Common Data Elements: Making the Mass of NIH Measures More Useful

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1 Common Data Elements WG Common Data Elements: Making the Mass of NIH Measures More Useful Jerry Sheehan Assistant Director for Policy Development Na?onal Library of Medicine Gene/c Alliance Webinar Series 09 July 2014

2 Common Data Elements WG SeXng the Stage Growing Mass of Biomedical Data Biomedical research is increasingly data- intensive and data- driven By one es/mate, NIH- funded research generates ~ 115,000 research papers per year ~ 3 data sets per paper (range in sample: 1-120) => ~ 445,000 new data sets per year Human subjects research ~ 25% = 110,000 data sets Mul/ple variables per data set 7/9/2014 Gene/c Alliance Webinar 2

3 Common Data Elements WG Growing Numbers of Data Elements & Measures dbgap 488 Studies 3,159 datasets 145,000 variables ClinicalTrials.gov - 19,000 studies registered per year Total of 170,000+ studies; 13,000+ with results Mul/ple outcome measures per trial (primary and secondary) Primary: median = 1 (max = 82) Secondary: median = 4 (max = 172) E.g., depression measured in > 4500 studies 888 Hamilton Depression Ra/ng Scale 718 Beck Depression Inventory 511 Montgomery Asberg Depression Ra/ng Scale 111 PHQ 9 Many, many others cadsr 46,000+ data elements Depression 118 data elements (some components of Beck, Hamilton, etc.) Smoking 192 data elements 7/9/2014 Gene/c Alliance Webinar 3

4 What is a Common Data Element (CDE)? Common Data Elements WG Common Data Elements as a Solu/on Fixed representa/on of a variable to be collected and analyzed in projects within a par/cular analy/c or clinical domain. Consists of a precisely defined ques/on and a specified format or set of permissible values for responses (answers). Ideally, a CDE is defined unambiguously in both human and machine- computable terms. Sets of CDEs can be combined into more complex ques/onnaires, survey instruments, and case report forms. 7/9/2014 Gene/c Alliance Webinar 4

5 Why Common Data Elements? Common Data Elements WG Facilitate cross- study comparison of results Enable aggrega/on of data from mul/ple studies greater sta/s/cal power, detect weaker signals Speed study start up by selec/ng from exis/ng measures, instruments Improve data quality via use of validated measures Improve replica/on and reproducibility 7/9/2014 Gene/c Alliance Webinar 5

6 Common Data Elements WG NIH CDE Efforts Several NIH ICs iden/fying common data elements NIH CDE Working Group established to improve coordina?on & communica?on of efforts to iden?fy, develop, & promote use of CDEs across NIH Develop Web portal of NIH CDE resources Encourage use of CDEs by funded inves/gators Reduce overlap, redundancy, and near misses among selected data elements Improve interoperability and compa/bility with other standards development ac/vi/es (e.g., other HHS standards, meaningful use of EHRs) Assist NIH staff and inves/gators in iden/fying and using relevant CDEs Almost 40 WG members from 22 ICs 7/9/2014 Gene/c Alliance Webinar 6

7 Common Data Elements WG NIH Common Data Element Resources CDE Ini<a<ves Standardized data elements, data collec/on instruments, lab tests, etc. Primarily for use in funded clinical research, pa/ent registries, surveillance Entail a vexng processes for selec/on Experimental valida/on Expert opinion What to collect and how to collect it CDE Tools & Resources Databases and repositories of data elements and case report forms Used in funded clinical research, pa/ent registries, surveillance Limited vexng of content Selec/on criteria Metadata standards Provide broad sets of examples of how data are collected May include tools to assist inves/gators in iden/fying and selec/ng data elements 7/9/2014 Gene/c Alliance Webinar 7

8 NIH CDE Ini/a/ves Common Data Elements WG 7/9/2014 Gene/c Alliance Webinar 8

9 NIH CDE Tools & Resources Common Data Elements WG 7/9/2014 Gene/c Alliance Webinar 9

10 hcp://cde.nih.gov Launched in January 2013 Links from BMIC, OER Sharing, and CDE IniBaBves web pages 7/9/2014 Gene/c Alliance Webinar 10

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14 Common Data Elements WG NINDS CDE Example: TBI Assessments & Examina/ons 7/9/2014 Gene/c Alliance Webinar 14

15 Common Data Elements WG NINDS CDE Example: TBI Assessments & Examina/ons 7/9/2014 Gene/c Alliance Webinar 15

16 7/9/2014 Gene/c Alliance Webinar 16

17 Common Data Elements WG CDE Portal - Resource Summaries 7/9/2014 Gene/c Alliance Webinar 17

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19 7/9/2014 Gene/c Alliance Webinar 19

20 NIH CDE Challenges Common Data Elements WG Making poten/al users aware of NIH CDEs? Encouraging use of NIH CDEs beyond original, limited research domains? Harmonizing NIH CDEs with other exis/ng or emerging data elements and data standards Minimizing (eliminate?) overlap between and among CDE ini/a/ves within them too? Providing more convenient access to NIH (and other) CDEs 7/9/2014 Gene/c Alliance Webinar 20

21 Common Data Elements WG Ongoing Ac/vi/es - Summary ü Promote awareness and use of CDEs among stakeholders ü Ar/cles, presenta/ons to relevant communi/es to raise awareness ü Language in funding announcements and grants to encourage use ü Sharing Lessons Learned - good prac/ce in developing CDEs ü Coordinate among NIH CDE ini/a/ves ü Reduce overlap and near misses in NIH CDEs ü Encouraging consulta/on/collabora/on prior to new starts ü Collabora/on with HHS agencies & others ü FDA data standards in 59+ priority therapeu/c areas ü ONC strategic data capture (SDC) ini/a/ve (for EHRs) ü Sharing informa/on with COMET, OMERACT, etc., ü Provide more convenient access to CDEs ü Expand portal content (addi/onal CDE ini/a/ves) ü Provide access to underlying data elements (e.g., linking to centralized repository or federated system) 7/9/2014 Gene/c Alliance Webinar 21

22 Outreach to User Communi/es Common Data Elements WG 7/9/2014 Gene/c Alliance Webinar 22

23 Encouraging Use of NIH CDEs Common Data Elements WG In RFAs, NOAs, NIH Guide... Parkinson's Udall Centers of Excellence... must u/lize the NINDS Common Data Elements Resource when construc/ng data element forms. NINDS expects... Inves/gator Ini/ated Phase III trial[s] will use the NINDS Common Data Elements resource when construc/ng data collec/on forms. FITBIR A data sharing plan should include use of the TBI Common Data Elements NIDA strongly encourages inves/gators involved in human- subjects studies to incorporat[e] the measures from the Core and Specialty collec/ons, which are available in the Substance Abuse and Addic/on Collec/on... NCATS Organiza/ons who are establishing rare diseases pa/ent registries are strongly encouraged to use the [ORD]/Global Rare Diseases Pa/ent Registry Data Repository Common Data Elements... 7/9/2014 Gene/c Alliance Webinar 23

24 Common Data Elements WG Encouraging Broader Use - Template Language Use of Common Data Elements in NIH- funded Research NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, pa?ent registries, and other human subject research to facilitate broader and more effec?ve use of data and advance research across studies. CDEs are data elements that have been iden?fied and defined for use in mul?ple data sets across different studies. Use of CDEs can facilitate data sharing and standardiza?on to improve data quality and enable data integra?on from mul?ple studies and sources, including electronic health records. NIH ICs have iden?fied CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome- wide associa?on studies (GWAS)), types of outcomes (e.g., pa?ent- reported outcomes), and pa?ent registries (e.g., the Global Rare Diseases Pa?ent Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" ( hwp://cde.nih.gov/) to assist inves?gators in iden?fying NIH- supported CDEs when developing protocols, case report forms, and other instruments for data collec?on. The Portal provides guidance about and access to NIH- supported CDE ini?a?ves and other tools and resources for the appropriate use of CDEs and data standards in NIH- funded research. Inves?gators are encouraged to consult the Portal and describe in their applica?ons any use they will make of NIH- supported CDEs in their projects. 7/9/2014 Gene/c Alliance Webinar 24

25 Promulgate Lessons Learned Common Data Elements WG 1. Don t reinvent the wheel Use exis/ng DEs if possible 2. Don t work alone Coordinate with others 3. Use validated data elements/instruments when possible. 4. Use data elements that conform to exis/ng data standards and are freely available, whenever possible. 5. Engage full range of needed exper/se: domain experts, informa/cs experts, others 6. Plan ahead to update CDEs over /me 7. Gain support of the user community 8. Develop a communica/ons strategy 9. Develop policies to promote the use of CDEs 10. Monitor compliance and uptake 7/9/2014 Gene/c Alliance Webinar 25

26 Common Data Elements WG Big Data To Knowledge (BD2K) hcp://bd2k.nih.gov Research Use of Clinical Data Frameworks for Community Based Standards 13- NOV CBIIT Seminar Series 26

27 Common Data Elements WG Inter- agency collabora/on: FDA 7/9/2014 Gene/c Alliance Webinar 27

28 Common Data Elements WG 7/9/2014 Gene/c Alliance Webinar 28

29 Common Data Elements WG Inter- agency collabora/on: ONC 7/9/2014 Gene/c Alliance Webinar 29

30 ONC Structured Data Capture Ini<a<ve Conceptual Workflow 2 Finds form/template 1 4 Inputs data 3 Converts, populates & displays form xx 5 Caches data Actor Key Provider/ End User x John Doe x x x x 6 Stores/ EHR System transmits data 7 7/9/2014 Gene/c Alliance Webinar 30

31 Common Data Elements WG Other Opportuni/es for Collabora/on PCORNet Healthcare systems research collaboratory COMET (Core Outcome Measures for Effec/veness Trials) Other HHS (ARHQ, CDC... ) Others 7/9/2014 Gene/c Alliance Webinar 31

32 Common Data Elements WG Integrate with EHR Data Standards Match CDEs to standards and terminologies required for meaningful use of cer/fied EHRs (i.e., SNOMED, LOINC, RxNORM) Several NIH CDE ini/a/ves now mapped to LOINC (Logical Observa/on IDs, Names & Codes) NLM Value Set Authority Center (VSAC) for Quality Measures Facilitate research use of clinical records (see hwp://bd2k.nih.gov/bd2k_workshop/index.html) 7/9/2014 Gene/c Alliance Webinar 32

33 Coordinate To Reduce Overlap 7/9/2014 Gene/c Alliance Webinar 33

34 Common Data Elements WG Prototype Data Element Repository 7/9/2014 Gene/c Alliance Webinar 34

35 7/9/2014 Gene/c Alliance Webinar 35

36 7/9/2014 Gene/c Alliance Webinar 36

37 Common Data Elements WG Next Steps Iden/fy other relevant efforts Iden/fy gaps where are CDEs needed (disease areas, condi/ons) Con/nued outreach Examine usage and impact Further development of repository and other tools Processes for harmoniza/on and integra/on 7/9/2014 Gene/c Alliance Webinar 37

38 Addi/onal Informa/on Common Data Elements WG CDE Web Portal hwp://cde.nih.gov BMIC Website hwp://nlm.nih.gov/nihbmic BD2K Website hwp://bd2k.nih.gov NLM Website hwp:// 7/9/2014 Gene/c Alliance Webinar 38

Welcome! Pragmatic Clinical Studies. David Hickam, MD, MPH Program Director Clinical Effectiveness Research. David Hickam, MD, MPH

Welcome! Pragmatic Clinical Studies. David Hickam, MD, MPH Program Director Clinical Effectiveness Research. David Hickam, MD, MPH Pragmatic Clinical Studies David Hickam, MD, MPH Program Director Clinical Effec2veness Research June 23, 2015 Welcome! David Hickam, MD, MPH Program Director Clinical Effectiveness Research 2 In this