 Munster Germany Univ Dundee Dundee DD2 4BF Scotland Hop Europeen Georges Pompidou AP HP Dept Informat Hosp F-75015 Paris France UCL Inst Hlth Informat CHIME London NW1 2DA England Previously Bayer Healthcare Bldg K9 D-51368 Leverkusen Germany Novartis Pharma AG CH-4002 Basel Switzerland Univ Erlangen Nurnberg Chair Med Informat D-91054 Erlangen Germany

Background: data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Methods: Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results: The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions: common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

关键词： Clinical trials common data elements data quality Electronic health records Metadata Secondary use

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common data elements for Subarachnoid Hemorrhage and Unruptured Intracranial Aneurysms: Recommendations from the Working Group on Subject Characteristics

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NEUROCRITICAL CARE 2019年第1-Sup期30卷 20-27页

作者： Bijlenga, Philippe Morita, Akio Ko, Nerissa U. Mocco, J. Morel, Sandrine Murayama, Yuichi Wermer, Marieke J. H. Brown, Robert D. Suarez, Jose I. Macdonald, R. Loch Amin-Hanjani, Sepideh Brown, Robert D., Jr. Manoel, Airton Leonardo de Oliveira Derdeyn, Colin P. Etminan, Nima Keller, Emanuela LeRoux, Peter D. Mayer, Stephan Morita, Akio Rinkel, Gabriel Rufennacht, Daniel Stienen, Martin N. Torner, James Vergouwen, Mervyn D. I. Wong, George K. C. Bijlenga, Philippe Ko, Nerissa McDougall, Cameron G. Mocco, J. Murayama, Yuuichi Werner, Marieke J. H. Suarez, Jose I. Damani, Rahul Broderick, Joseph Dhar, Raj Jauch, Edward C. Kirkpatrick, Peter J. Martin, Renee H. Mocco, J. Muehlschlegel, Susanne Mutoh, Tatsushi Nyquist, Paul Olson, Daiwai Mejia-Mantilla, Jorge H. Amin-Hanjani, Sepideh van der Jagt, Mathieu Bambakidis, Nicholas Brophy, Gretchen Bulsara, Ketan Claassen, Jan Connolly, E. Sander Hoffer, S. Alan Hoh, Brian L. Holloway, Robert G. Kelly, Adam Nakaji, Peter Rabinstein, Alejandro Vajkoczy, Peter Vergouwen, Mervyn D. I. Woo, Henry Zipfel, Gregory J. Keller, Emanuela Chou, Sherry Dore, Sylvain Dumont, Aaron S. Gunel, Murat Kasuya, Hidetoshi Roederer, Alexander Ruigrok, Ynte Vespa, Paul M. Sarrafzadeh-Khorrasani, Asita Simone Derdeyn, Colin P. Etminan, Nima Hackenberg, Katharina Huston, John, III Krings, Timo Lanzino, Giuseppe Meyers, Philip M. Rinkel, Gabriel Rufennacht, Daniel Wintermark, Max Torner, James Wong, George K. C. Broderick, Joseph Daly, Janis Ogilvy, Christopher Rhoney, Denise H. Roos, Y. B. Siddiqui, Adnan Etminan, Nima Rinkel, Gabriel Hackenberg, Katharina Algra, Ale Frosen, Juhanna Hasan, David Juvela, Seppo Langer, David J. Meyers, Philip M. Morita, Akio Salman, Rustam Al-Shahi Stienen, Martin N. Vergouwen, Mervyn D. I. Hanggi, Daniel Schweizer, Tom Visser-Meily, Johanna Amos, Liz Ludet, Christophe Moy, Claudia Odenkirchen, Joanne Ala'i, Sherita Esterlitz, Joy Joseph, Kristen Sheikh, Muniza Univ Geneva Fac Med Dept Clin Neurosci Neurosurg Rue Gabrielle Perret Gentil 4 CH-1211 Geneva 14 Switzerland Nippon Med Sch Dept Neurol Surg Tokyo Japan Univ Calif San Francisco Dept Neurol San Francisco CA USA Mt Sinai Hlth Syst Dept Neurosurg New York NY USA Jikei Univ Sch Med Dept Neurosurg Minato Ku Tokyo Japan Leiden Univ Med Ctr Dept Neurol Leiden Netherlands Mayo Clin Rochester MN USA Johns Hopkins Univ Sch Med Baltimore MD USA Univ Toronto Toronto ON Canada Univ Illinois Chicago IL USA Mayo Clin Rochester MN USA Univ Toronto Toronto ON Canada Univ Iowa Carver Coll Med Iowa City IA USA Univ Hosp Mannheim Mannheim Germany Univ Zurich Zurich Switzerland Main Line Hlth Wynnewood PA USA Henry Ford Hosp Detroit MI 48202 USA Nippon Med Sch Tokyo Japan Univ Med Ctr Utrecht Netherlands Klin Hirslanden Zurich Switzerland Univ Zurich Zurich Switzerland Univ Iowa Iowa City IA USA Univ Med Ctr Utrecht Netherlands Chinese Univ Hong Kong Shatin Hong Kong Peoples R China Mayo Clin Rochester MN USA Nippon Med Sch Tokyo Japan Geneva Univ Hosp Geneva Switzerland Henry Ford Hosp Detroit MI 48202 USA Johns Hopkins Univ Sch Med Baltimore MD USA Baylor Coll Med Houston TX 77030 USA Univ Illinois Chicago IL USA Univ Toronto Toronto ON Canada Erasmus MC Rotterdam Netherlands Univ Zurich Zurich Switzerland Univ Toronto Toronto ON Canada Univ Iowa Carver Coll Med Iowa City IA USA Univ Hosp Mannheim Mannheim Germany Univ Hosp Mannheim Mannheim Germany Univ Iowa Iowa City IA USA Chinese Univ Hong Kong Shatin Hong Kong Peoples R China Univ Hosp Mannheim Mannheim Germany Univ Med Ctr Utrecht Netherlands Univ Hosp Mannheim Mannheim Germany Univ Zurich Zurich Switzerland Univ Med Ctr Utrecht Netherlands Natl Lib Med Natl Informat Ctr Hlth Serv Res & Hlth Care Techn Bethesda MD USA Natl Lib Med Bethesda MD USA NINDS Bldg 36Rm 4D04 Bethesda MD 20892 USA Emmes Corp Rockville MD USA

BackgroundThe National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) have been generated to standardize and define terms used by the scientific community. The widespread use of these CDEs promotes harmonized data collection in clinical research. The aim of the NINDS Unruptured Intracranial Aneurysms (UIA) and Subarachnoid Hemorrhage (SAH), and Subject Characteristics working group (WG) was to identify, define, and classify CDEs describing the characteristics of patients diagnosed with an UIA and SAH. Thus, Participant/Subject characteristics is a set of factors defining a population of selected individuals and allowing comparisons with a reference population and *** on standard terms defined by the United States' Census Bureau, CDEs previously defined by several (Stroke, Epilepsy and Traumatic Brain Injury) NINDS CDE working groups literature and expert opinion of the WG, the Participant/Subject characteristics domain has been *** set of 192 CDEs divided in 7 subsections: demographics (8 CDEs), social status (8 CDEs), behavioral status (22 CDEs), family and medical history (144 CDEs), pregnancy and perinatal history (8 CDEs), history data source reliability (3 CDEs), and prior functional status (3 CDEs)was defined. SAH is characterized by 6 core elements, all classified in the Participant/Subject characteristics domain. Four exploratory elements out of the 39 for SAH overall are in the Participant/Subject characteristics domain, and all remaining 182 CDEs in the Participant/Subject characteristics domain are classified as Supplemental-Highly Recommended *** CDEs would allow the development of best practice guidelines to standardize the assessment and reporting of observations concerning UIA and SAH.

关键词： Intracranial aneurysm Subarachnoid Hemorrhage common data elements Participant Subject characteristics

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common data elements for Disorders of Consciousness: Recommendations from the Electrophysiology Working Group

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NEUROCRITICAL CARE 2023年第3期39卷 578-585页

作者： Carroll, Elizabeth Der-Nigoghossian, Caroline Alkhachroum, Ayham Appavu, Brian Gilmore, Emily Kromm, Julie Rohaut, Benjamin Rosanova, Mario Sitt, Jacobo Diego Claassen, Jan Columbia Univ Med Ctr Dept Neurol 177 Ft Washington AveMHB Ctr 8Room 300 New York NY 10032 USA NewYork Presbyterian Hosp New York NY 10032 USA Univ Miami Dept Neurol Miami FL USA Phoenix Childrens Hosp Barrow Neurol Inst Phoenix AZ USA Univ Arizona Coll Med Phoenix Phoenix AZ USA Yale Univ Dept Neurol Div Neurocrit Care & Emergency Neurol & Epilepsy Sch Med New Haven CT USA Yale New Haven Hosp New Haven CT USA Univ Calgary Dept Crit Care Med Calgary AB Canada Univ Calgary Dept Clin Neurosci Calgary AB Canada Univ Calgary Hotchkiss Brain Inst Calgary AB Canada Sorbonne Univ Hop La Pitie Salpetriere AP HP CNRSParis Brain Inst ICMInsermInst CerveauNeu Paris France Univ Milan Dept Biomed & Clin Sci Milan Italy Ctr Natl Rech Sci Paris Brain Inst ICM Paris France

BackgroundElectroencephalography (EEG) has long been recognized as an important tool in the investigation of disorders of consciousness (DoC). From inspection of the raw EEG to the implementation of quantitative EEG, and more recently in the use of perturbed EEG, it is paramount to providing accurate diagnostic and prognostic information in the care of patients with DoC. However, a nomenclature for variables that establishes a convention for naming, defining, and structuring data for clinical research variables currently is lacking. As such, the Neurocritical Care Society's Curing Coma Campaign convened nine working groups composed of experts in the field to construct common data elements (CDEs) to provide recommendations for DoC, with the main goal of facilitating data collection and standardization of reporting. This article summarizes the recommendations of the electrophysiology DoC working *** assessing previously published pertinent CDEs, we developed new CDEs and categorized them into "disease core," "basic," "supplemental," and "exploratory." Key EEG design elements, defined as concepts that pertained to a methodological parameter relevant to the acquisition, processing, or analysis of data, were also included but were not classified as *** identifying existing pertinent CDEs and developing novel CDEs for electrophysiology in DoC, variables were organized into a framework based on the two primary categories of resting state EEG and perturbed EEG. Using this categorical framework, two case report forms were generated by the working *** to the recommendations outlined by the electrophysiology working group in the resting state EEG and perturbed EEG case report forms will facilitate data collection and sharing in DoC research on an international level. In turn, this will allow for more informed and reliable comparison of results across studies, facilitating further advancement in the realm of DoC research.

关键词： Coma Consciousness common data elements Electrophysiology

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common data elements for Disorders of Consciousness: Recommendations from the Working Group in the Pediatric Population

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NEUROCRITICAL CARE 2023年第1期40卷 65-73页

作者： Boerwinkle, Varina L. Appavu, Brian Cediel, Emilio Garzon Erklaurer, Jennifer Ganesan, Saptharishi Lalgudi Gibbons, Christie Hahn, Cecil Larovere, Kerri L. Moberg, Dick Natarajan, Girija Molteni, Erika Reuther, William R. Slomine, Beth S. Univ North Carolina Chapel Hill Dept Neurol Chapel Hill NC 27599 USA Univ Arizona Dept Child Hlth & Neurol Coll Med Phoenix AZ USA Baylor Coll Med Div Crit Care Med Houston TX USA Baylor Coll Med Div Child Neurol Houston TX USA Baylor Coll Med Dept Pediat Div Dev Neurosci Houston TX USA Western Univ Schulich Sch Med & Dent Dept Clin Neurol Sci London ON Canada Phoenix Childrens Hosp Surg & Trauma Phoenix AZ USA Univ Toronto Hosp Sick Children Dept Paediat Div Neurol Toronto ON Canada Harvard Med Sch Boston Childrens Hosp Dept Neurol Boston MA USA Moberg Analyt Inc Philadelphia PA 19107 USA Cent Michigan Univ Childrens Hosp Michigan Mt Pleasant MI 48859 USA Kings Coll London Sch Biomed Engn & Imaging Sci London England Kennedy Krieger Inst Dept Neuropsychol Baltimore MD USA Johns Hopkins Univ Sch Med Dept Psychiat & Behav Sci Baltimore MD USA

BackgroundThe fundamental gap obstructing forward progress of evidenced-based care in pediatric and neonatal disorders of consciousness (DoC) is the lack of defining consensus-based terminology to perform comparative research. This lack of shared nomenclature in pediatric DoC stems from the inherently recursive dilemma of the inability to reliably measure consciousness in the very young. However, recent advancements in validated clinical examinations and technologically sophisticated biomarkers of brain activity linked to future abilities are unlocking this previously formidable challenge to understanding the DoC in the developing *** address this need, the first of its kind international convergence of an interdisciplinary team of pediatric DoC experts was organized by the Neurocritical Care Society's Curing Coma Campaign. The multidisciplinary panel of pediatric DoC experts proposed pediatric-tailored common data elements (CDEs) covering each of the CDE working groups including behavioral phenotyping, biospecimens, electrophysiology, family and goals of care, neuroimaging, outcome and endpoints, physiology and big data, therapies, and *** report the working groups' pediatric-focused DoC CDE recommendations and disseminate CDEs to be used in studies of pediatric patients with *** CDEs recommended support the vision of progressing collaborative and successful internationally collaborative pediatric coma research.

关键词： Coma Consciousness common data elements Pediatric Neonatal Disorder of consciousness Standardization

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common data elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints

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NEUROCRITICAL CARE 2024年第2期41卷 357-368页

作者： Bodien, Yelena G. LaRovere, Kerri Kondziella, Daniel Taran, Shaurya Estrano, Anna Shutter, Lori Harvard Med Sch Massachusetts Gen Hosp Ctr Neurotechnol & Neurorecovery Dept Neurol Boston MA 02114 USA Harvard Med Sch Dept Phys Med & Rehabil Spaulding Rehabil Hosp Charlestown MA 02129 USA Harvard Med Sch Boston Childrens Hosp Dept Neurol Boston MA USA Copenhagen Univ Hosp Rigshospitalet Dept Neurol Copenhagen Denmark Univ Copenhagen Dept Clin Med Copenhagen Denmark Univ Toronto Interdept Div Crit Care Med Toronto ON Canada IRCCS Don Carlo Gnocchi Fdn Dept Neurorehabil Florence Italy Univ Pittsburgh Dept Crit Care Med UPMC Healthcare Syst Sch Med Pittsburgh PA USA Univ Pittsburgh Dept Neurol UPMC Healthcare Syst Sch Med Pittsburgh PA USA Univ Pittsburgh Dept Neurosurg UPMC Healthcare Syst Sch Med Pittsburgh PA USA

BackgroundClinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with *** Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report *** hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for *** DoC outcome and endpoint CDEs are a starting point in the broader

关键词： Coma Consciousness common data elements Outcome Recovery

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