Author Archives: Al Shar

Time to Evolve Health Care's Gold Standard? Thoughts From 2011 Mobile Health Health Conference

May 9, 2011, 5:25 AM, Posted by Al Shar

What does "works" mean? Like many things that seem superficially simple, the reality is much deeper. When BJ Fogg chose that as his theme and condition for the recent Mobile Health 2011 conference, he set the bar very high. The good news is that at some level the sessions all had an aspect of things working.

But there was some not so good news as well. Many still see Randomized Controlled Trials (RCT) as the universal and exclusive gold standard for evidence.  For a number of reasons, I think that's unfortunate in the mobile health field. First, to be realistic, the time scale for testing an mHealth intervention needs to be short, often on the order of at most 90 days. That will not provide sufficient evidence for dealing with a long term chronic illness where the time scale is measured in years, not days. I believe that many mobile health treatments that work in the short term will not be sustained long term, unless they change – and change is something that is generally not part of an RCT model.

Second, RCTs generally take a long time and require a fixed methodology, something that doesn't make much sense when dealing in a space where the technology is rapidly changing. By the time you can reach a conclusion, the intervention is often obsolete.

Finally, and perhaps most importantly, by its nature, mobile technology generates a large amount of data that can't be well controlled and is generally discarded (or ignored) in an RCT. Medicine may be the only field that I know of where we discard real life data in favor of clean, laboratory controlled measures. Imagine if the manufactures and maintainers of jet engines relied only on controlled tests and ignored measuring the real world wear and tear on an engine. If that were the case, I would certainly fly a lot less.The United States dropped the monetary gold standard in 1933. Isn't it about time that we at least consider the same thing for medicine?

We recognize this, as do others, and an mHealth Evidence meeting that we are cosponsoring with National Institutes of Health, McKesson, Department of Health and Human Services and the National Science Foundation on August 16 is focused on dealing with this directly. I'm happy to say that the response to the call for white papers for the mHealth Evidence workshop was such that the flyers I brought to Mobile Health 2011 were insufficient to meet the demand, and copies had to be made, not once, but twice.

Luckily, there were enough people with whom this resonates.

You can submit a white paper here on our website. If yours is accepted, you will be invited to attend the mHealth Evidence workshop (travel support will be provided).

Hope to see you there!

Examining Innovation Through a Different Lens

Apr 21, 2011, 1:32 AM, Posted by Al Shar

Last week I had the opportunity to participate in the International Business Forum’s first Digital Healthcare Innovation Summit, which was held in New York City (Pioneer was a sponsor of the event). The sessions were good and had valuable content, but rather than rehash them, I will focus on those things that I learned about how some leaders in fields outside of health and health care think and work. Unlike many of the meetings we attend, this one was “created for all private equity investors and healthcare professionals to capitalize on the transformation of the healthcare industry.” This focus seemed offer a potentially different approach to technologies that can effectively support healthcare.

And while, superficially, the meeting was quite a bit like many others I’ve attended, there are a number of subtleties that are important and might help us in our work here.

  1. Finding a niche in which one can make inroads is more likely to succeed than a full on confrontation. A successful business strategy must be pragmatic.
  2. While high tech and wiz-bang solutions may excite, looking at good, stable and proven technologies used innovatively stands a better chance of adoption.
  3. Fail early; be prepared to walk away before considering multiple alternatives that might work. Don’t become too committed to either the idea or the constituency that might benefit.
  4. Be adaptable; be prepared to grow a small and peripheral kernel of a much bigger project. Major successes can grow from components that begin as ancillary to the main concept.
  5. Make sure that the right people are involved.

I think we in Pioneer do a fair amount of thinking along these same lines, but sometimes with what are likely to be different outcomes. For example, with regard to number one above, while we understand the value of finding a safer place to begin innovation, we seem to be more willing to directly confront conventional wisdom. With regard to number two, I think we’re more ready to look to a more unproven and less well vetted technology, with the belief that the technology will mature and become more stable. As for the third point, because the good that could come from success is so compelling, we sometimes are more unwilling to just walk away. While I can cite some major projects (most notably Project Echo and Changemakers) that have come somewhat unexpectedly from others, we don’t tend to look at the small opportunities that may emerge from grander visions. Finally, while we certainly want the right people involved, we’re unlikely to take the innovators and, as a condition of funding, make them turn over the enterprise to another.

Are these changes that we should make? I don’t think so. We are different and our measures of success need to be different as well. However, understanding the world and the way innovation can be supported by early and mid stage investors can help inform us in seeking breakthroughs with the potential to generate significant health and social impact.

Time to Accelerate Innovation: Takeaways from this Year's mHealth Summit

Nov 10, 2010, 6:03 AM, Posted by Al Shar

I just returned from the mHealth Summit in Washington, D.C. We’ve been sponsors of the event for 2009 and 2010 – both years it’s been held. Last year there were about 400 people who attended. This year there were about 2,500, including prominent guest speakers like Francis Collins, Bill Gates and Aneesh Chopra, among others. There was also a large hall with lots of exhibitors and an extensive poster session. I guess this means that means mobile health is coming of age.

I liked it a lot, but not for the reason you might think. At most of these types of events the presentations tend to expand on the great things that are going on in the field. Here there was a good, healthy dose of skepticism. And there’s a lot to be skeptical about. There are the “show me” skeptics, the ones that ask for evidence that it actually works. There are the regulation skeptics, the ones who know the problems in getting devices approved by the responsible government agencies. There are the “disruptive innovation won’t work here” skeptics. There are the “who will pay for it?” skeptics, not to mention the standards, open source, proprietary, silo, etc. skeptics. It makes my head spin and wonder how we’ll ever get there.

There are two reasons I’m still optimistic. First, in spite of all this, the field is growing and there are big players in the field. Second, many of the issues are starting to be formally addressed at what seems to be appropriate levels. That’s good. There is an area where I think more can be done, and that’s in developing better methods for validation and evidence. There’s still a huge emphasis on the traditional clinical trials model, which sets up a fixed and structured experiment, collects data over a period of time, consolidates and analyzes the data at the end of the trial, and, after a long period of time (maybe five years), reports the outcome.

The field shouldn’t have to wait five years to understand the effects of what by then will be an obsolete intervention. In addition, this is a field where there should be continuous improvement, where tinkerers thrive, where prototypes are the rule. It makes little sense to freeze development when you learn something that will make it better. One solution might be the type of adaptive trial that pharmaceutical companies are investigating. This is one where results at various stages in a trial can effect changes in the trial model. You might change the sample size, the target population, the delivery method, the formulation, etc., based upon analyzing data internal or external to the experiment. Analysis of this model is complex but can be manageable. In the end you should be able to deliver a safer, more effective product sooner.

That’s the germ of one idea for being able to develop an evidence base for mHealth quicker and better than today. These are my thoughts. I’m sure that there are smart and thoughtful people who have others.

TEDMED 2009 = Innovation, Technology & Inspiring Stories

Nov 2, 2009, 2:35 AM, Posted by Al Shar

I really liked TEDMED. There was lots of wiz-bang new technology stuff – genetics, organ regeneration, ways to slow the aging process, wearable sensors that can monitor and wirelessly transmit data that traditionally required a person to be in a controlled environment with leads connected to multiple body locations. It’s really exciting to see what may be possible in a few short years. Of course, no one really talks about how long it will take, how real people will be able to use these gadgets and how they’ll be paid for.

There are also great stories of human accomplishments – either overcoming tremendous adversities to triumph or innovative and caring ways to help others. Every one of the presentations is worthy of commentary. In addition, it’s amazing to realize the number of incredibly smart people that were there. Not only are they smart but each has accomplished more than one might expect, even given their brain power. And many of them are truly nice and approachable.

For me the highlight of the event was Jamie Heywood talking about the Patients Like Me site. The reason for this is less that they are using some pretty impressive analyses but more that you have a platform where ordinary people can record their experiences with their conditions and treatments in a way that contributes to a shared and actionable understanding, without expert clinical intervention. The reality is that right now this helps each participant deal with her or his condition. In addition, it is beginning to yield data that can expand clinical knowledge faster and more broadly than traditional methods. Whether the scientific community can learn how to make use of that data seems to me a question of how open the professionals are to exploring nontraditional sources. I certainly hope they are.

Better Informed Managers of Our Health

Oct 21, 2009, 5:10 AM, Posted by Al Shar

Most of what I read and almost all of what I believe is that we, as individuals, must assume primary responsibility for managing our health. I'm also told that I need to become a more informed consumer when making health and health care decisions. As a person who's spent a good part of my career doing research I think that I'm more ready than most to investigate, consider and make informed decision. However, no matter how ready I am, no matter how skilled I am at analytic reasoning, I can not make an informed decision if the information is not available to me.

I know that some of the data is hard to acquire and may be harder to analyze. It is difficult even for hospitals to predict the total cost to the patient of a hospital stay. For drugs used to treat many conditions it can be hard to understand the cost versus the benefit, especially where there are competing choices. The prescription drug situation is further complicated by the fact that there is so much direct to consumer advertising of patent medicines that almost never reveal enough data to make an informed decision.

The perspective article in the recent New England Journal of Medicine discusses the fact that, although the FDA collects and makes available what may be extremely important information about prescription drugs, it does so in a relatively haphazard way. The authors, Lisa M. Schwartz, M.D., and Steven Woloshin, M.D. have developed a format for a "Prescription Drug Facts Box" that has been shown to provide clearer, more actionable information to consumers. We funded an FDA pilot of the Facts Box and, most recently, the FDA's Risk Advisory Committee recommended that the FDA adopt these boxes as the standard for their communications. It seems to me that this is one relatively straight forward way that we can become better informed managers of our health.