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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.

Hospitals Still Struggling With HIE Data Sharing

Posted on September 30, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Hospitals are trying hard to make HIEs work, but establishing robust data exchange remains a major challenge, particularly given the difficulty involved in processing paper records, a new study by HIMSS Analytics suggests.

The report, sponsored by ASG Software Solutions, draws on a survey of 157 senior hospital IT executives.

More than 70 percent of respondents to the survey reported that they participated in an HIE with other hospitals and health systems.

The thing is, the facilities reported that they’re having difficulty exchanging patient information in meaningful, powerful ways. Also, survey respondents noted that sharing information outside of HIEs is held back by budget concerns and staffing problems.

Juggling electronic and paper-based data is still a major issue, the study suggests:

* 64 percent of health information organizations reported that they shared data with nonparticipating hospitals via fax
* 63 percent of the same organizations converted faxed information into digital form via scanning
* 84 percent of respondents integrated their output/print environment directly into their EMR/HIS system
* 42 percent of survey respondents said their output/print environment was “high effort”

Unfortunately for HIE fans, coordination and management of paper records is far from the only issue standing in the way of making them work acceptably in a hospital environment.

According to a study by Chilmark Research, the focus of most HIEs is still on secure clinical messaging, which doesn’t do the job for cross-enterprise care coordination. The Chilmark research estimates that queries of databases for patient information needed at the point of care account for just 2 percent to 10 percent of HIE transactions overall.

As Chilmark CEO John Moore recently told Information Week, the problem is particularly acute in ambulatory care. Most ambulatory EMRs haven’t been able to generate CCDs that other EMRs can consume or execute queries using a record locator service. This is a pretty serious weakness in the HIE space, given that 80 percent of care takes place in ambulatory setting.

Given their importance, it’s troubling to see how many obstacles remain to robust HIE use by hospitals and physicians. Let’s hope the next 12 months see some breakthroughs.

HIEs Unable To Keep Up With User Demands

Posted on August 7, 2013 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

While HIEs are expanding their offerings to include analytic and care coordination functions useful for population health management, they aren’t doing it quickly enough to meet market demand, according to a piece in Information Week.

The IW story, which outlines the conclusions of a new report from Chilmark Research, notes that the focus of most HIEs is still on secure clinical messaging, which is not adequate for cross-enterprise care coordination. The Chilmark report estimates that queries of databases for patient info needed at the point of care account for just 2 percent to 10 percent of HIE transactions overall.

Information Week also drew attention to a study appearing in Health Affairs noting that the most common functions of the 119 operational public HIEs were transmitting lab results, clinical summaries and discharge summaries. While there’s been a large increase in the number of HIEs that can exchange Continuity of Care Documents, few EMRs can integrate the data components of CCDs in to structured fields, the Health Affairs piece noted.

The problem is particularly acute in ambulatory care. As Chilmark CEO John Moore told Information Week, most ambulatory EMRs haven’t been able to generate CCDs that other EMRs can consume or do queries using a record locator service. “The value that HIEs provide to the ambulatory sector, where 80 percent of care takes place, is pretty limited,” Moore told IW.

Still, despite their weaknesses, public HIEs continue to hold onto life. For example, as various industry stats have shown, hospital CIOs increasingly see participation in an HIE as a key initiative, if nothing else because Meaningful Use will eventually demand interoperability.

But as the Chilmark study emphasizes, HIEs have a long way to go before they’re making a major contribution to patient care. And getting enough momentum to address these problems seems elusive. All told, while HIEs are clearly an important movement, getting them to the point of true usefulness could take years more.

HIMSS #NHITWeek e-Book

Posted on September 18, 2012 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 was happy to be invited to participate in the HIMSS #NHITWeek e-Book. They just recently posted the HIMSS ProBook (PDF) which includes mine and 17 other health IT experts responses. It’s nice to see my name alongside wonderful health IT pros like Regina Holliday, John Moore, and Eric J. Topol (to name a few). You can find my responses on page 26-27 in the e-book or I’ve posted my responses below.  I kind of got this last minute, so my responses are a bit off the cuff.  I’d love to hear your thoughts or your responses to these questions.

1. How has the conversation about health IT evolved and / or progressed since last year’s National Health IT Week?

With the announcement of meaningful use stage 2, we’re starting to see a real dividing line between those healthcare organizations that plan to show meaningful use of a certified EHR and those organizations that plan to stay far away from it. All but a few smaller hospitals are getting on board with EHR because the EHR incentive money is so large. In smaller practices, many are still afraid that EHR will slow them down, decrease their productivity, and cause them more headache than the value it will provide.

With EHR incentive money dominating the EHR discussions, ACOs are also drawing a lot of attention and discussion in the world of health IT. Everyone seems to realize that if we’re going to make ACOs a reality, then it’s going to take a heavy dose of well implemented health IT. The increase in discussion happening around health data warehouses has really increased and more and more health organizations are trying to find was to pull value out of all the data that’s now being stored in their health IT systems.

Mobile Health is still the wild wild west. Mobile health apps are popping up in every corner of the mobile world. However, we still don’t have any breakout mobile health app superstars which have captivated the imagination of the world. Considering the number of apps, one of them is bound to reach that point soon.

2. What are the major challenges to hospitals and healthcare providers as we move toward a new century of health technology?

I’ve often said that health IT is the great magnifier. Health IT will take the good and make it better, but it will also point out the bad just as easily. What I think the implementation of health IT has done is caused many healthcare organizations wake up to some of the problems they never realized they had. Overcoming much of the built in healthcare problems is going to be the biggest challenge to the implementation of health technology.

Along similar lines, the biggest built in problem in healthcare IT is the walled gardens which create incredibly difficult to access data silos. Much like a President once famously said, “Healthcare, take down your walls.” Unfortunately, there doesn’t seem to be any authority that can make such a strong statement. Breaking down the walls surrounding healthcare data is going to be an almost insurmountable challenge.

One other major challenge we’ll see and we’re starting to see already is how to handle the literal flood of healthcare data. Floods of data will be pointed at health care providers from HIEs, PHR’s, medical devices, genomics, etc. Creating IT systems which process all the data into a digestible format will be key to the future of healthcare.

3. How can we increase adoption and meaningful use of health IT in hospitals and health systems across the U.S.?

I think we need a fundamental change in how we define meaningful use. The current definition of meaningful use might provide benefits to healthcare in general, but I know very few hospitals and health systems that see value in what HITECH has defined as meaningful use.

The hospitals and health systems I talk to see meaningful use of an EHR as improved patient care, improved revenue integrity, and streamlined processes. This is a much different definition of “meaningful” use of EHR. Once EHR vendors achieve this type of meaningful, healthcare won’t know how to live without it.

4. What advice would you give to the next generation of health IT leaders and their role in improving our healthcare system through advancement of IT?

My advice is that “when you’re a hammer, everything looks like a nail.” To make the comparison, just because you’re an IT leader doesn’t mean that IT is always the solution. Sometimes the solution is to fix the process first. Applying IT to bad processes just makes things worse. Be thoughtful in when and where you implement health IT. IT has tremendous potential, but only when applied the right way to the right problems.

5. What’s one thing the general public should know about health IT that they do not already, and what’s an easy way for them to get involved?

I believe the general public doesn’t realize the power they yield. Patient demand is likely the most powerful force in healthcare. If enough patients requested online patient scheduling, we’d see more doctors providing online patient scheduling. If more patients demanded e-visits, we’d see more e-visits. Patients need to stop accepting the current method of care delivery and start caring more about the healthcare services they receive.

6. What’s one health technology you are most excited about?

I’m absolutely fascinated with non-obtrusive health monitoring devices. It’s amazing how much health data can be collected with a simple cell phone camera. Everything from pulse, blood pressure, and cholesterol can potentially be monitored with a digital camera. Plus, we’re just at the beginning of the health monitoring that will occur using a person’s cell phone.

7. Fill in the blank. Health IT is _________________
Health IT is integral to the future of healthcare.

Those were my responses. You can find the other 17 responses to these questions in the HIMSS ProBook (PDF).

Steve Jobs and Healthcare IT – EMR

Posted on October 7, 2011 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 like I’m sure many of you have been a bit overwhelmed by the amazing outpouring of love that’s happened after the passing of Steve Jobs. It was weird for me, because I knew that Steve Jobs health wasn’t good but I was still a bit shocked to see on Twitter that he’d passed away. Certainly a major loss for his family, but the effect will be felt well beyond them.

I’ve been touched by a number of posts throughout the healthcare IT and EMR blogosphere. Here’s a roundup of a few of the Steve Jobs posts I found.

Jim Tate did a post that considers what if Steve Jobs had developed an EHR. Here’s one section:

For the past 5 years I’ve kept hoping that Apple would develop an EHR. One that when someone first used it they would say: “Yes, this is how it should be”. Whatever he developed and released to the world didn’t even need an owner’s manual. It just worked in a very human way.

I know I’ve written about the possible Apple EHR as well and what it might look like. As I read Jim’s post I couldn’t help but wonder if the reason Steve Jobs didn’t take on a project like an EHR was because our regulations and reimbursement don’t work in a human way.

Dr. Liu on Kevin MD wrote a post about Steve Jobs as a physician mentor. I love the idea that Steve Jobs was his mentor even though they never met. He offered this heartfelt thought:

I as a doctor I’m incredibly sorry that medicine has not yet evolved to the point that a cure exists for the rare type of cancer Jobs. I’m sorry that he is so ill at an incredibly young age, in his mid 50s, when many people begin to contribute even more to society with all of the knowledge and experience they’ve acquired. The future might be a little less bright without Jobs leading his team at Apple on creating products and experiences none of us truly knew existed until he showed them to us.

It is such a shame that he died so young. In fact, I’d say that might be the hardest part of it all.

The self professed Mac Fan boy, John Moore from Chilmark research, paid a tribute as well. He highlights some of the key things that Steve Jobs did with Apple products:
-Design aesthetics combined with functionality rule
-Supporting a renegade
-Systems rather than parts
-Supporting innovation

Yep, Steve Jobs will be missed in healthcare and well beyond.

Google Health Resets…errr…Put on Ice?

Posted on May 12, 2011 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.

The always insightful John Moore (so many great John’s in Healthcare IT), posted a great blog post back in September of 2010 about Google Health hitting the reset button. The post was interesting as it tried to show Google Health going in a new direction. The irony was that almost a year ago John had posted about Google Health’s irrelevancy in the PHR market.

Despite the up downs of Google Health, today John put Google Health in Stasis. He sights a great list of yellow and dark orange flags that are a bad sign for those who love Google Health. Here’s one section from his post:

Beginning in late March 2011, we started hearing the rumors of the impending demise of Google Health once again (is this becoming some sort of annual thing with Google Health?). We waited a few weeks to see if the rumors would die down, they did not. We put a call into Google Health to set up a briefing, get an update. Response back was slow (one yellow flag). When they did get back to us, they said it will be at least a couple of weeks (two yellow flags). Next, our Google contact told us by email that they were going to hand Chilmark’s inquiry off to Google’s PR department (screaming dark orange flag). And now today, we received an email from one of Google Health’s most visible spokespersons, Missy Krasner that she is leaving Google.

He then projected that we shouldn’t “expect anything new out of Google Health for at least the next 5 years.” That’s quite the projection. However, I’d take it one step further. I don’t expect to see anything really mainstream out of PHR software for another 5 years either.

I do think that PHR software is going to have a strong showing in chronic patients. I could also see an interesting niche in secondary caretaker healthcare management using a PHR (I’ve got an interesting announcement about baby boomer healthcare coming soon). I definitely want an online means for tracking my parents healthcare. Not to mention, then all of my brothers and sisters could participate as well. A few other niches are likely to be successful as well. Not to mention, other consumer PHR-like applications for healthcare that will become popular like the Nike+.

The Demise of Google Health and Consumer PHR

Posted on May 31, 2010 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 was really interested to read John Moore’s post about the irrelevancy of Google Health leading to its demise. It’s a great post that’s worth a read for anyone interested in the PHR space and in particular Google’s participation in healthcare. I’m a little reticent to bet against Google, but the lack of commitment on Google’s part to healthcare says something. I mean, Google has quite a bit going on with cell phones (Android), web browsers (Chrome), and operating systems (Chrome) just to name a few. You can see why Google Health isn’t high on their priority list. Oh yes, and of course they still have to maintain their dominance in search and all the other products they have (gmail, google docs, calendar, etc etc etc).

With that said, some of the most interesting things were found in the comments of Chilmark’s post. Here’s a couple excerpts:

My college health class used car upkeep as a metaphor for how we take care of our health. With my car, I know I should pay more attention to everything: it’d probably run better if I looked at it more, kept up with the latest from my manufacturer (hey, actually read my owner’s manual).
But honestly? I’m just as happy to pay a mechanic to keep track of what I need, when I need it. The money I pay is as much to escape the tedium of keeping up with all that knowledge as it is for the service itself. I’m willing to bet a lot of people feel that way about health: they probably believe they should be involved, but when push comes to shove they’d rather just pay someone else to worry about it.

This rings far too true. We care, but not enough to really care (at least until we really need to care).

I belive what we are seing here is the end of the B2C direction for PHR. John Moore was the 1st to say that PHR is for B2B model. Google designed it’s solution for B2C (login to data through Google). this was wrong. if you see real addade value apps in the market they are offred as B2B under Microsoft HealthVault.

PHR = B2B Very important lesson learned.