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Implementation May Be a Science, But, Alas, Medicine Remains an Art

By KIM BELLARD

I’ve been working in healthcare for over forty (!) years now, in one form or another, but it wasn’t until this past week that I heard of implementation science.  Which, in a way, is sort of the problem healthcare has. 

Granted, I’m not a doctor or other clinician, but everyone working in healthcare should be aware of, and thinking a lot about, “the scientific study of methods to promote the systematic uptake of research findings and other EBPs into routine practice, and, hence, to improve the quality and effectiveness of health services” (Bauer, et. al). 

It took a JAMA article, by Rita Rubin, to alert me to this intriguing science: It Takes an Average of 17 Years for Evidence to Change Practice—the Burgeoning Field of Implementation Science Seeks to Speed Things Up.

It turns out that implementation science is nothing new. There has been a journal devoted to it (cleverly named Implementation Science) since 2006, along with the relatively newer Implementation Science Communications. Both focus on articles that illustrate “methods to promote the uptake of research findings into routine healthcare in clinical, organizational, or policy contexts.” 

Brian Mittman, Ph.D., has stated that the aims of implementation science are:

  • “To generate reliable strategies for improving health-related processes and outcomes and to facilitate the widespread adoption of these strategies.
  • To produce insights and generalizable knowledge regarding implementation processes, barriers, facilitators, and strategies.
  • To develop, test, and refine implementation theories and hypotheses, methods, and measures.”

Dr. Mittman distinguished it from quality improvement largely because QI focuses primarily on local problems, whereas “the goal of implementation science is to develop generalizable knowledge.” 

Ms. Rubin’s headline highlights the problem healthcare has: it can take an alarmingly long time for empirical research findings to be incorporated into standard medical practice.  There is some dispute about whether 17 years is actually true or not, but it is widely accepted that, whatever the actual number is, it is much too long.  Even then, Ms. Rubin reminds us, it is further estimated that only 1 in 5 interventions make it to routine clinical care.  

Continue reading…

THCB Spotlight: Glen Tullman, Transcarent & Aneesh Chopra, Carejourney

No THCB Gang today because my kid is in the hospital (minor planned surgery) So instead I am reposting this great interview from last week.

I just got to interview Glen Tullman, CEO Transcarent (and formerly CEO of Livongo & Allscripts) & Aneesh Chopra, CEO Carejourney (and formerly CTO of the US). The trigger for the interview is a new partnership between the two companies, but the conversation was really about what’s happening with health care in the US, including how the customer experience needs to change, what level of data and information is available about providers and how that is changing, how AI is going to change data analytics, and what is actually happening with Medicare Advantage. This is a fascinating discussion with two real leaders in health and health tech — Matthew Holt

Trump As Catalyst For Legal and Cultural Reform

BY MIKE MAGEE

Former President Donald Trump’s indictment this morning reinforces most Americans’ belief that “No man is above the law.” But few of us have taken the time to explore what that statement means when it comes to building a healthy nation, and why we believe it.

How do you create a healthy nation? 

This is at once a very simple and a very complex question. It is at the heart of successful and failed nation building. 

It applies equally to a self-assessment of our approach to rebuilding Germany and Japan as part of the Marshall Plan after WW II, and to our own struggles with autonomy and disparity in America where our very beginnings were (and continue to be) marred by a history of enslavement of blacks, forced migration and cultural destruction of Native Americans, and subjugation of women.

The law, a blend of agreed upon rules, regulations and boundaries, arose in layers over time, and reflected the communities where they emerged. Our own American legal system, on which we relied to launch this nation-building exercise in 1776, is dynamic and continues to evolve to this day. 

As legal historian Lawrence Friedman wrote, “Despite a strong dash of history and idiosyncrasies, the strongest ingredient in American law at any given time is the present – current emotions, real economic interests, and concrete political groups.” It is then “a study of social development unfolding through time…”

When building a nation, some countries like France and Germany, relied on written codified rules, statutes or “rational instruments” on which they leaned to create order and to base decisions. But our laws, upon which this nation was built, if they have a basis, were descendant from British law.

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I Have No Mouth, Yet Still I Scream

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BY KIM BELLARD

In light of the recent open letter from AI leaders for a moratorium on AI development, I’m declaring a temporary moratorium on writing about it too, although I doubt either one will last long (and this week’s title is, if you hadn’t noticed, an homage to Harlan Ellison’s classic dystopian AI short story).  Instead, this week I want to write about plants. Specifically, the new research that suggests that plants can, in their own way, scream. 

Bear with me.

To be fair, the researchers don’t use the word “scream;” they talk about “ultrasonic airborne sounds,” but just about every account of the research I saw used the more provocative term.  It has long been known that plants are far from passive, responding to stimuli in their environment with changes in color, smell, and shape, but these researchers “show that stressed plants emit airborne sounds that can be recorded from a distance and classified.”  Moreover, they posit: “These informative sounds may also be detectable by other organisms.”  

It should make you wonder what your houseplant is saying about you when you forget to water it or get a cat.  

They basically tortured – what else would you call it? – plants with a variety of stresses, then used machine learning (damn – I guess I am writing about AI after all) to classify, with up to 70% accuracy, different categories of responses, such as too much water versus too little.  Even plants that have been cut, and thus are dying, can still produce the sounds, at least for short periods.  They speculate that other plants, as well as insects, may be able to “hear” and respond to the sounds.

Continue reading…

Can American Democracy Pass The Trump Stress Test?

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BY MIKE MAGEE

As we enter a new and potentially historic week, with a former President doing his best to reignite a Civil War in our nation, we do well to take a breath and reread James Madison’s words from Federalist No. 51. But first, a few words of history.

When it came to checks and balances in this new national experiment in self governance, the Founders, while establishing three co-equal branches, left one of those branches the task of defining by practice its own power and influence.

The new Constitution in 1787 awarded one branch, the elected Congress, the daunting power to impeach, convict and remove representatives or appointed federal officials for due cause up to the President himself. But it also empowered a second branch, the Executive, through its President, veto power to check legislative excesses and the privilege of initiating appointments to the federal judiciary. Only the third branch of the government, the Judiciary, was left deliberately “elastic,” destined to grow into “the triangle of power.”

Thirteen years later, on February 17, 1801, Congress was forced to break a tie in the Electoral College vote, resolving a Constitutional crisis and declaring a victor in one of “the most acrimonious presidential campaigns” in U.S. history. Thomas Jefferson was awarded the victory, and John Adams acquiesced and was sent packing a month later. But two days before he departed, Adams unloaded multiple appointments of circuit justices and justices of the peace which the U.S. Senate quickly confirmed on March 3rd. In the rush, Adam’s Secretary of State, John Marshall (soon to become Chief Justice Marshall of the Supreme Court under President Jefferson) didn’t have time to complete a final necessary step, delivering the commissions, to some of the appointees.

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THCB Gang Episode 122, Thursday March 30

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday March 30th at 1PM PT 4PM ET are Olympic rower for 2 countries and DiME CEO Jennifer Goldsack, (@GoldsackJen); patient safety expert and all around wit Michael Millenson (@mlmillenson); benefits expert Jennifer Benz (@Jenbenz); and our special guest health economist & Chief Research Officer at Trilliant Health, Sanjula Jain @sanjula_jain.

If you’d rather listen, the “audio only” version is preserved as a weekly podcast available on our iTunes & Spotify channels — Matthew Holt

AI: Not Ready, Not Set – Go!

By KIM BELLARD

I feel like I’ve written about AI a lot lately, but there’s so much happening in the field. I can’t keep up with the various leading entrants or their impressive successes, but three essays on the implications of what we’re seeing struck me: Bill Gates’ The Age of AI Has Begun, Thomas Friedman’s Our New Promethean Moment, and You Can Have the Blue Pill or the Red Pill, and We’re Out of Blue Pills by Yuval Harari, Tristan Harris, and Aza Raskin.  All three essays speculate that we’re at one of the big technological turning points in human history.

We’re not ready.

The subtitle of Mr. Gates’ piece states: “Artificial intelligence is as revolutionary as mobile phones and the Internet.” Similarly, Mr. Friedman recounts what former Microsoft executive Craig Mundie recently told him: “You need to understand, this is going to change everything about how we do everything. I think that it represents mankind’s greatest invention to date. It is qualitatively different — and it will be transformational.”    

Mr. Gates elaborates:

The development of AI is as fundamental as the creation of the microprocessor, the personal computer, the Internet, and the mobile phone. It will change the way people work, learn, travel, get health care, and communicate with each other. Entire industries will reorient around it. Businesses will distinguish themselves by how well they use it.

Mr. Friedman is similarly awed:

This is a Promethean moment we’ve entered — one of those moments in history when certain new tools, ways of thinking or energy sources are introduced that are such a departure and advance on what existed before that you can’t just change one thing, you have to change everything. That is, how you create, how you compete, how you collaborate, how you work, how you learn, how you govern and, yes, how you cheat, commit crimes and fight wars.

Professor Harari and colleagues are more worried than awed, warning: “A.I. could rapidly eat the whole of human culture — everything we have produced over thousands of years — digest it and begin to gush out a flood of new cultural artifacts.”  Transformational isn’t always beneficial.

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Matthew’s health care tidbits: The drug model for DTx was wrong

Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

If you were to look at pharmaceuticals in the US you might make three observations. 1) They are the most important way health conditions are helped, cured or eradicated. 2) The way they are delivered to patients (via pharmacies) is very badly integrated with the health care delivery system. 3) They are way too expensive.

OK, so those are my observations not yours but I think you’ll agree they’re all true.

Now I am going to tell you that we’ve developed a technology that lives in your phone that has the same impact as a drug, if not better. It will cure your depression, insomnia, pain, even maybe Alzheimer’s. And because it is a software product, not a drug you ingest, it has no (or at least few) dangerous side effects. And because it’s software and easy to distribute to millions of people, it can be cheap. Wouldn’t it be a great idea for the people managing health conditions—a patient’s clinical care team—to directly integrate this technology into the care they are delivering?

Some of the people building these technologies agreed, but most of them decided that they liked the current model of prescription pharmaceuticals. They built these cool technologies and decided to distribute them via physician prescriptions and charge for them like pharmaceuticals. To do that, they had to get FDA approval for their “Prescription Digital Therapeutics” (DTx) via expensive clinical trials. Additionally, of course, they hoped to get government-backed monopoly status–called patents in the pharma business.

In general in health care, the FDA regulates things that go into the body and may cause damage. The rest of clinical medicine has great latitude for experimentation, technique and technology development, and allows others to copy what works.

The companies heading down the Prescription DTx route also used the business model of regular pharma and biotech companies. They raised large amounts of money up front, applied for patents, went through the FDA clinical trial process, and hoped to charge significant amounts per patient once their DTx were approved and prescribed.

None of them seemed to care that if they succeeded, their DTx would necessarily only be accessed by a small population at great cost. None of them seemed to notice that their DTx were usually an electronic distillment of teaching, patient advice, coaching therapy or other activities that look more like extensions of traditional clinical care, as opposed to ingested pharmaceuticals.

Many of these companies are now in deep trouble. They raised money when it was cheap or even, like Pear and Better Therapeutics, took advantage of the SPAC vehicles to IPO. Now they have found that they cant get their DTx through the FDA process quickly enough or aren’t seeing the prescribing numbers they needed to make their products a success. Since the digital health stock crash, it’s very hard for them to raise more money. Pear Tx this week announced it was trying to sell itself.

My hope is that we get a reset. I want digital therapies that are extensions of clinical care to be widely used and widely available as part of the care process, and for their care to be integrated into clinical care –rather than to be prescribed and then delivered by some third-party. And, because they are software and because software scales, I want them to be cheap. Hopefully that is the future of DTx.

On second thoughts, that wouldn’t be a bad future for regular pharmaceuticals either!

Nils Bottler, Angelini Ventures

I’ve been friends with Roberto Ascione for many years. Roberto is a keen Napoli fan who on the side runs the Healthware Group and also the Frontiers Health Conference that I’ve been going to for many years (and where Jess DaMassa is co-MC). Recently Healthware acquired the media company pharmaphorum and hired star reporter (and another friend) Jonah Comstock, ex MobiHealthNews and HIMSS Media. This is THCB’s second cross-posting with pharmaphorum.—Matthew Holt

Nils Bottler, who recently joined Angelini Ventures as Principal, is an avid skier, surfer, and digital health investor based in Berlin. In a new podcast, he spoke with Paul Tunnah, pharmaphorum founder, about his career, the German start-up landscape, and where Angelini Ventures aims to have an impact.

THCB Gang Episode 121, Thursday March 23

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday March 16 at 1PM PT 4PM ET are futurist Ian Morrison (@seccurve); writer Kim Bellard (@kimbbellard); Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune); and Olympic rower for 2 countries and all around dynamo DiME CEO Jennifer Goldsack, (@GoldsackJen).

The video will be below. If you’d rather listen to the episode, the audio is preserved from Friday as a weekly podcast available on our iTunes & Spotify channels

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