Perils of Digital Health - Promedica CME
Transcript of Perils of Digital Health - Promedica CME
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Perils of Digital Health Controversies & Advances in the Treatment of
Cardiovascular Disease 11-15-19
John Mandrola, MD
Baptist Health Louisville @drjohnm
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Disclosures:
• None
• Staci Mandrola, MD is a hospice and palliative care physician
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• A 95-year-old man who lives independently presents to the hospital with shortness of breath due to AF and HFpEF
• He has not seen a doctor in 5 decades. Q: Why did he live to 95 years?
• A) Pure luck • B) Because he did not interact with healthcare system
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What is your favorite medical app? #Meded #EPeeps #Dontdisthehis #CardioTwitter #RadialFirst #FOAMed #POCUS #AHA19
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• 9 RCTs, including 6,469 patients, • Remote Monitoring vs In-Office follow-up
Parthiban, N. et al. J Am Coll Cardiol. 2015; 65(24):2591–600.
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Basch JCO 2016 https://ascopubs.org/doi/10.1200/JCO.2015.63.0830
• RCT w/ 766 patients w/ advanced solid tumors undergoing chemoRx
• 12 symptoms recorded on tablet transmitted e-mail vs SC
• PEP – QOL change
• HRQL improved (34% v 18%) • Fewer ED visits
• Fewer hospitalized
• 75% vs 69% alive at one year (P =0.05)
Relative to control…
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Telehealth – Is better than no health
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What’s the common thread of all these (positive) examples?
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New stuff is used on sick people
People who are asking for our help
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Sontag’s Dual Citizenship
Kingdom of the Well
Kingdom of the Sick
Circa 1978
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Sontag’s Kingdoms circa 2019
HTN T2D
SCAF DCIS
Depression ADHD
Genetic risks Anxiety
Kingdom of the Well Kingdom of the Sick
Good intentions
Wishful thinking
Vested interests
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September 2019
Social medicine perspective—in which society’s culture shapes the notion of health, disease, and recovery. • Lead-time-bias – perception that screening has improved survival • Overdiagnosis -- perception that interventions work
Looping effects : feedback patterns among diagnosis, therapeutic interventions, and health behaviors influence the natural history and prognosis of diseases.
Aronowitz Green NEJM 2019
• Magnify fears • Lead to overuse of low value
Rx
Clinicians can strive to reduce the “evidence-free” spread of purportedly risk-reducing interventions.
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• 6100 words
• 80 references
• References to RCT w/outcomes = 0
Software as a Medical Device
Sim 2019 NEJM https://www.nejm.org/doi/full/10.1056/NEJMra1806949
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• “Companies that demonstrate a “culture of quality and organizational excellence” for streamlined review of their applications.”
• “Products of precertified companies do not have to be associated with improved clinical outcomes before market release …”
Sim 2019 NEJM
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Now for some reality
How is technology doing?
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Digital Revolution begins
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Prevention and the Dubious Cartesian Frame
Will the search for one problem lead to health?
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Disease-specific mortality vs Overall mortality
RCTs of Cancer Screening • 7 Mammography • 3 Fecal Occult Blood • 2 CXR for Lung Ca
The vast majority of deaths are from non-screened-for-
diseases
Black JNCI 2002
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”reductions in all-cause mortality are very rare or non-existent.”
19 diseases 39 screening tests 9 meta-analyses 48 individual trials
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Medical Check Ups “Tests” Flu Shots
17 trials 150K individuals
Krogsboll Cochrane Library 2019 Saquib I J Epi 2015
19 diseases 39 screening tests 9 meta-analyses 48 individual trials
“Among currently available screening tests for diseases where death is a common outcome, reductions in all-cause mortality are very rare or non-existent.”
52 RCTs ≈ 80K individuals
NNT to prevent flu = 71 NNT = infinity to prevent hospitalizations and/or mortality
Denucheli Cochrane Reviews 2018
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Who Does Screening Like This Benefit?
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Identifies Three Big Challenges of Remote / Digital Health
Perez NEJM 2019
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Perez NEJM 2019
Recruited 419k individuals in 8 months
Irregular Pulse in 341 (0.16%)
Incredible and Novel
Irregular Pulse noted in 775 (3.1%)
52% or 219K were less than 40 years
6% or 24k were ≥ 65 years
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Challenge 1: Looking for AF in Young Apple Watch Users
The Young The Old
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https://www.rand.org/pubs/tools/TL221.html
N = 100 million adults live with multiple chronic conditions
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ADL Limitations
Cognitive Impairment
https://www.rand.org/pubs/tools/TL221.html
1 in 4 adults age ≥ 65 w/ five or or more chromic conditions have cognitive limitations
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Who Does Screening Benefit?
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• 2,161 participants notified of an irregular pulse • 450 follow-up and returned ECG patches 79% drop out rate
• Systematic Rev • N = 33 studies • Barriers to Remote
Measurement Tech
Up to 44% Dropout Rate
Perez NEJM 2019 Simblett J Med Internet Res 2018
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Challenge #2 – Do people stick with remote measurement tools?
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Challenge 3 – Is it a good idea to send more people into the healthcare system?
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RCTs showing that Rx of screen-detected AF reduces stroke
• Click to add text
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Martin A Makary, and Michael Daniel BMJ 2016;353:bmj.i2139
Medical Error – 251,000 deaths
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• Psychological harm (68.4%) • Financial burden (57.5%) • Physical harm (15.6%) • Anxiety (45.4%)
Percent of physicians who reported cascades caused their patients
• N = 376 Physician • Survey on Cascades
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https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2752986
Troponin ??? ECG ??? Stress test ??? Echo ???
Everyday Banal Decisions – Unstudied
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• A 95-year-old man who lives independently presents to the hospital with shortness of breath due to AF and HFpEF
• He has not seen a doctor in 5 decades. Q: Why did he live to 95 years?
• A) Pure luck • B) Because he did NOT interact w/ healthcare system
49% 51%
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Petr Skrabanek, The Death of Humane Medicine, 1994
“The pursuit for health is a symptom of unhealth.”
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The Moral Core of Medicine
The relief of suffering
I don’t see digital medicine, big data or
biometric sensors relieving the subjective experience of fear and distress.
Heath BMJ 2017
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1. Clinical iatrogenesis Direct Harm done by us
2. Social Iatrogenesis 1. Medicalization of life
3. Cultural Iatrogenesis (Insidious)
https://www.rcpe.ac.uk/sites/default/files/jrcpe_46_2_omahony_0.pdf
Cicra 1976
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George Bernard Shaw -- • Shaw compared doctors to tradesmen and shopkeepers,
with a pecuniary interest in people being ill.
• Shaw’s health philosophy o Do not try to live forever, you will not succeed o Use your health, even to the point of wearing it out. That is what it is for o Spend all you have before you die and do not outlive yourself o Take utmost care to get born well, and well brought up.
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What is medicine for? • Keep the entire adult
population under permanent surveillance?
• Does longevity trump all other considerations?
• What if we won the war on Cancer?
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Interactions with the Healthcare System
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https://www.rand.org/pubs/tools/TL221.html
N = 100 million adults live with multiple chronic conditions
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• Death rates have not budged in years • What has risen is the numbers of people living with chronic conditions, dementia, frailty and loneliness
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ADL Limitations
Cognitive Impairment
https://www.rand.org/pubs/tools/TL221.html
1 in 4 adults age ≥ 65 w/ five or or more chromic conditions have cognitive limitations
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RCTs showing that Rx of Screen-detected AF reduces stroke
• Click to add text
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• 2,161 participants notified of an irregular pulse • 450 follow-up and returned ECG patches 79% drop out rate
• Systematic Rev • N = 33 studies • Barriers to Remote
Measurement Tech
Up to 44% Dropout Rate
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Challenge #2 – Do people really stick with Remote Measurements?
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• Attacker modified 3d medical imagery using deep learning
• Could inject or remove lung CA from CT scans using free medical imagery from the Internet
• Manipulation easily fooled radiologists and state of the art AI
“Machine learning is very accessible to the public these days; it is almost like plug and play.” -- PI Yisroel Mirsky
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Racial Bias
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Obermeyer Science 2019
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Retention of Wearables?
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Medicalization -- Can Normal be Saved?
Abnormal Abnormal
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How one feels about digital/mobile health turns
on this question?
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