Common data elements in epilepsy research: Development and implementation of the NINDS epilepsy CDE project
Summary The Common Data Element (CDE) Project was initiated in 2006 by the National Institute of Neurological Disorders and Stroke (NINDS) to develop standards for performing funded neuroscience‐related clinical research. CDEs are intended to standardize aspects of data collection; decrease study st...
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| Veröffentlicht in: | Epilepsia (Copenhagen) 2011-06, Vol.52 (6), p.1186-1191 |
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| creator | Loring, David W. Lowenstein, Daniel H. Barbaro, Nicholas M. Fureman, Brandy E. Odenkirchen, Joanne Jacobs, Margaret P. Austin, Joan K. Dlugos, Dennis J. French, Jacqueline A. Gaillard, William Davis Hermann, Bruce P. Hesdorffer, Dale C. Roper, Steven N. Van Cott, Anne C. Grinnon, Stacie Stout, Alexandra |
| description | Summary
The Common Data Element (CDE) Project was initiated in 2006 by the National Institute of Neurological Disorders and Stroke (NINDS) to develop standards for performing funded neuroscience‐related clinical research. CDEs are intended to standardize aspects of data collection; decrease study start‐up time; and provide more complete, comprehensive, and equivalent data across studies within a particular disease area. Therefore, CDEs will simplify data sharing and data aggregation across NINDS‐funded clinical research, and where appropriate, facilitate the development of evidenced‐based guidelines and recommendations. Epilepsy‐specific CDEs were established in nine content areas: (1) Antiepileptic Drugs (AEDs) and Other Antiepileptic Therapies (AETs), (2) Comorbidities, (3) Electrophysiology, (4) Imaging, (5) Neurological Exam, (6) Neuropsychology, (7) Quality of Life, (8) Seizures and Syndromes, and (9) Surgery and Pathology. CDEs were developed as a dynamic resource that will accommodate recommendations based on investigator use, new technologies, and research findings documenting emerging critical disease characteristics. The epilepsy‐specific CDE initiative can be viewed as part of the larger international movement toward “harmonization” of clinical disease characterization and outcome assessment designed to promote communication and research efforts in epilepsy. It will also provide valuable guidance for CDE improvement during further development, refinement, and implementation. This article describes the NINDS CDE Initiative, the process used in developing Epilepsy CDEs, and the benefits of CDEs for the clinical investigator and NINDS. |
| doi_str_mv | 10.1111/j.1528-1167.2011.03018.x |
| format | Article |
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The Common Data Element (CDE) Project was initiated in 2006 by the National Institute of Neurological Disorders and Stroke (NINDS) to develop standards for performing funded neuroscience‐related clinical research. CDEs are intended to standardize aspects of data collection; decrease study start‐up time; and provide more complete, comprehensive, and equivalent data across studies within a particular disease area. Therefore, CDEs will simplify data sharing and data aggregation across NINDS‐funded clinical research, and where appropriate, facilitate the development of evidenced‐based guidelines and recommendations. Epilepsy‐specific CDEs were established in nine content areas: (1) Antiepileptic Drugs (AEDs) and Other Antiepileptic Therapies (AETs), (2) Comorbidities, (3) Electrophysiology, (4) Imaging, (5) Neurological Exam, (6) Neuropsychology, (7) Quality of Life, (8) Seizures and Syndromes, and (9) Surgery and Pathology. CDEs were developed as a dynamic resource that will accommodate recommendations based on investigator use, new technologies, and research findings documenting emerging critical disease characteristics. The epilepsy‐specific CDE initiative can be viewed as part of the larger international movement toward “harmonization” of clinical disease characterization and outcome assessment designed to promote communication and research efforts in epilepsy. It will also provide valuable guidance for CDE improvement during further development, refinement, and implementation. This article describes the NINDS CDE Initiative, the process used in developing Epilepsy CDEs, and the benefits of CDEs for the clinical investigator and NINDS.</description><identifier>ISSN: 0013-9580</identifier><identifier>ISSN: 1528-1167</identifier><identifier>EISSN: 1528-1167</identifier><identifier>DOI: 10.1111/j.1528-1167.2011.03018.x</identifier><identifier>PMID: 21426327</identifier><identifier>CODEN: EPILAK</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Anticonvulsants - therapeutic use ; Anticonvulsants. Antiepileptics. Antiparkinson agents ; Antiepileptic agents ; Biological and medical sciences ; Communication ; Data Collection - standards ; Data Collection - trends ; Data collections ; Data processing ; Electrophysiology ; Epilepsy ; Epilepsy - diagnosis ; Epilepsy - epidemiology ; Epilepsy - therapy ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; Medical sciences ; National Institute of Neurological Disorders and Stroke ; National Institute of Neurological Disorders and Stroke (U.S.) - standards ; National Institute of Neurological Disorders and Stroke (U.S.) - trends ; Nervous system (semeiology, syndromes) ; Neurological diseases ; Neurology ; Neuropharmacology ; Pharmacology. Drug treatments ; Program Development - standards ; Quality of life ; Research Design - standards ; Seizures ; Stroke ; Surgery ; United States</subject><ispartof>Epilepsia (Copenhagen), 2011-06, Vol.52 (6), p.1186-1191</ispartof><rights>Wiley Periodicals, Inc. © 2011 International League Against Epilepsy</rights><rights>2015 INIST-CNRS</rights><rights>Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5638-6733bb1b6738d04d3f28dfb0b062d99de1d77a9f76d56bd2a32f45375aa90c363</citedby><cites>FETCH-LOGICAL-c5638-6733bb1b6738d04d3f28dfb0b062d99de1d77a9f76d56bd2a32f45375aa90c363</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1528-1167.2011.03018.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1528-1167.2011.03018.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27903,27904,45553,45554,46387,46811</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24339426$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21426327$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Loring, David W.</creatorcontrib><creatorcontrib>Lowenstein, Daniel H.</creatorcontrib><creatorcontrib>Barbaro, Nicholas M.</creatorcontrib><creatorcontrib>Fureman, Brandy E.</creatorcontrib><creatorcontrib>Odenkirchen, Joanne</creatorcontrib><creatorcontrib>Jacobs, Margaret P.</creatorcontrib><creatorcontrib>Austin, Joan K.</creatorcontrib><creatorcontrib>Dlugos, Dennis J.</creatorcontrib><creatorcontrib>French, Jacqueline A.</creatorcontrib><creatorcontrib>Gaillard, William Davis</creatorcontrib><creatorcontrib>Hermann, Bruce P.</creatorcontrib><creatorcontrib>Hesdorffer, Dale C.</creatorcontrib><creatorcontrib>Roper, Steven N.</creatorcontrib><creatorcontrib>Van Cott, Anne C.</creatorcontrib><creatorcontrib>Grinnon, Stacie</creatorcontrib><creatorcontrib>Stout, Alexandra</creatorcontrib><title>Common data elements in epilepsy research: Development and implementation of the NINDS epilepsy CDE project</title><title>Epilepsia (Copenhagen)</title><addtitle>Epilepsia</addtitle><description>Summary
The Common Data Element (CDE) Project was initiated in 2006 by the National Institute of Neurological Disorders and Stroke (NINDS) to develop standards for performing funded neuroscience‐related clinical research. CDEs are intended to standardize aspects of data collection; decrease study start‐up time; and provide more complete, comprehensive, and equivalent data across studies within a particular disease area. Therefore, CDEs will simplify data sharing and data aggregation across NINDS‐funded clinical research, and where appropriate, facilitate the development of evidenced‐based guidelines and recommendations. Epilepsy‐specific CDEs were established in nine content areas: (1) Antiepileptic Drugs (AEDs) and Other Antiepileptic Therapies (AETs), (2) Comorbidities, (3) Electrophysiology, (4) Imaging, (5) Neurological Exam, (6) Neuropsychology, (7) Quality of Life, (8) Seizures and Syndromes, and (9) Surgery and Pathology. CDEs were developed as a dynamic resource that will accommodate recommendations based on investigator use, new technologies, and research findings documenting emerging critical disease characteristics. The epilepsy‐specific CDE initiative can be viewed as part of the larger international movement toward “harmonization” of clinical disease characterization and outcome assessment designed to promote communication and research efforts in epilepsy. It will also provide valuable guidance for CDE improvement during further development, refinement, and implementation. This article describes the NINDS CDE Initiative, the process used in developing Epilepsy CDEs, and the benefits of CDEs for the clinical investigator and NINDS.</description><subject>Anticonvulsants - therapeutic use</subject><subject>Anticonvulsants. Antiepileptics. Antiparkinson agents</subject><subject>Antiepileptic agents</subject><subject>Biological and medical sciences</subject><subject>Communication</subject><subject>Data Collection - standards</subject><subject>Data Collection - trends</subject><subject>Data collections</subject><subject>Data processing</subject><subject>Electrophysiology</subject><subject>Epilepsy</subject><subject>Epilepsy - diagnosis</subject><subject>Epilepsy - epidemiology</subject><subject>Epilepsy - therapy</subject><subject>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>National Institute of Neurological Disorders and Stroke</subject><subject>National Institute of Neurological Disorders and Stroke (U.S.) - standards</subject><subject>National Institute of Neurological Disorders and Stroke (U.S.) - trends</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurological diseases</subject><subject>Neurology</subject><subject>Neuropharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Program Development - standards</subject><subject>Quality of life</subject><subject>Research Design - standards</subject><subject>Seizures</subject><subject>Stroke</subject><subject>Surgery</subject><subject>United States</subject><issn>0013-9580</issn><issn>1528-1167</issn><issn>1528-1167</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkVGL1DAUhYMo7jj6FyQg4lPrTdI0qaAgM6MOLKugPoe0SZ3WtqlJZ93596bOOKs-bV5u4H7ncJKDECaQknhetinhVCaE5CKlQEgKDIhMb-6hxXlxHy0ACEsKLuECPQqhBQCRC_YQXVCS0ZxRsUDfV67v3YCNnjS2ne3tMAXcDNiOTWfHcMDeBqt9tXuF1_badm6cEawHg5t-PAr01EQLV-NpZ_HV9mr9-Va-Wm_w6F1rq-kxelDrLtgnp7lEX99tvqw-JJcf329Xby-TiudMJjEiK0tSxikNZIbVVJq6hBJyaorCWGKE0EUtcsPz0lDNaJ1xJrjWBVQsZ0v05ug77svemiom9LpTo2967Q_K6Ub9uxmanfrmrhXjjGecR4MXJwPvfuxtmFTfhMp2nR6s2wclZfzujAp5B5JAAUBpJJ_9R7Zu74f4D4pwIiiTVECk5JGqvAvB2_qcmoCaq1etmhtWc8Nqrl79rl7dROnTv199Fv7pOgLPT4AOle5qr4eqCbdcxlgxo0v0-sj9jBUe7hxAbT5t5xv7BYKAyds</recordid><startdate>201106</startdate><enddate>201106</enddate><creator>Loring, David W.</creator><creator>Lowenstein, Daniel H.</creator><creator>Barbaro, Nicholas M.</creator><creator>Fureman, Brandy E.</creator><creator>Odenkirchen, Joanne</creator><creator>Jacobs, Margaret P.</creator><creator>Austin, Joan K.</creator><creator>Dlugos, Dennis J.</creator><creator>French, Jacqueline A.</creator><creator>Gaillard, William Davis</creator><creator>Hermann, Bruce P.</creator><creator>Hesdorffer, Dale C.</creator><creator>Roper, Steven N.</creator><creator>Van Cott, Anne C.</creator><creator>Grinnon, Stacie</creator><creator>Stout, Alexandra</creator><general>Blackwell Publishing Ltd</general><general>Wiley-Blackwell</general><general>Wiley Subscription Services, Inc</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201106</creationdate><title>Common data elements in epilepsy research: Development and implementation of the NINDS epilepsy CDE project</title><author>Loring, David W. ; Lowenstein, Daniel H. ; Barbaro, Nicholas M. ; Fureman, Brandy E. ; Odenkirchen, Joanne ; Jacobs, Margaret P. ; Austin, Joan K. ; Dlugos, Dennis J. ; French, Jacqueline A. ; Gaillard, William Davis ; Hermann, Bruce P. ; Hesdorffer, Dale C. ; Roper, Steven N. ; Van Cott, Anne C. ; Grinnon, Stacie ; Stout, Alexandra</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5638-6733bb1b6738d04d3f28dfb0b062d99de1d77a9f76d56bd2a32f45375aa90c363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Anticonvulsants - therapeutic use</topic><topic>Anticonvulsants. Antiepileptics. Antiparkinson agents</topic><topic>Antiepileptic agents</topic><topic>Biological and medical sciences</topic><topic>Communication</topic><topic>Data Collection - standards</topic><topic>Data Collection - trends</topic><topic>Data collections</topic><topic>Data processing</topic><topic>Electrophysiology</topic><topic>Epilepsy</topic><topic>Epilepsy - diagnosis</topic><topic>Epilepsy - epidemiology</topic><topic>Epilepsy - therapy</topic><topic>Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>National Institute of Neurological Disorders and Stroke</topic><topic>National Institute of Neurological Disorders and Stroke (U.S.) - standards</topic><topic>National Institute of Neurological Disorders and Stroke (U.S.) - trends</topic><topic>Nervous system (semeiology, syndromes)</topic><topic>Neurological diseases</topic><topic>Neurology</topic><topic>Neuropharmacology</topic><topic>Pharmacology. Drug treatments</topic><topic>Program Development - standards</topic><topic>Quality of life</topic><topic>Research Design - standards</topic><topic>Seizures</topic><topic>Stroke</topic><topic>Surgery</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Loring, David W.</creatorcontrib><creatorcontrib>Lowenstein, Daniel H.</creatorcontrib><creatorcontrib>Barbaro, Nicholas M.</creatorcontrib><creatorcontrib>Fureman, Brandy E.</creatorcontrib><creatorcontrib>Odenkirchen, Joanne</creatorcontrib><creatorcontrib>Jacobs, Margaret P.</creatorcontrib><creatorcontrib>Austin, Joan K.</creatorcontrib><creatorcontrib>Dlugos, Dennis J.</creatorcontrib><creatorcontrib>French, Jacqueline A.</creatorcontrib><creatorcontrib>Gaillard, William Davis</creatorcontrib><creatorcontrib>Hermann, Bruce P.</creatorcontrib><creatorcontrib>Hesdorffer, Dale C.</creatorcontrib><creatorcontrib>Roper, Steven N.</creatorcontrib><creatorcontrib>Van Cott, Anne C.</creatorcontrib><creatorcontrib>Grinnon, Stacie</creatorcontrib><creatorcontrib>Stout, Alexandra</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Epilepsia (Copenhagen)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Loring, David W.</au><au>Lowenstein, Daniel H.</au><au>Barbaro, Nicholas M.</au><au>Fureman, Brandy E.</au><au>Odenkirchen, Joanne</au><au>Jacobs, Margaret P.</au><au>Austin, Joan K.</au><au>Dlugos, Dennis J.</au><au>French, Jacqueline A.</au><au>Gaillard, William Davis</au><au>Hermann, Bruce P.</au><au>Hesdorffer, Dale C.</au><au>Roper, Steven N.</au><au>Van Cott, Anne C.</au><au>Grinnon, Stacie</au><au>Stout, Alexandra</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Common data elements in epilepsy research: Development and implementation of the NINDS epilepsy CDE project</atitle><jtitle>Epilepsia (Copenhagen)</jtitle><addtitle>Epilepsia</addtitle><date>2011-06</date><risdate>2011</risdate><volume>52</volume><issue>6</issue><spage>1186</spage><epage>1191</epage><pages>1186-1191</pages><issn>0013-9580</issn><issn>1528-1167</issn><eissn>1528-1167</eissn><coden>EPILAK</coden><abstract>Summary
The Common Data Element (CDE) Project was initiated in 2006 by the National Institute of Neurological Disorders and Stroke (NINDS) to develop standards for performing funded neuroscience‐related clinical research. CDEs are intended to standardize aspects of data collection; decrease study start‐up time; and provide more complete, comprehensive, and equivalent data across studies within a particular disease area. Therefore, CDEs will simplify data sharing and data aggregation across NINDS‐funded clinical research, and where appropriate, facilitate the development of evidenced‐based guidelines and recommendations. Epilepsy‐specific CDEs were established in nine content areas: (1) Antiepileptic Drugs (AEDs) and Other Antiepileptic Therapies (AETs), (2) Comorbidities, (3) Electrophysiology, (4) Imaging, (5) Neurological Exam, (6) Neuropsychology, (7) Quality of Life, (8) Seizures and Syndromes, and (9) Surgery and Pathology. CDEs were developed as a dynamic resource that will accommodate recommendations based on investigator use, new technologies, and research findings documenting emerging critical disease characteristics. The epilepsy‐specific CDE initiative can be viewed as part of the larger international movement toward “harmonization” of clinical disease characterization and outcome assessment designed to promote communication and research efforts in epilepsy. It will also provide valuable guidance for CDE improvement during further development, refinement, and implementation. This article describes the NINDS CDE Initiative, the process used in developing Epilepsy CDEs, and the benefits of CDEs for the clinical investigator and NINDS.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>21426327</pmid><doi>10.1111/j.1528-1167.2011.03018.x</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Epilepsia (Copenhagen), 2011-06, Vol.52 (6), p.1186-1191 |
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| language | eng |
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| source | Wiley Free Content; MEDLINE; IngentaConnect Free/Open Access Journals; Wiley Online Library Journals Frontfile Complete; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Anticonvulsants - therapeutic use Anticonvulsants. Antiepileptics. Antiparkinson agents Antiepileptic agents Biological and medical sciences Communication Data Collection - standards Data Collection - trends Data collections Data processing Electrophysiology Epilepsy Epilepsy - diagnosis Epilepsy - epidemiology Epilepsy - therapy Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy Humans Medical sciences National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke (U.S.) - standards National Institute of Neurological Disorders and Stroke (U.S.) - trends Nervous system (semeiology, syndromes) Neurological diseases Neurology Neuropharmacology Pharmacology. Drug treatments Program Development - standards Quality of life Research Design - standards Seizures Stroke Surgery United States |
| title | Common data elements in epilepsy research: Development and implementation of the NINDS epilepsy CDE project |
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