Duke University researchers, working with primary-care doctors, once needed eight months to enlist 100 parents for research on the early detection of autism. Now, they hope to recruit thousands more in a matter of weeks for a study by smartphone.
It may be a matter of days.
The researchers are among a small number to use Apple's ResearchKit, released earlier this year, to develop apps that collect data for studies on chronic and debilitating conditions, including diabetes and Parkinson's disease. Researchers see potential for new discoveries with the flood of new study participants and data made available by the broad reach of iPhones.
“Three thousand patients enrolled in the first three days, or something crazy like that,” estimated Dr. Yvonne Chan of Mount Sinai Health System in New York, which released one of the first apps in May. Eventually, the project enrolled 8,600 people to study asthma.
“This is comparable to the largest epidemiological studies out there already,” said Chan, who is director of digital health and personalized medicine at Mount Sinai's Icahn Institute for Genomics and Multiscale Biology. “It is possible to achieve that rapid enrollment.”
That wide reach, however, may not produce comprehensive data and could limit the use of results. The reason: Smartphones may appear ubiquitous, but they are more common among the young, college-educated and those with higher incomes, as data from the Pew Research Center show. That's not a complete picture of patients with diabetes, which is more prevalent among those who did not go to college, those with low incomes and the elderly. Chan's study predominantly enrolled white men, she said, which is not representative of those with asthma, who are more likely to be women and black.
“You want things that are going to be useful for everyone you want to help,” said Dr. Kevin Patrick, director of the center for wireless and population health systems at the Qualcomm Institute at the University of California at San Diego. “It's a public health issue … to ensure that this ecosystem of apps and devices and services evolves in ways that are truly capable of addressing the health needs of everyone.”
Chan said researchers are closely examining their data to see how closely they represent the Centers for Disease Control and Prevention's picture of those living with asthma. She expects the results to be published soon.
Apple announced its ResearchKit in March and named its first targets—asthma, breast cancer, cardiovascular health, diabetes and Parkinson's disease—for research apps developed with the tool.
The company is announcing new research apps Thursday, including an app from Duke researchers that will use the phone's camera to capture data on children's facial expressions as they watch videos. Johns Hopkins Medicine neurologists will use Apple's new watch to study epilepsy. Oregon Health & Science University will use the app to collect images of skin moles for research on melanoma detection.
The company unveiled the research tool at the same time that it introduced its pricey new watch, which entered the market amid speculation about Apple's ambitions for its use in healthcare. The watch lacks health features that Apple developers had hoped to introduce, such as sensors for blood pressure and stress, the Wall Street Journal reported. Technical snags and regulatory concerns scrapped those plans.
Researchers acknowledged the potential for data to be limited to those who have smartphones, but studies will nonetheless provide valuable information, they said.
To broaden their recruiting reach, Duke researchers have distributed smartphones to schools, so that parents without iPhones can use the app on the schools' phones, said Dr. Helen Egger, chief of Duke University's division of child and family mental health and developmental neuroscience. Autism clinics, too, can use the app with patients who lack smartphones. Parents can also use an app feature to volunteer for future studies. That might allow researchers to select more representative samples for further research. “We are very, very aware of iteratively working out scientific design issues,” Egger said.
Nonetheless, the use of smartphones for clinical trials holds major promise for Duke's study, she said. Video data can be more closely analyzed and may yield new discoveries. Smartphones also reach into rural communities that do not always have access to clinical trials. Plus, the scale of enrollment has significant potential to generate valuable data, Egger said.
Johns Hopkins Medicine's app will be the first designed for Apple's watch. The app will collect data on seizures and track medication adherence and side effects. Data on seizure types won't be limited by the customer base for Apple's pricey watch, said Dr. Gregory Krauss, a neurology professor at Johns Hopkins and one of the researchers behind the app. Researchers will adjust results for analysis of medication data where needed, he said.
Oregon Health & Science University's app will examine whether iPhones can be used to reliably track the growth of skin moles that could be cancerous. So little is known about this potential that any new data will be valuable, said Dr. Sancy Leachman, director of the university's Knight Cancer Institute melanoma research program.