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Apple revs up clinical research


Research has been given a shot in the arm by Apple Corp, which recently expanded the use of ResearchKit to include clinical trials.

YeungWhen Apple, Inc., announced the MyHeart Counts mobile app at a tech industry event in March, Alan Yeung, MD, said he hoped 1,000 people would download it. Built on the open source Apple ResearchKit platform, the app collects data for research studies.

By the next day, more than 10,000 people had signed up, and to date there are more than 36,000 participants. “I didn’t know people were that eager to sign up for research,” says Yeung, medical director of Stanford Cardiovascular Health, who is leading the MyHeart Counts efforts.

The MyHeart Counts app collects fitness data from iPhones and wearable fitness devices connected to iPhones over a seven-day period in order to assess cardiovascular disease risk. Stanford is already looking at ways to capitalize on the initial success. “Now there’s tremendous interest from other faculty who deal with other disease states and health issues to produce an app, and how much resources we would need to do that,” says Yeung.

The medical community has tweeted, Facebooked, and blogged about the endless possibilities now that Apple expanded the use of ResearchKit in April. The platform gives medical researchers access to Apple phone’s data collection capabilities, which can track activity levels, sleep, body measurements, nutrition, and more using the iPhone’s built-in accelerometer, microphone, camera, and pressure sensors.

Users can decide which apps to use and what data to share with medical research institutions. According to Apple, data is shared only between the participants and the medical research institution, and no data is shared with them. The ResearchKit technology uses the new Watson Health Cloud by IBM to stay HIPAA-compliant.

NEXT: Expanding the research pool


Expanding the research pool

The possibility of large-scale research that would include people who are interested in their health but who wouldn’t normally engage with a research institution was Apple’s goal in developing the technology. Analysts predict that the April launch of the Apple Watch coupled with the ResearchKit platform could give the technology company leverage to boost and sustain interest in the wearable technology market. In a press release, Apple states that ResearchKit apps have more than 60,000 users combined.

“iOS apps already help millions of customers track and improve their health. With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research,” said Jeff Williams, Apple’s senior vice president of operations in a press release. “ResearchKit gives the scientific community access to a diverse, global population and more ways to collect data than ever before.”

As of July 2014, there are 1.2 million apps available in Apple’s App Store--nearly 100,000 of them are health and fitness related, according to the 2014 mHealth App Developer Economics study.

For Yeung, ResearchKit allows for a broader perspective on the relationship between fitness, nutrition and patient behavior. One question that many want to know is: How accurate is the data from mobile devices? A report in the February Journal of the American Medical Association states that smartphones are imperfect devices, but better than wearable activity trackers when it comes to tracking important healthcare information. The accessibility that smartphones offer over costly wearables is also an advantage to researchers. However, Yeung points out that no form of research is perfect.

“The objective was to find out how active people are. With traditional research, there are recall issues, and people often overestimate their activity level. Wearables provide real time data,” says Yeung, who adds that medical researchers are able to get a clearer, more accurate picture of how behavior affects health outcomes. “When people are inactive or the phone is inactive, there’s no data. So in a sense, no data can be more accurate than data from recall.”

NEXT: First five trials


To launch the platform, Apple limited the use of the technology to just a few, prominent medical research organizations that focused on some of the nation’s most costly health issues. Currently, there are only five apps available that use the ResearchKit platform:

  • Stanford’s MyHeart Counts:

  • Share the Journey, developed by the University of California, Los Angeles and Sage Bionetworks to track breast cancer symptoms after treatment;

  • GlucoSuccess, a Massachusetts General Hospital app that studies pre-diabetes and diabetes behavior;

  • Parkinson mPower, a partnership between Sage Bionetworks, University of Rochester and Beijing Institute of Geriatrics that allows people with Parkinson disease to track their symptoms; and

  • Asthma Health, developed by Mount Sinai Medical Center, helps asthma patients to personalize and analyze their treatment.

Tracking asthma

ChanThe technology of ResearchKit removes barriers such as geography and time that limits participants, says Yu-Feng Yvonne Chan, MD, PhD, FACEP, director of personalized medicine and digital health and assistant professor of genetics and genomic sciences at the Icahn School of Medicine at Mount Sinai in New York City, which is collecting the Asthma Health mobile app research.

Mount Sinai, Weill Cornell Medical College, and LifeMap Solutions developed the app to help participants self-manage the disease as well as track symptom patterns. The app combines a user’s GPS cell phone data with information about a city’s air quality to help participants avoid areas that might trigger symptoms.

“The quantity of data, both subjective (patient reported) and objective/real time monitoring (through devices, environmental sources, etc.) as well as the rate of acquisition of this data are quite remarkable,” says Chan. “Study participants may also feel a greater sense of freedom and control in how their data is collected and their role in this research process,” she adds.

But Chan notes that the approach isn’t without concerns. The novelty of ResearchKit apps could fade, in the same way that some critics believe that wearable technology activity trackers, including Jawbone and Fitbit, could be a fad. Nearly one-third of wearable technology users stopped using their device in six months, according to a July 2014 whitepaper by Endeavor Partners.

“We are mindful of this factor and have worked closely with our technology partners on user interaction and user experience to ensure that the app is user-friendly. However, at the end of the day, this is a research app and is not designed to be entertaining,” Chan says. “We hope that, over time, the utility and impact of using the app (i.e., improved asthma control, better quality of life, and fewer unexpected medical visits) will keep users engaged. Our early engagement and retention numbers look fairly promising.”

NEXT: Future uses


Future uses

Currently, Yeung says that no private health plans or organizations are involved with the mobile app, and no data on pay is being collected. He says his team is looking for ways to broaden its reach by expanding to Android platforms and social media to provide health and wellness coaching, and spark competition between users.

Chan says that her team plans to publish their data in peer-reviewed journals and present findings at conferences. “Assuming our hypothesis is correct and that the usage of our app is associated with improved health outcomes for our patients, we hope that it becomes a standard tool for patients to better care for their asthma,” Chan says.

Donna Marbury is a freelance writer in Columbus, Ohio.

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