Patient participation and empowerment
Apple has launched a new initiative called ResearchKit that is already revolutionising medical research studies. The article below is extracted from the stories of three journalists. What they report on in the early use of the program and where it could be headed is nothing short of astounding. It is foreshadowed that even gene testing on an enormous scale might be possible via the iPhone.
Specifically regarding HSP, continuous collection of data relating to walking speed, distance covered and even possibly gait characteristics is both imaginable and feasible, as well as the ability to submit responses to questions asked of HSPers. For example, participants in a clinical trial could be providing walking and gait data on a continuous basis as an important part of the assessment of the effectiveness of a particular treatment, including the identification of patterns such as how long after taking a drug were changes apparent, as well as the extent and nature of the changes.
Apple’s ResearchKit Takes Medical Research Years Into the Future
David Pogue, Yahoo Tech. Mon, 4 May, 2015
Apple just released what history might say is its most important product ever. And guess what? Hardly anyone even knows it exists. It’s called ResearchKit. It’s a software toolkit that lets researchers write iPhone apps for medical studies.
Yawn, right? No. This is a huge deal.
Every year, people buy 1 billion smartphones and 70 million wearable health trackers. These devices monitor how much we move and sleep, and where we are in the world. Some of them track our pulse, stress, posture, sunlight exposure, perspiration, and so on.
Yet how much of this data is available to scientists? None of it. These phones and trackers spew out terabytes of useful data a day — and scientists can’t get at it, analyze it, or parse it to draw conclusions about medicine and health. We’re conducting the biggest clinical trial in human history, and we are throwing away the results.
How studies are conducted now
Today, studies on disorders, medicines, and treatments are conducted the same way they have been for 50 years. To get research subjects, a researchers seeks participants by low-tech means that are absurdly inefficient. Probably the most quoted line from Apple’s ResearchKit promotional video is this one, from Kathryn Schmitz, PhD, of the University of Pennsylvania Health System: “We have sent out over 60,000 letters. Those 60,000 letters have netted 305 women.”
Once you’ve found your subjects, you sit them down and go over the risks and benefits — a paperwork nightmare that takes at least half an hour per participant. Right there, you’ve limited the scope of your study, and limited it to people who live nearby.
That’s the world of medical research right now. Slow, small-scale, inefficient.
Consent and privacy
Apple worked with five medical institutions, associated with places like Harvard, Stanford, and Mount Sinai in New York City, to come up with the first five ResearchKit-based apps. They represent studies of asthma, diabetes, heart disease, Parkinson’s, and breast cancer. (You can enroll in the heart, breast cancer, and Parkinson’s studies even if you don’t have those diseases. The researchers will use your data as a control.)
The first time you open a ResearchKit app, you encounter the first huge breakthrough: The sign-in process is electronic. No more researcher sitting across from a table asking you questions and going over paperwork.
All five institutions currently running ResearchKit studies approved an electronic consent-granting process within the app. With just this one advancement, the world of medical research has changed forever. After you read the consent forms, you’re told exactly who will get to see your data and for what purpose it will be used. You can opt out of any part of the data collection at any time. Indeed, you can drop out of a study at any time, although you agree to let the researchers use the data you’ve generated up to that point.
In each app, you’re also asked: Do you grant permission for us to share your data with medical researchers at other institutions, conducting other studies?
75 percent of the people who’ve signed up for the asthma study have agreed to let their data be shared more widely. They truly want to help.
Apple never gets your data. The data is collected in the app, it is encrypted and very secure, meeting all the industry standards for shipping sensitive data. The only people who have access to the data are the investigators of the study.
Size and scope
ResearchKit hugely amplifies the size and scope of a study. Instead of generating some data, it generates big data. You can sign up a lot of people for a study, fast.
Using traditional recruitment techniques, you’re lucky if you get 300 or 500 over the course of a year. Over many years, you’ll get a thousand enrolled in a study and they’ll be geographically limited. But 7,500 asthma sufferers enrolled in the study using ResearchKit within the first month. Furthermore, the data they generate is continuous.
In traditional studies, participants are seen only every so often, and data and measurement occur at that time. But with the app, data can be continuously collected, providing a much deeper characterization of what’s going on.
The breast-cancer app, Share the Journey, had 6,000 downloads and 2,500 enrolments in the study within three weeks. For the Stanford heart study, a mind-blowing 30,000 people enrolled through the MyHeart Counts app in the first month of availability.
Typical for a ResearchKit app, the patient supplies some of the data by answering questions. The rest is generated automatically from the phone’s sensors: microphone, camera, accelerometer, GPS, gyroscope, and so on. If you have an external health device that talks to Apple’s HealthKit protocol — a fitness-tracker band, digital thermometer, Bluetooth scale, Bluetooth blood-pressure cuff, Bluetooth inhaler, and so on — that data can become part of the ResearchKit app’s data, too.
All of the researchers said the same thing: that a huge advantage of using an app to conduct the study is that it can become two-way. In a regular study, you provide data to the researchers — and then you never hear from them again. But ResearchKit apps can begin to give you advice based on your medication situation. For example, McConnell’s app, MyHeart Counts, is part of a study that examines relationships between activity, motivation, risk factors, and heart health. The app tracks your activity, either from the phone’s motion sensors or HealthKit-compatible wearables, for a week. You also take a six-minute walking test four times a year. After three months, the app starts giving you personalized motivational prompts to get you to move more.
Room for improvement
ResearchKit apps currently can’t incorporate genetic information and they don’t integrate with patients’ electronic medical records. Furthermore, plenty of external medical sensors still don’t work with HealthKit and so can’t generate data for ResearchKit.
And, of course, ResearchKit apps can’t do things like scan your body or analyze fluid samples. Maybe in version 2.0.
The ResearchKit future
Taking medical research digital with ResearchKit promises to be just as disruptive a change as when music went digital. We can answer questions now thousands of times faster, with much bigger test samples. ResearchKit solves a number of the current challenges to clinical research. How do you reach/recruit a large number of people? How to do help bring down the costs of large clinical research studies? How do you reach a broad geographic population? How do you make it easier and more engaging for people to participate? How can you collect more continuous, real-world, quantitative data? How can you give participants more feedback about their data, and the choice to share their research data broadly?”
Year Of The Participant — Brought To You By Apple’s ResearchKit
ResearchKit offers the possibility of bringing participatory research to the masses (those with an iPhone, anyway), and extracting at least a measure of control from the medical centers who have dominated it in the past. It is becoming increasingly clear to everyone from pharma companies to patient advocacy groups that medical centers may no longer be the only game in town, the gateway through which all robust patient information must inevitably pass. Even many academic researchers – frustrated by the often byzantine processes that dominate their own institutions – seem excited, nay delighted, by the changes that seem to be in the offing.
Expect the transition of power to be tumultuous, as threatened incumbents seek to retain the control to which they’ve grown accustomed, and as participants acclimate to the challenges and responsibilities associated with asserting data ownership.
But this adjustment, difficult as it will be, is also going to be one for the best, as I expect participants will be far more likely to share their data than academics might be, resulting in the opportunity for profound new insights that can help patients immediately (perhaps by connecting two families trying to cope with extremely rare genetic conditions), as well as contribute to the rich integrated data sets likely to drive profound scientific advances in the future.
Apple Has Plans for Your DNA
The iPhone could become a new tool in genetic studies.
By Antonio Regalado on May 5, 2015
Apple is collaborating with U.S. researchers to help launch apps that would offer some iPhone owners the chance to get their DNA tested, many of them for the first time, according to people familiar with the plans.
The apps are based on ResearchKit, a software platform Apple introduced in March that helps hospitals or scientists run medical studies on iPhones by collecting data from the devices’ sensors or through surveys.
“Apple launched ResearchKit and got a fantastic response. The obvious next thing is to collect DNA,” says Gholson Lyon, a geneticist at Cold Spring Harbor Laboratory, who isn’t involved with the studies.
Nudging iPhone owners to submit DNA samples to researchers would thrust Apple’s devices into the center of a widening battle for genetic information. Universities, large technology companies like Google (see “Google Wants to Store Your Genome”), direct-to-consumer labs, and even the U.S. government (see “U.S. to Develop DNA Study of One Million People”) are all trying to amass mega-databases of gene information to uncover clues about the causes of disease (see “Internet of DNA”).
In two initial studies planned, Apple isn’t going to directly collect or test DNA itself. That will be done by academic partners. The data would be maintained by scientists in a computing cloud, but certain findings could appear directly on consumers’ iPhones as well. Eventually, it’s even possible consumers might swipe to share “my genes” as easily as they do their location.
One person with knowledge of their plans said the company’s eventual aim is to “enable the individual to show and share” DNA information with different recipients, including organizers of scientific studies.