Evidence-Based Medicine: Cracks in the Foundation?

The practice of medicine was once described as an art.  Subsequently, large clinical trials and meta analyses became the foundation for what is known as evidence-based medicine.  This has become not only what is accepted as standard of care and best practice, but the criteria for which medical treatments and procedures are reimbursed, and now the basis for avoiding Department of Justice inquiries and prosecution. An editorial in the recent issue of the Journal of the American Medical Association (titled ‘Reversal of Established Medical Practices: Evidence to Abandon Ship’ questions the credibility of the role of these studies in their dogmatic application to clinical practice.  The inherent conflict of interest of specialists in performing further studies to discount evidence-based medicine is discussed, speculating that “…it is possible that some entire medical subspecialties are based on little evidence.”  The article cites an evaluation (published in 2009) of 35 trials that tested existing clinical practices, 46% were found to be consistent with beneficial practice, 46% reported evidence for which reversal of current practice was suggested, and 9% were inconclusive. The study goes on to state how surrogate end points and short-term follow-up has also questioned the credibility of studies. Interestingly, there is another editorial in the same issue of JAMA titled ‘Where are the Health Care Cost Savings?’ where the bottom line (pun intended) is pointed towards physicians taking the initiative in adopting new models of reimbursement and “…not look to drug companies, insurers or someone else’ to initiate and achieve cost savings.”

The relevance to the above to mHealth, I believe is profound.  For those that believe that mHealth technologies all require clinical studies, the fact that almost half of the practices founded on what we describe as evidence-based studies have been found to be incorrect is sobering.  Clinical studies for some mHealth technologies, I would submit, might need to be done for either FDA approval or for comparative research purposes. However even if they are done, post-market long-term follow-up studies will need to be done to avoid the pitfall of having mHealth be falsely accused as a new industry (and perhaps new medical subspecialties grown out of it) of the same violations of ethical or scientific standards as the above cited studies. Hopefully mHealth will learn from the observations described above.  Physicians can help by promoting mHealth as a potential cost-saver with technologies found to do so.  The articles (subscription required for full text) may be found at: http://jama.ama-assn.org/content/307/1/37.extract and http://jama.ama-assn.org/content/307/1/39.extract.

About davidleescher

David Lee Scher, MD is Founder and Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in advising digital health technology companies, their partners, investors, and clients. As a cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he understood early on the challenges that the culture and landscape of healthcare present to the development and adoption of digital technologies. He is a well-respected thought leader in mobile and other digital health technologies. Scher lectures worldwide on relevant industry topics including the role of tech in Pharma, patient advocacy, standards for development and adoption, and impact on patients and healthcare systems from clinical, risk management, operational and marketing standpoints. He is a Clinical Associate Professor of Medicine at Penn State College of Medicine.
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