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Early results from a first-of-its-kind study suggests that typical use of a fertility app is effective for avoiding an unplanned pregnancy. Payment mechanisms will need to be considered by payers.
Fertility apps are becoming increasingly popular among women as a method of contraception to prevent pregnancy. In August 2018, the FDA permitted marketing of the first mobile medical app Natural Cycles, a fertility awareness app, as a method of contraception.
Early results from a first-of-its-kind study suggests that typical use of a fertility app called Dot is effective as other modern methods for avoiding an unplanned pregnancy.
Dot was developed by Cycle Technologies working with researchers from the Institute for Reproductive Health (IRH) at Georgetown University and Duke University. The approach uses advanced statistical analysis and a proprietary algorithm to identify a woman’s individual conception risks using her period start dates.
“Dot is very different from other period tracking and fertility apps,” says Victoria Jennings, PhD, director of IRH and the Dot study’s principal investigator. She is also the corresponding author for the six-month efficacy paper. “First it is designed to be used for pregnancy prevention (as well as to help women who want to achieve pregnancy by timing intercourse on fertile days). Other period tracking apps are generally not. They may provide rough calculations of ovulation, but they are not designed for pregnancy prevention.”
There are also fertility apps that use symptoms-based approaches-cervical mucus, temperature, etc.-which can be used for pregnancy prevention, but they tend to be more complicated and require more daily inputs from women, according to Jennings. “Dot is designed to be both a contraceptive solution and extremely easy to use,” she says.
“When we first began thinking about what eventually became Dot, we were motivated by the need for an easy-to-use, flexible, and accessible approach to preventing or achieving pregnancy that could meet the needs of women who prefer non-hormonal approaches,” Jennings says. “We wanted to minimize the effort required of women to use the method, but we also wanted to offer them an effective option for family planning.”
The Dot study is a prospective, cohort study being conducted over 13 cycles of use to study the app’s efficacy in preventing pregnancy. The study needed to be designed according to established guidelines for contraceptive efficacy studies, but adapted to the context of an app, according to Jennings. The statistical methods researchers used to analyze the data - life-table analysis - are considered most appropriate for this type of study.
“We used an active follow-up strategy to minimize loss to follow-up, and we collected the vast majority of data via the app itself,” Jennings says. “Proofmode, the research platform we developed to conduct the study, helped us achieve our goal of a high-quality study that produces reliable data to support decision-making by potential users and providers.”
According to the CDC, the failure rate fertility-based awareness methods is 24%.
However, the initial results from this study indicate that the Dot fertility app is likely to be highly effective in both typical use and perfect use. After all participants in the study had completed a full six cycles, Jennings and her colleagues found the results during this time period to be a 3.5% failure rate with typical use. There were zero pregnancies in cycles when Dot was used correctly, meaning consistent condom use or no sex on high-risk days. This study is the first efficacy study of a fertility app that meets the established guidelines for conducting contraceptive efficacy studies.
“It’s important that rigorous research is done to ensure that [fertility apps] work and that they meet women’s needs,” Jennings says. “Healthcare executives should be able to compare these technologies to other modern contraceptive methods so that they can help patients make better decisions.”
Other unique findings
The idea of doing an efficacy study on an app-via a research platform embedded in the app itself-was new, according to Jennings.
“We weren’t sure how women would respond to being in a study like this, whether they would be able and willing to enter daily data, respond to questions, and continue in the study,” she says. “And we weren’t sure whether our data management system-Proofmode-would be sufficient for study purposes. In fact, a high percentage of women provided the required data, and the research platform allowed us to monitor and analyze study results in real time. Dot was designed to be very user-friendly, and we were able to design the research platform similarly.”
Fertility app interest
There is a growing interest in fertility apps because women are looking for ways to prevent (or achieve) pregnancy without the high costs and side effects of many methods, according to Jennings.
“As people become more comfortable using apps for everything from managing their checking accounts to buying groceries to making a dental appointment, this interest is likely to increase,” she says. “People want to have the control over their lives that a fertility app can give them.”
It is important for women who choose to use a fertility app to have the support of their healthcare providers, according to Jennings. This support can range from helping them identify an evidence-based app that meets their particular needs to counseling them on correct use.
“There are already billing codes that allow for this,” she says. “As health systems recognize the need to be more client focused, streamline their interactions with those they serve while continuing to provide high-quality care, and seek cost-effective options, fertility apps will likely be of great interest to insurers. Payment mechanisms will need to be considered, but we can envision a number of creative ways of dealing with this, from co-branding to meshing data with other medical records-with appropriate privacy policies in place.”