Common data elements for clinical research in Friedreich's ataxia.
Identifieur interne : 000B28 ( PubMed/Corpus ); précédent : 000B27; suivant : 000B29Common data elements for clinical research in Friedreich's ataxia.
Auteurs : David R. Lynch ; Massimo Pandolfo ; Jorg B. Schulz ; Susan Perlman ; Martin B. Delatycki ; R Mark Payne ; Robert Shaddy ; Kenneth H. Fischbeck ; Jennifer Farmer ; Paul Kantor ; Subha V. Raman ; Lisa Hunegs ; Joanne Odenkirchen ; Kristy Miller ; Petra KaufmannSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2013.
English descriptors
- KwdEn :
- Academic Medical Centers, Biological Markers, Biomedical Research (statistics & numerical data), Data Collection, Data Interpretation, Statistical, Databases, Factual, Demography, Friedreich Ataxia (classification), Friedreich Ataxia (diagnosis), Friedreich Ataxia (therapy), Heart Diseases (etiology), Humans, International Cooperation, National Institute of Neurological Disorders and Stroke, National Institutes of Health (U.S.), Neurologic Examination, Neurology (statistics & numerical data), Psychomotor Performance (physiology), Reference Standards, Telecommunications, Terminology as Topic, Treatment Outcome, United States.
- MESH :
- chemical : Biological Markers.
- geographic : United States.
- classification : Friedreich Ataxia.
- diagnosis : Friedreich Ataxia.
- etiology : Heart Diseases.
- physiology : Psychomotor Performance.
- statistics & numerical data : Biomedical Research, Neurology.
- therapy : Friedreich Ataxia.
- Academic Medical Centers, Data Collection, Data Interpretation, Statistical, Databases, Factual, Demography, Humans, International Cooperation, National Institute of Neurological Disorders and Stroke, National Institutes of Health (U.S.), Neurologic Examination, Reference Standards, Telecommunications, Terminology as Topic, Treatment Outcome.
Abstract
To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.
DOI: 10.1002/mds.25201
PubMed: 23239403
Links to Exploration step
pubmed:23239403Le document en format XML
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Delatycki</name></author><author><name sortKey="Payne, R Mark" sort="Payne, R Mark" uniqKey="Payne R" first="R Mark" last="Payne">R Mark Payne</name></author><author><name sortKey="Shaddy, Robert" sort="Shaddy, Robert" uniqKey="Shaddy R" first="Robert" last="Shaddy">Robert Shaddy</name></author><author><name sortKey="Fischbeck, Kenneth H" sort="Fischbeck, Kenneth H" uniqKey="Fischbeck K" first="Kenneth H" last="Fischbeck">Kenneth H. Fischbeck</name></author><author><name sortKey="Farmer, Jennifer" sort="Farmer, Jennifer" uniqKey="Farmer J" first="Jennifer" last="Farmer">Jennifer Farmer</name></author><author><name sortKey="Kantor, Paul" sort="Kantor, Paul" uniqKey="Kantor P" first="Paul" last="Kantor">Paul Kantor</name></author><author><name sortKey="Raman, Subha V" sort="Raman, Subha V" uniqKey="Raman S" first="Subha V" last="Raman">Subha V. Raman</name></author><author><name sortKey="Hunegs, Lisa" sort="Hunegs, Lisa" uniqKey="Hunegs L" first="Lisa" last="Hunegs">Lisa Hunegs</name></author><author><name sortKey="Odenkirchen, Joanne" sort="Odenkirchen, Joanne" uniqKey="Odenkirchen J" first="Joanne" last="Odenkirchen">Joanne Odenkirchen</name></author><author><name sortKey="Miller, Kristy" sort="Miller, Kristy" uniqKey="Miller K" first="Kristy" last="Miller">Kristy Miller</name></author><author><name sortKey="Kaufmann, Petra" sort="Kaufmann, Petra" uniqKey="Kaufmann P" first="Petra" last="Kaufmann">Petra Kaufmann</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2013" type="published">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Academic Medical Centers</term><term>Biological Markers</term><term>Biomedical Research (statistics & numerical data)</term><term>Data Collection</term><term>Data Interpretation, Statistical</term><term>Databases, Factual</term><term>Demography</term><term>Friedreich Ataxia (classification)</term><term>Friedreich Ataxia (diagnosis)</term><term>Friedreich Ataxia (therapy)</term><term>Heart Diseases (etiology)</term><term>Humans</term><term>International Cooperation</term><term>National Institute of Neurological Disorders and Stroke</term><term>National Institutes of Health (U.S.)</term><term>Neurologic Examination</term><term>Neurology (statistics & numerical data)</term><term>Psychomotor Performance (physiology)</term><term>Reference Standards</term><term>Telecommunications</term><term>Terminology as Topic</term><term>Treatment Outcome</term><term>United States</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Biological Markers</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Friedreich Ataxia</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Friedreich Ataxia</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Heart Diseases</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Psychomotor Performance</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Biomedical Research</term><term>Neurology</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Friedreich Ataxia</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Academic Medical Centers</term><term>Data Collection</term><term>Data Interpretation, Statistical</term><term>Databases, Factual</term><term>Demography</term><term>Humans</term><term>International Cooperation</term><term>National Institute of Neurological Disorders and Stroke</term><term>National Institutes of Health (U.S.)</term><term>Neurologic Examination</term><term>Reference Standards</term><term>Telecommunications</term><term>Terminology as Topic</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">23239403</PMID><DateCreated><Year>2013</Year><Month>02</Month><Day>25</Day></DateCreated><DateCompleted><Year>2013</Year><Month>08</Month><Day>06</Day></DateCompleted><DateRevised><Year>2014</Year><Month>11</Month><Day>04</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>28</Volume><Issue>2</Issue><PubDate><Year>2013</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Common data elements for clinical research in Friedreich's ataxia.</ArticleTitle><Pagination><MedlinePgn>190-5</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.25201</ELocationID><Abstract><AbstractText>To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements, which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich's ataxia (FRDA), a neurological disorder that involves multiple organ systems. To develop FRDA common data elements, FRDA experts formed a working group and subgroups to define elements in the following: ataxia and performance measures; biomarkers; cardiac and other clinical outcomes; and demographics, laboratory tests, and medical history. The basic development process included identification of international experts in FRDA clinical research, meeting by teleconference to develop a draft of standardized common data elements recommendations, vetting of recommendations across the subgroups, and dissemination of recommendations to the research community for public comment. The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The subgroups' recommendations are classified as core, supplemental, or exploratory. Template case report forms were created for many of the core tests. The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new, ongoing studies will be assessed in an ongoing fashion to define their utility in FRDA.</AbstractText><CopyrightInformation>Copyright © 2012 Movement Disorders Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lynch</LastName><ForeName>David R</ForeName><Initials>DR</Initials><AffiliationInfo><Affiliation>Department of Neurology, University of Pennsylvania and the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA. lynchd@mail.med.upenn.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pandolfo</LastName><ForeName>Massimo</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Schulz</LastName><ForeName>Jorg B</ForeName><Initials>JB</Initials></Author><Author ValidYN="Y"><LastName>Perlman</LastName><ForeName>Susan</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Delatycki</LastName><ForeName>Martin B</ForeName><Initials>MB</Initials></Author><Author ValidYN="Y"><LastName>Payne</LastName><ForeName>R Mark</ForeName><Initials>RM</Initials></Author><Author ValidYN="Y"><LastName>Shaddy</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Fischbeck</LastName><ForeName>Kenneth H</ForeName><Initials>KH</Initials></Author><Author ValidYN="Y"><LastName>Farmer</LastName><ForeName>Jennifer</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Kantor</LastName><ForeName>Paul</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Raman</LastName><ForeName>Subha V</ForeName><Initials>SV</Initials></Author><Author ValidYN="Y"><LastName>Hunegs</LastName><ForeName>Lisa</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Odenkirchen</LastName><ForeName>Joanne</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>Kristy</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Kaufmann</LastName><ForeName>Petra</ForeName><Initials>P</Initials></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>N01-NS-7-2372</GrantID><Acronym>NS</Acronym><Agency>NINDS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>R21 NS067270</GrantID><Acronym>NS</Acronym><Agency>NINDS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>12</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015415">Biological Markers</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Arch Neurol. 2002 May;59(5):743-7</RefSource><PMID Version="1">12020255</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Neurotrauma. 2012 Mar 1;29(4):639-53</RefSource><PMID Version="1">21939389</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Brain. 1981 Sep;104(3):589-620</RefSource><PMID Version="1">7272714</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Metabolism. 1986 Nov;35(11):1017-23</RefSource><PMID Version="1">3534514</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Neurology. 1988 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Statistical</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016208">Databases, Factual</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D003710">Demography</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005621">Friedreich Ataxia</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000145">classification</QualifierName><QualifierName MajorTopicYN="N" UI="Q000175">diagnosis</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000628">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006331">Heart Diseases</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000209">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007391">International Cooperation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D055825">National Institute of Neurological Disorders and Stroke</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009316">National Institutes of Health (U.S.)</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009460">Neurologic Examination</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009462">Neurology</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000706">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011597">Psychomotor Performance</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000502">physiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012015">Reference Standards</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013685">Telecommunications</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009626">Terminology as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" Type="Geographic" UI="D014481">United States</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">NIHMS403386</OtherID><OtherID Source="NLM">PMC3581713</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2012</Year><Month>6</Month><Day>14</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2012</Year><Month>8</Month><Day>22</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2012</Year><Month>12</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>12</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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