Comparative Effectiveness News
 

December 18, 2008, Issue #2

EHC Program

AHRQ 2008 Conference in Bethesda, Maryland

AHRQ held its annual conference Sept. 7-10, highlighting the Agency’s unique role in health services research and its goal of improving the effectiveness of health care delivery. The conference showcased many of the activities of the Effective Health Care Program and allowed attendees to discuss the larger issues of how to improve health care in the United States and how AHRQ research can facilitate that improvement.

The conference featured discussions that followed several different tracks, including Health Information Technology; Patient Safety; Effective Health Care; Prevention and Care Management; and Value, Innovations, and Emerging Issues. Also included was the “mAHRQet Place Café,” which featured displays of quality improvement tools and applications that attendees could try out.

At the closing plenary session on Sept. 10, Dr. Carolyn Clancy, AHRQ Director, posed this question: “What is it we need to do right now so we’re not having this same discussion in 5 years?”

This question was answered by members of an expert panel, who brought differing perspectives on the important priorities. Dr. Arthur Kellermann, associate dean for health policy at the Emory University School of Medicine, identified three innovations that would profoundly change the face of health care over the next 5 years: universal coverage; a basic set of universally available clinical services; and a cheap, simple electronic health record. “We are not possibly ever going to achieve the goals we aspire to in quality, safety, and effectiveness unless we cover everyone in this country,” said Dr. Kellermann. In describing a universal set of services, he used the analogy of “tap-water health care,” stating that the United States has a healthcare system today that is buying “Fiji water in supertankers.” “The fact of the matter is tap water works,” he said. “What I want all of you to do or your colleagues to do is, let’s figure out what tap-water health care in this country is… What are the interventions? What’s the primary care? What vaccinations? What disease management strategies should be on everybody’s benefit list?” Dr. Kellermann also suggested using public funds to bring electronic health records up to date, then giving the system to public health systems and selling it to private health systems on a sliding scale.

Carol Cronin, executive director of the Informed Patient Institute, gave four “paradigm shifts” that were integral to changing health care delivery: moving from a fragmented system to an integrated one, moving from a passive patient to an active one, taking responsibility, and moving from a focus on sickness to a focus on health. Ms. Cronin described an active patient model, in which patients want to feel better, don’t want to worry about money, and want to be respected. “Those three aspects… are universal across racial, cultural, and educational groups,” she said. “Two others that many people want: they want to be informed… and they want to ask questions and get them answered. And people to a certain extent want to be involved, but they don’t want to be the doctor. And I worry about some of the rhetoric about the informed patient. Pushing a lot of the responsibility of decision-making and the burden of choice on patients, it sometimes goes too far.”

Dr. Darrell Kirch, president and CEO of the Association of American Medical Colleges, said hospitals need to spend as much time and money on cultural assessment and organizational change as they do on consultant-driven strategic plans that search for new reimbursement streams. “As long as we’re on strategic planning, we’re short on cultural assessment and cultural change,” Dr. Kirch said. “When you become a patient today, we want it to be patient-centric, collaborative, communicative… All our rewards are designed to perpetuate the old culture, and the key step, I believe, is to purposefully assess the culture deficit and work to change it.”

Mission

Effective Health Care Program

The Effective Health Care (EHC) Program develops and synthesizes clinical evidence for comparing current medical interventions. The resulting reports are intended to assist patients, healthcare providers, and policymakers in making informed decisions. The program’s major 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 developed by AHRQ-funded Evidence-based Practice Centers.
• New Research 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 health research organizations with access to health information databases and the capacity to conduct rapid turnaround research. The research is conducted by centers known as Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Centers.
• Summary Guides are plain-language publications produced by the John M. Eisenberg Center, which synthesizes 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 on providing an early objective description of the state of science on the topic. The Technical Briefs are prepared by Evidence-based Practice Centers.

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 (http://effectivehealthcare.ahrq.gov) to see draft research questions, reports, and guides.

Comparative Effectiveness Review

Premixed Insulin Analogues for Adults With Type 2 Diabetes

Although oral diabetes medicines are used as first-line treatments in patients with type 2 diabetes, insulin is often required to achieve the desired level of glucose control. According to the National Health Interview Survey, 28 percent of patients with type 2 diabetes use insulin either alone (16 percent) or in combination with oral diabetes medicines (12 percent). 

To mimic the release of insulin from the pancreas in response to food intake, insulin replacement regimens involve giving insulin at mealtimes along with a longer-acting insulin that provides a slow release of insulin throughout the day. However, these insulin regimens may decrease a person’s flexibility in the timing of meals and activities, increase the frequency of blood glucose monitoring, and increase the risk of hypoglycemia. Also, the requirement of multiple injections may affect patients’ overall satisfaction with their treatment regimen.

Premixed insulin preparations are an alternative that may permit a smaller number of daily insulin injections. They combine both mealtime insulin and a longer lasting insulin. The newest premixed insulin preparations use insulin analogues, which are insulins with amino acid substitutions that alter their rate of entering the bloodstream after a subcutaneous injection. It is important to evaluate the evidence for the safety and effectiveness of these premixed insulins compared with other regimens for managing blood glucose. The EHC Program commissioned the Evidence-based Practice Center at Johns Hopkins University to perform a systematic review of premixed insulin analogues. The review found that:

• There is more evidence available on some comparisons than others. When compared with premixed NPH (neutral protamine Hagedorn) and regular insulin, people who use premixed insulin analogues achieve similar reductions in A1c (average blood glucose) and fasting glucose levels, but those who use premixed insulin analogues achieve lower glucose levels after meals. Rates of hypoglycemia are also similar.
• People who use premixed insulin analogues achieve lower A1c levels than people who use long-acting insulin analogues alone, but rates of hypoglycemia are higher.
• People who use premixed insulin analogues experience more episodes of hypoglycemia but also achieve better glycemic control than those who use oral diabetes drugs.

Evidence was insufficient to determine whether the effectiveness or harms of premixed insulin analogues vary by demographic factors. There was insufficient evidence to draw conclusions about the effectiveness of premixed insulin analogues for people with poor glycemic control or coexisting medical conditions. There was also insufficient evidence about the impact of premixed insulin analogues on quality of life and treatment satisfaction. Most available studies of premixed insulin analogues lasted 1 year or less and focused on short-term outcomes. Therefore, evidence was insufficient to determine the effects of premixed insulin analogues on long-term outcomes, such as mortality and cardiovascular disease.

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

Get Involved!

Research Topic Development

Developing relevant topics for research is a key aspect of the EHC Program. Topic identification creates the framework for all of our research. However, it is not easy. Researchers spend their careers trying to identify meaningful questions, and funding agencies continually seek to maximize the return on their investment by funding research on important, answerable questions. 

The EHC Program is committed to enhancing opportunities for consumers, policymakers, practitioners and others to be involved in determining topics for research. We are looking for organizations that may be interested in working with EHC staff on topic nomination as well as improving our research. Individuals or organizations interested in suggesting research can most easily do so through the EHC Web site: http://effectivehealthcare.ahrq.gov/getInvolved.cfm?involvetype=sr.

Organizations interested in broadening their involvement in topic nomination should contact Pam Curtis at curtispa@ohsu.edu.

We seek to develop research topics that will be of broad interest and will meet the needs of people receiving care under the Medicare, Medicaid and other Federal health care programs, such as the State Children’s Health Insurance Program (SCHIP). The EHC Program places an emphasis on the following factors:

• Burden of disease including severity, incidence and/or prevalence, as well as whether the organizational/financial implications of research are relevant to the general population and/or AHRQ's priority populations, which include:

1. Low-income groups.
2. Minority groups.
3. Women.
4. Children.
5. The elderly.
6. Individuals who have special health care needs, such as those with disabilities, those who need chronic care or end-of-life health care, or who live in inner-city and rural areas.

• Controversy or uncertainty about the topic and availability of scientific data to support the systematic review and analysis.
• Total costs associated with a condition, procedure, treatment, technology, or organizational/financial topic, whether due to the number of people needing care, the unit cost of care, or indirect costs.
• Potential impact for reducing clinically significant variations in the prevention, diagnosis, treatment, or management of a disease or condition, or in the use of a procedure or technology; potential impact for informing and improving patient and/or professional decision-making, improving health outcomes, and/or reducing costs.
• Relevance to the needs of the Medicare, Medicaid, and other Federal health care programs.
   

DEcIDE Research

Infrastructure to Monitor Utilization and Outcomes of Gene-Based Applications: An Assessment

More than 1,000 gene-based tests are now clinically available, with an additional 300 available for research purposes only. By 2009, the world market for gene-based testing is expected to reach $12.5 billion.

With the completion of the human genome sequence, the development and utilization of gene-based tests is expected to proliferate. These tests may be used to help make early diagnoses, improve risk prediction, and target therapies for both traditional gene-based disorders and common chronic diseases.

However, much remains unknown about the effectiveness and appropriate use of these tests. Information is currently lacking on the use of gene-based tests and the outcomes of clinical interventions based on these tests. A first step toward obtaining this information is to gain understanding of trends in use, appropriateness of use, and potential disparities in use of these tests.

The EHC Program commissioned the RTI International DEcIDE Center to approach this topic in two ways. The first was to conduct an assessment of existing databases in the U.S. health care system for monitoring the utilization and outcomes of gene-based applications. Second, the RTI group developed recommendations to establish appropriate and practical systems to assess the use and outcomes of gene-based clinical applications.

The study found that only limited, sporadic information is currently available on the utilization of gene-based tests. Some research suggests that knowledge on the part of some providers about the availability and utility of tests may be reasonably widespread and accurate. However, little or nothing is known about the extent to which patients and their families are aware of tests and knowledgeable about their benefits and harms. Also, there are few longitudinal data to indicate the benefits and risks of using genetic tests to guide interventions and medical decisions, such as in the selection of therapies, and their short- or long-term outcomes. A number of challenges will have to be addressed before the ideal of being able to compile and link data from existing health databases and surveys for public health surveillance and health services research can be realized. These include:

• Developing standard codes for genetic tests and database architecture standards to allow interoperability between databases,
• Addressing concerns about privacy and confidentiality,
• Reducing the proprietary and regulatory barriers that inhibit sharing of data.
   

You can view a copy of the full report, "Infrastructure To Monitor Utilization and Outcomes of Gene-Based Applications: An Assessment."
 

DEcIDE Research

Treatment of Dementia Among Community-Dwelling and Institutionalized Medicare Beneficiaries

In 2002, an estimated 3.4 million Medicare beneficiaries, or 8.1 percent of the Medicare population, were diagnosed with Alzheimer’s disease and related dementias (ADRD). ADRD are prevalent, devastating, and costly diseases affecting U.S. elderly residents in both community and long-term care (LTC) settings. Between 50 percent and 75 percent of residents in nursing homes have dementia, and as many as 75 percent of all persons with dementia will eventually reside in a nursing home.

People with ADRD who reside in the community may tend to receive different treatment for the condition than people in LTC settings. Examining rates of use of dementia drugs and behavioral agents is one way to gain insight into such differences. Clinical trials of treatments for dementia have mostly been conducted in community settings, and the applicability of these trial results to LTC settings may be limited if the treatment patterns differ substantially from those in the community. In order to fill this gap, the EHC Program commissioned the DEcIDE Center at the University of Maryland at Baltimore to establish nationally representative estimates of the use of agents to treat ADRD and related behavioral symptoms among Medicare beneficiaries and to describe medication use by residential status and other patient characteristics.

The study found that, although there is little difference in the proportions receiving anti-dementia drugs across residential settings, the use of atypical antipsychotics, especially risperidone, olanzapine, and quetiapine, was much higher in LTC settings (21.0 percent, 11.9 percent, and 7.1 percent, respectively) than in the community (5.1 percent, 4.0 percent, and 2.3 percent).

You can view the complete DEcIDE report, "Treatment of Dementia Among Community-Dwelling and Institutionalized Medicare Beneficiaries." 
 

DEcIDE Research

Improving Patient Safety and Pharmacovigilance: Methods Using Observational Data and Cohort Studies

The use of prescription drugs has grown dramatically with the advent of increased insurance coverage and greater numbers of products available. Consequently, prescription drug expenditures grew from $5.5 billion in 1970 to $179.2 billion in 2003. Growth in the number of elderly having access to drug coverage will likely increase utilization in this population.

Pharmaceuticals, like all health care interventions, offer benefits to patients but also pose risks. Clinical trials, which provide basic information on the efficacy and safety of drugs, often do not provide insight into adverse drug events (ADEs) that occur in low frequencies. Observational studies, voluntary systems for reporting adverse events, and post-marketing surveillance studies are strategies for detecting serious but rare adverse events that were undiscovered during premarketing clinical trials.

The EHC Program commissioned the RTI International DEcIDE Center to study ways to improve methods for using claims data to examine patient safety and pharmacovigilance issues. The Center developed a data analytic framework and methods for pharmacoepidemiologic research on ADEs using population-based claims and administrative data sources. They tested their framework and methods by performing pilot analyses using drugs for dementia, including Alzheimer’s disease, as the illustrative case. Because Medicare prescription drug claims are not yet available, the Center used pharmacy and medical claims and death records from the State of Utah Medicaid program.

The Center developed a database that allowed the characterization of drug exposure and evaluation of the association between drug exposure and three types of adverse drug effects (death, expected events, and idiosyncratic events).

The Center concluded that researchers could easily apply their framework for working with observational data, particularly pharmacoepidemiologic databases. Data from Medicaid, employer, insurer, and (eventually) Medicare claims can be used to examine specific drug classes and individual drugs for known and unknown ADEs. You can view a copy of the full report, "Improving Patient Safety and Pharmacovigilance: Methods Using Observational Data and Cohort Studies."