SAN FRANCISCO — A new computerized tool helps pregnant women decide whether they want invasive prenatal testing, Miriam Kuppermann, Ph.D., said during a meeting on antepartum and intrapartum management, sponsored by the University of California, San Francisco.
The tool should be ready for clinical use in 2006, said Dr. Kuppermann of the university.
In a randomized, controlled trial, 496 pregnant women seen at three institutions in the San Francisco Bay area used the computerized decision-assistance tool or viewed a computer version of age-appropriate brochures that the state requires clinicians to give to all pregnant women. Both were available in English and Spanish. Investigators assessed the impact of the tool or the brochures during three follow-up interviews.
“We do emphasize throughout that the goal of our program is neither to get women to test nor to get them not to test. The goal is to help them make an informed decision that is consistent with their own preferences and values,” she said.
Immediately after the computer session, 75% of women using the decision-assistance tool correctly estimated their risk for having a baby with Down syndrome, compared with 5% of women in the control group. A significant difference in knowledge persisted in the second follow-up interview 2 weeks later.
The state pamphlets do not provide an individual's risk for Down syndrome, so the difference in knowledge between groups is not too surprising, but it's nevertheless encouraging to see that a high percentage of women understood their risk for trisomy 21 after using the computerized tool, Dr. Kuppermann said.
Immediately after the computer session, about 50% of women in the intervention group correctly estimated their risk for miscarriage related to prenatal testing, compared with 20% of women in the control group.
This difference in knowledge between groups also persisted 2 weeks later, she said.
The third follow-up interview, conducted at 30 weeks' gestation after any decisions about prenatal testing were made, found that women in the intervention group had less uncertainty about their decisions, reported fewer factors contributing to uncertainty, and had less decisional conflict, meaning they were more comfortable with their decisions.
Women in the intervention group were more likely to undergo invasive prenatal testing, compared with the control group. Women in this group who entered the study very inclined to undergo invasive testing were more likely to change their minds during the study and not be tested, Dr. Kupperman said.
Women who came in with little inclination to be tested were more likely to change their minds and undergo testing.
“So it's working in both directions, which makes me feel good that it's not a biased tool,” she said. “We believe that our tool does lead to more informed decisions that better reflect underlying preferences.”
The computerized tool first reassures women that most babies are born healthy, but it notes that 3%–4% will have a birth defect and that Down syndrome is one of the defects that can be detected by prenatal testing.
The woman enters her age, answers questions about other risk factors, and then receives an individualized risk presentation. For example, a 36-year-old woman's mid-trimester risk for carrying a fetus affected by trisomy 21 is about 4 in 1,000, so the computer might show her a photo of 1,000 balls, 4 of which are highlighted yellow to represent the risk.
In a “values clarification exercise,” the woman answers questions about various aspects of testing scenarios to elicit their value to her, ranging from “absolutely critical” to “not at all important.” Based on the woman's responses, the program suggests testing strategies that might fit her values and risks, and it gives summaries of strategies she chooses. “Again, there's no absolute recommendation,” Dr. Kuppermann said.
She and her associates now are modifying the tool to include first-trimester screening and testing strategies and models for other genetic tests for prenatal disorders besides Down syndrome. They also are creating a low-literacy version of the tool that relies less on text.