Stanford’s MyHeart Counts was especially popular, with 11,000 people agreeing to participate in the first 24 hours. It will use data surveys and iPhone-enabled tasks to help researchers gather data from participants that will shed light on the risk factors of cardiovascular disease. In order to figure out which forms of instruction and behavioral change work best, participants will take a crude stress test consisting of a 6-minute power walk, both before and after being randomized into three months of various types of coaching.
“To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country,” Alan Yeung, medical director of Stanford Cardiovascular Health, told Bloomberg. “That’s the power of the phone.”
Some are skeptical about the new forms of research that ResearchKit enables. They fear it induce bias due to the fact that the owners of iPhone are not representative of the general population. A lack of personal contact with study coordinators or researchers is another concern. “Just collecting lots of information about people–who may or may not have a particular disease, and may or may not represent the typical patient–could just add noise and distraction,” said the Dartmouth Institute for Health Policy and Clinical Practice’s Lisa Schwartz to Bloomberg. “Bias times a million is still bias.”
One advantage of ResearchKit is objectivity. There are risks about relying on patient-reported information when it comes to facts, as opposed to subjective feelings. “People don’t want to say they did zero exercise, they want to say they did something.” Stanford’s Yeung told Bloomberg. “They don’t really tell us the truth.” With ResearchKit exercise activity is tracked as long as the iPhone is on.
Bloomberg reports that at least three of the first 5 apps are off to promising starts. The mPower app, which measures dexterity, balance, memory and gait in Parkinson’s patients, had 5,589 participants as of the early days of the study. And the Asthma Help app had 2,500 people enroll. Because the apps are meant for research purposes, and not diagnosis and treatment, they are not regulated by the FDA.
Apple’s desire to take a bite out of the med tech apple is well known. Previously, the focus was on the company trying (so far unsuccessfully) to overcome FDA regulations on possible iPhone features like blood glucose monitors, or the (so far unsurmounted) technical challenges of installing those devices on the Apple Watch.
ResearchKit is a return to the company’s core strengths in a relatively unregulated space: big data, the smartphone, and the ability to generate excitement.
REFERENCE: Fierce Medical Devices; 12 MAR 2015; Varun Saxena