‘Wearables' warrant wary expectations

When using data from personal fitness tracking devices in health care, it's important to be creative and excited, yet prudent, a mood that panel moderator Avital Y. O’Glasser, MD, FACP, described as “dampened enthusiasm” at Internal Medicine Meeting 2018.

Dr. O’Glasser surveyed the audience of the session and found that half wore personal fitness trackers. She uses one and offered her own reasons for adopting it: She's a busy physician, with not only a career but a family, and wanted more exercise. Using her wearable, she told the audience, she logged 3,000 steps from her hotel to the conference center, so she had already accomplished that much by the start of her early-morning session.

Dr. O’Glasser, assistant medical director of the preoperative medicine clinic at Oregon Health & Science University in Portland, noted that when she conducts perioperative assessments with patients who look frail on paper, asking about wearable use can be “a great 30-second conversation that adds a data point.” On the primary care side, she added that many patients feel energized and engaged when using fitness trackers, even if there is no evidence that they improve clinical outcomes.

The evidence for data

Another panelist in the session, Alisa L. Niksch, MD, said she has seen progress with remote patient monitoring technology since she began her medical training. Dr. Niksch, who is the director of pediatric electrophysiology and the Exercise Stress Lab at Tufts Medical Center in Boston, cautioned that there isn't a significant amount of evidence supporting the use of recreational wearable technology in health care.

A study published in npj Digital Medicine on Jan. 15 looked at 4,328 articles in the literature on wearable biosensors, said panelist Priya Radhakrishnan, MD, FACP, chief academic officer of Honor Health in Phoenix. There were only 64 randomized controlled trials, and only 16 articles had sufficient power to be deemed high quality. The largest cohort was 1,437 patients.

Dr. Radhakrishnan said she first became interested in wearables after seeing a 65-year-old patient who used an app that tracked atrial fibrillation and sleep apnea. She believes that wearables have the potential to effortlessly provide detailed longitudinal data to monitor patient progress compared to uncomfortable or expensive alternatives. They can monitor conditions such as depression, obesity, sleep apnea, and hypertension, plus record vital signs, steps, and body mass index.

But she told the audience that much of the literature surrounding use of fitness trackers is Grade C (low-quality evidence), which presents an opportunity to further investigate the technology. “We have to look at the validity of the data,” she said. “It's fine to say your heart rate is going up, but is a smartphone app really equal to a Holter monitor?”

Dr. Radhakrishnan also noted that there is a human component to wearable device effectiveness. For example, research on fitness trackers and obesity has not proven their efficacy. “Most of our trials with behavioral changes sometimes don't work. … It's a population piece as well,” she said.

However, she warned that physicians shouldn't dismiss fitness trackers entirely. If they do that, she said, “I think we are doing patients harm, because cost is something that can be tremendously reduced if this technology pans out,” later adding, “From an innovation perspective, this actually has the potential to disrupt a lot of our medical testing.”

Medical potential

Despite the current uncertainties, there is potential for growth in medical-grade wearables, the experts said. Medical-grade wearable technology will be a $24 billion market by 2022, said Dr. Niksch, who predicted that it will shift from recreation toward disease diagnosis and management. FDA oversight and HIPAA compliance efforts are underway.

Dr. Niksch cited several broadly agreed upon attributes that might make wearables useful in clinical practice:

• accurate data that are comparable to standard-of-care devices,
• continuous data versus episodic data (“We want what's trending,” she said),
• contextual data that let physicians know what patients are doing (instead of just measuring heart rates, physicians want to know what patients are doing while their heart rates are varying throughout the day), and
• filtered data (“Physicians don't like loads of data,” she said, but they do want to be notified when patients take a turn for the worse).

She also cited the importance of passive transmission of data from wearable devices. “Patients are not reliable in generating their own data and putting it into the system,” Dr. Niksch said. “The more passive you make these systems, the better it is for accurate information.”

Finally, Dr. Niksch added that regulations need to be created, because to date, it's been the “Wild West.” Wearable device data need to be integrated into the rest of the electronic health record, be secured against hacking, and have associated reimbursement for the management of the data, she said.

Other challenges including getting the devices to the patient populations who could most benefit. “It's really the healthy patients, the worried well that tend to use wearables a lot more than patients who are chronically ill with complex medical problems,” said Dr. Radhakrishnan, who sits on ACP's Medical Informatics Committee. “That's something that we really want to make sure that we take into account as we are operationalizing the data that wearables can get.”

The future

Dr. Niksch cited examples of medical-grade wearables that are expected soon. They include wearable patches that can measure pulse oximetry or conduct an electrocardiogram to a smartphone. Embedded sensors in smart pills already exist. The FDA has approved Abilify MyCite (aripiprazole tablets with sensor) for mental health disorders. The pill has an embedded ingestible sensor that sends a message to a wearable patch, which transmits to a mobile app on a smartphone when the pill is consumed.

And, moving from the micro to the macro, an entire home for Parkinson's patients in New York is embedded with sensors to track patient movement, Dr. Niksch said. The home monitors activities of daily living and is capable of detecting and tracking possible mobility problems in residents under drug treatment protocols.

Despite the potential, Dr. Radhakrishnan reminded the audience to be cautious. “The next five to seven years are going to be turbulent for us as practicing clinicians,” she said. “We are going to be inundated with data. And patients want us to see this data. We really have to be clear in our expectations by making sure that they are partners as we go down this track.”