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National Advisory Council

Meeting Summary

April 9, 2010

Minutes from the April 9, 2010, meeting of the Agency for Healthcare Research and Quality's National Advisory Council (NAC) are available on this page.

Call to Order; Approval of November 13 Summary Report
Director's Update
Patient Safety Portfolio Highlights
The 2009 National Quality Report/Disparities Report Update
Patient Care for the Hospital-to-Home Transition
Comparative Effectiveness Research Progress Report
Public Comment
Chairman's Wrap-Up, Member Comments
Adjournment

NAC Members Present

Arthur Garson, Jr., M.D., M.P.H., University of Virginia (Chair)
Nancy E. Donaldson, D.N.Sc., R.N., FAAN, Center for Nursing Research & Innovation, University of California, San Francisco
Junius J. Gonzales, M.D., M.B.A., University of South Florida
Wishwa N. Kapoor, M.D., M.P.H., University of Pittsburgh
Lisa M. Latts, M.D., M.B.A., M.S.P.H., WellPoint Inc. (by telephone)
Kathleen Lohr, Ph.D., RTI International
Keith J. Mueller, Ph.D., Nebraska Center for Rural Health Research
Welton O'Neal, Jr., Pharm. D., Takeda Pharmaceuticals North America, Inc.
Michael K. Raymond, M.D., Skokie Hospital
Xavier Sevilla, M.D., FAAP, Manatee County Rural Health Services Inc.
David L. Shern, Ph.D., Mental Health America (by telephone)
Katherine A. Schneider, M.D., M.Phil., AtlantiCare Health System
Bruce Siegel, M.D., M.P.H., George Washington University
William Smith, Pharm.D., Ph.D., M.P.H., Virginia Commonwealth University
Myrl Weinberg, C.A.E., National Health Council

Alternates Present

David Atkins, M.D., M.P.H., Veterans Health Administration
Sarah Lutter, J.D., Office of Science Policy, National Institutes of Health (NIH)
Jane Sisk, Ph.D., Centers for Disease Control and Prevention (CDC)
Barry Straube, M.D., Centers for Medicare and Medicaid Services (CMS)

AHRQ Members and Staff Present

Carolyn M. Clancy, M.D., Director
Karen Brooks, C.M.P., NAC Coordinator
Kathie Kendrick, M.S., C.S., R.N., Deputy Director
Ernest Moy, M.D., M.P.H.
Jean Slutsky, P.A., M.S.P.H., Director, Center for Outcomes and Evidence
Jaime Zimmerman, M.P.H., NAC Coordinator

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Call to Order; Approval of November 13 Summary Report

NAC Chairman Arthur Garson, Jr., M.D., M.P.H., called the meeting to order at 8:30 a.m., welcoming the NAC members, other participants, and visitors. The NAC members introduced themselves. Dr. Garson referred to the draft minutes of the previous NAC meeting (November 2009) and asked for changes and approval. The NAC members approved the November meeting minutes with no changes.

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Director's Update

The Big Picture

Carolyn Clancy, M.D., AHRQ Director, welcomed the NAC members and noted that new members Welton O'Neal, Jr., Pharm. D., and Katherine A. Schneider, M.D., M.Phil., were in attendance. Five additional new members plan to attend the July 2010 meeting. They are Helen Darling, M.A., Louise-Marie Dembry, M.D., M.S., M.B.A., Silvia M. Ferretti, D.O., Helen W. Haskell, and Ardis Dee Hoven, M.D.

Dr. Clancy reported on AHRQ activities during the previous months. She noted that a number of former NAC members have taken leadership positions in the administration, including Regina Benjamin, M.D., the U.S. Surgeon General, and Mary Wakefield, Ph.D., R.N., Administrator of the Health Resources and Services Administration (HRSA).

The Patient Protections and Affordable Care Act was passed and became Public Law 111-148. This health care reform law instructs the Secretary of the Department of Health and Human Services (HHS) to create a national strategy to improve health care quality. Many strategies have been and are being pursued—they are characterized by a need for data. The new emphasis on strategy is timely because of the concomitant efforts to advance health information technologies, which will address the need for data. The new law also establishes an Interagency Working Group on Health Care, featuring senior representatives from HHS, AHRQ, CMS, CDC, HRSA, the Department of Defense (DoD), and other federal agencies. HHS Director Kathleen Sebelius will serve as chair of the group.

Dr. Clancy listed areas in the health care act that relate directly to AHRQ. These include efforts to identify gaps in health care quality measures, a project to develop episode-of-care and post-acute quality measures, the development of training in best practices for quality (AHRQ's Center for Quality Improvement and Patient Safety), the establishment of changes in Medicare coverage based on deliberations of the U.S. Preventive Services Task Force, and support for an independent Patient-Centered Outcomes Research Institute (as board member and disseminator of findings). Other aspects of the health care act that will involve AHRQ include a community health team to support a patient-centered model home, medication management services, emergency care, shared decision-making, a primary care extension service, medical liability, and the collection of health disparities data.

The President Obama's proposed FY 2011 budget includes $611 million for AHRQ, a significant increase from AHRQ's FY 2010 budget of $397million. The new budget features $286 million for patient-centered health research (comparative effectiveness research, or CER), $32 million for health information technology research, and $65 million for patient safety research, which includes $34 million to reduce and prevent health care-associated infections.

In discussion, Dr. Clancy noted that the new primary care extension service project will seek to aid small practices, which have limited structures. The Patient-Centered Outcomes Research Institute will include representation from industry on its board and will feature a methodologies panel. Kathleen Lohr, Ph.D., wondered whether the healthcare bill's language about that institute could lead to an easing of constraints on publication. Dr. Clancy explained that the new effort in shared decisionmaking refers to a grant program for organizations to explore new strategies for expanding input in decisionmaking, exploring issues such as timing and pathways.

Regarding the question of a detailed focus versus a broad focus for improving quality, Dr. Clancy stated that the process likely will be iterative and one key will be finding transitional pathways. The legislation's emphasis on collaboration should strengthen AHRQ's potential to work with other offices. Its call for communications efforts refers to the dissemination of research findings. Sarah Lutter, J.D., wondered about a likely linkage between the efforts of the new Patient-Centered Outcomes Institute and the current national strategy, which features a priority regarding CER. Nancy Donaldson, D.N.Sc., suggested seeking ways to leverage and increase the use of data that are collected by states for outcomes reports.

Recent Accomplishments

Dr. Clancy reviewed the following recent accomplishments:

AHRQ personnel had two pieces published in the Journal of the American Medical Association. Mary Barton authored a commentary on the challenges of comorbodity, and Claudia Steiner contributed to an article about acute care ustilization and rehospitalilzations related to sickle cell disease.
An evidence-based practice center study within AHRQ's Effective Healthcare Program compared the use of surgical biopsy and various core-needle biopsies, finding that the latter lead to a lower risk of severe complications.
AHRQ began a collaboration with the American College of Cardiology to study implantable cardioverter difibrillators, to evaluate frequencies and measurements of shocks and types of patients who require them.
AHRQ has begun to offer Spanish-language podcasts to present health information. These are monthly 60-second audio reports.
AHRQ-supported research through the Effective Healthcare Program determined the benefit of using proton-pump inhibitors with blood thinners (Clopidogrel) to reduce hospitalization for bleeding ulcers.
A state Medicaid Medical Directors Learning Network has been using AHRQ products in policy deliberations regarding a variety of medical issues.
A knowledge transfer case study in Oregon has employed AHRQ-supported quality diagnostic tools—regarding preventable hospitalizations and prevention quality indicators.
A knowledge transfer case study in Virginia (at Bon Secours St. Mary's Hospital) has employed AHRQ-supported training and a patient safety tool kit for emergency departments, reducing wait times.
A knowledge transfer case study in Montana is making use of the AHRQ-supported Medicaid Care Management Learning Network, allowing officials to adopt a population-based care management approach.
A knowledge transfer case study in Pennsylvania involved the use of the AHRQ-supported Medicaid Care Management Learning Network to revise the state's management program to increase in-person care management services.
An impact case study by the Association of Perioperative Registered Nurses featured use of Team Strategies and Tools To Enhance Performance and Patient Safety (TeamSTEPPS®) in the perioperative environment.
A knowledge transfer case study at Kimball Medical Center employed the AHRQ-supported Web-based report, "Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults with Type 2 Diabetes."
An impact case study in North Dakota employed TeamSTEPPS® to tailor a curriculum for critical access hospitals.

AHRQ Program Updates

Dr. Clancy provided the following program updates:

To increase transparency, AHRQ made available on the Web a listing of requests that it has received and subsequent responses.
The Maryland Health Care Commission used Medical Expenditure Panel Survey (MEPS) data to inform residents and legislators about employer-based insurance in the state.
To inform Medicare policymakers, the Acumen Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Center performed an analysis of the use of erythropoiesis-stimulating agents in patients with chronic kidney disease.
The Effective Health Care (EHC) Program released new translation products about reducing the risk for breast cancer and having breast biopsies.
The AHRQ Web site has been redesigned and features a database of funded CER grants.
A new analysis found that, if all patients with diabetes took medications as prescribed, their hospitalization rate would drop by 23 percent and there would be 46-percent fewer emergency department visits. Drug costs would rise, but net cost savings would increase.
A new HCUP statistical brief revealed that more than half of all hospital procedures are performed on an outpatient basis. Hospital outpatient surgery charges totaled $55.6 billion compared with $259 billion for inpatient surgeries.
Minnesota became the 19th state to use prevention quality indicators in a public report, covering more than half of all hospitalizations.
There are now 79 Patient Safety Organizations (PSOs) in 29 states and the District of Columbia. A second annual PSO meeting will take place in Baltimore in May. Dr. Clancy noted upcoming efforts to address patient reporting.
A meeting of the Consumer Assessment of Health Providers and Systems (CAHPS®) is taking place this month. It will feature input from the Patient Safety Culture Survey user groups.
The Health Information Technology (Health IT) portfolio included a 2007 grant to support a regulation that allows electronic prescribing of controlled substances, the use of an evaluation tool for computerized physician order entry (by the Leapfrog Group), and analysis of the Consumer Health Informatics Applications Evidence Based Report.
The Prevention/Care Management Portfolio is convening a meeting on creating composite measures of appropriate clinical preventive services for older adults. in May there will be a summit on linking clinical practice and community organizations for prevention.
The Prevention/Care Management Portfolio plans to offer grants for transforming primary care practice, for studying comparative effectiveness in complex patients, and for optimizing prevention and health care management for the complex patient.
The fourth annual AHRQ conference will take place September 26–29, 2010, in Bethesda, Maryland. The theme is "Improving Care Today, Empowering Change Tomorrow."

In discussion, Dr. Lohr suggested including input from midwives in the development of a CAHPS® survey on maternity care. Dr. Garson noted that a recent issue of Academic Medicine featured a paper on teaching teamwork.

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Patient Safety Portfolio Highlights

William B. Munier, M.D., M.B.A., Director, Center for Quality Improvement and Patient Safety, AHRQ

Dr. William Munier reviewed activities within AHRQ's patient safety portfolio. He began by citing data from the Institute of Medicine's 1999 publication, To Err Is Human, which stated that lapses in health care safety were the 8th leading cause of death in the United States, representing a national cost of between $17 billion and $29 billion. A study of personal experience with medical errors found that about 35 percent of either the public or physicians reported experience with preventable medical errors. The complexity of care today increases the opportunities for error.

AHRQ represents the Department of Health and Human Services' effort to address improvement in healthcare quality and safety. AHRQ works with non-federal partners in the effort—consumer advocacy groups, the Institute for Healthcare Improvement, the National Safety Foundation, the National Quality Forum, the Joint Commission, and the World Health Organization. Dr. Munier presented trends in the AHRQ patient safety budget, which was increased significantly in 2010 (to $91 million).

Dr. Munier listed the many areas of emphasis in the AHRQ patient safety portfolio and described, in particular, the efforts in healthcare-associated infections and PSOs. The Pronovost-AHRQ Michigan-Keystone study found that multiple interventions could reduce the median rate of central line catheter-related bloodstream infections in intensive care units. AHRQ has been building on that success with other projects to reduce hospital-acquired infections, and the Department of Health and Human Services created a steering committee focused on ruducing such infections. The Michigan-Keystone program was expanded to 20 additional states (on the way to 50), and will address additional sites of infection.

Dr. Munier reviewed the PSO program. Today there are 79 PSOs in 29 states and the District of Columbia. in the PSO program, organizations can set up and become listed federally, allowing the analysis of patient safety events without fear of legal issues. Locally, the program affords enhanced reporting, analysis, and improvements in quality and safety performance. On a larger scale, the program, over time, will lead to faster identification of problems through aggregated data, enhance learning through dissemination of best practices, create a better use of resources, and identify where research is needed. Future efforts will focus on best practices, changes in care processes, redesigns of systems, identification of high quality providers, and research. Areas for future progress include measurement (e.g., common definitions), patient and consumer engagement, and increased use of health information technologies.

In discussion, Dr. Clancy noted that AHRQ will be supporting planning grants and demonstration projects to study issues of harms and compensation. It is difficult to assess effects related to fears of malpractice suits. Research is needed. AHRQ also will be funding an overarching evaluation of the patient safety culture. Dr. Lohr suggested that research include patient and family reactions to safety events. Could the Medicare ombudsman play a role? Barry Straube, M.D., stated that this is a complex area and there is not, at this point, a single locus within CMS for receiving patient/family input. Dr. Munier agreed that consumers must play a role but stressed issues of confidentiality and reporting. AHRQ is engaged in a study of consumer reporting. Dr. Donaldson referred to a program in Sweden that makes use of county councils to receive consumer reports. Bruce Siegel, M.D., called for a program that would engage low performers (regarding safety). There are, of course, state licensure systems. Dr. Garson wondered whether the recent approaches for dealing with MRSA infection might serve as models. Dr. Straube noted that CMS employs quarterly goals and safety monitoring for the QIOs. Dr. Clancy proposed that the issue of dealing with poor performers be placed on the agenda of the next NAC meeting.

Dr. Munier noted that new measurements and data, at the granular, or event, level, will be available soon. AHRQ will be able to roll up the data by provider, by PSO, and nationally. Wishwa N. Kapoor, M.D., emphasized a need to consider medical errors that result from transitions in care.

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The 2009 National Quality Report/Disparities Report Update

Ernest Moy, M.D., M.P.H., and Karen Ho, M.H.S., Center for Quality Improvement and Patient Safety, AHRQ

Dr. Ernest Moy reported that the 2009 editions of AHRQ's National Healthcare Quality Report and National Healthcare Disparities Report will be released soon. He reviewed the history of the reports, beginning with AHRQ's reauthorization by Congress in 1999. The first reports were released in 2003. Since then, experience has revealed trade-offs and assumptions that are necessary to develop the reports. The primary audience for the reports comprises policymakers. The primary uses are for tracking, and the primary analytical unit is the geographical area. The reports use broad measures and emphasize consensus measures, composite measures, and simple analyses. Dr. Moy listed topics covered, including patient safety, effectiveness, timeliness, efficiency, and patient-centeredness. To build the reports, AHRQ tracks about 250 measures from about 40 databases.

The 2009 reports feature new sections on the uninsured, healthcare-associated infections, care coordination, and lifestyle factors. The quality report features a new section on patient safety culture in hospitals and more efficiency measures. The disparities report features a new section on the financial burden of healthcare costs. Dr. Moy noted findings in the reports, including the following:

Healthcare quality needs improvement, especially for the uninsured.
Quality is improving but at a very slow pace.
Disparities remain common.
Many disparities are not decreasing and some are getting worse.
Healthcare-associated infections have changed very little.
Half of children (and especially poorer children) receive no advice about diet and exercise.
A lack of insurance is the largest factor affecting health care quality and disparities.

Karen Ho noted that the new reports include improvements in the state snapshots, for example, additional linkages that will facilitate their use, more information on disparities, and a focus on payer types. Subsequent reports (2010, 2011) will feature new recommendations by the Institute of Medicine as well as the NAC.

Discussion

Dr. Moy stated that most items in the reports are based on process measures, although some patient perspectives are obtained through information from doctors. David Atkins, M.D., encouraged the report developers to consider specific issues related to underinsurance in future reports. Dr. Garson suggested tracking outcomes for the uninsured, to determine whether they change over time. Dr. Atkins wondered about disparities involving the lack of pre-surgical antibiotics—could that be an issue based on the facilities rather than differential treatment based on race? Dr. Straube called for development of an approach that targets specific disparities.

Dr. Garson wondered what it might cost to tackle a particular disparity. Dr. Clancy cited the call for a national strategy to reduced healthcare-associated infections, with a leveraging of assets across departments—so, an opportunity exists. That project does not have a mandate for AHRQ to address particular disparities. Dr. Siegel wondered about a threshold for tolerance of low performance.

Dr. Lohr suggeseted that the report developers include some simple models, with explanations, in the reports. This could help readers to understand how to interpret and apply the information. Katherine A. Schneider, M.D., M.Phil., noted that AHRQ has a mandate to help improve health care across systems. Perhaps a focus on health disparities could especially serve that aim. Dr. Clancy cited an intention to create a science of improvement. She suggested placing the topic of targeting disparities on the agenda of the next NAC meeting. This could include issues of care-delivery interventions.

Dr. Donaldson envisioned a potential synergy between the data related to disparities in the use of preoperative antibiotics and the federal commitment to reduce hospital-acquired infections. Perhaps funds could be leveraged to address special populations. Also, we need to train users and train enterprises to use implementation science. Dr. Lohr pointed to the Innovations Clearinghouse (about health care delivery) and action task order contracts that target rapid implemenation research.

William Smith, Pharm.D., Ph.D., suggested studying how decisions are made in health systems and how data are used. David L. Shern, Ph.D., proposed developing a theory of action to address health disparities, focusing perhaps on consumer education. Dr. Atkins proposed pairing toolkits with data. Dr. Garson noted that disparities are present in the insured population, although less so. Perhaps a first effort should be to increase the availability of insurance. That might be followed by efforts to disseminate information, to address the profit motive and fear of lawsuits, and to change behaviors in hospitals.

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Patient Care for the Hospital-to-Home Transition

Timothy W. Bickmore, Ph.D., Northeastern University

Dr. Timothy Bickmore demonstrated a computer-based virtual patient advocate designed to reduce adverse drug events by communicating with patients who are transitioning from hospital to home. The computerized program, featuring, on a small screen, a virtual advocate providing medical information as well as nonverbal, emotional communication, is dynamic and interacts with the patient (the patient engages the touch screen) to encourage medication adherence and detect adverse events. The system is undergoing a trial at present, with a pilot test to be completed soon. Dr. Bickmore also provided a demonstration of similar tool used to address infant mortality and low birth rate, which will be piloted in the fall of 2010. in response to questions, he noted that he and his colleagues plan to develop multilingual versions of the programs. The NAC members urged Dr. Bickmore to obtain feedback on the systems—to ensure understanding by patients—and to consider complexities such as differential dosages of medications and multiple medications.

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Comparative Effectiveness Research Progress Report

Jean Slutsky, P.A., M.S.P.H., Director, Center for Outcomes and Evidence, AHRQ

Jean Slutsky reviewed AHRQ's Effective Health Care (EHC) Program, which was created in 2005 and authorized by Congress's Medicare Prescription Drug Improvement and Modernization Act of 2003. The legislation called for improving the quality, effectiveness, and efficiency of health care delivered through the Medicare, Medicaid, and S-CHIP programs. in 2009, the stimulus, or recovery act (ARRA), featured $1.1 billion for comparative effectiveness research (CER). of that, AHRQ was given $300 million. The president's budget request for FY 2011 features a large increase in funding for the EHC (to $286 million).

CER is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings. Ms. Slutsky presented a framework for CER and described AHRQ's contribution within the EHC program. The program's work features evidence synthesis, evidence generation, and evidence communication/translation. Ms. Slutsky showed where AHRQ's investments are made (e.g., 3 percent for horizon scanning, 57 percent for evidence generation, 13 percent for evidence synthesis, 12 percent for dissemination and translation). She presented a long list of priority conditions that are targeted by the EHC program, including cancer, arthritis, cardiovascular disease, dementia, depression, diabetes, and infectious diseases. The EHC program features public engagement to nominate topics for research, to obtain comments on key research questions, and to perform focus testing on translation products. A new Citizens' Forum for Comparative Effectiveness Research, supported by ARRA funds, will develop mechanisms and refine approaches to elicit public views on healthcare decisions. in particular, the forum will inform CER within AHRQ's EHC program.

Ms. Slutsky noted that current EHC products include research reviews, original research reports, and summary guides. They are online at http://www.effectivehealthcare.ahrq.gov. AHRQ has provided leadership in areas including CER methods research, distributed research networks, training, public engagement, and innovation (establishing new programs). Notable findings of AHRQ-supported CER have included reductions in cardiovascular events when drug eluting stents were applied and information about localized prostate cancer. Ms. Slutsky showed features of the EHC Web site, including a list of funded CER grants.

Discussion

Myrl Weinberg suggested that AHRQ be transparent in describing CER strategies. Dr. Kapoor noted that randomized clinical trials are very expensive and mostly will be impractical for CER. There will be a need to develop buy-in and credibility for other research methods. Xavier Sevilla, M.D., suggested that CER researchers consider chronic childhood diseases, delivery systems, and nonmedical treatments. Dr. Lohr also pointed to health care delivery issues and expressed hope that observational studies in CER will fit design to study purpose (e.g., addressing clinical heterogeneity). Michael K. Raymond, M.D., recalled that Ms. Weinberg and Dr. Clancy expressed in print the view that CER must link relevant research to strategies of care.

Dr. Donaldson stated a need to retool methods. She suggested that AHRQ consider how to reduce variation in reviewers, to avoid knowledge-based differences (while retaining diverse views). Dr. Kapoor called for development of synergy among databases. We need to get electronic health records, with rich data based on multiple patients, into the clinical work space. When will this happen? Dr. Garson suggesteed that it will be important for all groups using CER funds to move forward together (e.g., developing structures), with a good strategy. Dr. Clancy noted plans to create an inventory and a registry of registries.

Dr. Kapoor cited the need for various types of clinical trials in response to funding conditions. Institutions should have greater interest in CER. Dr. Smith called for new ideas in healthcare-delivery research. We need requests for proposals (RFPs) for such research. Ms. Slutsky suggested that program announcements (PAs) are appropriate. Ms. Weinberg pointed to changes at the FDA that will allow companies to perform research in new ways, beyond clinical trials. Sarah Lutter, J.D., noted how the large stimulus funding program caused NIH, AHRQ, and others to shift their styles of interaction, which can serve CER. Strategies for CER may be complex (for example, issues about information and decision-making) and, noted Ms. Slutsky, there is a need for public debate about costs and policy. Dr. Lohr added that CER tends to generate hypotheses rather than answer questions. It can indicate where trials are needed—that is, head-to-head comparisons. We need a consistent nomenclature for study terms for CER. One question is whether, for a given study, a comparator is required.

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Public Comment

There were no public comments.

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Chairman's Wrap-Up, Member Comments

Dr. Garson invited the NAC members to make final comments.

Dr. Kapoor reminded AHRQ not to lose focus in other areas (safety, doctor shortages) as it pursues programs in CER.
Dr. Sevilla raised the topic of customizing care.
Dr. Siegel urged AHRQ to continue to support new Medicaid practices.
Dr. Donaldson called for synergistic efforts regarding state reporting for the quality and disparities reports. That could support improvement initiatives.
Dr. Lohr called for clarity in the language used to discuss personalized care. Perhaps "individualized care plan" should replace "personalized care." She also called for an emphasis on the patient's voice, on patient-reported outcomes.
Dr. Schneider urged the development of actionable tool kits for local care.
Dr. Smith emphasized issues in medication use (errors, etc).
Junius J. Gonzalez, M.D., stressed the community piece for programs—considering community levels and federal partners.

Dr. Clancy asked the NAC members to take part in some preparatory work prior to the July meeting. This will involve conference calls.

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Adjournment

Dr. Clancy thanked the council and expressed enthusiasm for the July NAC meeting, which will feature the additional new members and interesting agenda. Dr. Garson thanked the AHRQ staff and NAC members, and adjourned the meeting.

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Current as of March 2011

Internet Citation:

National Advisory Council: Meeting Summary, April 9, 2010. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/nacminutes/nacmin040910.htm