Briefs & Reports

The EDM Forum has produced briefs and reports examining the use of electronic clinical data for comparative effectiveness research (CER), patient-centered outcomes research (PCOR) and quality improvement (QI) that can lead to meaningful improvements in patient outcomes. A list of available briefs and reports, including a description and link to the PDF, is provided below.


Issue Brief: Informatics Tools and Approaches To Facilitate the Use of Electronic Data for CER, PCOR, and QI: Resources Developed by the PROSPECT, DRN, and Enhanced Registry Projects

A major charge of the PROSPECT Studies, Scalable Distributed Research Networks (DRN), and Enhanced Registry projects has been to develop tools and informatics processes that facilitate exploration of new research questions, as well as the exchange and analysis of data across multiple institutions and settings. The result of these efforts is a suite of workable, extendable, and flexible informatics strategies across the 11 research projects. This brief describes 31 informatics platforms and tools that have been developed, adopted, or adapted by the PROSPECT, DRN, and Enhanced Registry projects as they apply to various dimensions in the development and execution of research and QI.

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Issue Brief: Collecting and Using Patient-Reported Outcomes (PRO) for Comparative Effectiveness Research (CER) and Patient-Centered Outcomes Research (PCOR): Challenges and Opportunities

This EDM Forum issue brief provides a framework which outlines key considerations for leveraging PRO for CER and PCOR. The challenges and opportunities highlighted in the brief emerged from discussions with the community engaged in collecting and using PRO to incorporate the patient perspective into CER and PCOR efforts. In particular, the growing use of electronic PRO (ePRO) in these types of research has the potential to improve the efficiency of data collection and analysis, and to also provide new opportunities to bring meaningful evidence back to decision makers and patients in innovative ways. The framework identifies more than 50 challenges, organized by issues when collecting or using PRO around governance, informatics and technology, analytic methods, and the implementation of PRO in learning health systems. Each of these sets of issues are explored and a series of examples are provided that illustrate the possibilities and challenges of using PROs with electronic health data to improve patient outcomes.

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 Issue Brief: Getting Answers We Can Believe In: Methodological Considerations When Using Electronic Clinical Data for CER and PCOR

The EDM Forum is pleased to present a new issue brief that outlines important research design considerations when using ECD for comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). This brief provides practical orientation to study designs to encourage consideration of which methods are best suited to answer particular research and quality improvement (QI) questions using ECD. It also discusses ways of making information obtained from ECD more useful in the clinical setting, differences between observational studies and randomized controlled trials (RCTs), specific challenges, and analytic approaches that can be used with observational ECD for CER.

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 Issue Brief: Building the Informatics Infrastructure for CER: A Review of the Grey Literature

The EDM Forum is pleased to present a new issue brief that describes our structured review of the grey literature on the use of electronic clinical data for Comparative Effectiveness Research. The brief includes a structured methodology with reproducible guidelines; findings based on the volume and characteristics of the literature; lessons learned from conducting a highly-structured search; and potential next stops for addressing identification and quality issues in future reviews.

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 A Framework for Patient and Consumer Engagement in Evidence Generation

The EDM Forum is pleased to present a framework that reflects the philosophy that patients and consumers are important partners in research who have a shared interest in improving health and health care. Specifically, it points to the need for greater participation in both infrastructure development and research, as well as elements that cut across both (e.g., governance).This interactive resource, based on work conducted by AcademyHealth under the auspices of the EDM Forum, and developed in coordination with patients, consumers, and health services researchers, outlines key opportunities for engagement, and proposes a set of activities to enable patients and consumers to become more active participants in the process of evidence generation. This resource is available for download to your iPad through the iTunes app store. A PDF version is provided below.

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Issue Brief: CER Infrastructure Investments to Support Evidence Generation in a Learning Health System

The American Recovery and Reinvestment Act (ARRA) of 2009 made a substantial new investment to build capacity for the use of electronic clinical data (e.g., distributed data networks or patient registries) for QI and research. ARRA-funded infrastructure awards focus on developing data, methods, training, and governance that is sustainable, flexible, and extensible over time. This brief examines the current requirements and approaches to building electronic data infrastructure, which is important when considering the mechanisms to ensure the sustainability of evidence generation in a learning health system.

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Issue Brief: Involving Patients and Consumers in Research: New Opportunities for Meaningful Engagement in Research and Quality Improvement

This brief examines the rationale for engaging patients and consumers in health care research, and discusses several opportunities and challenges based on the experiences of several efforts to leverage electronic clinical data (ECD) for comparative effectiveness research (CER), patient centered outcomes research (PCOR), and quality improvement (QI). It also identifies a number of challenges to meaningful engagement of patients and consumers in the research process. Finally, this brief raises new possibilities for thinking more holistically about ways to engage communities in evidence generation—expanding the continuum of activities potentially benefiting from patient and consumer involvement—so that technology and infrastructure development are included.

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Electronic Data Methods (EDM) Forum Overview

This brief profiles the EDM Forum, including background information on the participating research projects. AHRQ priority populations and conditions addressed by the CER studies conducted by the PROSPECT, DRN, and Enhanced Registry Projects are also provided.

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Issue Brief: Approaches to Using Protected Health Information (PHI) for Patient-Centered Outcomes Research (PCOR): Regulatory Requirements, De-identification Strategies, and Policy

This brief describes current regulations regarding PHI and common challenges researchers face in using personal health information. The brief also explores new infrastructure approaches that seek to meet these regulations and generate data that are more useful , as well as potential policy approaches to clarifying the privacy regulations.

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Building the Electronic Data Infrastructure to Improve Patient Outcomes: CER Project Profiles

This report provides a background and profiles of 12 research projects funded through the American Recovery and Reinvestment Act of 2009 (ARRA) focused on building the electronic clinical data infrastructure for comparative effectiveness research (CER) and patient centered outcomes research (PCOR). An introduction to infrastructure investments in CER and PCOR is provided, as well as descriptions of the major grant programs supporting this work. The profiles describe the specific aims and elements for each project, including the infrastructure and research aims, outcomes of interest, priority populations and conditions of focus, and key partners involved in the projects. Supporting material, including a glossary of acronyms and key terms, is included in a series of appendices. Opportunities to get engaged in discussions about the research and potential future uses of the infrastructure are provided. 

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Comparative Effectiveness Research (CER) and Clinical Informatics: An Annotated Bibliography

Significant national investment in developing key infrastructure to support Comparative Effectiveness Research (CER) necessitates developing techniques for information and knowledge management, such as those pioneered by the Clinical Informatics community. Motivated by the need for resources that specifically track the literature at the intersection of CER and Clinical Informatics, this report provides an annotated bibliography of 132 articles in the peer-reviewed literature.
 
In particular, this review emphasizes publications that provide insight into the uses of clinical informatics for population-based research. The selected articles address the use of clinical informatics for CER from a historical perspective and consider the development and application of several key projects, platforms, networks, and technologies that are most relevant for CER. The review also includes information on the structured approach used to identify key papers that are relevant to the emerging body of literature related to developing CER infrastructure with prospective electronic clinical data.

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