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Evidence Based Digital
Medicine
- From Hype to Hope
Ashish Atreja, MD, MPH
Chief Innovation and Engagement
Officer, Medicine
2
Exponential Innovation in Apps,
Wearables and Analytics
50M Wearables
Shipped Globally
245,000 Apps
Terabytes of new data
per second
Digital Medicine: An answer to
value based care
‱  In RCT, patients using BlueStar saw a greater mean
A1c decline than those receiving usual care
‱  1.2% (1.9% vs 0.7%) over a 12 month period
Quinn, C et al, Diabetes Care, 2011
From: Effect of Lifestyle-Focused Text Messaging on Risk Factor ModiïŹcation in Patients With Coronary Heart
Disease:  A Randomized Clinical Trial
JAMA. 2015;314(12):1255-1263. doi:10.1001/jama.2015.10945
Enrollment of Participants in the TEXT-ME Randomized Clinical TrialLDL-C indicates low-density lipoprotein cholesterol.
Figure Legend:
At 6 months, levels of LDL-C were significantly
lower in intervention participants (mean
difference, −5 mg/dL with reductions in systolic
blood pressure (−7.6 mm Hg) and BMI (−1.3),,
and a significant reduction in smoking (26% vs
44%; relative risk, 0.61 [95% CI, 0.48 to 0.76]; P  
<  .001).
The majority reported the text-message program
to be useful (91%), easy to understand (97%),
and appropriate in frequency (86%).
After 500 pilots, we know almost nothing about the likely
uptake, best strategies for engagement, efficacy, or
effectiveness of these initiatives
- World Bank
Tsai et al. PLOS Medicine. Scaling up mHealth: Where is the evidence? 6
BOTTLENECK : Innovation to
Evidence and Transformation
INNOVATION
Evidence
Transformation
https://peerj.com/articles/1554/
RCT of 471 adult participants between October 2010 and October 2012
Addition of a wearable technology device to a standard behavioral intervention
resulted in less weight loss over 24 months.
“In the wake of reports that question the
accuracy and effectiveness of
[Theranos’] technology
 health-tech
companies will now face a greater
burden of proof to demonstrate that
their technology is effective.”
The ‘Burden of Proof’
Future generations of startup founders should ensure they are working with
venture capital firms that have ample experience in health care. These
investors will understand that it takes time to build a successful and long-
lasting company.”
- Christina Farr, Fast Company
Evidence-Based Digital Medicine
(EBDM)
RIGOR
Evidence-based Medicine
INNOVATION
Digital Technologies
Mount Sinai / Presentation Slide / December 5, 2012 12
Evidence Generation in EBDM
13
Population: Real world
Intervention: Dose change, combinations, EHR integration
Comparison: Non RCT Research Designs
Outcome end points: (Patients, payer, system perspective)
Effectiveness, safety, usability, cost-saving
Mount Sinai Health System
Innovation, Evidence and Transformation
Sinai App Lab: Joint initiative of DOM with IT and
Innovation Partners
Best Care at Lower Cost: The Path to Continuously Learning Health Care in
America. IOM 2012
Apps Registries QI dashboard CER Trial recruitment
Sinai AppLab: Digital Medicine Innovation Hub
MISSION
Remote Monitoring for Chronic diseases:
HealthPROMISE with app, telemed and wearables
Atreja A, JMIR Res Protocol, 2015
High Engagement (3x), improved Quality of life in IBD
Now piloted for readmission reduction in CHF
Atreja A, DDW, San Diego. 2016
Apps	
  here	
  sorted	
  by	
  
most	
  evidence	
  
Cura5ng	
  Evidence	
  based	
  Apps	
  
	
  
RxUniverse TM : The Time for
Prescribing Apps has Come!!
20
‱  Licensed to Responsive Health, Inc
‱  $ 100 Million/ Year Lost Revenue if we do not choose effective apps
Accenture: Losing Patience: Why Healthcare Providers Need to Up Their Mobile Game
Evidence
Curation
Listing of all DigMed pilots
Innovation Portal/ Site
Best practices
Regulatory guidance
Publication and Dissemination
IT, MSIT, MSIP
Sinai AppLab
Next Gen Institute
Icahn Institute
eHealth Team
MS Innovation Champions Forum
Dig med Clinical
Implementations
Internal Shark Tank
Payer engagement
External Collaborations
Innovation
Transformation
21
Evidence Curation leading to Clinical Transformation
TRANSFORMATION THROUGH MOUNT
SINAI INNOVATION CHAMPIONS GROUP
Providers
Researchers
HouseStaff
Patients
25 + Projects, 100 investigators served, Digital Medicine Community created
Collaborators
Consortium to address the burden of
clinical proof
Startups need $$,
market validation
VC’s need clinical
insight
MD’s need access to
startup ecosystem
Hospital Systems need
efficacious product
Burden of
Clinical Proof
Mount Sinai / Presentation Slide / December 5, 2012 24
Hospital
System
Startup
Grant
Agency
Provider
Org
Pharma
Payer
VC and
Angel
Consortium of Academic Health Centers
Organizations at NODE Health Launch at
25
Journey From Innovation to Transformation
No Patient or Provider Gets Left Behind
Email ashish.atreja@mssm.edu
Twitter @atreja
LinkedIn Group: Digital Medicine Evidence
RSVP, Dec 13, DC: http://tinyurl.com/NODEReception

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Digital Medicine: From Hype to Hope

  • 1. Evidence Based Digital Medicine - From Hype to Hope Ashish Atreja, MD, MPH Chief Innovation and Engagement Officer, Medicine
  • 2. 2 Exponential Innovation in Apps, Wearables and Analytics 50M Wearables Shipped Globally 245,000 Apps Terabytes of new data per second
  • 3. Digital Medicine: An answer to value based care
  • 4. ‱  In RCT, patients using BlueStar saw a greater mean A1c decline than those receiving usual care ‱  1.2% (1.9% vs 0.7%) over a 12 month period Quinn, C et al, Diabetes Care, 2011
  • 5. From: Effect of Lifestyle-Focused Text Messaging on Risk Factor ModiïŹcation in Patients With Coronary Heart Disease:  A Randomized Clinical Trial JAMA. 2015;314(12):1255-1263. doi:10.1001/jama.2015.10945 Enrollment of Participants in the TEXT-ME Randomized Clinical TrialLDL-C indicates low-density lipoprotein cholesterol. Figure Legend: At 6 months, levels of LDL-C were significantly lower in intervention participants (mean difference, −5 mg/dL with reductions in systolic blood pressure (−7.6 mm Hg) and BMI (−1.3),, and a significant reduction in smoking (26% vs 44%; relative risk, 0.61 [95% CI, 0.48 to 0.76]; P   <  .001). The majority reported the text-message program to be useful (91%), easy to understand (97%), and appropriate in frequency (86%).
  • 6. After 500 pilots, we know almost nothing about the likely uptake, best strategies for engagement, efficacy, or effectiveness of these initiatives - World Bank Tsai et al. PLOS Medicine. Scaling up mHealth: Where is the evidence? 6 BOTTLENECK : Innovation to Evidence and Transformation INNOVATION Evidence Transformation
  • 8. RCT of 471 adult participants between October 2010 and October 2012 Addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months.
  • 9.
  • 10. “In the wake of reports that question the accuracy and effectiveness of [Theranos’] technology
 health-tech companies will now face a greater burden of proof to demonstrate that their technology is effective.” The ‘Burden of Proof’ Future generations of startup founders should ensure they are working with venture capital firms that have ample experience in health care. These investors will understand that it takes time to build a successful and long- lasting company.” - Christina Farr, Fast Company
  • 11. Evidence-Based Digital Medicine (EBDM) RIGOR Evidence-based Medicine INNOVATION Digital Technologies
  • 12. Mount Sinai / Presentation Slide / December 5, 2012 12
  • 13. Evidence Generation in EBDM 13 Population: Real world Intervention: Dose change, combinations, EHR integration Comparison: Non RCT Research Designs Outcome end points: (Patients, payer, system perspective) Effectiveness, safety, usability, cost-saving
  • 14. Mount Sinai Health System Innovation, Evidence and Transformation
  • 15. Sinai App Lab: Joint initiative of DOM with IT and Innovation Partners Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. IOM 2012 Apps Registries QI dashboard CER Trial recruitment Sinai AppLab: Digital Medicine Innovation Hub MISSION
  • 16. Remote Monitoring for Chronic diseases: HealthPROMISE with app, telemed and wearables Atreja A, JMIR Res Protocol, 2015
  • 17. High Engagement (3x), improved Quality of life in IBD Now piloted for readmission reduction in CHF Atreja A, DDW, San Diego. 2016
  • 18.
  • 19. Apps  here  sorted  by   most  evidence   Cura5ng  Evidence  based  Apps    
  • 20. RxUniverse TM : The Time for Prescribing Apps has Come!! 20 ‱  Licensed to Responsive Health, Inc ‱  $ 100 Million/ Year Lost Revenue if we do not choose effective apps Accenture: Losing Patience: Why Healthcare Providers Need to Up Their Mobile Game
  • 21. Evidence Curation Listing of all DigMed pilots Innovation Portal/ Site Best practices Regulatory guidance Publication and Dissemination IT, MSIT, MSIP Sinai AppLab Next Gen Institute Icahn Institute eHealth Team MS Innovation Champions Forum Dig med Clinical Implementations Internal Shark Tank Payer engagement External Collaborations Innovation Transformation 21 Evidence Curation leading to Clinical Transformation
  • 22. TRANSFORMATION THROUGH MOUNT SINAI INNOVATION CHAMPIONS GROUP Providers Researchers HouseStaff Patients 25 + Projects, 100 investigators served, Digital Medicine Community created Collaborators
  • 23. Consortium to address the burden of clinical proof Startups need $$, market validation VC’s need clinical insight MD’s need access to startup ecosystem Hospital Systems need efficacious product Burden of Clinical Proof
  • 24. Mount Sinai / Presentation Slide / December 5, 2012 24 Hospital System Startup Grant Agency Provider Org Pharma Payer VC and Angel Consortium of Academic Health Centers
  • 25. Organizations at NODE Health Launch at 25
  • 26. Journey From Innovation to Transformation No Patient or Provider Gets Left Behind Email ashish.atreja@mssm.edu Twitter @atreja LinkedIn Group: Digital Medicine Evidence RSVP, Dec 13, DC: http://tinyurl.com/NODEReception