February 27, 2020 Read Advisory Board's take: The major implications of this study for CV and beyond

Johnson & Johnson (J&J) and Apple on Tuesday announced they're teaming up to conduct the largest randomized controlled trial on cardiovascular disease ever in order to determine whether the Apple Watch can detect atrial fibrillation (AFib) among seniors.

Background

AFib is a heart condition that can increase the risk of stroke. It's estimated to affect about 2.7 million Americans and 34 million people around the globe. People with AFib do not always show symptoms, which can make it difficult to diagnose.

In September 2018, Apple revealed its Apple Watch Series 4, which features an FDA-approved electrocardiogram (EKG). A typical EKG is conducted in a doctor's office or hospital and requires attaching electrodes to a patient's chest. But Apple's EKG app requires only a simple press—and 30-second hold—of a button on the watch, after which it informs a user if their heart rhythm is normal or if they are experiencing atrial fibrillation. The data, which Apple says is encrypted, is then stored in the iPhone's Health app, where users can access it and create PDFs to share with their physicians.

Details on the partnership

With the new trial, Apple and J&J want to see if the watch can help catch cases of AFib early and lower the risk of stroke. 

For the trial, the companies will recruit at least 150,000 seniors, who will be randomly assigned to use either an iPhone app called Heartline, which gives them health education and tips, or an Apple Watch in addition to the Heartline app. Researchers will monitor participants to see how accurately the Apple Watch can detect AFib and whether the Heartline app is effective at encouraging patients to take their medications.

The study is open to individuals who are at least 65 years old, enrolled in traditional Medicare, and have an iPhone 6s or newer model with iOS 12.2 or more recent software. Participants who are assigned to the Apple Watch group can buy the watch at a discount or "rent" the watch for free for the duration of the trial.

Best Buy
is also involved in the trial. According to Paul Burton, VP of medical affairs for J&J, seniors who are assigned a watch for the trial can pick it up or have it sent from Best Buy. Customer service representatives are available to help participants set up the watches, and participants can also get help at the store. 

Individuals who already have an Apple Watch may join the trial, but certain restrictions apply, the researchers said. 

The companies said that the study could take three years to publish, given its size, and they cautioned that the study may not be successful as there are still some unknowns to explore. Either way, however, the companies will publish the study's results, according Burton.

"Heartline could go down as a landmark clinical trial," Burton said. "We are bringing amazing digital wearable tech and engagement apps for health care to patients and doctors."

Some experts concerned about the app

Some experts have expressed concerns that the Apple Watch's ability to screen for AFib may not be particularly helpful.

Around the time the Apple Watch launched its EKG feature, Aaron Carroll, a professor of pediatrics at Indiana University, in the New York Times' "The Upshot" noted that there are already a number of effective ways to screen for AFib, including blood pressure monitors and even simply taking a pulse during a routine checkup.

He wrote that, if providers believed "detecting asymptomatic people who might have atrial fibrillation" was important enough, "we could screen everyone with electrocardiograms."

The U.S. Preventive Services Task Force considered doing exactly that for adults ages 65 and older but ultimately decided there wasn't enough evidence that it would be better than the current level of care to recommend the practice.

There's also the concern that the watch could lead to false positives and misdiagnosis, Carroll said. "Patients at high risk of stroke who have atrial fibrillation (i.e. older people) might be treated with anticoagulation. For younger ones at lower risk, it's not immediately clear how we would treat them, or if we should," Carroll wrote. "And it's younger people who are more likely to have a smart watch."

However, Jeffrey Wessler, a cardiologist in New York, praised Apple's approach with the new Heartline study specifically focusing on seniors, saying the study "represents an important step forward for the clinical utility of consumer-grade wearables."

He added, "Apple can move beyond the dubious effects of broad based screening and actually demonstrate the effectiveness of a watch-based intervention to improve clinical outcomes" (Farr, CNBC, 2/25; Haselton, CNBC, 2/25; La Monica, CNN, 2/25; Carroll, "The Upshot," New York Times, 12/26/19).

Advisory Board's take

What this study means for CV leaders

The expanding applications of wearables has certainly been the talk of the town in cardiovascular (CV) circles lately, particularly as more high-profile tech, pharma, and insurance companies get into the game. In addition to this Apple and Johnson & Johnson study, we have seen several other unique partnerships emerge. For instance, Oscar Health is partnering with Cardiogram to provide high-risk members with remote diabetes and AFib monitoring, and Devoted Health has started to subsidize the Apple Watch for its Medicare Advantage members.

From my conversations with CV administrators and physician leaders alike, the tone I typically get is "cautiously optimistic." There is certainly excitement over the opportunity for scaling earlier detection of conditions from AFib to diabetes. Also, many physicians highlight the benefit of empowering patients to manage their own health, which can be a particular challenge in cardiovascular disease.

But at the same time I hear trepidation, and many valid concerns. Will our already-strained emergency departments now be overrun with false AFib alerts? Will this technology only be available to those who can afford an Apple Watch or other device? What protocols do we need to put in place to take in and triage this new stream of health data within our care teams? How will our clinicians be reimbursed for the time necessary to interpret these new data inputs?

CV leaders are looking for evidence to help them make their decisions. Evidence on not only how clinically effective wearables are at detecting AFib and other conditions or risk of disease, but also how patients utilize these devices in real life, and how cost- and resource-efficient these technologies will be in the long-run. Without this evidence, it will be difficult for programs to eagerly adopt these new technologies and incorporate them into existing workflows. Clinical trials like this one are necessary to provide evidence on how wearables perform in detection and disease management, and also in a more expansive population than those who may purchase and use an Apple Watch on their own.

What this study means for the way we recruit for, conduct, and analyze large clinical trials

Like many of the CV administrators Megan mentions, I'm "cautiously optimistic" that this latest study will generate compelling evidence which can improve long-term patient monitoring and care. By focusing exclusively on seniors (aged 65+), the study designers aim to target those most likely to develop AFib, while reducing the likelihood of unnecessary utilization and angst among the "worried well." And by making the Apple Watch available to interested parties via loans and discounts, the study designers seem intent on attracting a more economically diverse population than most existing Apple Watch users.

What really excites me about this study, however, is its potential to re-frame how we think about randomized controlled trials (RCTs). First and foremost, this study appears to blur the lines between RCTs and RWE (real-world evidence). Traditionally, RWE is defined as evidence generated outside of a standard RCT.  But it's also often described as encompassing data sources, such as adherence apps and remote EKG monitors, which capture health information outside of traditional clinical settings. With this study, Apple and Johnson & Johnson place real-world sources of data, the Apple Heartline app and the Apple Watch EKG, at the center of a randomized, controlled, and prospective large-scale trial.

Second, this study challenges conventional thinking about patient recruitment. Not only are the sponsors aiming for sky-high enrollment numbers of 150,000 seniors, but they are also recruiting through open enrollment—dramatically reducing the barriers to participation. Granted, open enrollment for a three-year longitudinal study comes with its own set of challenges, especially related to verification, compliance, and continuity. But in an era when most trials struggle to recruit a sufficient numbers of patients who meet strict inclusion or exclusion criteria, the scale and scope of this study are worth acknowledging. Though, of course, recruiting a large number of participants is most valuable only when the majority remain engaged in the study. In the early days of wearable studies, patients were found to stick with using devices to track their health for about four months—and then there was a significant drop off in adherence. Meanwhile, most mHealth apps see a usage drop-off rate of 64% after a single month. I know this is a problem in regular clinical trials as well, so I’ll be watching to see if the adherence rates for this trial are better or worse than typical clinical trials or previous wearable-based studies.

Third, and perhaps most intriguing, there's little to no mention of clinical investigators, academic medical centers (AMCs) or traditional sites of care in any of the initial press surrounding the Heartline study. Unlike Apple's prior study with Stanford Medical Center, this new study appears to challenge conventional wisdom about the centrality of AMCs or academic physicians in running major RCTs. In fact, it involves the partnership of a major retail partner, Best Buy, instead. This isn't to say physicians won't be interpreting data generated from the Apple devices or caring for patients involved in the study, but their importance to the overall study design seems less central. Could this study represent yet another attempt by Big Tech to disrupt costly, inefficient parts of our health care system? The role of Big Tech as evidence-generator and clinical trial enabler may feel less ominous than some of their other likely health care moves (although patient data ownership and data privacy in these trials remains an outstanding question). Technology companies like Optum* and Verily have already made substantial strides in this space, but the near-fully virtual nature of this Heartline study may elevate the disruptive potential to an entirely new level.

Want to learn more about what Apple is planning in health care and what impact they could have on the industry? Join us on March 31st at 3pm ET to envision What Apple 'Health Care' could look like in 5 years.

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*The Daily Briefing is published by Advisory Board, a division of Optum, which is a wholly owned subsidiary of UnitedHealth Group

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