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This summary describes a meeting held February 2, 2000, for potential bidders for a Request for Applications (RFA)—Translating Research Into Practice (TRIP II). Select to access the RFA online.
Background of Evidence-based Medicine
Dr. Carolyn Clancy, Director of the Center for Outcomes and Effectiveness Research, a division of the Agency for Healthcare Research and Quality (AHRQ), opened the meeting by presenting background information on the growing movement in the U.S. toward evidence-based decisionmaking. This trend is manifested in clinical practice guidelines, disease management programs, quality measurements, the Patient Bill of Rights, and outcomes research.
In the past two decades there has been substantial progress in the measurement of the effectiveness and quality of clinical procedures. From 1990 to 1997, the number of MEDLINE citations dealing with outcomes research more than quadrupled. However, taking the next step to implement the research findings into clinical practice is a prodigious challenge. Nevertheless, there are reasons for optimism. For example, based on the meta-analysis documenting the effectiveness of anticoagulation for the prevention of stroke in patients with atrial fibrillation and a study that demonstrated that physicians were underutilizing this effective therapy, Peer Review Organizations (PROs) sought to implement this research into practice. The PROs developed 73 programs in 42 States and documented an increase in the appropriate use of warfarin from 58 to 71 percent. The Health Care Financing Administration (HCFA) estimates that as a result of the increase, 1,285 strokes were prevented.
From this and other similar studies, researchers have demonstrated that evidence-based medicine can improve patient health outcomes. As a result, a focus of outcomes and effectiveness research has shifted from hypothesis generation and description to definitive answers, quality improvements and, ultimately, the incorporation of patient-oriented outcomes into practice.
Together with this new evidence, however, challenges and questions continue to arise. New dimensions of outcomes research are now developing across a spectrum of organizational, delivery and reimbursement models. In addition, unanticipated consequences (e.g. ineligible patients receiving therapy) and costs are often inadequately assessed. In this context, AHRQ developed the Translating Research Into Practice (TRIP) I and TRIP II programs in order to move from periodic, isolated success stories to sustained improvement of patient health outcomes in the U.S.
In December 1999, the Agency for Health Care Policy and Research (AHRQ) became the Agency for Healthcare Research and Quality (AHRQ). The word "policy" was replaced by "quality," stressing the agency focus on quality improvement efforts while continuing to support, conduct, and disseminate research to improve access, outcomes, utilization and costs.
The reauthorized agency has three main priorities:
The TRIP I Request For Applications (RFA) was based on an efficacy model, falling under the first priority of developing new knowledge. The TRIP II RFA, based on an effectiveness model, focuses more on the Priority III. It is designed to build on and evaluate the information gathered from TRIP I research and other studies of translation and to implement outcomes into practice to improve the quality, outcomes and cost-effectiveness of health care. Three divisions within AHRQ are jointly supporting the TRIP II effort:
Dr. Daniel Stryer of the Center for Outcomes and Effectiveness Research, presented an overview of the TRIP II RFA, highlighting the important aspects. The two major goals of TRIP II are:
The mechanism of the RFA is a cooperative agreement demonstration project, or "assistance" mechanism, which will focus specifically on evaluating strategies for translating research into practice through the development of partnerships between researchers and health care systems and organizations. The objective of such a partnership is to help accelerate and magnify the impact of the research on clinical practice and patient outcomes in applied settings. The intent of the RFA is to support the evaluation of currently planned or recently initiated programs which focus on outcomes and quality research. Under the cooperative agreement mechanism, AHRQ will work jointly with award recipients as a partner without assuming the direction of or responsibility for the project.
Applicants are encouraged to focus their research on one or more conditions of high national priority; in particular, pediatric asthma, mental health or one of the six specified areas of the President's Initiative to Eliminate Racial and Ethnic Disparities in Health (infant mortality, cancer screening and management, cardiovascular disease, diabetes, HIV infection, and child and adult immunizations). Of the $7 million in funds available, specific set-asides include:
Dr. Stryer emphasized that the identification of sustainable and replicable research strategies is essential. Thus, research projects must focus on the relationships between researchers and health care providers, with an emphasis on applied settings.
A coordinating committee composed of AHRQ representatives will be formed to meet the following objectives:
Responsibilities of the coordinating committee will include organizing semi-annual meetings of Principal Investigators and other key personnel, and collecting and disseminating research tools.
In addition, a steering committee, comprised of AHRQ staff and two investigators from each study, one from the research side and one from the systems side, will be formed. The committee will provide an opportunity for investigators to discuss common issues and identify common data elements such as descriptors of patient populations and measures of patient and provider satisfaction.
Organizations interested in partnering with a research team to develop a proposal for the TRIP II RFA responded to a Request for Expressions of Interest (RFEI) published in June 1999 in the Federal Register. A list of these organizations can be accessed online at www.ahrq.gov/fund/partners.htm. Although working with RFEI respondents is not a requirement, researchers are encouraged to develop relationships with these organizations or to build on existing relationships with other organizations.
In composing research proposals for the TRIP II RFA, researchers should keep the following questions in mind:
Dr. Harold Goldstein of the National Institute of Mental Health (NIMH) encouraged those applicants interested in focusing their projects on mental health issues to contact the NIMH Dissemination Research Program. This program supports studies on the array of influences that affect the adoption of valid mental health research findings into clinical practice and mental health services system policy. Mental health research is widespread but the NIMH is facing the same challenges as AHRQ: ensuring that research strategies are sustainable and reproducible.
In addition to being part of the TRIP II RFA, NIMH has also expressed its interest in this area in the form of a Program Announcement (PA). PA No. 99-068, Dissemination Research in Mental Health, states a number of mental health program priorities. Under this funding program, there is no limitation on the size of grants. Pilot-like studies go through a small grant mechanism; larger grants, over $500,000, require Dr. Goldstein's approval. To find out more about PA No. 99-068, visit the Funding Opportunities section in NIMH's Web site, www.nimh.nih.gov.
One participant asked how researchers could take advantage of both the TRIP II RFA and PA No. 99-068. Dr. Goldstein stressed that the programs and mechanisms of support are different and it is up to the PI to determine which RFA would best meet the needs of the study. Requests submitted to the TRIP II RFA that focus on mental health issues would go through the special emphasis panel at AHRQ and would be referred to Dr. Goldstein for consideration of funding.
Joan Hurley, of the AHRQ Office of Research Review, Education and Policy (ORREP), explained the review process for the TRIP II RFA. She described the review process as a "complex, scientific system." The guidelines for submitting applications are clearly spelled out in the RFA, but Ms. Hurley wanted to stress the importance of following the precise instructions for completing research grant application form PHS 398. Requirements are rigorously enforced and noncompliant applications will be returned without review.
A Grants Management perspective of the TRIP II RFA was presented by Joan Metcalfe. The following are the specific requirements and suggestions she outlined:
The applicant organization must:
Both non-profit and for-profit organizations are eligible for the TRIP II RFA. Partnership issues on which researchers and organizations should focus are as follows:
Ms. Metcalfe strongly recommends that PIs touch base with AHRQ's business office regarding questions of partnership issues in order to receive guidance to prevent problems from arising in the future. In terms of budget, the majority of funds must be allocated to evaluation, not to development and implementation. In addition, researchers cannot include usual care expenses in the grant.
Questions concerning intellectual property and copyright issues were answered by Susan Merewitz, Senior Attorney, Office of the Secretary's General Counsel Office. AHRQ's approach to these issues is to encourage private-sector grantees to develop copyrights while ultimately reserving the right to disseminate information through the agency. Specific legislative mandates are outlined on page 12 of the RFA.
Daniel Stryer and Joan Metcalfe answered questions of the attendees.
Question: The Coordinating Committee will require sharing of data—what about constraints on identifiable data?
Answer: Identifiers will be removed before pooling. AHRQ would agree to send a letter in certain circumstances to facilitate obtaining of data.
Question: Idealized settings don't quite fit into researcher or system categories—how will AHRQ handle them?
Answer: The RFA will recognize those organizations.
Question: Will the Health Insurance Portability and Accountability Act (HIPPA) affect data sharing?
Answer: That issue will be addressed by the data center.
Question: Is it feasible to use past data?
Answer: The use of past data would not be appropriate in most cases because of the need to guard against secular trends.
Question: Does the budget include travel?
Answer: The submitted budget should include the travel expenses for two investigators to travel to Rockville two times per year.
Question: Will AHRQ regard new investigators differently?
Answer: Value will be given to new investigators but it will depend on the study section. No specific targets are outlined.
Question: Are cooperative agreements more vulnerable to loss of funding?
Answer: No. The TRIP II RFA is of top priority to AHRQ. If you fulfill the agreement to AHRQ, it will fulfill its agreement to you.
Question: Does the RFA call for the use of specific tools?
Answer: No. Protocol and data collection forms specifically developed for these projects would become part of the "toolbox." Researchers are encouraged but not required to use these tools.
Question: Who holds ownership rights of data?
Answer: AHRQ does not foresee any instance when they would need access to data. However, situations can arise in which AHRQ would need to see the data in order to validate conclusions. The application should outline all tools to be used in the project.
Question: How early is the external review process introduced?
Answer: As soon as the grants are awarded, the steering committee will be formed and the external review process will begin.
Question: Are there relative risks or benefits to focusing on one of the risk criteria as opposed to two or more?
Answer: No. All projects will have reviewers with significant background in that particular area. AHRQ has the option of getting as many as five collateral reviewers, so focusing on one very specialized topic would not be a disadvantage.
Question: Is informed consent needed for patients when the intervention is on the provider level?
Answer: This is a rapidly evolving area, often without definitive answers. In general, informed consent is needed from patients (and providers in the case of provider-level interventions) for research, as opposed to quality improvement, projects. If the normal process of care is directly altered in any way, informed consent is required. Implied consent should not be inferred from participation in any aspect of a study such as filling out a questionnaire. Investigators are encouraged to look at the local standards and contact the Office for Protection from Research Risks (OPRR) at the National Institutes of Health (NIH) with any questions. Also, investigators should be aware that this is a rapidly evolving area that may be directly affected by privacy legislation and departmental regulations.
Dr. Stryer concluded the meeting by reminding participants that the deadline for letters of intent for the TRIP II RFA is March 10, 2000. He encouraged researchers to contact staff at AHRQ and NIMH with any questions they may have before that time. In addition, communication with partnership organizations should begin as soon as possible. AHRQ is very excited about the TRIP II RFA and the potential of the cooperative agreement mechanism. Agency staff are looking forward to the opportunity to work with researchers to accelerate and amplify the impact of work on implementing evidence into daily practice.
Current as of March 2000
The information on this page is archived and provided for reference purposes only.