(Oliur Rahman, Pexels)
17 January 2018. A review of published research since 2000 shows little evidence to support claims of beneficial health outcomes from the use of wearable devices like smart watches or wristbands, at least not yet. A team from Cedars-Sinai Medical Center in Los Angeles discusses its findings in the 15 January issue of the journal npj Digital Medicine.
Researchers led by Brennan Spiegel, director of the Center for Outcomes Research and Education at Cedars-Sinai, are seeking hard evidence to back the enthusiasm and claims of individuals and companies making wearable devices to monitor a person’s health. These devices usually have biosensors built into wristbands, skin patches, belts, shoes, or other articles of clothing connected to smartphones, or integrated into the device’s app software. The devices often allow individuals to share the data they collect with other people, including health care professionals, as well as on social networks.
And the devices are popular. According to market research company International Data Corporation some 26.3 million devices were shipped during the second quarter of 2017 alone, with shipments growing by more than 10 percent over the first half of the year.
The prospect of remote patient monitoring opens up many more opportunities for data collection, particularly with non-invasive, passive processes that track a variety of health-related indicators in real time. While the devices promise to improve the timeliness of care and health outcomes, as well as increase adherence to treatments, the research team found little hard data to support these hopes, other than anecdotal evidence.
Spiegel and colleagues reviewed published research on wearable devices that measure the health outcomes of individuals using these devices. The researchers looked for randomized clinical trials evaluating these systems in more than 4300 studies published from January 2000 to March 2016. The search yielded only 27 randomized clinical trials in peer-reviewed journals. Applying a quality standard for research methods called the Jadad scale shows 16 of these studies are considered high-quality research.
Many of the trials investigated devices to measure cardiac and respiratory functions, as well as overall physical activity, often compared against standards of care alone or supplemented with education. The vast majority of the studies, 22 of 27, included a feedback loop with a doctor or nurse who received data from a device and at least discussed the results with the individual. In the other 5 trials, the person checked in with a web portal or mobile app to monitor or receive an analysis of the results.
The team normalized the data from the 27 studies to aggregate the results, and measured differences in outcomes between trial participants using the devices and people in comparison groups for 6 health indicators — body mass index, weight, waist circumference, body fat percentage, and two common measures of blood pressure: systolic and diastolic. The researchers found no statistically reliable differences overall on any of the 6 measures between wearable device users and non-users.
“As of now, we don’t have enough evidence that they consistently change clinical outcomes in a meaningful way,” says Spiegel, referring to wearable health devices in a Cedars-Sinai statement. “But that doesn’t mean they can’t.” In fact, a closer look at the data reveals the trials most likely to show statistically reliable results were those grounded in behavioral health models or including personalized coaching for participants.
As lead author and research associate Benjamin Noah notes, “Many of the studies we reviewed were still in the pilot phase,” which suggests more randomized clinical trials may be in the works. In addition, the authors recommend that future assessments identify and remedy potential barriers to remote patient monitoring on clinical outcomes, particularly by focusing on measures that matter to participants, such as symptom severity, hospital readmissions, and quality of life.
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