michael f. huerta, ph.d. associate director for program development national library of medicine,...
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Michael F. Huerta, Ph.DMichael F. Huerta, Ph.D..Associate Director for Program Development Associate Director for Program Development
National Library of Medicine, NIHNational Library of Medicine, NIH
BD2K CDE Webinar – September 8, 2015BD2K CDE Webinar – September 8, 2015
Common Data Elements*: Common Data Elements*: Communication & Coordination Communication & Coordination
Across NIHAcross NIH
Michael F. Huerta, Ph.DMichael F. Huerta, Ph.D..Associate Director for Program Development Associate Director for Program Development
National Library of Medicine, NIHNational Library of Medicine, NIH
BD2K CDE Webinar – September 8, 2015BD2K CDE Webinar – September 8, 2015
*for human subject research*for human subject research
Common Data Elements*: Common Data Elements*: Communication & Coordination Communication & Coordination
Across NIHAcross NIH
What is a CDE?
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion
Q: What is the participant’s sex?
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion A fixed set of A fixed set of permissible answerspermissible answers, which can be , which can be
discrete or continuous over a rangediscrete or continuous over a range
Q: What is the participant’s sex?
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion A fixed set of A fixed set of permissible answerspermissible answers, which can be , which can be
discrete or continuous over a rangediscrete or continuous over a range
A: Male, Female, or Other
Q: What is the participant’s sex?
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion A fixed set of A fixed set of permissible answerspermissible answers, which can be , which can be
discrete or continuous over a rangediscrete or continuous over a range
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion A fixed set of A fixed set of permissible answerspermissible answers, which can be , which can be
discrete or continuous over a rangediscrete or continuous over a range Used in common Used in common across multiple sites, projects, across multiple sites, projects,
initiatives, etc.initiatives, etc.
What is a CDE?
A A fixed representation fixed representation of a variable comprisingof a variable comprising A precisely specified A precisely specified questionquestion A fixed set of A fixed set of permissible answerspermissible answers, which can be , which can be
discrete or continuous over a rangediscrete or continuous over a range Used in common Used in common across multiple sites, projects, across multiple sites, projects,
initiatives, etc.initiatives, etc. Typically represent Typically represent core variablescore variables – not all variables– not all variables
What is a CDE? A fixed representation of a variable comprising
A precisely specified question A fixed set of permissible answers, which can be discrete or
continuous over a range Used in common across multiple sites, projects, initiatives, etc. Typically represent core variables – not all variables Individual CDEs can be Individual CDEs can be combinedcombined to to
Populate case report formsPopulate case report forms Constitute a validated survey instrument, e.g., Constitute a validated survey instrument, e.g.,
Patient Health Questionnaire-9Patient Health Questionnaire-9• Nine questions to measure depressionNine questions to measure depression
Why use CDEs?
Why use CDEs?
Consistent data collection of Consistent data collection of core set of variablescore set of variables from different sources (sites, projects, initiatives) from different sources (sites, projects, initiatives) valid sharing & comparing of datavalid sharing & comparing of data allowing:allowing: Aggregation of data to increase statistical powerAggregation of data to increase statistical power Rigorous comparison of data & resultsRigorous comparison of data & results
Why use CDEs?
Consistent data collection of core set of variables from different sources (sites, projects, initiatives) valid sharing & comparing of data allowing: Aggregation of data to increase statistical power Rigorous comparison of data & results
Can be used to promote research:Can be used to promote research: EfficiencyEfficiency – off-the-shelf data elements – off-the-shelf data elements QualityQuality – validated instruments & measures – validated instruments & measures ClarityClarity – unambiguously defined data elements– unambiguously defined data elements ReproducibilityReproducibility – from rigorous comparison– from rigorous comparison
How are CDEs Typically Developed?
How are CDEs Typically Developed?
The need for a CDE is first identified byThe need for a CDE is first identified by Research funder (e.g., NIH IC)Research funder (e.g., NIH IC) Regulatory agency (e.g., FDA)Regulatory agency (e.g., FDA) Professional society (e.g., ACC)Professional society (e.g., ACC) Research communityResearch community
How are CDEs Typically Developed?
The need for a CDE is first identified by Research funder (e.g., NIH IC) Regulatory agency (e.g., FDA) Professional society (e.g., ACC) Research community
Stakeholders & expert groups convened to develop Stakeholders & expert groups convened to develop or select CDE for identified purposeor select CDE for identified purpose
How are CDEs Typically Developed?
The need for a CDE is first identified by Research funder (e.g., NIH IC) Regulatory agency (e.g., FDA) Professional society (e.g., ACC) Research community
Stakeholders & expert groups convened to develop or select CDE for identified purpose
Iterations & updates w input from broader communityIterations & updates w input from broader community
How are CDEs Typically Developed?
The need for a CDE is first identified by Research funder (e.g., NIH IC) Regulatory agency (e.g., FDA) Professional society (e.g., ACC) Research community
Stakeholders & expert groups convened to develop or select CDE for identified purpose
Iterations & updates w input from broader community CDEs are endorsed by the convening organization and CDEs are endorsed by the convening organization and
their use is then required, recommended, encouraged or their use is then required, recommended, encouraged or merely acknowledged as a possibilitymerely acknowledged as a possibility
NIH CDE Collections & Efforts
NIH CDE Collections & Efforts
Broadly applicable Broadly applicable & formally evaluated collections& formally evaluated collections PhenX Toolkit PhenX Toolkit > 350 standard measures of > 350 standard measures of
phenotypes & exposuresphenotypes & exposures PROMISPROMIS Validated patient reported outcome Validated patient reported outcome
measures, ~ 100 computerized adaptive testsmeasures, ~ 100 computerized adaptive tests NIH Toolbox NIH Toolbox – Validated measures of cognitive, – Validated measures of cognitive,
emotional, sensory and motor functionsemotional, sensory and motor functions
NIH CDE Collections & Efforts Broadly applicable & formally evaluated collections
PhenX Toolkit > 350 standard measures of phenotypes & exposures
PROMIS Validated patient reported outcome measures, ~ 100 computerized adaptive tests
NIH Toolbox – Validated measures of cognitive, emotional, sensory and motor functions
More More narrowly focused narrowly focused collectionscollections NINDSNINDS CDEs for disease-specific studies CDEs for disease-specific studies NCINCI Early Detection Research Network Early Detection Research Network NEINEI eyeGENE ophthalmic phenotype CDEs eyeGENE ophthalmic phenotype CDEs NIDANIDA substance use disorders CDEs for EHRs substance use disorders CDEs for EHRs NCATSNCATS Global Rare Diseases Patient Registry Global Rare Diseases Patient Registry
Three Important Facts About CDEs
Three Important Facts About CDEs
CDE use and efforts will continue toCDE use and efforts will continue to increaseincrease > 40 active FOAs // > 300 FOAs in last few years> 40 active FOAs // > 300 FOAs in last few years Data from Electronic Health RecordsData from Electronic Health Records Use by other organizations (eg., FDA, PCORnet)Use by other organizations (eg., FDA, PCORnet)
Three Important Facts About CDEs
CDE use and efforts will continue to increase > 40 active FOAs // > 300 FOAs in last few years Data from Electronic Health Records Use by other organizations (eg., FDA, PCORnet)
Communication about and coordination of CDE Communication about and coordination of CDE efforts across NIH is a efforts across NIH is a good thinggood thing
Three Important Facts About CDEs
CDE use and efforts will continue to increase > 40 active FOAs // > 300 FOAs in last few years Electronic Health Records Other relevant organizations (eg., FDA, PCORnet)
Communication about and coordination of CDE efforts across NIH is a good thing
NIH has an NIH has an excellent venue excellent venue for communicating & for communicating & coordinating: coordinating: BMICBMIC
Biomedical Informatics Coordinating Committee
Biomedical Informatics Coordinating Committee
BMIC established 2007 by NIH DirectorBMIC established 2007 by NIH Director To improve communication & coordination of clinical-To improve communication & coordination of clinical-
informatics & bioinformatics across NIHinformatics & bioinformatics across NIH All NIH ICsAll NIH ICs
Biomedical Informatics Coordinating Committee
BMIC established 2007 by NIH Director To improve communication & coordination of clinical-
informatics & bioinformatics across NIH All NIH ICs BMIC Products includeBMIC Products include
Working Group on Clinical IT StandardsWorking Group on Clinical IT Standards Working Group on Community Based Standards Working Group on Community Based Standards Portal to NIH-supported Data RepositoriesPortal to NIH-supported Data Repositories Portal to NIH Data Sharing Policies Portal to NIH Data Sharing Policies Common Data Elements Working GroupCommon Data Elements Working Group
Biomedical Informatics Coordinating Committee
BMIC established 2007 by NIH Director To improve communication & coordination of clinical-
informatics & bioinformatics across NIH All NIH ICs BMIC Products includeBMIC Products include
Working Group on Clinical IT StandardsWorking Group on Clinical IT Standards Working Group on Community Based Standards Working Group on Community Based Standards Portal to NIH-supported Data RepositoriesPortal to NIH-supported Data Repositories Portal to NIH Data Sharing Policies Portal to NIH Data Sharing Policies Common Data Elements Working GroupCommon Data Elements Working Group
BMIC CDE Working Group
Established 2012 by BMICEstablished 2012 by BMIC Focus on the many CDE efforts across NIHFocus on the many CDE efforts across NIH 22 NIH ICs22 NIH ICs
BMIC CDE Working Group Established 2012 by BMIC Focus on the many CDE efforts across NIH 22 NIH ICs BMIC CDE WG Products BMIC CDE WG Products
Ongoing, common engagement of NIH ICsOngoing, common engagement of NIH ICs Sharing lessons learned & best practicesSharing lessons learned & best practices Paper on CDEs & CDE efforts at NIHPaper on CDEs & CDE efforts at NIH
Authors from NCATS, NCI, NEI, NHGRI, NIAMS, NICHD, Authors from NCATS, NCI, NEI, NHGRI, NIAMS, NICHD, NIDA, NINDS & NLMNIDA, NINDS & NLM
NIH rep to CDE efforts (FDA, ONC, CFAST, etc.)NIH rep to CDE efforts (FDA, ONC, CFAST, etc.) Several CDE resources facilitating communication & Several CDE resources facilitating communication &
coordination of CDE efforts at NIH coordination of CDE efforts at NIH
BMIC CDE Resource Portal
Information about CDEs from across NIH:Information about CDEs from across NIH: Glossary of termsGlossary of terms Specific CDE use guidance from ICsSpecific CDE use guidance from ICs Organized and sorted information & links toOrganized and sorted information & links to
NIH/IC CDE collectionsNIH/IC CDE collections NIH CDE tools & resourcesNIH CDE tools & resources
NIH CDE Repository
Structured human & machine readable definitions of Structured human & machine readable definitions of NIH CDEs allowing NIH CDEs allowing Search for individual CDE or sets per FOA, etc.Search for individual CDE or sets per FOA, etc. Compare & harmonize similar but distinct CDEsCompare & harmonize similar but distinct CDEs Select or create CDEs with minimal duplicationSelect or create CDEs with minimal duplication Etc.Etc.