The truth about mobile health apps and remote monitoring from ACOG 2021

Editor's Note: A factually inaccurate statement was made during the event which has been repeated in the article. A spokesperson for the brand addressed the error in a statement to Contemporary OB/GYN® below.

"Clue Birth Control is designed for contraception and has been tested in a rigorous clinical trial for that purpose. In order to obtain FDA clearance to offer this feature, the US regulator examined not just the clinical trial but subjected the entire app as well as Clue’s software development processes to extensive scrutiny. Clue had to satisfy the FDA that its science is sound and that its way of working is up to the standards expected of a medical device manufacturer. As a result of the clinical trial, Clue Birth Control was approved as ‘a a Software Application for contraception’.

Further to this, it should be noted that Clue Birth Control is a separate piece of software from Clue Period Tracker & Ovulation app, which utilizes a different algorithm, and that the disclaimer for the latter entity is not applicable when discussing Clue Birth Control."

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With nearly 2000 pregnancy and fertility apps available to mobile phone users, app overload and inaccuracy are major problems for ob/gyns and their patients. During the 2021 American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting, 3 experts—Kathryn Marko, MD, NCMP; Katherine T. Chen, MD, MPH; and Tamika Auguste, MD—led presentations on these types of apps and remote monitoring, as well as the role they play in patient care.

Marko, who is the residency program director and assistant professor at the George Washington University in Washington, DC, discussed the good and bad aspects and future of mobile apps and remote monitoring. Through her work, she saw positive changes regarding smoking cessation and breastfeeding.

Moderate-quality randomized control trials (RCTs), Marko said, led to improved smoking cessation with text message intervention (4 RCTs) that provided information on the risks to the mother and fetus in those who smoke. In addition, telehealth and text- and web-based interventions showed significant improvement in exclusive breastfeeding and breastfeeding continuation rates (3 RCTs). Vaccination rates, however, were not affected by telehealth interventions. No significant clinical or behavioral outcome related to pregnancy wellness, including healthy eating, physical activity, and maternal weight gain, was significantly changed by telehealth intervention with smartphone app and text messaging. “We can use this information to help patients more concretely connect with providers,” Marko said. “We can utilize this information to push out changes.”

App overload was highlighted by Chen, who compared the abundance of apps to a crowded flea market. “No one is telling you to seek out the yellow tent as the most accurate app. You don’t know to avoid the red tents,” Chen said. A major influx of available apps occurred from November 2013 to March 2021. For example, Chen explained, PubMed papers citing mobile apps went from 275 to 15,456 citations. Google’s search results went from 3.7 million to 1.63 billion results. Apps available on Apple’s App Store and Google Play went from 65,000 to 325,000. “A systematic process to identify and evaluate apps may help with the issues,” Chen concluded.

Auguste wrapped up the presentation with a focus on the gaps in mobile medical apps—namely, fertility awareness and fetal heart rate monitoring. Her first analysis was of Clue, an app that is marketed as a period and cycle tracker and ovulation calendar. Its website states, “The United States Food and Drug Administration (FDA) has classified Clue Birth Control as a software application that can be used as a contraception to prevent pregnancy.” However, the app was approved as a software application, not contraception. A disclaimer reads, “Note: Clue Period Tracker & Ovulation App should not be used as a contraceptive.” Auguste emphasized the importance of communicating this information to patients. It is crucial for providers to “know what’s out there and know the data,” Auguste said. “Patients are going to use these apps.”

Reference

1. Marko K, Chen KT, and Auguste T. Mobile apps in obstetrics and gynecology: The good, the bad, and the ugly. Presented at: 2021 American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; April 30 to May 2, 2021; virtual.