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.

Outline

I. Overview of the EDM Forum

II. Challenges for Building Electronic Clinical Data Infrastructure

III. Innovative Approaches and Solutions

IV. Opportunities to Engage and Interact with the EDM Forum

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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

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ARRA-CER Funding Electronic Clinical Data Infrastructure

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

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

Infrastructure & Methods Development

$417.2 million (37.9% of ARRA-CER Funding)Governance Data Methods Training

Total ARRA-CER Funding

$1.1 billion Evidence development and

synthesis

Translation and dissemination

Infrastructure and methods

developmentPriority Setting Stakeholder

Engagement

Landscape of Electronic Health Data Initiatives for Research

Convening Bodies:EDM Forum

BEINCTSA CER KFC

HIT Taskforce (ONC)RoPR

Implementation & Application

Clinical & Community Care

(Delivery)Research

Discovery (Cutting Edge)

CER PILOTSEnhanced Registry – DRN – PROSPECT

SHARPn (ONC)

DARTNet

REDCap

PACES & JANUS (FDA)

DEcIDE (AHRQ)

Sentinel Network (FDA)

VINCI (VA)

MPCD

HMORN

INFRASTRUCTURE BUILDINGEnhanced Registry – DRN – PROSPECT

HITIDE (VA)

Query Health (ONC)

Beacon Communities

High Value Healthcare

Collaborative

QI PILOTSEnhanced Registry

State HIEs

OMOP (FNIH)

eMerge

caBIG

i2b2

iDASH

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

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

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)

III. Challenges of Traditional Studies and Electronic Data for CER

“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

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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

Approaches to Accelerate CollaborationLimitations to Facilitate Multi-Site

Research

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

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)

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.

Governance Approaches to Facilitate Trust

Governance Challenges

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

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

Governance Approaches to Facilitate Trust

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.

Efforts to AchieveMeaningful Engagement

Challenges to Achieve Engagement

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

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)

Efforts to AchieveMeaningful Engagement

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.

Approaches to Address Methodological Issues

Methodological Challenges

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

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)

Approaches to Address Methodological Issues

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 Data & Informatics Issues

Data & Informatics Challenges

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

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)

Approaches to Address Data & Informatics Issues

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

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)

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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 archivesInteractive Channels & Events: eGEMS publication Wiki glossary Webinars

– October 31st: Innovations in HIT for CER & PCOR

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