An overview of the evidence for the effectiveness of connected health

1. 1
CLOSING THE EVIDENCE GAP
IN CONNECTED HEALTH
John Sharp, MSSA
Personal Connected Health Alliance

2. 2
Personal Connected Health
•Patient-facing devices and technology, promising to
support patients in their proactive, self-
management efforts
•Enabled by apps and devices, pervasive mobile
networks and innovation

3. 3
Sunrise - optimist
Sunset - pessimist

4. 4
Looking at the evidence
• Optimist – promising signs
• Pessimist – not enough, need randomize controlled
clinical trials
• Implicit Bias - refers to the attitudes or stereotypes
that affect our understanding, actions, and
decisions in an nconscious manner.

5. 5
Outline
•Topical review of the evidence
•Intervention types
•Research issues
•Solutions
•New terminology

6. 6
LITERATURE REVIEW
Evidence for Personal Connected Health

7. 7
Digital Medicine’s March on Chronic Disease
Digital medicine offers the possibility of
• continuous monitoring,
• behavior modification,
• personalized interventions at low cost,
• potentially easing the burden of chronic disease in
cost-constrained health systems
Kvedar JC, Fogel AL, Elenko E, Zohar D. Digital Medicine’s March on Chronic
Disease. Nature Biotechnology, 34:3, 239–246, March 2016.

8. 8
Summary of systematic review results
Functional Theme Description Number of studies
Remote Patient
Monitoring
Quantitative data collection on
patient health indicators such as
blood pressure, weight, or blood
sugar
9
Behavior
change/self-care
Interventions intended to
encourage behavior change and
motivation to make healthy
choices
34 studies (35 publications)
Remote counseling
and mental health
Interventions providing advice,
guidance or qualitative
monitoring by health
professionals through
technology in the patient’s
home (telemedicine, video
conferencing)
10 studies (12 publications)
Total 53 studies (56 publications)

9. 9
What outcomes to measure?
• Heart failure readmission, mortality
• Frailty Score
• Blood pressure
• HA1c for diabetes
• Mental Health Wellbeing
• Smoking cessation
• Pain score
• Overall cost or cost savings/reduction

10. 10
Findings of our literature review
Developing an evidence base for personal connected
health is in its infancy.
• Many technologies, disease states and wellness interventions are being
evaluated,
• Many studies have small sample sizes, are industry sponsored or are
from a single institution.
• Clinical improvement, prevention and adherence are examined but the
appropriate and optimal research methodological approaches, as
distinct from drug trials, are still evolving.
• Validation of devices and apps is essential to produce reliable and
replicable results.

11. 11
Impact of remote patient monitoring on clinical
outcomes: an updated meta-analysis of randomized
controlled trials
Nature
Digital Medicine
2018

12. 12
Impact of remote patient monitoring on clinical
outcomes: an updated meta-analysis of randomized
controlled trials
Conclusions:
• Studies were highly heterogeneous in
their design, device type, and outcomes
• Interventions based on health behavior
models and personalized coaching were
most successful.
• Substantial gaps in the evidence base that
should be considered before
implementation of remote patient
monitoring in the clinical setting.

13. 13
Topical review of the evidence
•Wellness
•Prevention programs/coaching
•Chronic conditions
•Mental health

14. 14
Wellness
• Fitness trackers – steps, distance, heart rate
• employee wellness program can increase the number of
steps and time spent walking,6 but demonstrating
prevention of disease and reduction of healthcare costs is
more of a challenge.
•Diet
• modest evidence that app-based interventions to improve
diet, physical activity and sedentary [behaviors] can be
effective. Multi-component interventions appear to be
more effective.

15. 15
Wellness
•Sleep tracking
•some validation studies of sleep trackers.
•These point to strengths and limitations in sleep
estimates produced by personal health
monitoring devices, requiring further study.

16. 16
Prevention
Digital Diabetes Prevention Programs
•significant weight loss, improved
glucose control and lower total
cholesterol at 12 months
•return on investment for digital
behavioral counseling for
prediabetes and cardiovascular
disease to be break even at 3
years

17. 17
CHRONIC CONDITIONS
Evidence for Personal Connected Health

18. 18
Remote Cardiac Monitoring
•Mobile ECG
• After cardiac surgery - a non-
invasive, inexpensive, convenient
and feasible way to monitor for AF
recurrence in post-cardiac surgery
patients
•Hypertension monitoring
• demonstrated a significant
reduction both in the overall costs
and in the number of days of
hospitalization over two years

19. 19
Behavioral Health
•One of the studies reviewed indicated that self-
monitoring of mood can boost overall emotional
self-awareness
•Substance abuse
• systematic review found that the majority of studies
provided support for the efficacy of mHealth in reducing
substance use.

20. 20
Research Issues
•Unique challenges
•Resistance from providers
•Speed of technological change
•Regulatory challenges
•Possible solutions

21. 21
Negative study results
•There was little evidence of differences in health care
costs or utilization as a result of the intervention.
•There are not large short-term increases or decreases
in health care costs or utilization associated with
monitoring chronic health conditions using mobile
health or digital medicine technologies.
• PeerJ. 2016 Jan 14;4:e1554.

22. 22
Designing randomized control trials in Connected
Health
•What is the mechanism of effect in personal
connected health — does monitoring itself produce
change or only monitoring plus incentives plus
coaching?
•What can we learn from psychology and behavioral
economics?
•Does behavior change require ‘patient activation’ or
a motivation to change?
•Can results be generalized from one app or device to
another?

23. 23
http://jamanetwork.com/journals/jama/fullarticle/2553448
Conclusions and Relevance Among young adults with a BMI between
25 and less than 40, the addition of a wearable technology device to a
standard behavioral intervention resulted in less weight loss over 24 months.
Devices that monitor and provide feedback on physical activity
may not offer an advantage over standard behavioral weight loss approaches.

24. 24
Negative or Inconclusive Results
Clinical trials can contribute knowledge about both efficacy and
mechanisms of action.
• Efficacy concerns whether the intervention is “better” than a
control, such as standard of care; mechanisms concern how the
intervention produces desired outcomes — its hypothesized
causal pathways.
• For pharmacotherapies, after years of bench research, a new
drug’s action pathways are typically understood well enough
that a clinical trial can both test efficacy and generate evidence
about causal mechanisms

25. 25
Device Issues
•By the time the results are published, the
device is outdated and no longer available
•Device accuracy needs to be validated and
the subjects should be questioned about
whether they are using other consumer-
grade personal connected health technology
•Signal vs noise – e.g., home cardiac
monitoring

26. 26
Solutions
•Studies that strive to understand the
underlying psychology of motivation and
behavior change in lifestyle choices will
remain relevant
•Society of Behavioral Medicine
– Digital Health Council

27. 27
Developing and Evaluating Digital Interventions
to Promote Behavior Change in Health and
Healthcare
• JMIR 2017 article addressed:
•Pace and efficiency
•Engagement
•Theory
•Evaluation of effectiveness
•Evaluation of Cost effectiveness
•Regulation, ethics and information governance

28. 28
Network of Digital Evidence
www.nodehealth.org
•Combine the rigor of Evidence Based Medicine
(EBM) with emerging healthcare technologies
to help create evidence-based digital medicine.
•Sharing Info on Digital Medicine Pilots
•Standardizing practices for adoption
•Supporting multi-site trials and collaborations

29. 29
New Terminology
Digital Therapeutics
•medication augmentation
e.g., medication adherence app, smart pillbox
•medication replacement
e.g., virtual coaching, diabetes prevention
programs
•Using digital tools in research, e.g., continuous
monitoring or symptom checkers, QOL surveys

30. 30
New Terminology

31. 31
Digital Biomarkers
•Objective, quantifiable measures of biology
or health collected and measured through
digital devices
•Digital Biomarkers Journal
•Section for the Network of Digital Evidence

32. 32
Digital Phenotyping
www.thelancet.com/psychiatry Vol 4 October 2017

33. 33
Remote Patient Monitoring -
The Need forGood Research Methodology
Jan 25, 2018 LinkedIn post
• Impact of remote patient monitoring on clinical
outcomes: an updated meta-analysis of
randomized controlled trials
• Comparative Effectiveness of Implementation
Strategies for Blood Pressure Control in
Hypertensive Patients: A Systematic Review and
Meta-analysis
• Evaluation Criteria of Noninvasive Telemonitoring
for Patients With Heart Failure: Systematic Review

34. 34
Recommendations
•Increase the size of studies in personal
connected health to enhance the body of
meaningful evidence, working collaboratively
if necessary.
•Develop and disseminate consensus-based
guidelines for research methodology in
personal connected health, working with
experts from across the field.

35. 35
Recommendations (continued)
•As part of developing consensus-based guidelines
for research methodology, consider ways to
accelerate research without compromising the
quality of results.
•Endeavor to validate apps and devices in
comparative studies.
•Fund studies exploring new ways for individuals to
act independently to improve their health using
personal connected health technologies.

36. 36
Addressing the Evidence Gaps
Better study design
• What is the mechanism of effect in personal connected
health — does monitoring itself produce change or only
monitoring plus incentives plus coaching?
• What can we learn from health psychology and behavioral
economics?
• Does behavior change require ‘patient activation’ or a
motivation to change?
• Can results be generalized from one app or device to
another and scaled?

37. 37
Sunrise or Sunset?
@JohnSharp - linkedin/in/johnsharp