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Randomized Controlled Trials and Longitudinal Analysis for Health Apps at Twine Health (Part 1 of 2)

Posted on February 17, 2016 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

Walking into a restaurant or a bus is enough to see that any experience delivered through a mobile device is likely to have an enthusiastic uptake. In health care, the challenge is to find experiences that make a positive difference in people’s lives–and proving it.

Of course, science has a time-tested method for demonstrating the truth of a proposition: randomized tests. Reproducibility is a big problem, admittedly, and science has been shaken by the string of errors and outright frauds perpetrated in scientific journals. Still, knowledge advances bit by bit through this process, and the goal of every responsible app developer in the health care space is the blessing offered by a successful test.

Consumer apps versus clinical apps

Most of the 165,000 health apps will probably always be labeled “consumer” apps and be sold without the expense of testing. They occupy the same place in the health care field as the thousands of untested dietary supplements and stem cell injection therapies whose promise is purely anecdotal. Consumer anger over ill-considered claims have led to lawsuits against the Fitbit device manufacturer and Lumosity mental fitness app, leading to questions about the suitability of digital fitness apps for medical care plans.

The impenetrability of consumer apps to objective judgment comes through in a recent study from the Journal of Medical Internet Research (JMIR) that asked mHealth experts to review a number of apps. The authors found very little agreement about what makes a good app, thus suggesting that quality cannot be judged reliably, a theme in another recent article of mine. One might easily anticipate that subjective measures would produce wide variations in judgment. But in fact, many subjective measures produced more agreement (although not really strong agreement) than more “objective” measures such as effectiveness. If I am reading the data right, one of the measures found to be most unreliable was one of the most “objective”: whether an app has been tested for effectiveness.

Designing studies for these apps is an uncertain art. Sometimes a study may show that you don’t know what to measure or aren’t running the study long enough. These possible explanations–gentler than the obvious concern that maybe fitness devices don’t achieve their goals–swirl about the failure of the Scripps “Wired for Health” study.

The Twine Health randomized controlled trials

I won’t talk any more about consumer apps here, though–instead I’ll concentrate on apps meant for serious clinical use. What can randomized testing do for these?

Twine Health and MIT’s Media Lab took the leap into rigorous testing with two leading Boston-area partners in the health care field: a diabetes case study with the Joslin Diabetes Center and a hypertension case study with Massachusetts General Hospital. Both studies compared a digital platform for monitoring and guiding patients with pre-existing tools such as face-to-face visits and email. Both demonstrated better results through the digital platform–but certain built-in limitations of randomized studies leave open questions.

When Dr. John Moore decided to switch fields and concentrate on the user experience, he obtained a PhD at the Media Lab and helped develop an app called CollaboRhythm. He then used it for the two studies described in the papers, while founding and becoming CEO of Twine Health. CollaboRhythm is a pretty comprehensive platform, offering:

  • The ability to store a care plan and make it clear to the user through visualizations.

  • Patient self-tracking to report taking medications and resulting changes in vital signs, such as glycemic levels.

  • Visualizations showing the patient her medication adherence.

  • Reminders when to take medication and do other aspects of treatment, such as checking blood pressure.

  • Inferences about diet and exercise patterns based on reported data, shown to the patient.

  • Support from a human coach through secure text messages and virtual visits using audio, video, and shared screen control.

  • Decision support based on reported vital statistics and behaviors. For instance, when diabetic patients reported following their regimen but their glycemic levels were getting out of control, the app could suggest medication changes to the care team.

The collection of tools is not haphazard, but closely follows the modern model of digital health laid out by the head of Partners Connected Health, Joseph Kvedar, in his book The Internet of Healthy Things (which I reviewed at length). As in Kvedar’s model, the CollaboRhythm interventions rested on convenient digital technologies, put patients’ care into their own hands, and offered positive encouragement backed up by clinical staff.

As an example of the patient empowerment, the app designers deliberately chose not to send the patient an alarm if she forgets her medication. Instead, the patient is expected to learn and adopt responsibility over time by seeing the results of her actions in the visualizations. In exit interviews, some patients expressed appreciation for being asked to take responsibility for their own health.

The papers talk of situated learning, a classic education philosophy that teaches behavior in the context where the person has to practice the behavior, instead of an artificial classroom or lab setting. Technology can bring learning into the home, making it stick.

There is also some complex talk of the relative costs and time commitments between the digital interventions and the traditional ones. One important finding is that app users expressed significantly better feelings about the digital intervention. They became more conscious of their health and appreciated being able to be part of decisions such as changing insulin levels.

So how well does this treatment work? I’ll explore that tomorrow in the next section of this article, along with strengths and weaknesses of the studies.

We’re Just Getting Started with an Internet of Healthy Things (Part 1 of 3)

Posted on November 24, 2015 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The release of Joseph Kvedar’s book The Internet of Healthy Thingscoincided with the 15th annual symposium on Connected Health, which he runs every year and which I reported on earlier. Now, more than ever, a health field in crisis needs his pointed insights into the vision widely shared by all observers: collaborative, data-rich, technology-enabled, transparent, and patient-centered.

The promise and the imminent threat

A big part of Dr. Kvedar’s observations concern cost savings and “scaling” clinicians’ efforts to allow a smaller team to treat a larger community of patients with more intensive attention. As I review this book, shock waves about costs are threatening the very foundations of the Affordable Care Act. Massive losses by insurers and providers alike have led to the abandonment of Accountable Care Organizations by many who tried them. The recent bail-out by UnitedHealth was an ominous warning, eagerly jumped on by Fox News. Although other insurers issued assurances that they stay with the basic ACA program, most are reacting to the increased burden of caring for newly signed up patients by imposing insufferably high deductibles as well as extremely narrow networks of available providers. This turns the very people who should benefit from the ACA against the system.

There is nothing surprising about this development, which I have labeled a typical scam against consumers. If you sign up very sick people for insurance and don’t actually make them better, your costs will go up. T.R. Reid averred in his book The Healing of America: A Global Quest for Better, Cheaper, and Fairer Health Care that this is the sequence all countries have to follow: first commit to universal healthcare, then institute the efficiencies that keep costs under control. So why hasn’t that happened here?

Essentially, the health care system has failed us. Hospitals have failed to adopt the basic efficiency mechanisms used in other industries and still have trouble exchanging records or offering patients access to their data. A recent study finds that only 40% of physicians shared data within their own networks, and a measly 5% share data with providers outside their networks.

This is partly because electronic health records still make data exchange difficult, particularly with the all-important behavioral health clinics that can creat lifestyle changes in patients. Robust standards were never set up, leading to poor implementations. On top of that, usability is poor.

The federal government is well aware of the problem and has been pushing the industry toward more interoperability and patient engagement for years. But as health IT leader John Halamka explains, organizations are not ready for the necessary organizational and technological changes.

Although video interviews and home monitoring are finding footholds, the health industry is still characterized by hours of reading People magazine in doctors’ waiting rooms. The good news is that patients are open to mobile health innovations–the bad news is that most doctors are not.

The next section of this article will continue with lessons learned–and applied–both by Dr. Kvedar’s organization, Partners Connected Health, and by other fresh actors in the health care space.

Connected Health Conference Tops Itself–But How Broad is Adoption? Part 1 of 3

Posted on November 5, 2015 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

Along the teeming circuit of health care conferences that Boston enjoys year-round, a special place is occupied by the Connected Health Conference sponsored by Massachusetts giant Partners HealthCare. For 12 years this conference, shepherded by the spirited Joseph Kvedar, has shown Boston and the rest of the world what can be accomplished by the integration of data, technology, and clinical empathy.

But people I talked to at the conference were asking: where’s change visible in the health care field? Why aren’t we seeing these great things adopted throughout the country to support value-based care? The much-vaunted Accountable Care Organization model is failing to thrive, interoperability continues to elude medical sites, and consequently, health care costs are “eating” American’s incomes.

The way forward may have been shown by the two final keynotes of the conference, delivered by executives at Massachusetts General Hospital (one of the central institutions in Partners HealthCare and a destination for patients around the world).

Chief Clinical Officer Gregg Meyer referred to “punctuated evolution” to suggest that the health care field is at an “inflection point” where change is starting to happen fast. What makes this change hard is that two major initiatives separate most health care institutions from the fee-for-value world we want. One initiative focuses on organizational change and payment regimes, whereas the other involves wrenching changes to technology that track, record, and analyze what doctors and patients are doing.

I believe the reason many ACOs and other fee-for-value systems are failing (or at least not showing cost improvements) is that they took on the organizational change before they were ready with the technological parts. According to Meyer, Massachusetts General Hospital took on the technological change first, years before a payment system was offered that reimburses them for it.

Many speakers at the conference pointed to recent payment changes, such as Medicare Advantage, that promote fee-for-value. Programs along those lines in Massachusetts have shown modest headway against costs.

Even so, MGH has made only some early steps in health IT. Some doctors allow virtual visits, but it’s not done strategically and most providers don’t understand that such visits could reduce their workloads in the long run. Chief Health Information Officer O’Neil Britton said that the Epic EHR they installed still can’t accept streaming data. But he vaunted MGH’s growing use of genomics, wearables, video information delivery, and telehealth. The use of video was praised frequently at the conference for bringing information to people when they need it and reducing office visits that are costly and inconvenient for everyone.

The next section of this article will contrast techno-optimists with techno-skeptics and mention some advances reported at the conference.

Treating a Healthy Patient

Posted on November 21, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I first coined the concept of what I call treating a healthy patient back in 2011. I’ve always loved the concept of a doctor actually treating someone who thinks and feels completely healthy. The challenge is that this type of relationship is very different than what we have in our current health system today.

While our current model is very different, I’m hearing more and more things that get me back to healthcare treating an otherwise healthy patient. Although, someone recently pointed out to me that we’re not really treating a healthy patient, because we’re all sick. We just each have different degrees of sickness. It’s a fine point, but I still argue we’re “healthy” because we feel “healthy.”

This analysis points out one layer of change that I see happening in healthcare. This change is being able to detect and predict sickness. Yes, that still means a doctor is treating a sickness. However, I see a wave of new sensors, genetics, and other technology that’s going to absolutely change what we define as “sick.”

This is a massive change and one that I think is very good. I recently read an article by Joseph Kvedar which commented that we’re very likely to seek medical help when we break our arm, because the pain is a powerful motivating factor to get some help. Can this new wave of sensors and technology help us know the “pain” our bodies are suffering through and thus inspire us to seek medical attention? I think they will do just that.

The problem is that our current health system isn’t ready to receive a patient like this. Doctors are going to have to continue to evolve in what they consider a “disease” and the treatment they provide. Plus, we’ll likely have to include many other professionals in the treatment of patients. Do we really want our highly paid doctors training on exercise and nutrition when they’ve had almost no training in medical school on the subjects? Of course, not. We want the dietitian doing this. We’ll need to go towards a more team based approach to care.

I’ve regularly said, “Treating a healthy patient is more akin to social work than it is medicine.” Our health system is going to have to take this into consideration and change accordingly.

Treating a healthy patient won’t solve all our healthcare problems. In fact, I’ve wondered if in some ways treating a healthy patient isn’t just shifting the costs as opposed to lowering the costs. Regardless of the cost impact, this is where I see healthcare heading. Yes, we’ll still need many doctors to do important procedures. Just because you detect possible heart issues doesn’t mean that patient won’t eventually need a heart bypass surgery some day. In fact, a whole new set of medical procedures will likely be created that treat possible heart issues before they become straight up heart issues.

What other ways do you see the system moving towards or away from “treating healthy patients”?