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Investigators Doubt Wearables' Impact in Improving Some Clinical Outcomes

NEW YORK (360Dx) – Investigators said today that based on a statistical analysis of relevant literature, remote patient monitoring using wearable devices provided "no significant impact" on some of the clinical outcomes they reported, but showed "early promise" in improving outcomes for certain other conditions.

The investigators from Cedars Sinai, the University of Arizona, and the UCLA Fielding School of Public Health published the results of a study online today in the Nature Partner Journal npj Digital Medicine.

The investigators conducted a statistical analysis and in-depth literature review of 27 studies from 13 countries published between January 2000 and October 2016. Each study examined the effects of remote patient monitoring using wearable biosensors. The devices — embedded in watches, belts, skin patches, and textiles — included physical activity trackers, blood-pressure monitors, electrocardiograms, electronic weight scales, accelerometers, and oxygen saturation monitors, among others.

"Despite growing interest in remote patient monitoring, limited evidence exists to substantiate claims of its ability to improve outcomes," the researchers wrote in their paper. They noted that they found "substantial gaps in the evidence base that should be considered before implementation of remote patient monitoring in the clinical setting."

Brennan Spiegel, director of Health Services Research at Cedars-Sinai, said in a statement, "As of now, we don’t have enough evidence that [wearable biosensors] consistently change clinical outcomes in a meaningful way. But that doesn’t mean they can't."

Proponents have touted noninvasive, wearable devices — which use biosensors and automatically transmit data to a web portal or mobile app for patient self-monitoring or health provider assessment — as a means to reduce healthcare utilization, decrease costs, generate research data, and increase physician satisfaction. 

In their literature analysis, Spiegel and his co-authors studied the impact of the devices on patients who were overweight or suffering from heart disease, lung disease, chronic pain, stroke, or Parkinson's disease.

They found that remote patient monitoring with the biosensors had "no statistically significant impact on any of six clinical outcomes studied" — body mass index, weight, waist circumference, body fat percentage, and systolic and diastolic blood pressure.

However, they reported that their analysis found that wearable devices "did show early promise" in improving outcomes for certain conditions, including obstructive pulmonary disease, Parkinson's disease, hypertension, and low back pain.

The apparent lack of significant clinical impact for some conditions could be linked to a lack of data, the researchers said.

Of more than 4,000 studies that they initially reviewed, fewer than one percent were eligible to be included in the study, and only 16 were considered high-quality research. They noted that there were few randomized controlled trials for each of the clinical outcomes analyzed, and studies varied significantly in terms of the types of devices used, the populations studied, and the interventions tested. 

Citing a need for more data, lead author Benjamin Noah, a clinical research associate at the Cedars-Sinai Center for Outcomes Research and Education, said that many of the studies they reviewed were still in the pilot phase.  

The researchers concluded in their paper that future studies "should be powered to analyze sub-populations to better understand when and for whom [remote patient monitoring] is most effective."