Pressed to demonstrate utility, digital health struggles — just like traditional medicine

Digital health Shutterstock.com

Article Highlights

  • Most everyone appreciates the promise of digital health

    Tweet This

  • The question is whether digital health can actually deliver

    Tweet This

  • What everyone’s asking for now is evidence – robust data

    Tweet This

After absorbing several years of increasingly extravagant promises about the remarkable potential of digital health, investors, physicians, and other stakeholders are now unabashedly demanding: “Show me the data.”

By now, most everyone appreciates the promise of digital health, and understands how, in principle, emerging, patient-focused technologies could help improve care and reduce costs.

The question is whether digital health can actually deliver.

A recent NIH workshop, convened to systematically review the data on digital health, acknowledged, “evidence is sparse for the efficacy of mHealth.”

As Scripps cardiologist Eric Topol and colleagues summarized in JAMA late last year,

“Most critically needed is real-world clinical trial evidence to provide a roadmap for implementation that confirms its benefits to consumers, clinicians, and payers alike.”

What everyone’s asking for now is evidence – robust data, not like the vast majority of wellness studies that experts like Al Lewis and others havedefinitively shredded.

The goal is to find solid evidence that a proposed innovation actually leads to measurably improved outcomes, or to a material reduction in cost.  Not that itcould or should, but that it does.

Applications ranging from GPS-enabled asthma inhalers to cloud-based EMR services to iphone-based medical diagnostics typically highlight the transformative potential of these technologies, and often emphasize the exceptional value said to reside in all the collected data.  It might even be true – but let’s see the evidence.

Given the striking disparity between digital health’s breadth and depth, between the sheer number of health-oriented apps and the data that even a handful of these products really do something substantial, it’s not unreasonable to presume digital health gadgets are, at best, amusing wellness devices — wellutainment — until proven otherwise.

However, before we get too self-righteous in our critique of the digital health evidence base, we might take a moment to recognize how fragile the data are for much of what we do in medicine.   The evidence for the utility of digital health devices may be weak to non-existent, but it’s not much better for a startling number of medical tests and procedures.

A major study published by Vinay Prasad and colleagues last year, for example, found that about 40% of established medical practices failed to stand up to scrutiny when deliberately studied.   In an accompanying editorial, legendary Stanford statistician John Ioannidis observed, “the introduction of interventions with limited or no evidence of benefit continues at a fast pace,” adding,

“Once we divert beyond traditional treatments (eg drugs or devices) to diagnostic tools, prognostic markers, health systems, and other health care measures, randomized trials are a rarity.  For example, it has been estimated that, on average, there are only 37 publications per year of randomized trials assessing the effectiveness of diagnostic tests.”

The results of such careful testing can often be surprising; for example, for years, it was standard practice to utilize a pulmonary artery catheter (PAC) to optimize the care of critically-ill patients, before randomized controlled studies demonstrated the intervention was generally of little value.  A recent “obituary” for the procedure concluded, “there is no evidence that the use of the PAC has improved patients outcomes.”

The real issue, then, isn’t whether digital health is being excessively scrutinized: we unquestionably should continue to demand evidence for efficacy and impact.  But we – entrepreneurs, investors, care providers, stakeholders — also should recognize what an incredibly high bar this represents, a bar many traditional and long-established medical interventions and approaches would likely fail to clear.

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

David
Shaywitz
  • Dr. Shaywitz trained in internal medicine and endocrinology at MGH, and conducted his post-doctoral research in the Melton lab at Harvard. He gained experience in early clinical drug development in the Department of Experimental Medicine at Merck, then joined the Boston Consulting Group’s Healthcare and Corporate Development practices, where he focused on strategy and organizational design. He is currently Director of Strategic and Commercial Planning at Theravance, a publicly-held drug development company in South San Francisco. He recently wrote Tech Tonics: Can Passionate Entreprenuers Heal Healthcare With Technology? 

  • Email: davidshaywitz.aei@gmail.com

What's new on AEI

image Dad and the diploma: The difference fathers make for college graduation
image A better way to finance that college degree
image Fracking for bigger budgets
image Earth Day: Hail fossil fuels, energy of the future
AEI on Facebook
Events Calendar
  • 21
    MON
  • 22
    TUE
  • 23
    WED
  • 24
    THU
  • 25
    FRI
Wednesday, April 23, 2014 | 12:00 p.m. – 1:30 p.m.
Graduation day: How dads’ involvement impacts higher education success

Join a diverse group of panelists — including sociologists, education experts, and students — for a discussion of how public policy and culture can help families lay a firmer foundation for their children’s educational success, and of how the effects of paternal involvement vary by socioeconomic background.

Thursday, April 24, 2014 | 12:00 p.m. – 1:30 p.m.
Getting it right: A better strategy to defeat al Qaeda

This event will coincide with the release of a new report by AEI’s Mary Habeck, which analyzes why current national security policy is failing to stop the advancement of al Qaeda and its affiliates and what the US can do to develop a successful strategy to defeat this enemy.

Friday, April 25, 2014 | 9:15 a.m. – 1:15 p.m.
Obamacare’s rocky start and uncertain future

During this event, experts with many different views on the ACA will offer their predictions for the future.   

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.