ANNUAL OCT. 31-NOV. 2, 2017 MEETING ARLINGTON, VA Lessons Learned (so far) about PCORI Grantee Data Sharing Amy Pienta Associate Research Scientist, ICPSR @apienta 11/1/2017 #PCORI2017
ANNUAL MEETING | #PCORI2017 Amy Pienta, Ph.D. Disclosures Rela latio ionship ip Company ny(ies es) Speakers Bureau Advisory Committee Qualitative Data Repository, Syracuse University Consultancy Review Panel Ad Hoc NIH, NSF, NIDILRR Board Membership Honorarium Ownership Interests Ingenex Digital Marketing November 5, 2017 2
ANNUAL MEETING | #PCORI2017 Objectives At the conclusion of this activity, the participant should be able to: • Understand the Goals of the Pilot Repository Project at ICPSR at the University of Michigan • Understand Select Lessons Learned when PCORI Grantees Share Data with a Repository November 5, 2017 3
ANNUAL MEETING | #PCORI2017 Pilot Project Goals • The ICPSR repository is working with a variety of PCORI data collection projects (completed and in progress) to archive data (of varying types) with ICPSR • We will document and record how it was to work with the various research projects in hopes of enabling PCORI to plan for broader data sharing activities amongst its grantees • Create a demonstration repository for PCORI, initially for internal review and use. November 5, 2017 4
ANNUAL MEETING | #PCORI2017 Pilot Project Progress Working with 4 data collection projects (completed and in progress) Pre-Deposit Stage -- 1 project depositing soon; Consulting with 2 projects on what to send Deposit Stage -- None currently, but 1 project completed this stage Curation Stage -- 1 project in preparation for release Data Release Stage -- None November 5, 2017 5
ANNUAL MEETING | #PCORI2017 Pre-Deposit Stage: Lessons Learned • Data Sharing Materials and Resources sent to grantees (Tips, Checklist, IRB Planning Guidance) • Working with a wide Variety of Data Types • Described as challenging – EHR, CMS hospital profiles, admin data • IRB Issues –Some IRBs want to approve deposit and dissemination agreement • Need for Understandable Terminology – limited-use refers to data requiring safe harbor method of de-identification vs. restricted use. • Grantees require Guidance on Using Multiple Repositories for the same data • Authoritative source of data, version control, interoperability November 5, 2017 6
ANNUAL MEETING | #PCORI2017 Pre-Deposit Data Review (one study) • Where We Need More Information/Recommendations: • Raw data has higher disclosure risk compared to summary variables • Clarify some variable and value labels • Identify missing data codes (and standardize where possible) • Recommend random generation of CaseIDs • Categorize some continuous/ordinal variables • Alter some of the date variables November 5, 2017 7
ANNUAL MEETING | #PCORI2017 Challenge: Deciding Who Does What • Data archiving best practice requires more attention to detail and to careful documentation than is typically required for analysis. • Research Team Data Preparation – Team knows the data well and the methodology, but is not at arm’s length to know what a secondary user would need to know to use the data well into the future. • Data Repository Curation Services – Repository understands required documentation and how to improve usability; also has tools available to reduce much of the routine work. Repository staff may require some input from the researcher. November 5, 2017 8
ANNUAL MEETING | #PCORI2017 Additional Guidance for Grantees • Clarification about what data to deposit in an archive • e.g., raw data, analysis files of summary variables, derived and scale variables, open-text responses; all time points, only from subjects that consented at some point-not always at beginning of data collection • Code instead of data • Guidance on Data File Structure – 1 row/case vs. hierarchical vs relational database November 5, 2017 9
ANNUAL MEETING | #PCORI2017 Learning About Related Publications • Starting point we used the PCORI page to identify related publications (also will collect info from PIs) • PCORI Page links to HRSP (Health Services Research Projects) and NCT (ClinicalTrials.gov) IDs which give MeSH terms, keywords, and grant numbers • NIH Grant Number (via PMCID) often associated with a much wider set of publications (how does this field associate grants and pubs with one another) • Primary use of data vs. secondary use (harder to capture) • Large Number of PIs – difficult to track November 5, 2017 10
ANNUAL MEETING | #PCORI2017 Relevant Metadata Standards • MeSH is the National Library of Medicine's controlled vocabulary thesaurus. • Consists of sets of terms naming descriptors in a hierarchical structure that permits searching at various levels of specificity • MeSH thesaurus is widely accepted and used • Useful for describing the topical aspects of the data • A preliminary search of terms for the one study – able to identify several terms appropriate and sufficient for discovery • Also, SNOWMED-CT; PICO; Consumer Health Vocabularies November 5, 2017 11
ANNUAL MEETING | #PCORI2017 Looking Forward • Continuing to work with the 4 PCORI-funded projects • Populating the internal data repository in order to offer a full demonstration of a PCORI repository • Talking to a broader set of PCORI-funded projects • Making recommendations on data governance, technology, and promotion November 5, 2017 12
ANNUAL MEETING | #PCORI2017 Learn More • www.pcori.org • info@pcori.org • #PCORI2017 • ICPSR: www.icpsr.umich.edu November 5, 2017 13
ANNUAL MEETING | #PCORI2017 Questions? November 5, 2017 14
ANNUAL MEETING | #PCORI2017 Thank You! Amy Pienta Associate Research Scientist @apienta 11/1/2017 November 5, 2017 15
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