Building the Electronic Data Infrastructure: Lessons Learned from the EDM Forum
AHRQ's 2012 Annual Conference Slide Presentation
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Slide 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.
Slide 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.
Slide 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.
Image: A map of the United States represents the geographic scope of the networks.
Slide 4
ARRA-CER Funding Electronic Clinical Data Infrastructure
Image: A flow chart shows Electronic Clinical Data Infrastructure Funds from the Total ARRA-CER Funding.
Total ARRA-CER Funding: $1.1 billion:
- Evidence development and synthesis.
- Translation and dissemination.
- Infrastructure and methods development.
- Priority Setting.
- Stakeholder Engagement.
↓
Infrastructure & Methods Development: $417.2 million (37.9% of ARRA-CER Funding):
- Governance.
- Data.
- Methods.
- Training.
↓
Electronic Clinical Data Infrastructure: $276 million (25.1% of ARRA-CER Funding):
- Clinical and claims databases, electronic health records, and data warehouses.
- Patient Registries.
- Distributed and federated data networks.
- Informatics platforms, systems and models to collect, link and exchange data.
↓
AHRQ Awards to Build Infrastructure Using Prospective Electronic Clinical Data for CER, PCOR, and QI: $100 million (9% of ARRA-CER Funding):
- PROSPECT.
- Enhanced Registries.
- Scalable Distributed Research Networks.
- EDM Forum.
Slide 5
Landscape of Electronic Health Data Initiatives for Research
Image: The landscape of electronic health data initiatives for research is displayed on a plane with 4 quadrants. The x-axis ranges from clinical and community care (delivery) to research. The y-axis ranges from implementation and application to discovery (cutting edge). The origin includes convening networks and initiatives.
Quadrant one:
- I2b2.
- VINCI (VA).
- Sentinel Network (FDA).
- CER Pilots: Enhanced Registry, DRN, and PROSPECT grants.
- HMORN.
- DARTNet.
- MPCD.
Quadrant two:
- High Value Healthcare Collaborative.
- QI Pilots: Enhanced Registries.
- Beacon Communities.
- Query Health (ONC).
- eMerge.
Quadrant three:
- SHARPn (ONC).
- HITIDE (VA).
Quadrant four:
- REDCap.
- PACES & JANUS (FDA).
- DEcIDE (AHRQ).
- OMOP (FNIH).
- caBIG.
- iDASH.
Slide 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:
- Social media.
- Translation and dissemination opportunities.
- Peer-reviewed Literature:
- Issue briefs.
- Commissioned papers.
- Collaborative Methods Projects.
Image: A photograph of an elephant is shown beneath the text.
Slide 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.
Image: The cover of the Medical Care special supplement is shown.
Slide 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).
Slide 9
III. Challenges of Traditional Studies and Electronic Data for CER
Image: A table lists methodological challenges and data and informatics challenges of traditional research studies and electronic clinical data necessary to meet specific requirements to conduct CER.
Slide 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.
Slide 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.
Slide 12
Approaches to Accelerate Collaboration
| Limitations to Facilitate Multi-Site Research | Approaches/Solutions |
|---|---|
| CER arguably requires a transdisciplinary approach to evidence generation that integrates the perspectives of highly multi-disciplinary teams | Building teams that include multiple disciplines such as outcomes research, biomedical informatics, statistics, and specialized clinical perspectives, among others. (All projects) |
| Substantial level of effort is needed to establish and sustain data sharing partnerships | 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) |
| A culture shift among researchers is needed to facilitate collaborative science and new ways of conducting biomedical and outcomes research | 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) |
Slide 13
Approaches to Accelerate Collaboration
Image: The table shown on Slide 12 is repeated; a 12-pointed green star is superimposed over it containing the following text: "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."
Slide 14
Governance Approaches to Facilitate Trust
| Governance Challenges | Approaches/Solutions |
|---|---|
| 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. | 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) |
| Transparency and clear guidelines are important because data partners are cautious when sharing patient-level data | Developing published guidance to outline expected conduct for organizations and investigators in their data sharing network. (SPAN, Cincinnati Enhanced Registry) |
| 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 |
|
Slide 15
Governance Approaches to Facilitate Trust
Image: The table shown on Slide 14 is repeated; a 12-pointed green star is superimposed over it containing the following text: "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."
Slide 16
Efforts to Achieve Meaningful Engagement
| Challenges to Achieve Engagement | Approaches/Solutions |
|---|---|
| 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. | 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) |
| .Not meeting patients "where they are" with familiar/relevant resources. | 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) |
| Limited opportunities for collaboration between researchers and end-users, and a lack of a clear pathway for engaging interested patients and consumers | Working with providers directly to develop and test patient-activation tools (e.g., reminders, checklists, and prompts to improve patient management). (Pediatric Enhanced Registry) |
Slide 17
Efforts to Achieve Meaningful Engagement
Image: The table shown on Slide 16 is repeated; a 12-pointed green star is superimposed over it containing the following text: "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."
Slide 18
Approaches to Address Methodological Issues
| Methodological Challenges | Approaches/Solutions |
|---|---|
| Non-standard definitions to define cohorts and prognostic factors | Using diagnostic, laboratory or prescription codes to monitor management and adherence in large cohorts (PEAL Network; SUPREME-DM) |
| In RCTs, highly selected populations and limited generalizability, especially for population sub-groups (such as rare diseases or traditionally underrepresented populations) | 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) |
| In observational studies, there is a lack of validity in the results, and a lack of randomization results in selection bias | Developing rigorous data quality assessment methods and frameworks for multi-site observational studies (SAFTINet, SPAN, SCANNER) |
Slide 19
Approaches to Address Methodological Issues
Image: The table shown on Slide 18 is repeated; a 12-pointed green star is superimposed over it containing the following text: "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)."
Slide 20
Approaches to Address Data & Informatics Issues
| Data & Informatics Challenges | Approaches/Solutions |
|---|---|
| Unstructured data capture/entry in EHRs | Natural language processing (NLP) with clinical notes to extract research grade information (CER Hub; SUPREME-DM; SCOAP CERTAIN; WICER) |
| Current systems not optimized to identify potential enrollees for trials | Integrating prospective study recruitment tools at the point-of-care (Indiana PROSPECT; WICER; COMET) |
| Limited ability to link streams of data, especially in EHRs | 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) |
Slide 21
Approaches to Address Data & Informatics Issues
Image: The table shown on Slide 20 is repeated; a 12-pointed green star is superimposed over it containing the following text: "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."
Slide 22
V. Opportunities to Engage and Interact with the EDM Forum
- Visit the EDM Forum Web site 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.
- Updates on EDM Forum activities.
- Register to participate in events.
- Contribute comments.
Slide 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
Image: A screenshot of the EDM Forum Home page is shown.
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