On March 9, 2015, Apple introduced an innovative research tool called ResearchKit. It is an open source software platform that allows medical researchers to design studies and gather data from participants using their iPhones. At the time of Apple’s announcement, five free ResearchKit apps were released in the app store. Among these five initial research apps is the MyHeart Counts app created by Stanford Medicine in collaboration with the University of Oxford. Studies using MyHeart Counts data are ongoing, yet top researchers are encouraged by early participation and expect to see a great leap forward in clinical research as a result of Apple’s new software platform.
What is ResearchKit?
ResearchKit provides a software framework for doctors and scientists to create their own research apps for iPhone users. These apps will allow researchers to gather data more frequently and accurately than traditional studies have accommodated in the past. “This technology enhances research in the clinical setting, changing the landscape of health care,” states Lee Ann Johnson, Chair of the Invasive Cardiovascular Specialty Programs at Pennsylvania College of Health Sciences. She believes apps designed to meet the needs of health care professionals “open the door to extensive research and enhancing lives for the patient and professional.”
Apple’s new platform brings together the fast-paced mindset of tech circles and the cautious, deliberate approach of clinical research. With capabilities in patient recruitment, screening and enrollment, electronic informed consent, data collection, data management, and data analysis, ResearchKit allows researchers to gather information via surveys, user activities, and passive data collection enabled by built-in iPhone sensors.
About the MyHeart Counts App
ResearchKit enables doctors to get a very broad research pull of populations well beyond what they can get at a traditional medical center. In fact, less than 24 hours after the platform’s release, Stanford researchers discovered that 11,000 people had already signed up for their cardiovascular study using the MyHeart Counts app. As of March 17, 2015, there were 25,000 iPhone users who had signed up for the study. Getting that many participants using traditional means would have required at least 50 medical centers around the country and would have taken a year to complete the enrollment process, explains the medical director of Stanford Cardiovascular Health.
Apple summarizes the MyHeart Counts app as a means of measuring activity and using “risk factor and survey information to help researchers more accurately evaluate how a participant’s activity and lifestyle relate to cardiovascular health.”1 Principal investigator for the MyHeart Counts study, Michael McConnell, explains that one of the most difficult challenges physicians face as they try to help their patients improve their heart health is finding effective methods for enhancing healthy behaviors. McConnell and his team intend to study what types of behavior-modification methods actually succeed with participants. “Preventive medicine hasn’t worked by having doctors make to-do lists for their patient[s], then seeing them six months later and hoping they did everything on the list,” says McConnell.2 So researchers plan to use the broad-scale capabilities afforded by ResearchKit to collect data on physical activity, fitness, and cardiovascular risk factors in order to find ways of helping people enhance activity and fitness, and decrease their chances of heart disease.
How Data is Collected
MyHeart Counts uses participant surveys to learn about an individual’s history of cardiovascular disease and current risk factors. The study also collects user activity data for seven days by employing the sensors built into iPhone models 5, 5s, 6, and 6 Plus, as well as the latest generation of iPod touch. This weeklong data collection period requires participants to do a six-minute walk test in addition to keeping their phone on them at all times. Research activities should take individuals less than 15 minutes per day to complete. Participants can then continue to use the app for activity monitoring, and MyHeart Counts will check back every three months to have them update their data.
One of the most obvious concerns surrounding the introduction of ResearchKit is privacy. Medical information is highly sensitive and should not be shared frivolously. Apple maintains that it never sees participant information and that “users decide…how their data is shared.”1 Once a user opts into the MyHeart Counts study using the app’s electronic consent form, his or her data is encrypted and sent to a secure database, where individual names are replaced with a random code. These data are provided directly to researchers rather than to Apple.
With the broad reach of Apple’s new software platform and high initial response rates to the MyHeart Counts app, the medical community has good reason to be excited for the future of clinical research in cardiovascular health. The integration of consumer technologies with clinical research studies is already leading to discoveries in the pursuit to provide more personalized care.
Want to contribute to Stanford’s study on heart health, or learn more about their ResearchKit app? MyHeart Counts is available as a free download from iTunes or from the App store.
- Apple Introduces ResearchKit, Giving Medical Researchers the Tools to Revolutionize Medical Studies. Apple. Published March 9, 2015. Available online at https://www.apple.com/pr/library/2015/03/09Apple-Introduces-ResearchKit-Giving-Medical-Researchers-the-Tools-to-Revolutionize-Medical-Studies.html. Accessed July 9, 2015.
- Stanford Launches Smartphone App to Study Heart Health. Stanford Medicine. Published March 9, 2015. Available online at https://med.stanford.edu/news/all-news/2015/03/stanford-launches-smartphone-app-to-study-heart-health.html. Accessed July 9, 2015.
About PA College: Pennsylvania College of Health Sciences (www.pacollege.edu/) is a private, accredited, four-year college offering associate, baccalaureate, and master degree programs as well as certificate programs. PA College offers a dynamic and academically rigorous environment for students to learn from faculty who are experts in their specialty areas.