Digital evidence year in review-2017

Society for Digital Medicine

Digital Medicine: Year in ReviewJohn Sharp and Ashish Atreja

PCHAlliance/ HIMSS and Mount Sinai

@johnsharp @atreja

Our Approach

• Published in peer-reviewed journals

• Pilot and feasibility studies

• Validation Studies

• RCTs

• Literature reviews and meta-analysis

Digital Health Innovation Action Plan

• Launching an innovative

pilot precertification

program to work with our

customers to develop a

new approach to digital

health technology oversight

(FDA Pre-Cert for Software)

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New CPT codes Approved for Remote

Patient Monitoring

11/5/17 CMS Expands

Telehealth

Reimbursement in

New Rule

covers remote

chronic care

management

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PCHAlliance

White Paper

Including

• review of 34 studies,

• latest evidence by condition

and

• call to action

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Classic Studies

Problem: Diabetes- chronic disease management

Intervention: Remote Monitoring, connected glucometer with AI

Control: Usual Care, RCT over 12 months

Outcome: 1.9% vs 0.7% mean HbA1c decline in Bluestar arm vs.usual care

NODE Pearl: First App to get FDA approved based on evidence. Still not mainstream due to

transformation challenge

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 TrialJAMA. 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%).

SnowWorld (VR)SnowWorld,

developed at the

University of

Washington HITLab is

the first immersive

virtual world designed

for reducing pan and

anxiety. SnowWorld

was specifically

designed to help burn

patients. Published

RCT of 54 patients

show 15-44%

decrease in pain

Schmitt YS et al, Burns

2011. PMID 20692769https://www.youtube.com/watch?v=jNIqyyypojg

https://peerj.com/articles/1554/

HeadStrong Study in AMI survivors

Year 2017 SummarySubstantial evidence for

• Text messaging and Remote monitoring

• Telemedicine in right setting

Increasing Evidence for

• Wearable devices for right use case

• AI

Need more Evidence

• VR

• Blockchain

Text messaging

Text Messaging and Mobile Phone Apps as Interventions to

Improve Adherence in Adolescents With Chronic Health

Conditions –JMIR 5/17

Problem – Medication adherence is a major challenge in adolescents with chronic

conditions

Research design – meta-analysis of 15 studies, most from US

Outcome - Seven articles reported significant improvement in adherence

NODE Pearl - promising feasibility and acceptability, and there is modest

evidence to support the efficacy of these interventions

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Remote monitoring

Problem – Is the use of a Blue-tooth enabled inhaler sensor feasible in an elderly

population?

Intervention – use of Propeller Health inhaler sensor, data transmitted via a

wireless hub.

Research design – 198 with COPD, 38 with asthma followed for 12 months.

Outcome – SABA use decreased by 51%, Symptom-free days increased by 28%

NODE Pearl - management of remote monitoring feasible with elderly, COPD

management shows long term improvement.

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Telemedicine in right settingTelehealth Interventions to Support Self-Management of

Long-Term Conditions – JMIR 5/17

Problem - Self-management support is one mechanism by which telehealth

interventions have been proposed to facilitate management of long-term

conditions

Research Design - Metareview of Diabetes, Heart Failure, Asthma, Chronic

Obstructive Pulmonary Disease, and Cancer. 53 systematic reviews,

comprising 232 unique RCTs

Outcome – Telehealth self monitoring not superior to usual care except in

heart failure and type 2 diabetes where the practice is more mature. No

reports of harm.

NODE Pearl – Studies to date encouraging but more theory based studies

needed. 16

Wearable devices for right use case

Cardiovascular Risk Stratification Using Off-the-Shelf Wearables and a Multi-

Task Deep Learning Algorithm – 2017 AHA Scientific Session - UCSF

Research Design - 6,115 active users of the Cardiogram app for Apple Watch

- Heart rate and step counts were collected for a period of 1 to 53 weeks

(mean=8.9).

Outcome - Deep Neural Network outperformed a baseline logistic regression

model incorporating age, sex, and beta blocker use, predicting prevalent

hypertension

NODE Pearl – wearables combined with AI demonstrating

usefulness in predicting disease events.

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Wearables

Problem – Monitoring physical activity essential in Cardiac Rehab

Intervention - 40 patients wore Fitbit-Flex for four consecutive days x 8 wks

Research design – Measured changes with the Physical Activity Scale for the

Elderly (PASE) and 6 minute walk test (6MWT)

Outcome – significant increases in PASE score and 6MWT and average steps

NODE Pearl – Use of an activity monitor wearable a helpful adjuct to Cardiac Rehab18

Year 2017 Pick

PLEASE ADD PICO details for

1. Google AI Retinopathy

2. OMADA more

3. ALIVE Cor

4. FDA Digital pill approval

5. Telemedicine failure study

Google AI Retinopathy

-9963 images from 4997 patients

-Algorithm based on deep machine

learning had high sensitivity and

specificity for detecting referable

diabetic retinopathy

-NODE Pearl could lead to improved

care and outcomes compared with

current ophthalmologic assessment20

Virtual Coaching in Diabetes Prevention Programs

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk

Reduction in a Medicare Population

Method: People at risk for diabetes enrolled in a program combining digital

health with human coaching (Omada Health)

Outcome: 501 patients, participants lost 7.5% (SD = 7.8%) of initial body

weight, glucose control improved (HbA1c change = −0.14%)

NODE Pearl: Virtual DPP is an

mature intervention which can

be applied to other chronic

conditions21

Problem -integration of mHealth technology with self-management approaches to

improve the detection and management of atrial fibrillation

Intervention to determine if an FDA approved wireless ECG monitor designed for use with

smartphones (AliveCor™ ECG) could be utilized to detect and manage recurrent AF or other

atrial arrhythmias better than usual medical care

Research design Subjects with documented history of AF and were scheduled to undergo a

cardioversion, intervention group trained in device usage

Outcome no significant differences between groups with respect to the prevalence of coronary

artery disease, stroke/TIA, congestive heart failure, cardiovascular risk factors, or medication

usage.

NODE Pearl – Digital self monitoring of AF equally effective as current standard of care and with

better quality of life.

Journal of AFIB

11/29/17 FIRST APPLE WATCH GADGET CLEARED BY FDA:

AliveCor, the manufacturer of EKG gadgets, has expanded to the Apple Watch

FDA approves pill with sensor that digitally

tracks if patients have ingested their medication

11/13/17 - Abilify MyCite should not be used to track drug ingestion in “real-

time” or during an emergency because detection may be delayed or may not

occur. Proteus Digital Health.

For treatment of Schizophrenia and

Bipolar disorder

Sends a message from the pill’s sensor to a wearable

patch which transmits to a mobile application so that

patients can track the ingestion of the medication

on their smart phone.

NODE Pearl: Encouraging new use of digital in

medication adherence; new category - ingestibles23

Telemedicine Failure

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Conclusions (1)

• Evidence in several areas is growing and being featured in major journals:

telehealth and remote monitoring, text messaging, virtual coaching and

some wearables (CGMs, etc.)

• Increasing evidence for use of wearables including for research and AI

• More evidence needed for VR, Blockchain

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Conclusions (2)

Encouraging new developments with FDA approval of devices to monitor Atrial

Fibrillation, Artificial Pancreas for Type 1 Diabetes and an ingestible sensor.

More common use of connected devices an apps in research, rehabilitation,

post-discharge and procedure follow up

Emerging field of Digital Therapeutics which looks

to be an adjunct to traditional therapies or

to replace them with digital tools.

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