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Annual Report

Year 7

CERTs Research Centers Added in 2006

In April 2006, four new research centers were added to the CERTs program: the University of Texas MD Anderson Cancer Center and Baylor College of Medicine; Rutgers, The State University of New Jersey; Weill Medical College of Cornell University; and the University of Iowa. Investigators at these new centers are working on a wide range of topics, including consumer and patient education and adherence, mental health therapeutics, medical devices, aging, and the elderly.

Consumer and Patient Education and Adherence

Improving outcomes for multiple morbidities—Despite the demonstrated efficacy and cost-effectiveness of treatment and prevention strategies for many chronic conditions, many older persons, especially those with comorbid conditions, continue to suffer from uncontrolled hypertension, hyperglycemia, and other predictors of poor health outcomes. To address this gap in the implementation of effective and efficient medical care, CERTs researchers will develop and test a model of collaborative group clinics that seeks to empower older patients to adopt goal-setting behaviors and communicate with their health care provider to improve diabetes-related outcomes.

Informed decisionmaking about statins—Studies have consistently shown that statins reduce the risk of heart attack and stroke by 30-40 percent. Despite this, many patients reject or stop taking statins because of concerns about potential side effects and other problems. A patient education intervention that improves statin compliance would likely prevent many heart attacks and strokes. Researchers are working to develop and evaluate the potential efficacy of a new statin decision aid in Spanish and English for low-literacy primary care patients.

Mental Health Therapeutics

Pharmaceutical care for mental illness under Medicare Part D—Pharmaceutical care provided through the Medicare Part D program is critical for elderly and disabled persons with mental illnesses. A particular concern involves persons dually eligible for Medicare and Medicaid, a population that includes many with severe chronic mental illness. To address this problem, CERTs researchers are examining the provision, quality, and outcomes of pharmaceutical care for beneficiaries with mental illness under the Medicare Part D program.

Psychotropic therapy among children and adolescents—Rates and use of psychotropic medications among children and adolescents have increased sharply in recent years, raising a number of concerns related to safety, quality, appropriateness, and management of these regimens. Since there is considerable variation in treatment patterns, studies are needed to examine patterns across multiple States, especially for economically disadvantaged children and adolescents. CERTs researchers are examining treatment patterns, predictors, and trends in the use of psychotropic medications among child and adolescent Medicaid patients.

SSRI use and suicidality in depressed children and adolescents—Scientific uncertainty and controversy continue over the possible impact and magnitude of selective serotonin reuptake inhibitors (SSRIs) on suicidality, particularly among depressed youths. Recent analyses raise significant safety concerns about such effects. Analyses of large administrative databases such as Medicaid can support informed treatment decisionmaking by physicians, patients, families, and others. Investigators are examining the rates of suicide and suicide attempts in high-risk youths who received treatment for depression with SSRIs.

Medical Devices

Impact of regionalization—Regionalization of complex surgical procedures involves moving patients from low-volume sites and moving surgeons to high-volume sites. This may lead to better short- and long-term outcomes, but the impact on patient populations, including rural and minority populations, has not been assessed. CERTs researchers are evaluating whether the regionalization of total joint replacement procedures would lead to a reduction of in-hospital adverse events.

Volume-outcome relationships—Automatic implantable cardioverter defibrillators (AICDs) are being used more frequently across a wide population of patients with cardiovascular disease. It is not clear whether physician and hospital experience is associated with improved short-term outcomes. CERTs investigators are conducting research to determine whether there is a relation between physician volume of AICD implantation and short-term complication rates.

Prospective registry—Predictors of short- and long-term outcomes from total joint replacement, variations in outcomes across different models of joint prostheses, and cost-effectiveness of joint prosthetic devices are important areas of concern in light of the growing use of these procedures in the aging population. CERTs researchers are working to determine the clinical, demographic, patient, and device characteristics associated with improved outcomes for patients undergoing total joint replacement procedures.

Aging and the Elderly

Guideline implementation—Numerous studies have documented that practitioners are not providing care in a manner that conforms to clinical practice guidelines. Blood pressure is controlled in only 34 percent of patients with hypertension, despite six sets of guidelines over the last 30 years. Most cases of uncontrolled hypertension occur in patients who are over 65 years of age with access to health care and relatively frequent contact with physicians. It is possible that physicians' decisions and behavior, rather than limited access to care, may be factors contributing to poor blood pressure control. Improving adherence to hypertension guidelines is critical, but little information is available about underlying factors that contribute to poor adherence rates. Investigators are evaluating blood pressure control and guideline adherence among elderly patients. In addition, they are identifying barriers to achieving and sustaining blood pressure control and developing strategies for improvements in blood pressure management.

Medical decisionmaking for persons with lymphoma—Older adulthood is a time of complex decisionmaking regarding medical issues. A significant proportion of healthy older adults have impaired cognitive decisionmaking abilities. Cognitive studies have suggested age-related declines in the amount of information used and in the thoroughness of the information search process undertaken by older adults engaged in various decisionmaking tasks. Treatment decisionmaking is particularly complex for the low-grade non-Hodgkin's lymphomas. A popular treatment choice (anthracycline-based combinations of chemotherapy) has the potential for significant morbidity, with uncertain impact on long-term disease control. Therefore, such patients must make difficult treatment decisions (e.g., short-term cost vs. long-term benefit). Older patients may be at increased risk for disadvantageous decisionmaking. Investigators are evaluating which patient-related variables predict both strong and poor decisionmaking capacity. They are creating abbreviated and extended "menus" of medical treatment options that are appropriate for poor and strong medical decisionmakers.

Botanical dietary supplements—There is growing use of dietary supplements in the United States, with sales for 2004 estimated at $19 billion. At least 15 million American adults are at potential risk for interactions between botanical dietary supplements and medications. Most physicians are not aware of their patients' use of botanical dietary supplements and are not able to advise their patients because they do not have sufficient knowledge about the safety and effectiveness of these supplements. As data become available, it is critical that they be widely disseminated to consumers and health care professionals. Investigators are developing new venues for disseminating information about the safety and efficacy of botanical dietary supplements for the elderly.

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CERTs Program Resources

ADHD Online Toolkit for Providers, Patients, and Families: Web Tool
nichq.org/resources/toolkit

Arthritis Outcomes Initiative Resource for Patients and Families: Web Resource
www.engalitcheff.uab.edu

Arthritis Self-Help for Patients: Web Site
www.arthritispatient.cme.uab.edu/

Beta-Blocker Fact Sheet for Providers
dukecerts.dcri.duke.edu

Challenging Cases in Musculoskeletal Medicine: Online Education Course for Providers
www.giop.certs.cme.uab.edu/

Doubly Robust SAS Macro: Data Analysis Tool
HarryGuess.unc.edu

Drug Interaction Card: Reference Guide for Providers and Patients
www.drug-interactions.com

Drugs That Prolong the QT Interval and/or Induce Torsades de Pointes: List for Providers and Patients
www.qtdrugs.org

Harry Guess Virtual Research Community: Web-Based Repository of Pediatric Therapeutics Tools
HarryGuess.unc.edu

Head and Chest Colds: Brochure for Patients
http:www.cceb.upenn.edu/cert/consumers.html

Medications That Interact with Methadone: Wallet Card for Patients and Providers
www.arizonacert.org/methadone-card.pdf

Osteoporosis Management: Online Case-Based Disease Education Program for Providers
www2.edserv.musc.edu/osteo/index.lasso

Over-the-Counter Medicine "Interaction" Cabinet: Web Tool for Patients
www.arizonacert.org/consumers/MCsurvey/
router.asp

Preventable Adverse Drug Reactions—A Focus on Drug Interactions: Education Course for Providers
www.arizonacert.org/medical-pros/education/ module01.cfm

REACH: REducing Antibiotics for CHildren: Education for Providers, Patients, and Families
www.reachmass.org/

Safer Use of Nonsteroidal Anti-Inflammatory Drugs: Online Education Course for Providers
www-cme.erep.uab.edu/nsaids/nsaids.html

Saving Lives with Beta-Blockers: CyberSession for Providers
dukecerts.dcri.duke.edu

Tools and Techniques of Improved Medication Use: Web Site for Providers
http://www.ahip.org/content/default.aspx?bc=
38|77|529

Treating Congestive Heart Failure with Beta-Blockers: Brochure and Videotape for Patients
dukecerts.dcri.duke.edu

Understanding the QT Interval—Web-Based Education Module for Providers
qtmodule.mc.duke.edu

NOTE: For additional information about CERTs program resources, please contact the CERTs Coordinating Center at certs@kpchr.org.

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CERTs Partnerships and Collaborations

Public-private partnership is a cornerstone of the CERTs program. Program activities are greatly enhanced by working with partner organizations. Collaboration among organizations with similar missions is essential to accomplishing program objectives. In addition to the many partnerships that enable the CERTs centers to study issues concerning therapeutics, the CERTs also collaborate with other public and private organizations on initiatives to support and enhance other program projects.

Partnerships to Advance THerapeutics (PATHs)

Established by the CERTs in 2001, the PATHs program is a means to cultivate partnerships among national organizations interested in promoting the safe and effective use of therapeutics.

Every year, the CERTs host a meeting for PATHs partners. Participating organizations represent patients, health care providers, government, academia, delivery systems, payers, purchasers, and manufacturers of medical products.

The annual PATHs meeting provides a forum for organizations to plan and implement goals related to the improvement of therapeutics. With the expansion of the program this year (four new centers were added midyear), no annual meeting was held. In lieu of the meeting, program activities focused on the development of internal partnerships through a comprehensive orientation process. As a core value of the program, centers will continue to build upon this strong base of partnership within the program to help attract new external partners.


The PATHs program is an integral part of the CERTs program and exemplifies the value of public-private partnership. See the list of project partners in this report. A registry of PATHs partner projects can be accessed through the CERTs Web site at: http://certs.hhs.gov/collaboration/paths.htm.


Partnership and CERTs Medical Devices Workshop*

As published in the July 2006 issue of the American Heart Journal, the CERTs convened a group of experts to discuss the key issues affecting the development and use of medical devices in this country. Medical devices include products such as coronary stents, glucose monitoring devices, and joint prosthetic devices.

Although many new medical devices are available in the United States, there are many knowledge gaps concerning benefits and risks. This lack of information impacts patients and physicians, as well as decisionmakers at insurance companies and government agencies. Everyone involved needs sensible, evidence-based information to determine which products offer the best long-term benefits without unnecessary risks. These decisionmakers need cost-benefit information when weighing policy decisions so that they can be good stewards of society's health care dollars.

The United States would benefit from efficient ways to evaluate medical devices. Given our aging population, the number of patients in whom medical devices could be used poses a significant impact to the health care budget. The goal of the workshop was to develop a list of ideas for future research projects to improve our current system.

Representatives from the Centers for Medicare & Medicaid Services, health services researchers, practitioners, device manufacturers, and regulators discussed various perspectives, issues, and hurdles surrounding the limitations in knowledge about medical devices. Funding shortages were identified as a central issue; therefore, the group shared ideas for developing better public-private partnerships to help increase research funding. In addition, the workshop participants discussed ideas for priority setting, ways to improve current research methods, and new approaches to integrate the Federal agencies to address needs.


* Califf RM, for the Workshop Participants. Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop. Am Heart J 2006;152:50-8.


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Conclusion

Although drugs and other therapeutic products have improved the lives of many Americans, our current health care system does not always guarantee that they will be used safely and effectively, nor that all adverse effects will be identified before they are put on the market. Today, with more choices available than ever before, people need independent, unbiased information about the benefits and risks of various therapeutic products. While government, the medical products industry, and others have made progress, vital questions remain unanswered. The CERTs program was created to address this need and continues to conduct research and disseminate information about the benefits and risk of the various therapeutic options available.

Whether the challenge is using technology to reduce medical errors or developing ways to improve communications to help people make more informed decisions, CERTs researchers are undertaking projects on a wide range of topics to improve everyday health care for the American people.

This year the CERTs program expanded, with the addition of four new centers and several new partners. We look forward to increasing the scope of our projects as we continue to advance knowledge of medical therapeutics in ways that will inform health care providers, patients, policymakers, and others, leading to improvements in the safe and effective use of therapeutics.

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The CERTs Organization

Agency for Healthcare Research and Quality
Center for Outcomes and Evidence (COE)
Rockville, Maryland
Director, COE: Jean R. Slutsky, PA, MSPH
Contact: Anne Trontell, MD, MPH
CERTs Program Director
Fax: 301-427-1520
E-mail: anne.trontell@ahrq.hhs.gov
Alternate contact: Carmen Kelly, PharmD, RPh
E-mail: carmen.kelly@ahrq.hhs.gov
Web: www.ahrq.gov

Coordinating Center

Duke University Medical Center
Durham, North Carolina
Principal Investigator: Robert M. Califf, MD
Web: www.certs.hhs.gov

Centers

Arizona CERT at The Critical Path Institute (C-Path)
Tucson, Arizona
Principal Investigator: Raymond L. Woosley, MD, PhD
Contact: Linda Johnson
Fax: 520-547-3456
E-mail: ljohnson@c-path.org
Web: www.arizonacert.org

Duke University Medical Center
Durham, North Carolina
Principal Investigator: Judith M. Kramer, MD, MS
Contact: Nancy Allen LaPointe, PharmD
Fax: 919-668-7166
E-mail: allen003@mc.duke.edu
Web: https://dukecerts.dcri.duke.edu/

HMO Research Network
Boston, Massachusetts
Principal Investigator: Richard Platt, MD, MS
Contact: Kimberly Lane, MPH
Fax: 617-859-8112
E-mail: kimberly.lane@channing.harvard.edu
Web: www.certs.hhs.gov/centers/hmo.html

Rutgers, The State University of New Jersey
Newark, New Jersey
Principal Investigator: Stephen Crystal, PhD
Contact: Emily Peterson, MBA
Fax: 732-932-8579
E-mail: epeterson@ifh.rutgers.edu
Web: www.certs.hhs.gov/centers/rutgers.html

University of Alabama at Birmingham
Birmingham, Alabama
Principal Investigator: Kenneth G. Saag, MD, MSc
Contact: Mary Melton
Fax: 205-975-6859
E-mail: melkins@uab.edu
Web: www.uab.edu/certs

University of Iowa
Iowa City, Iowa
Principal Investigator: Elizabeth A. Chrischilles, PhD
Contact: Angela Kuehl, PharmD, MS
Fax: 319-335-8253
E-mail: angela-kuehl@uiowa.edu
Web: www.public-health.uiowa.edu/cert/

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Principal Investigator: Harry A. Guess, MD, PhD (October-January)
Alan D. Stiles, MD (January-September)
Contact: Sue Tolleson-Rinehart, PhD
Fax: 919-966-2089
E-mail: stolleso@email.unc.edu
Web: www.certs.unc.edu; HarryGuess.unc.edu

University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania
Principal Investigator: Brian L. Strom, MD, MPH
Contact: Judith L. Kinman, MA
Fax: 215-573-5315
E-mail: jkinman@cceb.med.upenn.edu
Web: www.cceb.upenn.edu/pages/cert/

University of Texas MD Anderson Cancer Center and Baylor College of Medicine
Houston, Texas
Principal Investigator: Maria E. Suarez-Almazor, MD, PhD
Contact: Carol Looney
Fax: 713-563-4491
E-mail: cmlooney@mdanderson.org
Web: www.certs.hhs.gov/centers/houston.html

Vanderbilt University Medical Center
Nashville, Tennessee
Principal Investigator: Wayne A. Ray, PhD
Contact: William O. Cooper, MD, MPH
Fax: 615-343-6249
E-mail: william.cooper@vanderbilt.edu
Web: www.certs.hhs.gov/centers/vanderbilt.html

Weill Cornell Medical Center
New York, New York
Principal Investigator: Alvin I. Mushlin, MD, ScM
Contact: Alvin I. Mushlin, MD, ScM
Fax: 212-746-8544
E-mail: aim2001@med.cornell.edu
Web: http://www.med.cornell.edu/cert

Steering Committee

Hugh H. Tilson, MD, DrPH
Chair, CERTs Steering Committee

Georges C. Benjamin, MD, FACP
Executive Director
American Public Health Association

Marc L. Berger, MD
Vice President, Outcomes Research and Management
Merck & Company Inc.

Enriqueta C. Bond, PhD*
President
Burroughs Wellcome Fund

Lynn A. Bosco, MD, MPH
CERTs Program Officer
Agency for Healthcare Research and Quality

Janice K. Bush, MD*
Vice President, Quality, Education, and Business Support
Johnson & Johnson Pharmaceutical Research and Development

Robert M. Califf, MD
Principal Investigator
CERTs Coordinating Center

Elizabeth A. Chrischilles, PhD
Principal Investigator
University of Iowa
(April-September)

Stephen Crystal, PhD
Principal Investigator
Rutgers, The State University of New Jersey
(April-September)

Susan N. Gardner, PhD
Director, Office of Surveillance and Biometrics Center for Devices and Radiological Health
U.S. Food and Drug Administration

Harry A. Guess, MD, PhD
Principal Investigator
University of North Carolina at Chapel Hill
(October-January)

Judith M. Kramer, MD, MS
Principal Investigator
Duke University Medical Center

Alvin I. Mushlin, MD, ScM
Principal Investigator
Weill Cornell Medical Center
(April-September)

Richard Platt, MD, MS
Principal Investigator
HMO Research Network

Wayne A. Ray, PhD
Principal Investigator
Vanderbilt University Medical Center

Kenneth G. Saag, MD, MSc
Principal Investigator
University of Alabama at Birmingham

Marcel E. Salive, MD, MPH
Director
Division of Medical & Surgical Services
Centers for Medicare & Medicaid Services
(October-April)

David G. Schulke
Executive Vice President
American Health Quality Association

Paul J. Seligman, MD, MPH
Associate Director for Safety Policy and Communication
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Scott R. Smith, RPh, PhD
Senior Service Fellow for Pharmaceutical Outcomes Research
Agency for Healthcare Research and Quality

Steven L. Solomon, MD
Associate Director for Healthcare Systems
Centers for Disease Control and Prevention
(Alternate Member: October-April)

Alan D. Stiles, MD
Principal Investigator
University of North Carolina at Chapel Hill
(January-September)

Brian L. Strom, MD, MPH
Principal Investigator
University of Pennsylvania School of Medicine

Maria E. Suarez-Almazor, MD, PhD
Principal Investigator
University of Texas MD Anderson Cancer Center and Baylor College of Medicine
(April-September)

Myrl Weinburg, CAE
President
National Health Council

Raymond L. Woosley, MD, PhD
Principal Investigator
Arizona CERT at The Critical Path Institute (C-Path)


* Alternate member


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Principles of CERTs Public-Private Partnerships

Issues of Public Interest. CERTs is a national initiative to foster the optimal use of therapeutics through research and education activities that are in the public interest but would not otherwise be done.

Public-Private Partnership. CERTs is a public-private partnership on two levels: (1) between the U.S. Department of Health and Human Services and the CERTs centers and (2) between CERTs centers as representatives of the government-sponsored CERTs program and other research-sponsoring organizations. In the latter relationship, the CERTs centers seek useful, appropriate interactions with private organizations to support and enhance education, research, and demonstration projects. AHRQ works with the centers to establish appropriate agreements to optimize use and sharing of resources.

Conflicts of Interest. Public-private partnerships typically present the potential for conflicts of interest. While these potential conflicts of interest cannot be completely avoided or eliminated, a CERTs center has an obligation to disclose fully and to manage conflicts in a manner that minimizes the risk of those conflicts, while at the same time permitting as much progress as possible to achieve CERTs goals within the constraints of maintaining respected research activity.

Academic Integrity. As academic researchers, individuals conducting projects under the CERTs umbrella make the final decision about study design, analysis, conclusions, and publication in any partnership with other organizations and ensure that their work complies with their respective institutions' conflict-of-interest rules.

Activities. CERTs activities are defined as projects supported in whole or in part by AHRQ funds under the CERTs demonstration program. Activities such as the review of potential conflicts of interest are subject to processes established for the CERTs program. Individuals affiliated with the centers also conduct education and research activities outside of CERTs that are not subject to CERTs processes.

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