By Cindy Atoji

October 14, 2008 | In a new federal project to develop computer-based tools that will use gene-based tests for breast cancer, there is some uncertainty as to when the tools will be ready for prime time, or clinical practice. The $1 million project, funded by the Agency for Healthcare Research and Quality (AHRQ), aims to create four computer-based clinical decision-support tools (CDS) to help clinicians and patients use genetic tests to evaluate and treat breast cancer.

“Our hope is to come up with tools that can be used right away in clinical practice, but there are so many different unknowns that this might be more of a learning project; at the end, the tools might be ready to go, or perhaps they will need to be modified for the next version,” says project head Gurvaneet Randhaw, a senior advisor on Clinical Genomics and Personalized Medicine Center for Outcomes and Evidence (COE) at AHRQ. “One of the challenges is that different clinics are configured with different workflows and medical records; we want to make sure these limited first phase findings are applicable to other clinics and settings.”

RTI International, an independent, non-profit research institute, is slated to complete the project in about 16-month time frame. The first pair of tools is an interactive decision-making tool aimed at primary care providers and patients, and the second is a static portal designed for the oncology clinic setting, says Randhaw. Specifically, the first set of tools will access whether a woman with a family history of cancer should be tested for the gene mutations BRCA1 and BRCA2, which may help determine her chances of developing cancer. “There are a lot of family history tools available; we’ll be looking at those tools and how usable they are, and will incorporate the best features,” says Linda Squiers, a senior health communication analyst at Research Triangle Park, N.C.-based RTI, and the project’s manager.

The other pair of tools, for women already diagnosed with breast cancer, will determine which patients are appropriate for a Gene Expression Profiling (GEP) test. GEP tests can help evaluate which patients are at a high risk for cancer recurrence and therefore good candidates for chemotherapy and other treatments. “The GEP test can be challenging to interpret; this tool will help connect the provider to appropriate clinical guidelines,” says Squiers.

Squiers says development of these CDS tools will take place at Baylor College of Medicine, where a team will study interfaces and work on developing them for different cultural groups, including low-literacy populations. The tools will then be tested at two different clinical sites, Baylor and the Providence Healthcare System.

"We're excited to partner with AHRQ to develop these decision tools," said Squiers. "Our goal is to develop tools that are accurate, usable, and easily integrated into clinical workflow. If effective, these tools could change the clinical practices of both primary care physicians and oncologists.”

There are extensive gaps in knowledge about genetic tests and their impact on patient care, according a recent report from the U.S. Department of Human Services Secretary’s Advisory Committee on Genetics, Health, and Society. “This project addresses two major issues: Making sure that genetic tests are used appropriately in the right setting, and, as we move toward informatics and a paperless clinic, how do we used computer-based decision tools to be more efficient in how we communicate information and use it,” says Randhaw.

Development of these tools also supports AHRQ’s mission of translating research into clinical practice in the areas of genetic tests, health information technology and patient care.