Comparative Effectiveness News

September 1, 2008, Issue #1

Welcome

Inaugural Issue

Welcome to the first issue of the newsletter for the Effective Health Care Program. In this quarterly publication we will summarize the Program’s recent activities and new research findings.

In this issue, we highlight some of our most recent studies, including prostate cancer treatments, the use of beta blocker therapy for heart failure, the off-label use of atypical anti-psychotic drugs, medication therapy management programs, and associations between antidepressant use and pneumonia risk in the elderly.

Message

From the Director of the EHC Program

Welcome to the inaugural issue of Comparative Effectiveness News! AHRQ is very excited to provide researchers, policymakers, industry leaders, and others with this quarterly update on research findings and other developments of AHRQ's Effective Health Care Program.

Many of you already know our story: Created in 2003 by the Medicare Prescription Drug, Improvement, and Modernization Act, the Effective Health Care Program is the Federal Government's ground-breaking initiative to make head-to-head comparisons of health care interventions. We feel fortunate to be stewards of an enterprise whose principles speak so directly to the mission of improving the effectiveness and safety of American health care. Our research relies faithfully on evidence-based research that has been published in peer-reviewed journals. Our research also is conducted with a healthy dose of public input that is essential to our mission of transparency.

We are proud of the work produced so far — 13 Comparative Effectiveness Reviews; 18 summary guides on 10 topics; a user’s guide to creating and managing patient registries; and a 24-article supplement to the journal Medical Care that advanced the national discussion on how electronic health information can improve patient care.

Jean R. Slutsky

We’re using various tools to spread the word about the Effective Health Care Program. Aside from being translated into plain-language translational guides for clinicians, consumers, and policymakers, many of our comparative effectiveness reports have been made into AHRQ podcasts. Drug information software provider ePocrates has featured many EHC reports, resulting in more than 300,000 messages sent to clinicians’ hand-held devices or computers. Large newspapers, magazines, and health Web sites have generously highlighted our work.

Is it time to rest? Not a chance. Increased funding by Congress and an energetic staff have set a full agenda for months to come. Here are some items to watch for as our Effective Health Care Program moves forward:

• A new 17-member EHC Stakeholder Group will be helping the Effective Health Care Program set research priorities, develop research products, and disseminate research findings.
• An expansion of research boundaries will lead to new research projects in the areas of obesity, autism, infectious diseases, substance abuse, and other areas.
• AHRQ’s Sept. 7-10 annual meeting in Bethesda, MD, will include numerous sessions related to comparative effectiveness.
• More research products will reach completion. The Effective Health Care Program has launched numerous comparative reviews, rapid-turnaround DEcIDE research reports, and summary guides, many of which will be available in Spanish.
• And soon to be added to the Effective Health Care inventory (and highlighted on the EHC Web site) will be a series of “technical briefs” — quick turnaround reports on emerging diagnostic or therapeutic technologies.

Yes, we’re busy. But we’re grateful for the chance to share some of our work via the new Comparative Effectiveness News. And we’d appreciate your thoughts on the Effective Health Care Program and the rapidly advancing science of comparative effectiveness. Let’s keep the conversation going!

— Jean

Mission

EHC Program

The Effective Health Care (EHC) Program draws on evidence-based scientific information to make objective comparisons of current medical interventions. The resulting reports are intended to guide patients, health care providers, and policymakers in making informed decisions. The Program’s main products include:

• Comparative Effectiveness Reviews are comprehensive reports that compare health care treatments, including pharmaceuticals, devices, and other types of interventions. The reviews cover evidence about effectiveness and harms and point out gaps in research. They are completed by AHRQ-funded Evidence-based Practice Centers.
• DEcIDE Reports are derived from accelerated practical studies about the outcomes, comparative clinical effectiveness, safety, and appropriateness of health care items and services. They are prepared by research-based health organizations with access to electronic health information databases and the capacity to conduct rapid turnaround research. The centers are known as Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Centers.
• Translational Guides are plain-language publications produced by the John M. Eisenberg Center to translate comprehensive reports into practical tools to help people use evidence in their decision-making.
• Technical Briefs provide an overview of key issues related to an emerging clinical intervention. Technical Briefs focus on interventions for which there are limited published data and too few completed protocol-driven studies to support definitive conclusions. The emphasis of the Technical Briefs is to provide an early objective description of the state of science on the topic.

To maintain transparency and to ensure research is being conducted on issues of importance to the public, the EHC Program seeks your input at several points throughout the research process. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions, reports, and guides.

DEcIDE Research

Beta Blocker Therapy in Heart Failure

Chronic congestive heart failure (CHF) is common in the Medicare population and has a substantial impact on quality of life and longevity. A large body of clinical evidence has shown that appropriate use of several types of medication can improve both patient functioning and mortality rates for CHF.

One class of these medications are known as beta (β) blockers. There has been clinical uncertainty about whether some drugs in this class are more effective in preventing deaths and other complications than other drugs. There have been few head-to-head studies comparing one β blocker to another, so the evidence base to help guide choosing a β blocker has been limited.

To help address this evidence gap, AHRQ’s Effective Health Care Program commissioned the HMO Research Network DEcIDE Center to conduct a study comparing rehospitalization rates among people with CHF. The study compared people treated with one of three commonly used β blockers: atenolol, carvedilol, and metoprolol tartrate (the conventional short-acting metoprolol preparation). It also compared people who were not treated with a β blocker with those who were treated with a β blocker. The patient cohort was obtained from two large health plan databases.

After controlling for socio-demographic factors, coexistent illnesses, and treatment with other types of medication, the study found that there were no significant differences in rehospitalization rates among the patient groups treated with each type of β blocker. The findings support the role of β blockers in the management of heart failure and suggest that atenolol, metoprolol tartrate, and carvedilol may be similarly effective in preventing rehospitalization within 12 months. The complete DEcIDE report is available here.

Comparative Effectiveness Review

Treatments for Localized Prostate Cancer

Over the last 20 years, there has been widespread adoption of prostate cancer screening programs for middle-aged and older men. This has led to a marked increase in the detection of prostate cancer. As a result, most newly diagnosed cases have been small tumors that have not yet shown signs of spreading beyond the prostate.

While several types of treatment are available, they all cause unpleasant side effects, such as erectile dysfunction or problems urinating. However, some prostate cancers that grow at a slower rate may not lead to death or serious complications if left untreated. Men with localized prostate cancer thereby face a difficult decision to choose among treatments with known harms or to choose to pursue no initial treatment. This clinical challenge is the type of problem for which Comparative Effectiveness Reviews (CERs) can provide valuable insight to guide decision-making.

The EHC Program commissioned the Evidence-based Practice Center at the University of Minnesota to prepare a CER on treatments for localized prostate cancer, and the CER was released in February 2008. As has been customary with the CERs released by the EHC Program over the last 2 years, a companion article was published by Annals of Internal Medicine that is available on that journal’s Web site.

The CER found that no single treatment approach provides superior outcomes for all men. For those with a new diagnosis of localized prostate cancer, individualized decision-making should be based on the person’s overall health and preferences about the risks of the treatment options. For men who choose complete surgical removal of the prostate (known as radical prostatectomy), the CER found that men who have an operation performed by an experienced surgeon in a hospital that frequently performs the operation are are less likely to experience urinary incontinence or other complications.

Further information about the CER, including both an Executive Summary and the complete report, is available here.

DEcIDE Research

Medication Therapy Management Programs

One goal of the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA) was to improve outcomes for people who have multiple chronic conditions and who may be prescribed a large number of medications. MMA permitted Prescription Drug Plans (PDPs) and Medicare Advantage Drug Plans (MA-DPs) to develop a wide variety of services known as Medication Therapy Management (MTM) programs. The purpose of MTM programs is to improve understanding of medications, increase adherence to treatment, and detect and reduce adverse events.

Individual MTM programs vary widely in their design. To gain a better understanding of the types of services provided by MTM programs, the Effective Health Care Program commissioned the DEcIDE Center at the University of Illinois-Chicago to collect information about MTM programs that were in operation in 2006.

The DEcIDE investigators developed a survey to investigate enrollment criteria, the services that are provided, and how they are provided within large and/or national MTM programs. Completed surveys were obtained from 70 health insurance plans that work with 21 unique MTM programs and service 12.1 million Medicare enrollees. This represents about 60% of all people who were enrolled in PDPs and MA-DPs at the time of the study.

Nearly all (90.5%) of the MTM programs required that enrollees have at least two chronic diseases, and about half had restrictions based on the type of chronic disease. The MTM programs provided from two to seven services. Three-quarters provided patient education programs, and 70% offered adherence services. Sixty percent provided medication reviews to compile comprehensive medication lists for patients, and 55% also provided assessments to determine possible adverse drug interactions. Other services, e.g., patient counseling or physician consultation, were offered by fewer than half of the programs surveyed. Nearly all the programs provided the services by in-house call centers and mailed interventions.

Clinical Topic

Off-Label Use of Atypical Antipsychotic Drugs

The Food and Drug Administration (FDA) sent advisory warnings in 2005 about atypical antipsychotic drug treatments and the increased risk of mortality in older patients. In response, three of AHRQ’s Effective Health Care Program components (EPC, DEcIDE, and Eisenberg Center) conducted research on this topic. This focus on a clinical topic is an example of the way that the Effective Health Care Program develops information collectively to answer questions and get the word out to stakeholders.

AHRQ commissioned the Southern California/Rand Evidence-based Practice Center to develop a Comparative Effectiveness Review on off-label uses of atypical antipsychotics. The CER report, Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics, describes the currently available evidence and gaps in that evidence. The report included information about the use of atypical antipsychotics for treating agitation in people with dementia, which is a common reason for prescribing using these drugs in older people.

The Eisenberg Center translated the findings of the CER into a brief summary guide for clinicians and policymakers entitled Off-Label Use of Atypical Antipsychotic Drugs. The Center not only engaged clinicians and policymakers to review the guide, but it also developed a Confidence Scale for summarizing the strength of evidence for the key findings of the CER. This Confidence Scale has been adopted for use in summary guides on several other clinical topics.

The Brigham and Women’s Hospital DEcIDE Center conducted a rapid turn-around retrospective cohort study that compared mortality rates among people older than 65 who had received either atypical or typical (first generation, conventional) antipsychotic drugs. The study found no difference in mortality rates between the groups treated with each type of drug. The report is titled Comparative Safety of Conventional and Atypical Antipsychotic Medications: Risk of Death in British Columbia Seniors.
The EHC Program's research has influenced clinical policy. On June 16, 2008, the FDA issued a new alert stating that both conventional and atypical antipsychotics are associated with an increased risk of mortality in older patients treated for dementia-related psychosis. The alert cites the DEcIDE research report as part of the evidence that prompted it to issue the new warning.

DEcIDE Research

No Association Between Antidepressant Use and Pneumonia

Pneumonia is a major cause of morbidity and mortality in the elderly. Together with influenza, pneumonia constitutes the fifth-leading cause of death in those age 65 years and older in the United States.

A recent study undertaken to identify possible signals of iatrogenic illness in the elderly found that hospitalization for aspiration pneumonia was three times as likely to occur in the 90-day period following a hospitalization for depression; this led to the hypothesis that antidepressant drugs may increase the risk of aspiration pneumonia. If true, it could have major therapeutic implications for the treatment of elderly depressed patients, since the benefit of pharmacotherapy would need to be weighed against the risk of aspiration pneumonia. However, this prior study did not measure exposure to antidepressants or attempt to control for patient factors that may change over time.

The EHC Program commissioned the University of Pennsylvania School of Medicine DEcIDE Center to evaluate the hypothesis that antidepressant use in the elderly is associated with hospitalization for pneumonia, or for aspiration pneumonia or pneumonitis.

Researchers identified 12,044 cases of hospitalization for pneumonia (the primary aim) and 48,176 controls. The odds ratio (OR) for any antidepressant use, adjusting for age, sex, and calendar year, was 1.61 (95% confidence interval 1.46 to 1.78). After further adjustment for comorbidity measures, the OR was 0.89 (0.79 to 1.00). The researchers also identified 159 cases of hospitalization for aspiration pneumonia (the secondary aim) and 636 controls. The OR for any antidepressant use, adjusted for age, sex and calendar year was 1.45 (0.65 to 3.24). After further adjustment for comorbidity measures, the OR was 0.63 (0.23 to 1.71).

Findings failed to confirm the hypothesis that use of antidepressants by elderly patients increases the risk of hospitalization for pneumonia or for aspiration pneumonia. Based on currently available evidence, decisions regarding the use of antidepressants in elderly persons should not be affected by concern about pneumonia risk.

Stakeholders

Stakeholder Group Provides Input to EHC Program

Input from health care experts is key to the success of the Effective Health Care Program. Over the last 3 years, a Stakeholder Group has met regularly with EHC leaders. Its role includes providing input on critical research information gaps for practice and policy and identifying and developing the key research questions to address these gaps. It also advises on implementation issues for the research findings and reports produced by the EHC Program.

Program Information about the current members of the Stakeholder Group is available. The Stakeholder Group holds day-long meetings three times per year. Its most recent meeting was May 2, 2008, at AHRQ Headquarters in Rockville, MD.