Chapter 2: Effective Health Care Program Activities

Core activities contribute to the conduct of comparative effectiveness research through the Effective Health Care Program and to the continuing development of an infrastructure to sustain and advance these efforts. These activities make up the integrated components of a national comparative effectiveness program in the United States—the first coordinated comparative effectiveness clinical studies program in our Nation's history (Go to Figure 1).

To ensure the relevance of the research to those making health care decisions, stakeholders are kept involved in all core activities, at every stage of the research process. These core EHC activities are described here.

Horizon Scanning

Some of the richest topics for comparative effectiveness research will likely be found at the frontier of new therapies that hold great promise but entail uncertain benefits and risks. Therefore AHRQ is in the process of establishing a horizon scanning program which is expected to begin operations in the fall of 2010. EHC researchers will scan the horizon to track emerging clinical interventions and investigate how these new interventions are likely to fit into current care pathways. These include important issues such as costs, possible risks, factors that may affect outcomes, and the availability of appropriate facilities and training.

Evidence Need Identification

Identification of evidence needs is a central, recurring activity that drives research and dissemination throughout the Effective Health Care Program. In order to gain the widest perspective into what questions need to be answered, all stakeholders are encouraged to identify and suggest topics for research, including consumers, clinicians, policymakers, and other decisionmakers. Research suggestions from all sources and all topic nominations are posted on the EHC Program Web site at http://effectivehealthcare.ahrq.gov. These suggestions are reviewed by AHRQ staff, based on a series of questions:

• How widespread and serious is the disease or problem proposed for study?
• What are the costs associated with the disease and available treatments?
• How much controversy exists about treatment?
• What are the potential impacts for improving care and/or reducing costs?
• Would research results be relevant to Federal health care programs such as Medicare, Medicaid or the Children's Health Insurance Program (CHIP)?
• Would research results be relevant or helpful for vulnerable and underserved populations: low-income groups; racial/ethnic minorities; women; children; the elderly; individuals with special health care needs, such as those with disabilities; those who need chronic care or end-of-life care; or those who live in inner-city and rural areas?

Evidence needs are also identified through issue forums, where stakeholders are brought together to discuss specific clinical areas and identify the most pressing questions of evidence. Finally, both evidence synthesis and evidence generation reports (described below) identify future research needs as part of the research process. In the case of Comparative Effectiveness Reviews, this includes a formal engagement with stakeholders to prioritize gaps identified during the review of research.

Evidence Synthesis

Evidence synthesis is a rigorous, systematic research process that adheres to explicit, scientific methods to analyze and summarize the existing scientific evidence on a specific topic. These methods are designed to reduce bias and allow research investigators to incorporate large amounts of information from different sources, while focusing on objective analysis and interpretation. The EHC produces two types of evidence synthesis reports, Comparative Effectiveness Reviews (CERs) and Technical Briefs, depending on the nature and amount of evidence available for synthesis:

Comparative Effectiveness Reviews

Comparative Effectiveness Reviews are summaries of available scientific evidence that compare the benefits and harms of treatment options. CERs are designed to provide decisionmakers with accurate, independent, scientifically rigorous information for comparing the effectiveness and safety of various health care options. CERs have become a foundation for decisionmaking in clinical practice and health policy because they provide more reliable and less biased answers than individual studies. The EHC updates CERs if new information becomes available and the topic is still of high clinical importance.

Technical Briefs

A technical brief explains what is known—and what is not known—about new or emerging health care tests or treatments. Technical briefs provide an overview of issues related to emerging technologies or clinical interventions. Technical briefs generally focus on interventions for which there is limited published information, or too few studies to support definitive conclusions. The briefs provide objective descriptions of the state of the science, potential frameworks for assessing the applications, implications of the interventions, summaries of ongoing research, and identification of future informational needs.

All evidence synthesis reports are produced by the Evidence-based Practice Centers (EPCs). For more information on the EPCs, see the AHRQ Web site at http://www.ahrq.gov/clinic/epc/ or the EHC site at http://www.effectivehealthcare.ahrq.gov/index.cfm/who-is-involved-in-the-effective-health-care-program1/about-evidence-based-practice-centers-epcs/.

Evidence Generation

If there is not enough evidence to answer an important question, the Effective Health Care Program may sponsor new research. Original research reports are based on clinical research and studies that use health care databases and other scientific resources and approaches to explore practical questions about the effectiveness and safety of treatments. The reports are derived from studies of actual patients in clinical settings and are based on scientific methodologies. New research reports can focus on the comparative effectiveness, appropriateness, safety, and/or outcomes of health care services or treatments. They are produced by AHRQ grantees and researchers in the DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network and the Centers for Education & Research on Therapeutics (CERTs).

The DEcIDE Network is comprised of research-based health organizations located throughout the U.S. with access to electronic health information databases and the capacity to conduct rapid turnaround research. DEcIDE research focuses on the outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services, particularly prescription medications and medical devices. The CERTs program is comprised of research centers, each focusing on broad therapeutic themes relating to the optimal use of drugs, biologics, and medical devices. CERTs generally focus on areas where comparative information about the risks, benefits, and interactions of new and older treatments is limited. In addition, AHRQ has begun to invest significantly in investigator-initiated research through grant mechanisms. More information about ongoing grants and grant opportunities may be found at http://www.effectivehealthcare.ahrq.gov/index.cfm/comparative-effectiveness-research-grant-and-arra-awards/.

All research reports are available on the AHRQ Effective Health Care Program Web site, http://www.effectivehealthcare.ahrq.gov. Many reports are available in Spanish and audio formats. Free printed copies are available by calling 1-800-358-9295.

Translation and Dissemination of Research Findings to Diverse Stakeholders

AHRQ has a strong and long-term commitment to bridging the gap between research and practice by translating and disseminating findings on the comparative effectiveness of interventions for different audiences, including consumers, clinicians, and policymakers.

Summary guides translate complex scientific information into short, plain-language publications for use by decisionmakers. The information in the summary guides can be used to assess options and help make informed decisions. Summary guides are developed for three targeted groups of decisionmakers—consumers, clinicians, and policymakers. They are designed to assist in the evaluation of benefits and risks of health care interventions and services. Summary guides are available in both written and audio formats, and many are available in Spanish. The summary guides present information about:

• Strengths and limits of evidence.
• Which interventions are supported by strong evidence and which options are less certain.
• Trade-offs between various decisions.
• How to sort through the options.
• Basic wholesale price information on medications (if relevant).

The John M. Eisenberg Clinical Decisions and Communications Science Center translates scientific reports into different summary guides, each tailored for practical use by consumers, clinicians or policymakers. New types of summary guides are developed as the need is identified. The Eisenberg Center is developing continuing medical education lessons and examinations, slide sets for use by medical faculty, and electronic decision aids for clinicians and patients/consumers. Podcasts will also be developed to facilitate Web dissemination of EHC information. AHRQ also supports investigator-initiated efforts in translation and dissemination of EHC program products. All completed reports and summary guides, as well as many reports in progress, are available on the EHC Web site at http://www.effectivehealthcare.ahrq.gov.

Training and Development of Clinical Researchers

AHRQ builds the capacity for comparative effectiveness research by providing support to institutions to boost their intellectual and organizational capacity for larger-scale programs, and by providing for fellowship training opportunities. AHRQ funding supports the career development of clinicians and researchers on the doctoral level, who focus their research on the synthesis, generation, and translation of new scientific evidence, and on the development of analytic tools for comparative effectiveness research. The goal of this training and development activity is to increase the Nation's research and methodological capacity for conducting and improving the quality of systematic review, retrospective studies, and clinical trials in comparative effectiveness research, and to develop data sources and other aspects of the research infrastructure.

Stakeholder Input and Involvement

The Effective Health Care Program gathers stakeholder input through the Stakeholder Group and the Citizen's Forum.

The Stakeholder Group

The EHC Stakeholder Group provides input to improve program quality and impact among users. This volunteer panel, which has included consumers, practicing clinicians, researchers, policymakers, industry representatives, private and public health care purchasers, and other health care leaders, brings unique experiences and perspectives to the table. The Stakeholder Group provides feedback on concerns such as program transparency, quality improvement of products and processes, types of products that will be most useful to health care decisionmakers, dissemination and implementation issues for EHC Program findings, and report content.

Citizens' Forum

The Citizens' Forum is an initiative funded by the American Recovery and Reinvestment Act (ARRA) to expand and systematize citizen and stakeholder engagement in AHRQ's comparative effectiveness research initiative (award anticipated in July/August 2010). The Citizens' Forum will develop and demonstrate deliberative methods and tools for obtaining informed public opinion as an input to decisions related to the conduct of comparative effectiveness research, as well as the application of research results in policy and practice.

As part of its activities, the Citizens' Forum will provide support for the Effective Health Care (EHC) Program Stakeholder Group, consistent with Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which mandates broad and ongoing consultation with relevant stakeholders in AHRQ's comparative effectiveness research program. The Citizens' Forum will facilitate Stakeholder Group meetings, manage logistical requirements, improve methods and opportunities for stakeholder engagement, and work with the EHC program components to expand stakeholder involvement in EHC research processes and activities.

Stakeholder Involvement in Research

In addition to the formal involvement of stakeholders described above, the Effective Health Care Program offers many opportunities for stakeholders to get involved at all stages in the research process. This helps ensure that the program responds to the issues that are most pressing for health care decisionmakers and in ways that are accessible and useful. This is the subject of the next chapter.

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