Evidence Based Digital Medicine - From Hype to Hope

Ashish Atreja, MD, MPH Chief Innovation and Engagement Officer, Medicine

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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 Modification 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

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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 SystemInnovation, 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

Figure 2: Interim analysis showing improvement in symptom burden among intervention cohort at MSMC (P- value based on linear mixed effects model)

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!!

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•  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

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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

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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