MovDisordV3, Main, Exploration, bibRecord, 000E34

Common Data Elements for Clinical Research in Friedreich Ataxia

Identifieur interne : 000E34 ( Main/Exploration ); précédent : 000E33; suivant : 000E35

Common Data Elements for Clinical Research in Friedreich Ataxia

Auteurs : David R. Lynch [États-Unis] ; Massimo Pandolfo [Belgique] ; Jorg B. Schulz [Allemagne] ; Susan Perlman [États-Unis] ; Martin B. Delatycki [Australie] ; R. Mark Payne [États-Unis] ; Robert Shaddy [États-Unis] ; Kenneth H. Fischbeck [États-Unis] ; Jennifer Farmer [États-Unis] ; Paul Kantor [Canada] ; Subha V. Raman [États-Unis] ; Lisa Hunegs [États-Unis] ; Joanne Odenkirchen [États-Unis] ; Kristy Miller [États-Unis] ; Petra Kaufmann [États-Unis]

Source :

Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2012.

RBID : PMC:3581713

Descripteurs français

Wicri :
- geographic : États-Unis.

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

Background

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 ataxia, a neurological disorder that involves multiple organ systems.

Methods

To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: 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 Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment.

Results

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.

Conclusions

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 and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3581713

DOI: 10.1002/mds.25201
PubMed: 23239403
PubMed Central: 3581713

Affiliations:

Le document en format XML

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<author><name sortKey="Payne, R Mark" sort="Payne, R Mark" uniqKey="Payne R" first="R. Mark" last="Payne">R. Mark Payne</name>
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<author><name sortKey="Shaddy, Robert" sort="Shaddy, Robert" uniqKey="Shaddy R" first="Robert" last="Shaddy">Robert Shaddy</name>
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<author><name sortKey="Fischbeck, Kenneth H" sort="Fischbeck, Kenneth H" uniqKey="Fischbeck K" first="Kenneth H." last="Fischbeck">Kenneth H. Fischbeck</name>
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<author><name sortKey="Farmer, Jennifer" sort="Farmer, Jennifer" uniqKey="Farmer J" first="Jennifer" last="Farmer">Jennifer Farmer</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Kantor, Paul" sort="Kantor, Paul" uniqKey="Kantor P" first="Paul" last="Kantor">Paul Kantor</name>
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<author><name sortKey="Raman, Subha V" sort="Raman, Subha V" uniqKey="Raman S" first="Subha V." last="Raman">Subha V. Raman</name>
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<author><name sortKey="Hunegs, Lisa" sort="Hunegs, Lisa" uniqKey="Hunegs L" first="Lisa" last="Hunegs">Lisa Hunegs</name>
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<author><name sortKey="Miller, Kristy" sort="Miller, Kristy" uniqKey="Miller K" first="Kristy" last="Miller">Kristy Miller</name>
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<author><name sortKey="Kaufmann, Petra" sort="Kaufmann, Petra" uniqKey="Kaufmann P" first="Petra" last="Kaufmann">Petra Kaufmann</name>
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<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>
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<term>National Institute of Neurological Disorders and Stroke</term>
<term>National Institutes of Health (U.S.)</term>
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<term>Reference Standards</term>
<term>Telecommunications</term>
<term>Terminology as Topic</term>
<term>Treatment Outcome</term>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P2">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 ataxia, a neurological disorder that involves multiple organ systems.</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P3">To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: 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 Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P4">The full recommendations were published online in September 2011 at <ext-link ext-link-type="uri" xlink:href="http://www.commondataelements.ninds.nih.gov/FA.aspx">http://www.commondataelements.ninds.nih.gov/FA.aspx</ext-link>
. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests.</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P5">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 and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Indiana</li>
<li>Maryland</li>
<li>Ohio</li>
<li>Pennsylvanie</li>
<li>Région de Bruxelles-Capitale</li>
</region>
<settlement><li>Bruxelles</li>
</settlement>
<orgName><li>Université libre de Bruxelles</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Lynch, David R" sort="Lynch, David R" uniqKey="Lynch D" first="David R." last="Lynch">David R. Lynch</name>
</region>
<name sortKey="Farmer, Jennifer" sort="Farmer, Jennifer" uniqKey="Farmer J" first="Jennifer" last="Farmer">Jennifer Farmer</name>
<name sortKey="Fischbeck, Kenneth H" sort="Fischbeck, Kenneth H" uniqKey="Fischbeck K" first="Kenneth H." last="Fischbeck">Kenneth H. Fischbeck</name>
<name sortKey="Hunegs, Lisa" sort="Hunegs, Lisa" uniqKey="Hunegs L" first="Lisa" last="Hunegs">Lisa Hunegs</name>
<name sortKey="Kaufmann, Petra" sort="Kaufmann, Petra" uniqKey="Kaufmann P" first="Petra" last="Kaufmann">Petra Kaufmann</name>
<name sortKey="Miller, Kristy" sort="Miller, Kristy" uniqKey="Miller K" first="Kristy" last="Miller">Kristy Miller</name>
<name sortKey="Odenkirchen, Joanne" sort="Odenkirchen, Joanne" uniqKey="Odenkirchen J" first="Joanne" last="Odenkirchen">Joanne Odenkirchen</name>
<name sortKey="Payne, R Mark" sort="Payne, R Mark" uniqKey="Payne R" first="R. Mark" last="Payne">R. Mark Payne</name>
<name sortKey="Perlman, Susan" sort="Perlman, Susan" uniqKey="Perlman S" first="Susan" last="Perlman">Susan Perlman</name>
<name sortKey="Raman, Subha V" sort="Raman, Subha V" uniqKey="Raman S" first="Subha V." last="Raman">Subha V. Raman</name>
<name sortKey="Shaddy, Robert" sort="Shaddy, Robert" uniqKey="Shaddy R" first="Robert" last="Shaddy">Robert Shaddy</name>
</country>
<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Pandolfo, Massimo" sort="Pandolfo, Massimo" uniqKey="Pandolfo M" first="Massimo" last="Pandolfo">Massimo Pandolfo</name>
</region>
</country>
<country name="Allemagne"><noRegion><name sortKey="Schulz, Jorg B" sort="Schulz, Jorg B" uniqKey="Schulz J" first="Jorg B." last="Schulz">Jorg B. Schulz</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Delatycki, Martin B" sort="Delatycki, Martin B" uniqKey="Delatycki M" first="Martin B." last="Delatycki">Martin B. Delatycki</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Kantor, Paul" sort="Kantor, Paul" uniqKey="Kantor P" first="Paul" last="Kantor">Paul Kantor</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Movement Disorders (revue)

Common Data Elements for Clinical Research in Friedreich Ataxia

Common Data Elements for Clinical Research in Friedreich Ataxia

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