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Common Data Elements (CDEs)
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<h2>Common Data Elements (CDEs)
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<h3>Examples of Activities and Groups using CDEs</h3>
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<p>Here are a few examples of activities and groups using common data elements at NIH. Some CDEs are developed into collections that cross disciplines and domains, such as NIH Toolbox, PhenX Toolkit, PROMIS and Neuro-QoL. Some are domain or disease focused, such as the NINDS Common Data Elements (Neurology), eyeGENE (ophthalmic disease), and the National Heart, Lung and Blood Institute (NHLBI) Cure Sickle Cell Initiative.</p>
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<p>While CDEs may be new to some, several collections have been established for years in their communities. One example is the National Cancer Institute (NCI), which has been promoting CDEs for over 20 years.</p>
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<p>Let’s take a closer look at two collections: <strong>NHLBI Cure Sickle Cell Initiative</strong> and <strong>PhenX</strong>.</p>
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<h4>NHLBI Cure Sickle Cell Initiative</h4>
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<p>The NHLBI Cure Sickle Cell Initiative has developed a set of CDEs “to facilitate the collection of data on clinical research studies of genetic therapies for sickle cell disease,” with the goal of making research more efficient, open, and rapid to help identify, treat, and reduce sickle cell disease.</p>
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</div>
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<div class="col-lg-8">
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<p>The <a href="https://cde.curesickle.org/datatools-overview" title="NHLBI Cure Sickle Cell Initiative Data Standards" target="_blank">NHLBI Cure Sickle Cell Initiative Data Standards</a> include a list of domains and subdomains to narrow in on specific topics. Domains include:</p>
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<ul>
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<li>Participant Characteristics</li>
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<li>Disease or Treatment Related Events</li>
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<li>Assessments and Examinations</li>
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<li>Treatment/Intervention Data</li>
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<li>Safety Data</li>
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<li>Outcomes and End Points</li>
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<li>Additional Proposed Instruments</li>
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</ul>
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<div class="col-sm-3">
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<div class="graphic">
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<img class="img-fluid" src="img/DNA.jpg" alt="DNA icon. Black and blue colors.">
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</div>
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<div class="text-center">
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<p>
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<em><small>(Image Source: iStock Photos, Sylfida©)</small></em>
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</p>
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</div>
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</div>
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<div class="col-lg-12">
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<p>These CDEs can also be found in the NIH Common Data Element Repository CDEs > NHLBI > <a href="https://cde.nlm.nih.gov/cde/search?selectedOrg=NHLBI&classification=Sickle%20Cell%20Disease" title="Sickle Cell Disease" target="_blank">Sickle Cell Disease</a>. <em>Note: As of this writing, the Sickle Cell CDEs in the Repository have not yet been endorsed by the NIH CDE Governance Committee, but the Cure Sickle Cell team has begun the submission process.</em></p>
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<br>
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<h4><i class="fas fa-user-edit"></i> Exercises</h4>
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<div>
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<p>On the <a href="https://cde.curesickle.org/sickle%20cell" title="NHLBI Cure Sickle Cell Initiative Data Standards" target="_blank">NHLBI Cure Sickle Cell Initiative Data Standards</a> webpage, scroll down to "Outcomes and Endpoints" and select "Daytime Sleepiness."</p>
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<p>Next to "Epworth Sleepiness Scale (ESS) - Adult Version," click on "CDE Details." Review the CDE Detailed Report.</p>
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<div class="card shadow-sm">
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<div class="card-body">
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<ol class="pubmed-numbers p-l-0">
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<li class="mb-2">Which of the following is <strong>not</strong> a description of a permissible value for daytime sleepiness?</li>
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</ol>
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<div class="form-check mb-2 ms-5">
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<input class="form-check-input" type="radio" name="flexRadioDefaultQ1" id="flexRadioDefault1a">
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<label class="form-check-label" for="flexRadioDefault1a">
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a) No chance of dozing
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</label>
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</div>
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<div class="form-check mb-2 ms-5">
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<input class="form-check-input" type="radio" name="flexRadioDefaultQ1" id="flexRadioDefault1b">
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<label class="form-check-label" for="flexRadioDefault1b">
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b) Slight chance of dozing
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</label>
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<div class="form-check mb-2 ms-5">
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<input class="form-check-input" type="radio" name="flexRadioDefaultQ1" id="flexRadioDefault1c">
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<label class="form-check-label" for="flexRadioDefault1c">
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c) Moderate chance of dozing
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</label>
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<div class="form-check mb-2 ms-5">
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<input class="form-check-input" type="radio" name="flexRadioDefaultQ1" id="flexRadioDefault1d">
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<label class="form-check-label" for="flexRadioDefault1d">
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d) Possible chance of dozing
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</label>
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</div>
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<div class="form-check mb-2 ms-5">
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<input class="form-check-input" type="radio" name="flexRadioDefaultQ1" id="flexRadioDefault1e">
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<label class="form-check-label" for="flexRadioDefault1e">
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e) High chance of dozing
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</label>
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<p><strong>d) Possible chance of dozing</strong> is not a description of a permissible value for daytime sleepiness.
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</div>
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<br>
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<div class="row">
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<h4>PhenX Toolkit</h4>
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<p>The PhenX (consensus measures for <strong>Phen</strong>otype and e<strong>X</strong>posures) Toolkit is a project from the <a href="https://www.genome.gov/" title="National Human Genome Research Institute" target="_blank">National Human Genome Research Institute (NHGRI)</a>. It includes measurement protocols addressing multiple research domains, including COVID-19, Social Environments, Diabetes, Oral Health, and more.</p>
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<div class="col-lg-8">
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||
<p>These protocols are intended to facilitate cross-study analysis and therefore increase the scientific impact of individual studies. Because the protocols are accessible from one toolkit, researchers can quickly find standardized data collection tools and find other investigators who are using the same protocol.</p>
|
||
|
||
<p>The <a href="https://www.phenxtoolkit.org/" title="PhenX Toolkit" target="_blank">PhenX Toolkit</a> includes a COVID-19 Variable Compare Tool that is designed to assist investigators who are evaluating or choosing between COVID-related questionnaires or surveys to include in their research or study design. Users can search by keyword, perform a side-by-side comparison of variables, or compare questionnaires.</p>
|
||
</div>
|
||
<div class="col-sm-3">
|
||
<div class="graphic">
|
||
<img class="img-fluid" src="img/question.jpg" alt="Question and answer icon. Black and blue colors.">
|
||
</div>
|
||
<div class="text-center">
|
||
<p>
|
||
<em><small>(Image Source: iStock Photos, Hiranmay Baidya©)</small></em>
|
||
</p>
|
||
</div>
|
||
</div>
|
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<div class="col-lg-12">
|
||
|
||
<br>
|
||
|
||
<h4><i class="fas fa-user-edit"></i> Exercises</h4>
|
||
<p>Try using the <a href="https://www.phenxtoolkit.org/variable-compare" title="COVID-19 Variable Compare Tool" target="_blank">COVID-19 Variable Compare Tool</a> in the PhenX Toolkit. Select the Keyword Search tab and search for <strong>smoking</strong>.</p>
|
||
<div>
|
||
|
||
|
||
<div class="card shadow-sm">
|
||
<div class="card-body">
|
||
<ol class="pubmed-numbers p-l-0" style="counter-reset: my-counter 1;">
|
||
<li class="mb-2">How many questionnaires are using Variable ID PX9915001037000 (Current Smoking)?</li>
|
||
</ol>
|
||
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ2" id="flexRadioDefault2a">
|
||
<label class="form-check-label" for="flexRadioDefault2a">
|
||
a) 2
|
||
</label>
|
||
</div>
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ2" id="flexRadioDefault2b">
|
||
<label class="form-check-label" for="flexRadioDefault2b">
|
||
b) 3
|
||
</label>
|
||
</div>
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ2" id="flexRadioDefault2c">
|
||
<label class="form-check-label" for="flexRadioDefault2c">
|
||
c) 4
|
||
</label>
|
||
</div>
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ2" id="flexRadioDefault2d">
|
||
<label class="form-check-label" for="flexRadioDefault2d">
|
||
d) More than 5
|
||
</label>
|
||
</div>
|
||
|
||
|
||
|
||
<!-- Button trigger modal -->
|
||
<div class="text-center">
|
||
<button type="button" class="btn btn-primary" data-bs-toggle="modal" data-bs-target="#Exercise2Modal">
|
||
Show Answer
|
||
</button>
|
||
</div>
|
||
<br>
|
||
|
||
<!-- Modal -->
|
||
<div class="modal fade" id="Exercise2Modal" tabindex="-1" role="dialog" aria-labelledby="Exercise2ModalLabel" aria-hidden="true">
|
||
<div class="modal-dialog" role="document">
|
||
<div class="modal-content">
|
||
<div class="modal-header">
|
||
<h5 class="modal-title" id="Exercise2ModalLabel">Answer</h5>
|
||
<button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close">
|
||
</button>
|
||
</div>
|
||
<div class="modal-body">
|
||
<p><strong>d) More than 5.</strong> Look in the <em>Instruments with Similar Variables</em>
|
||
column.</p>
|
||
</div>
|
||
<div class="modal-footer">
|
||
<button type="button" class="btn btn-secondary" data-bs-dismiss="modal">Close</button>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<ol class="pubmed-numbers p-l-0" style="counter-reset: my-counter 2;">
|
||
<li class="mb-2">What is the source of this variable?</li>
|
||
</ol>
|
||
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ3" id="flexRadioDefault3a">
|
||
<label class="form-check-label" for="flexRadioDefault3a">
|
||
a) WHO Global COVID-19 Clinical Platform: Pregnancy Case Report Form (CRF)
|
||
</label>
|
||
</div>
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ3" id="flexRadioDefault3b">
|
||
<label class="form-check-label" for="flexRadioDefault3b">
|
||
b) C4R COVID-19 Questionnaire
|
||
</label>
|
||
</div>
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ3" id="flexRadioDefault3c">
|
||
<label class="form-check-label" for="flexRadioDefault3c">
|
||
c) All of Us Covid 19 Participant Experience Survey (COPE)
|
||
</label>
|
||
</div>
|
||
<div class="form-check mb-2 ms-5">
|
||
<input class="form-check-input" type="radio" name="flexRadioDefaultQ3" id="flexRadioDefault3d">
|
||
<label class="form-check-label" for="flexRadioDefault3d">
|
||
d) Novel Coronavirus (nCOV) Acute Respiratory Infection Clinical Characterisation Data Tool
|
||
</label>
|
||
</div>
|
||
|
||
|
||
|
||
<!-- Button trigger modal -->
|
||
<div class="text-center">
|
||
<button type="button" class="btn btn-primary" data-bs-toggle="modal" data-bs-target="#Exercise3Modal">
|
||
Show Answer
|
||
</button>
|
||
</div>
|
||
<br>
|
||
|
||
<!-- Modal -->
|
||
<div class="modal fade" id="Exercise3Modal" tabindex="-1" role="dialog" aria-labelledby="Exercise3ModalLabel" aria-hidden="true">
|
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<div class="modal-dialog" role="document">
|
||
<div class="modal-content">
|
||
<div class="modal-header">
|
||
<h5 class="modal-title" id="Exercise3ModalLabel">Answer</h5>
|
||
<button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close">
|
||
</button>
|
||
</div>
|
||
<div class="modal-body">
|
||
<p><strong>a) WHO Global COVID-19 Clinical Platform: Pregnancy Case Report Form (CRF).</strong></p>
|
||
</div>
|
||
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|
||
<button type="button" class="btn btn-secondary" data-bs-dismiss="modal">Close</button>
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