About CERTs
Annual Report Year 1
Year 2 and Beyond
Developing Knowledge | Managing Risk | Improving Practice | Informing Policies
Managing Risk
We will work to assess the effects, maximize the benefits, and minimize the harm of therapies by working jointly among the research centers, AHRQ, and the FDA. We will evaluate the use of a range of approved medical products, including therapeutic devices, nonsteroidal anti-inflammatory drugs, and systems to report adverse events in children.
Children and Adolescents
We will be analyzing data available from our Year 1 project on a new reporting system for adverse drug events and releasing the results as soon as possible.
We will continue our efforts to improve the care of children and teens with asthma. A new project in a Medicaid population will test different interventions designed to increase the appropriate use of corticosteroids in asthma.
Children with cystic fibrosis are susceptible to decreases in bone mass and outright loss of bone tissue. Late in 2001, we will begin to assess the effects on the bones of replacing vitamin D and calcium in children and adolescents with cystic fibrosis.
Adults
For the TMR project, we hope to develop a surveillance mechanism that manufacturers of cardiovascular devices easily could use to fulfill their regulatory requirements.
We will host a conference with representatives from academia, the FDA, the device industry, and professional societies. The goal is to develop more efficient models for studying approved cardiovascular devices. In conjunction, we will submit a "white paper" that describes current ways to monitor approved devices and proposes a model to address the limitations of these methods.
The increasingly high cost of therapy is a problem for many areas of disease. This is especially true for rheumatoid arthritis, where new biological agents have been shown to be very effective but also carry heavy costs. We will compare these newer treatments with traditional drug regimens.
Ever since antibiotics emerged in the 1940s, we have encountered the problem of resistant germs. Some bacteria and viruses are sensitive to almost all antimicrobial drugs; others are resistant to several drugs. The latter problem threatens our ability to treat many common community- and hospital-acquired infections.
These observations highlight a unique aspect of antimicrobial drugs—their misuse threatens not only individuals but also society as a whole. How to reduce antibiotic resistance is the subject of five projects that will begin in Year 2.
The first project will examine ways to reduce the use of antibiotics for acute bronchitis in outpatients. Another will assess how the drugs approved for use at different hospitals may affect the rate of antibiotic resistance for two types of bacteria. A third project will assess the effects of tetracycline on patterns of antibiotic resistance in people with acne. Fourth, we will study the use of a large, general-practice database in measuring the patterns of antibiotic use that place people at risk for pneumonia caused by drug-resistant bacteria.
The fifth project will explore the greater use of meta-analysis, a way to combine the results from different studies, in measuring rare side effects of antibiotics.
Results from different studies often are combined to overcome two possible problems of single studies: smaller populations, which can have a rate of rare events too low to measure accurately; and systematic bias, which can mask the true effect of therapy. The problem is that the most convenient mathematical methods for such analyses can produce results not easily applied to clinical situations.
We will develop statistical approaches to estimate risk that people can readily use to evaluate therapies, for overall populations and for subgroups by sex, age, and race.