Health IT, Startups

Georgetown study sets out to evaluate efficacy and effectiveness of Dot’s pregnancy prevention app

Georgetown University's Institute for Reproductive Health is conducting the year-long study — the first of it's kind — and could mean the difference between DOT gaining wider credibility and adoption from clinicians.

Fertility applications are among the bestselling healthcare apps Apple and Android have on offer in their app stores. But most of them tend to fall into the direct to consumer digital health category that the AMA likened to “snake oil” last year. Amidst the the push for greater clinical validation of digital health tools, several studies are underway to evaluate how effective these and other apps are to improving healthcare outcomes.

Georgetown University’s Institute for Reproductive Health is doing a one-year clinical study of the pregnancy prevention app, DOT.  The acronym stands for Dynamic Optimal Timing. Users enter the date when their menstrual cycle starts into the app each cycle. The app informs users of their personal risk of pregnancy.

Dr. Victoria Jennings, the director and a principal investigator of the Institute, noted that this study will be the first efficacy trial ever conducted on an app-based method of family planning that’s designed in line with gold-standard criteria for contraceptive efficacy studies, in emailed responses to questions.

“There have been studies that looked at historical information on apps, and some that looked prospectively but with a poorly defined design. So these were limited and are not considered contraceptive efficacy studies. We would expect that there may be others that would plan to do similar studies in the future. We hope they will apply these high standards to their work.”

Jennings acknowledged the growing trend of validating digital health tools, but pointed out that the group’s study was spurred by the need to validate apps that people are using as contraception.

“App-based family planning methods should be based on the same rigorous scientific research as other methods of family planning,” Jennings said. “Women should be confident that whatever contraception they are using— whether it’s an app or a pill — is safe and has been rigorously tested and validated.”

In support of Dot, Jennings noted that the Institute liked the app’s approach. She said the research done for the app’s development was extensive and viewed it as having “great potential” as a family planning option with a foundation of research.

Dot’s predictions are based on Bayesian statistical calculations and use pooled datasets of 9,000 cycles from fertility studies to identify a woman’s fertile window, according to a summary of the Georgetown study.

Jennings contrasted Dot’s approach with the thousands of menstrual apps on the market. She added that most of them were designed to help women plan for pregnancy or track their menstrual cycle, and can be misleading and confusing.

Research conducted at Georgetown showed that these kinds of apps are not effective for determining a woman’s optimum fertility “window” and aren’t very accurate. Out of more than  100 apps that designed for pregnancy prevention, only six were accurate, Jennings said.

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