Building the Electronic Data Infrastructure: Lessons Learned from the EDM Forum

1. Building the Electronic Data Infrastructure: Lessons Learned from the EDM Forum September 10, 2012 Erin Holve, PhD, MPH, MPP Director, Research & Education in HSR AcademyHealth The EDM Forum is supported by the Agency for Healthcare Research and Quality (AHRQ) through the American Recovery & Reinvestment Act of 2009, Grant U13 HS19564-01.

2. Outline • Overview of the EDM Forum • Challenges for Building Electronic Clinical Data Infrastructure • Innovative Approaches and Solutions • Opportunities to Engage and Interact with the EDM Forum 2

3. EDM Forum: Research Networks in CER and QI • Networks include between 12,000 and 7.5 million patients each; more than 25 million in total • 38 CER studies are underway or will be conducted • Address most of AHRQ’s priority populations & Conditions • Over 300,000 participants in the CER studies 3

4. ARRA-CER Funding Electronic Clinical Data Infrastructure

5. Landscape of Electronic Health Data Initiatives for Research Implementation & Application i2b2 VINCI (VA) State HIEs High Value Healthcare Collaborative Sentinel Network (FDA) QI PILOTS Enhanced Registry CER PILOTS Enhanced Registry – DRN – PROSPECT HMORN Beacon Communities eMerge Convening Bodies: EDM Forum BEIN CTSA CER KFC HIT Taskforce (ONC) RoPR DARTNet Query Health (ONC) MPCD Clinical & Community Care (Delivery) Research REDCap SHARPn (ONC) PACES & JANUS (FDA) HITIDE (VA) DEcIDE (AHRQ) INFRASTRUCTURE BUILDING Enhanced Registry – DRN – PROSPECT OMOP (FNIH) caBIG iDASH Discovery (Cutting Edge)

6. Many Perspectives on the Landscape • Discussions to identify priorities and challenges • Steering Committee • Stakeholder Symposium • Connections/collaboration with • Relevant e-Health initiatives • Stakeholder groups • Site Visits (n=6) • Stakeholder Interviews (n=50) • Literature Reviews • Peer-reviewed Literature • Grey Literature • Social media • Translation and dissemination opportunities • Issue briefs • Commissioned papers • Collaborative Methods Projects

7. Lessons from Experts at the Frontier • 24 commissioned and invited papers on governance, informatics, analytic methods, and the learning healthcare system • > 90 collaborators; >40 institutions • First half of these published in Medical Care June 22, 2012

8. By Design, Papers Address Current Gaps in the Literature • A review of challenges of traditional research designs and data that can potentially be addressed using electronic clinical data (Holve et.al) • A framework for comprehensive data quality assessment (Kahn et.al) • Cohort identification strategies for diabetes and asthma (Desai, et. al.) • A review of informatics platforms for research, including i2b2, RedX, HMORN VDW, INPC, SCOAP, CER Hub (Sittig et.al.) • Desirable attributes of common data models (Kahn, et.al) • Comparison of data collection methods including paper, websites, tablet computers (Wilcox et.al.) • Privacy-preserving strategies for hard-coded data (Kushida et. al.) • Comparison of processes to facilitate multi-site IRB review (Marsolo)

9. III. Challenges of Traditional Studies and Electronic Data for CER

10. “Non-technical” Challenges Are Important • Collaborative science is key, but requires extensive management and effort among investigators • Navigating transdisciplinary approaches • Explicit staff allocations needed to support intensive project management • Requires a culture shift among researchers • Establish governance to facilitate trust • IRB and regulatory issues • Need for transparency and guidelines • Significant effort to establish trust and protect privacy • A need to define and achieve meaningful engagement with key stakeholders, especially patient-centeredness 10

11. IV. Innovative Approaches and Solutions for CER Distributed & Federated Research Networks Moving away from centralized data repositories Platforms enable: Application development Use of new tools Data harmonization Data extraction (e.g., Limited Data Sets) End-user interface for research Ability to aggregate data across settings and systems Analytic tools for researchers (e.g., cohort development) Data visualization and statistical tools

12. Approaches to Accelerate Collaboration Limitations to Facilitate Multi-Site Research Approaches/Solutions Building teams that include multiple disciplines such as outcomes research, biomedical informatics, statistics, and specialized clinical perspectives, among others. (All projects) A high level of staff support allocated to develop governance and relationships enables intensive project management to convene data partners to build a culture of trust, including efforts to educate the participating sites about the infrastructure and approaches to achieve network security and privacy (All projects) Internally working with advisory groups, and externally working with the EDM Forum, provides the opportunity to share lessons learned and facilitate scientific collaboration (All projects) CER arguably requires a transdisciplinary approach to evidence generation that integrates the perspectives of highly multi-disciplinary teams Substantial level of effort is needed to establish and sustain data sharing partnerships A culture shift among researchers is needed to facilitate collaborative science and new ways of conducting biomedical and outcomes research

13. Approaches to Accelerate Collaboration Explicit Process to Convene and Manage Collaborators The SAFTINet project engages IT personnel; national informatics and research experts; state and clinical policy leaders; and, clinical professionals and clinical professional societies through a variety of mechanisms, including regular internal meetings and an annual convocation. These opportunities for exchange are crucial to solicit input on research and QI topics, and to understand implementation issues users and sites may face.

14. Governance Approaches to Facilitate Trust Governance Challenges Approaches/Solutions Using strategies to facilitate IRB approval for multicenter research studies, including working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. (All Projects) Developing published guidance to outline expected conduct for organizations and investigators in their data sharing network. (SPAN, Cincinnati Enhanced Registry) 1) Privacy preserving strategies for hard-coded data have been utilized, including de-identification and anonymization of EHR data 2) Distributed research networks can automate and regulate data access and stewardship, often providing aggregated results or limited datasets rather than sharing or collecting raw data There is a high time and cost burden to navigating privacy and data sharing across multiple sites and institutions. In addition, a common issue in multi-site projects is the degree of variation in way IRBs interpret regulations and conducted their review Transparency and clear guidelines are important because data partners are cautious when sharing patient-level data Sharing or pulling together raw, identifiable data from various sites might facilitate research, but would not be acceptable to data partners who want to manage the security and privacy of their own data and limit access to proprietary data

15. Establishing Research User Interface Principles and Requirements The SPAN project has developed guidance that outlines roles and responsibilities for data partners, and provides guidance for using research user interface query modules and navigating workflow via the network. The documents include a process for ‘ceding’ IRB and Privacy Board review to facilitate multi-site research. Governance Approaches to Facilitate Trust

16. Efforts to AchieveMeaningful Engagement Challenges to Achieve Engagement Approaches/Solutions Establish stakeholder advisory workgroups or ‘Cores’ that are involved throughout the infrastructure development process to provide input on the measures, instruments, methods, and conduct of PRO analyses. (SCOAP CERTAIN; WICER) Using tools or settings that patients/consumers are familiar with or are easily accessible to facilitate engagement. For example social networking tools, mobile devices, or leveraging community centers, liaisons, and local leadership organizations. (WICER; Pediatric Enhanced Registry) Working with providers directly to develop and test patient-activation tools (e.g., reminders, checklists, and prompts to improve patient management).(Pediatric Enhanced Registry) The full set of potential uses of infrastructure and data resources is complex; determining who to involve, and at what level, is not always obvious. Not meeting patients “where they are” with familiar/relevant resources. Limited opportunities for collaboration between researchers and end-users, and a lack of a clear pathway for engaging interested patients and consumers

17. Building a “Framingham for the 21st Century” The WICER study is building a community-based, EHR-linked cohort to understand factors impacting hypertension in a diverse, lower SES neighborhood. The WICER project works with community organizations and leaders to ensure questions are culturally and linguistically appropriate, and that the research is of interest to the community and provides valuable evidence-based information and resources to participants and the community. Efforts to AchieveMeaningful Engagement

18. Approaches to Address Methodological Issues Methodological Challenges Approaches/Solutions Using diagnostic, laboratory or prescription codes to monitor management and adherence in large cohorts (PEAL Network; SUPREME-DM) Using EHRs to build registries for rare diseases and/or vulnerable populations in order to conduct surveillance on relevant subgroups and capture rare outcomes (Pediatric Enhanced Registry; SUPREME-DM) Developing rigorous data quality assessment methods and frameworks for multi-site observational studies (SAFTINet, SPAN, SCANNER) Non-standard definitions to define cohorts and prognostic factors In RCTs, highly selected populations and limited generalizability, especially for population sub-groups (such as rare diseases or traditionally underrepresented populations) In observational studies, there is a lack of validity in the results, and a lack of randomization results in selection bias

19. Learning as a collaboration among patients and specialists to build a rare disease registry The Pediatric Enhanced Registry, led by CCHMU, engages specialty clinicians to design and implement ‘smart forms’ in the EHR that capture the information clinicians find most meaningful and actionable, improving the efficiency and quality of data (“data in once”). These innovations make it feasible to study special populations and rare diseases (e.g. Crohn’s disease). Approaches to Address Methodological Issues

20. Approaches to Address Data & Informatics Issues Data & Informatics Challenges Approaches/Solutions Natural language processing (NLP) with clinical notes to extract research grade information (CER Hub; SUPREME-DM; SCOAP CERTAIN; WICER) Integrating prospective study recruitment tools at the point-of-care (Indiana PROSPECT; WICER; COMET) Common data models are employed in all of the projects (including the OMOP CDM, HMORN VDW) to map data to common concepts, in order to standardize and harmonize the various structures and data elements (All Projects) Unstructured data capture/entry in EHRs Current systems not optimized to identify potential enrollees for trials Limited ability to link streams of data, especially in EHRs

21. Streamlining Patient Enrollment at the Point-of-Care The Indiana PROSPECT leverages characteristics of the INPC network, including unique patient identifiers, to integrate prospective study recruitment tools into the eMR-ABC software, provide clinical decision-support, and enable enrollment at the point-of-care Approaches to Address Data & Informatics Issues

22. V. Opportunities to Engage and Interact with the EDM Forum • Visit the EDM Forum website http://www.edm-forum.org/ for: • Announcements • New papers • New presentations • New resources (data, software, etc.) • Sign up! • Updates on EDM Forum activities • send request to edmforum@academyhealth.org) • EDM Forum on Twitter, @edm_ah • Register to participate in events • Contribute comments 22

23. Join the discussion!http://www.edm-forum.org/ Current Resources: • Medical Care supplement • Issue Briefs: • Meaningful Engagement • ARRA Infrastructure Investments • CER Project Profiles • eHealth data initiatives for research & QI • Event archives Interactive Channels & Events: • eGEMS publication • Wiki glossary • Webinars • October 31st: Innovations in HIT for CER & PCOR Join the Discussion Sign up at edmforum@academyhealth.org