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PCORI September & October 2013

AAMC Patient Centered Research Newsletter

As I See It - Engaging the community in research

Sequestration and budgetary uncertainties weigh heavily on the minds of all of us in academic medicine and on the minds of all those committed to improving health through research. Amidst this environment of severely constrained resources and understandable angst, some encouraging trends in the research community endure. There is a palpable convergence of energy, attention and resources towards engaging persons in the community and patients as part of the research community. This convergence is playing out:

  • via funding mechanisms, such as the new PCORI-funded clinical data and patient-powered research networks (CDRNs and PPRNs);within research regulations, such as the FDA's Patient Preference Initiative, intended to incorporate patient preferences into decisions relating to medical devices;
  • in the recommendation from the IOM's recent review of the clinical and translational science awards (CTSAs), that the National Center for Advancing Translational Science (NCATS) and the CTSA program ensure that patients, family members and persons in the community (broadly defined) are involved across the continuum of research from basic science to first-in-human studies to community-based and population health research; and,
  • in requirements of the Affordable Care Act for non-profit hospitals to undertake a Community Health Needs Assessment (CHNA) that involves substantial input from community members, particularly medically underserved, low-income, and minority populations, served by the hospital.


This convergence is forcing us to take a fresh look at how we define our research community, moving us from the traditional silos of health systems, researchers, scientific disciplines, funders and participants towards a single, inclusive framework, which unites us all with a commitment to effectively harness research investments to improve the health of the public.

As we develop strategies to cope with the ongoing decline in federal funding for research, we must strive to uphold this positive trend which strengthens the ties among researchers and communities writ large- whether that community is defined as the group of patients or persons with a rare disease, residents of a target geographical area, demographic subpopulations, or other vulnerable groups.

Ann Bonham., Ph.D.
Chief Scientific Officer, AAMC

Headlines

The PCORI Board of Governor's meeting on September 23, 2013 marked Dr. Eugene Washington's last meeting as Chair of the Board. PCORI welcomes Dr. Grayson Norquist as the new Chair of the Board of Governors. At the same meeting, Deputy Executive Director Dr. Anne Beal proposed three new engagement awards that would be named in honor Dr. Washington's contribution to the formation of PCORI. Awards in the areas of Knowledge, Training and Development, and Dissemination are designed to be relatively short term and of modest amounts, designed to provide wraparound support for research.

At the PCORI Board meeting on September 23, 2013, PCORI announced two realignments in its approach to funding patient-centered research. Also announced was that although there will continue to be a mix of broad and targeted funding, emphasis will shift from broad to targeted, with an anticipated greater potential for impact. PCORI realigned the projected mix of funding for 2014 to provide for $230 million for broad areas and $270 million for targeted areas. The Methodology Committee revised the Methodology Report, identifying two new standards for inclusion: cluster randomized trials and complex interventions. Two additional standards are under consideration: value of information analysis and additional standards on systematic review methodologies. Working groups will develop the scope of work for these areas, and a Clinical Trials Advisory Panel will be convened.

Recently PCORI's Board of Governors approved more than $114 million in funding for 71 new projects to conduct comparative effectiveness research (CER). These additions contribute substantially to PCORI's effort to fund research that produces information vital to patients and their health care providers to make better-informed health care decisions. The awards address a variety of chronic conditions such as heart disease, dementia and mental health disorders, and investigate ways to improve the design and conduct of research, reduce disparities in clinical outcomes, and improve healthcare delivery systems. These funded projects promote greater involvement by patients and other healthcare stakeholders in clinical research. Overall, this research strives to improve capacity on a national level to conduct CER through improvement in research methods. In this latest round, PCORI distributed funding among 48 institutions in 20 states. These awards bring the total support PCORI has approved and awarded to 197 projects nationwide in 35 states.

PCORI also announced the award of a contract to Harvard Pilgrim Health Care Institute to serve as a coordinating center for the new National Patient-Centered Clinical Research Network recently proposed by PCORI. The $9 million contract will coordinate the initiative to create a large network of health data that is representative of patients nation-wide.

The Association of American Medical Colleges (AAMC) has announced two new challenge programs designed to recognize innovations in medical education, care delivery, research, and diversity and inclusion. AAMC-member medical schools and teaching hospitals are encouraged to apply to both the Learning Health System Challenge and Planning awards, and the Clinical Care Innovation Challenge.
The Learning Health System Challenge awards recognize institutions that have implemented innovative, system-wide processes that improve the opportunity for research within one or more of three research areas (quality improvement research, health equity research, and research that utilizes data from the institution's Electronic Health Record). The Learning Health System Planning awards recognize institutions that wish to enhance capacity in one or more of these three research areas. The applications are due on October 30, 2013. For further information visit www.aamc.org/initiatives/rocc/

The Clinical Care Innovation Challenge awards recognizes transformational clinical care initiatives that lead to improved value and quality. Themes for this Challenge will include innovations in care delivery, payment, and training models. This Challenge will launch the week of October 21, 2013. For complete program details and submission guidelines, visit www.aamc.org/iq

Winners from both awards programs will be featured at the Sixth Annual 2014 AAMC Integrating Quality Meeting, which will be held June 12-13 in Chicago, Ill.

Improving the Application Review Process PCORI announces changes to the application and review process, based on feedback it received from reviewers. Highlights include simplified criteria and critiques, and the introduction of standing panels to evaluate certain applications. The Research on Care Community (ROCC) at the AAMC recently aired a discussion on the Patient-Centered Outcomes Research Institute (PCORI) peer review process. The archive is available on the ROCC website.

A special Board of Governors Teleconference/Webinar on PFA Cycle III was held September 10, 2013. Slides are available from PCORI's special Board of Governors webinar on their most recent PFA cycle and the inaugural Improving Methods for Conducting PCOR funding awards.

Beginning with the End in Mind - Study Endpoints: Targeting Patient-Centered Outcomes will be held Oct 21, 2013 - Oct 23, 2013. This conference focuses on the role of study outcome measures in research development and objectives. Attendees will hear various stakeholder perspectives and discuss balancing strategies in the development of study endpoints. More information is available on the Global Forum for Therapeutic Innovation and Regulatory Science website.

Of Interest

AHRQ released a new report regarding communicating confidence in various research methods. Titled 'Towards a Framework for Communicating Confidence in Methodological Recommendations for Systematic Reviews and Meta-Analyses', the report documents practice recommendations and a framework toward making trust-worthy methodological recommendations for these two analytical approaches. As CER demands methodological expansion beyond traditional random control designs (RCT), researchers must learn to communicate confidence effectively within various designs.

The Commonwealth Fund recently announced it "will hone its focus to address emerging issues in the post-health reform landscape." It announced it will focus its grant making and research resources on "Tracking the results of the Affordable Care Act, improving how health care is delivered to the sickest patients, ensuring access and improving quality of care for low-income, minority, and immigrant populations, and supporting breakthroughs in health care...The Fund will also expand its policy analysis efforts to focus more explicitly on controlling health care costs, improving Medicare, and tracking the nation's health system performance." David Blumenthal, M.D., joined The Commonwealth Fund as its president earlier this year.

'Health Care in the Two Americas': Findings from the Scorecard on State Health System Performance for Low-Income Populations, 2013 was released from the Commonwealth Fund. The scorecard developed in the study compares and contrasts 30 indicators of health across states, finding sharp disparities among states in areas such as access, prevention, quality and health outcomes.

Do Bayesian adaptive trials offer advantages for CER?: Pragmatic trial design is the topic of a new article in the journal Clinical Trials. Using the ALLHAT trial data, Conner and colleagues assess whether a Bayesian approach to design and analysis of the data offers any efficiencies over RCT design, through proposing seven adaptive designs and selecting one to compare with the original data.

Hospital infections cost U.S. $10 billion a year: A new report in JAMA Internal Medicine reported that infections acquired in the hospital cost the U.S. health care system $10 billion a year. According to a Reuters article on the findings, the CDC reported that "about one in every 20 hospitalized patients contracts a hospital-acquired infection."

Implementation strategies for collaborative primary care-mental health models: Dixon and colleagues review the literature on collaborative primary care mental health models, and generate an overview of current strategies for implementation.

Risks (and Benefits) in Comparative Effectiveness Research Trials: Feudtner and colleagues wrote a perspective in a recent issue of NEJM, listing and discussing multiple risks and benefits of CER, noting that Institutional Review Boards (IRB) must consider each risk or benefit separately and the risk/benefit of the study as a whole.

Aligning Academic Continuing Medical Education with Quality Improvement: A Model for the 21st Century: In Academic Medicine, Davis and colleagues describe the Aligning and Educating for Quality (ae4Q) model to align graduate medical education and quality improvement.

Teaching While Learning While Practicing: Reframing Faculty Development for the Patient-Centered Medical Home: Patient Centered Medical Homes are the topic in an article by Clay and co-authors, who consider various faculty development models and recommend adaptations for training clinical teachers for roles as facilitators of system change.

Individual Physician-Level and Practice-Level Financial Incentives on Hypertension Care: In a recent issue of JAMA, Peterson and colleagues describe their randomized trial of financial incentives for physicians and practices, and the impact on hypertension care, concluding that individual incentives influenced some but not all areas of practice.

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