Medicine Unplugged:

mHealth Beyond the

Hype

Steve Steinhubl, MD

September 10, 2014

Disclosures

• Scripps Translational Science Institute has received grant support for research, including salary support, from the Qualcomm Foundation.

• I am a medical advisor for DynoSense and FocusMotion for which I have received stock options.

Gartner's 2014 Hype Cycle for All Emerging Technologies

http://www.gartner.com/newsroom/id/2819918

How many of you are set up to collect these data from your patients?

1. Activity

2. Pulse

3. +/- Sleep

How about this information? 1. Activity

2. Pulse

3. Sleep stages

4. Blood pressure

5. Cardiac Output / Stroke Vol.

6. ECG

7. Stress HRV EDA

8. Respiration rate

9. Temperature

10. Oxygen saturation

11. CO2 levels

12. Glucose (?)

Medicine Unplugged: mHealth Beyond the Hype

1.What is mhealth , how did we get here, and why should we care?

2.Examples of how mhealth can transform healthcare.

3.Where is the evidence?

4.What will it mean for providers?

Medicine Unplugged: mHealth Beyond the Hype

1.What will it mean for providers?

2.What is mhealth , how did we get here, and why should we care?

3.Examples of how mhealth can transform healthcare.

4.Where is the evidence?

August 30, 2014

Healthcare Providers: Much Room for Improvement in Professional Satisfaction

1. In general, physicians are unsatisfied with their careers:1

Morale considered poor to very poor by 80% of physicians.

Two-thirds would not recommend it to younger individuals

One-third, if given the chance, would no longer choose to be a physician.

2. ~80% of physicians rate the doctor-patient relationship to be the most satisfying aspect of their work.1 However,

Today, average face-to-face time with a patient is ~10 minutes2

It would take between 11-18 hours daily for a PCP to provide just the preventative and chronic disease management required for a typical patient compliment. 3,4

1. http://www.physiciansfoundation.org/ 2. Gottschalk A. Annals of family medicine 2005;3(6):488-493. 3. Yarnall KS. American journal of public health 2003;93(4):635-641 4. Ostbye T. Annals of family medicine 2005;3(3):209-214

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The Best Care at Lower Cost Institute of Medicine 2012 Lundberg GD. Bull Med Libs Assoc 1992;80:110-4 Alper BS. J Med Libr Assoc 2004;92:429-37 Davidoff F. Br Med J 1995;310:1085-6 Cranney M. Br J Gen Pract 1996;46:661-3

Information Explosion in Medicine

• Currently > 18 million articles indexed in the biomedical literature.

• The accession rate has doubles in last 20 years with ~ 1 million new articles indexed in 2012.

• To read everything of potential importance PCP would need to read ~7,287 articles a month. Assuming ~2 minutes/article would require 11.7 hours/day.

• 75% of physicians admit to having trouble understanding statistics in publications.

What are the Consequences of Information Overload?

The average lag between definitive clinical trial and changing the majority of clinical practice is 17 years.

Balas EA. Yearbook Med Informatics 2000: 65-70

• For these examples, use increased on average of 3.2% per year.

• From the time of definitive trial publication to 50% clinical uptake + 15.6 years.

12 Lancet. 1988;2(8607):349-60.

• ISIS-2 study was completed in Dec 1987.

• Found that For every 1000 MI patients treated with aspirin about 25 deaths and 10-15 non-fatal re-infarctions or strokes were avoided.

• By 1996, one out of every 4 individuals admitted into a US hospital with an MI didn’t receive ASA within the first 24 hours.(Data from >220,000 patients in

NRMI-2)

Becker RC. J Thromb Thrombolysis 2000;9:207–15

Even the Simplest Therapeutic Changes…

Wellness

Diabetes

Healthcare Team

Personalized Predictive Analytics Automated Clinical Decision Support

Learning Healthcare System

Physician (diagnostician, educator), nurse,

pharmacist, dietician, physical therapist, IT Respiratory

Home Diagnostics

Hypertension

What mHealth can Mean for Healthcare Providers

1. mHealth technologies will dramatically change the practice of medicine, which, at first blush is very concerning to physicians.

2. However mHealth will eventually free physicians of being directly involved in precision, algorithmic medicine that currently takes up a majority of their day.

3. Instead providers will regain their primary role as a diagnostician and educator allowing for longer and more rewarding interactions for both patients and providers.

“That it will ever come into general use, notwithstanding its value, is extremely doubtful; because its beneficial application requires much time and gives a good bit of trouble both to the patient and the practitioner; because its hue and character are foreign and opposed to all our habits and associations.”

But It helps to Remain Open Minded to New Technologies

From the preface to the first addition by translator

John Forbes, MD. 1829

Medicine Unplugged: mHealth Beyond the Hype

1.What will it mean for providers?

2.What is mhealth , how did we get here, and why should we care?

3.Examples of how mhealth can transform healthcare.

4.Where is the evidence?

“mHealth (or mobile health) is the use of mobile or wireless devices to improve health outcomes, healthcare services and health research.”

-NIH Consensus group

What is mHealth?

ASCI Red

• World’s fastest super-computer in 1996 – 1.8 teraflops/sec (1.8 trillion operations /sec)

• $55 million to develop.

• Occupied 1,600 square feet of floor space.

• Used 800 KW/hr (~800 homes)

• 2006 – 1.8 teraflops/ sec

• $500

• 200 watts

• 64 million units sold

May, 1997 IBM’s Deep Blue beat World Chess Champion Garry Kasparov.

Deep Blue

http://www.nydailynews.com/news/world/check-contrasting-pics-st-peter-square-article-1.1288700#ixzz2ePFO9300

PC

Smartphones Tablets

In the US, 91% of adults own a mobile phone, with the majority of them (61%)

being smartphones.

KPCB, 2014

194 minutes a day looking at smartphone or tablet screen. 147 looking at TV, 103 at laptop or PC.

A Historical (and Present Day) Look at Our Tools for a Patient’s Office Visit

Blood Pressure

ECG

Physical Exam/Auscultation

House Calls

• Sphygmomanometer invented 1881.

• Popularized by Harvey Cushing 1901

1904

• Willem Einthoven 1901.

• Precordial leads introduced 1944

1911

• Laënnec 1816.

• Binaural stethoscope 1851

1852

~1900

• In 1930’s ~40% of all patient encounters were in their home.

Unwin BK. Am Fam Physician 2011

National Healthcare Expenditure (NHE) Forecast

Dan Munro, Forbes 2014

“The $2.8 trillion US healthcare

industry is being upended by companies

attuned to the needs and desires

of empowered consumers.”

pwc. Health Research Institute April 2014. Healthcare’s new entrants: Who will be the industry’s Amazon.com?

“When we talk about mobile health, we are talking about taking the biggest technology breakthrough of our time and using it to take on one of the greatest national challenges of our time.” Kathleen Sebelius, Former US Secretary of HHS

mHealth Summit December 2011

“Are you open to trying new, non-traditional ways of seeking medical attention and treatment?”

pwc. Health Research Institute April 2014. Healthcare’s new entrants: Who will be the industry’s Amazon.com?

83% of consumers would be open to

new, non-traditional forms of medical

care.

Medicine Unplugged: mHealth Beyond the Hype

1.What will it mean for providers?

2.What is mhealth , how did we get here, and why should we care?

3.Examples of how mhealth can transform healthcare.

4.Where is the evidence?

Eye / Ear Smart Hearing Aids Contact lens-based glucose sensing Digital otoscope / fundoscope Noninvasive Intraocular pressure Automated refractive error

Miscellaneous Pill-box & bottle sensors Fetal monitoring Posture / Position sensors Activity monitors Sleep trackers

Brain/Emotion Wireless, mobile EEG Head impact sensing Noninvasive intracranial pressure monitor Continuous sensing ANS activity Stress recognition via voice / respirations

Heart / Vascular Continuous & intermittent rhythm monitors Noninvasive continuous BP tracking Thoracic impedance (fluid status) Handheld echocardiography

Stomach / Intestine Esophageal pH sensing Endoscopic image transmission Medication compliance sensors Fecal blood / bilirubin detection Gut electrical activity sensing

Urine / Bladder Comprehensive urinalysis Genomic identification of STDs Diaper-based sensors

Lung Home Spirometry Continuous pulse oximetry Inhaler Utilization Breath-based diagnostics Breath sound detection Environmental exposures identification

Skin Surface & core temperature Gross lesion assessment Pressure sensing for wound care Sweat chemistry Epidermal electronics for plasma constituents.

Blood Continuous, noninvasive glucose Point-of-care blood tests Transdermal hemoglobin

mHealth for Chronic Disease Management – The Beginning

Urine testing for glucose first available 1945.

1974 Reflomat – first evidence of home monitoring lead to improved glucose control

Studies initiated in the 1970s found that tighter glucose control improves outcomes, leading to a call for greater ease of patient monitoring.

Clarke SF. Br J Med Sci 2012;69:83-93

Diabetes Management Today 1. Over 25 million US adults have diabetes, roughly 8% of

the adult population, while an additional 79 million are pre-diabetic. 1

2. The total cost of diabetes in the US for 2012 was $245 billion, with $176 billion in direct costs. 2

3. Interventions that train patients in self-management and improve their communication channels with providers can significantly improve outcomes and decrease costs. 3

1. CDC. National diabetes fact sheet: 2011. 2. ADA. Diabetes Care. Apr 2013;36(4):1033-1046. 3. Aubert RE. Annals of internal medicine. Oct 15 1998;129(8):605-612.

The Next Generation of Continuous Glucose Monitoring

Hypertension Management Today

1. One of every 3 adults in America have HTN. 1

2. Nearly $100 billion in total costs are attributed to HTN annually in the US. 2

3. Nearly 40 million office visits every year in the US have a primary diagnosis of HTN making it the single most common reason for an office visit.3

4. Less than half of all hypertensive individuals have their blood pressure under control. 1

1. MMWR. Morbidity and mortality weekly report 2011;60(4):103-108. 2. Heidenreich PA. Circulation 2011;123(8):933-944. 3. National Ambulatory Medical Care Survey: 2010 Summary Tables.

Improving HTN Management Through mHealth

• Home BP monitoring alone is already known to improve BP control, although only slightly.1

• When home monitoring is couple with provider feedback and patient engagement there is much greater BP control than with monitoring alone.2

• Cuffless and continuous non-invasive BP monitoring devices will soon allow for a substantially greater depth of understanding of BP and its control.

1. Uhlig K. Annals of Intern Med 2013;159(3):185-194.. 2. Green BB. JAMA. 2008;299(24):2857-2867

COPD Management Today 1. 15 million Americans have COPD. 1

2. ~50% of Americans with diminished pulmonary function do not know that they have COPD. 2

3. Total estimated costs of COPD is $38.8 billion (2005 dollars) with excess annual health costs per individual with COPD vs. not of ~$6,300.3

4. A pilot RCT of connected care with home monitoring of 80 COPD pts. found a non-significant decrease in ER visits & hospitalizations.4

1. MMWR. 2012;61(46):938-943 2. Mannino DM. Arch Intern Med. 2000;160:1683-9 3. Foster TS. COPD. 2006 Dec;3(4):211-8 4. De San Miguel K. Telemed & eHealth 2013;19:652-7

COPD Management with mHealth

Faria I. Telemed & eHealth 2014;20:1-7

Acute Home Diagnostics - The Beginning

1. The e.p.t. home pregnancy test was first marketed in 1977. “A private little revolution.”

2. Today, approximately 20 million tests used annually in the US with annual sales of $227 million.

Upper Respiratory Tract Infection (URI) Management Today

1. Viral respiratory tract infections, “colds” are the most common acute illness in humans and the most common reason for an urgent office visit. 1

2. Adults average 2-4 colds annually.

3. The estimated total annual economic impact of non-influenza viral URIs is ~$40 billion in the US alone.2

4. There is no role for radiologic or lab studies in the diagnosis or treatment of URIs.

1. Cooper RJ. Ann Intern Med. 2001, 134: 509-517 2. Fendrick A. Arch Intern Med 2003;163:487-94

Potential mHealth Solutions for the Common Cold

• iPhone-linked thermometer that tracts symptoms, informs you of others in same community with similar symptoms, and sends information to provider’s office

• Tyto handheld remote physical exam linked to provider.

• In the near future, POC salivary tests for home diagnosis of exact pathogen.

Temperature Mouth & Throat Lungs Ear Eye Heart Skin

Urinary Tract Infections

1. Most common bacterial infections in adults. 1

2. Accounts for roughly 7 million office visits, 1 million ER visits and 100,000 hospitalizations annually. 1

3. UTIs are responsible for an estimated cost of $2 billion dollar annually. 1

4. Only ~50% of women presenting with symptoms concerning for UTI are actually diagnosed as having one after evaluation.2

1. Foxman B. The American Journal of Medicine. 2002;113:5-13. 2. Bent S. JAMA. 2002;287(20):2701-2710.

mHealth Solutions for the Home Diagnosis of UTI

1. Mohan R. PLoS One 2011;6(10):e26846.

• Several mobile devices are designed for at-home urinalysis with analytic, tracking and transmission capability.

• Future advances will likely allow for the detection of both the presence of infection and the exact pathogen via a mobile electrochemical biosensor .1

Otitis Media 1. Recurrent ear infection is the most common

acute complaint of children leading to ~30 million pediatrician visits annually.1

2. Responsible for annual costs over $5 billion dollars, not including lost work time by family caregivers. 1

3. For every 100 children utilizing a healthcare service because of their parent’s suspicion for an acute ear infection, only 50 are actually diagnosed to have an ear infections.2

1. Bondy J. Pediatrics 2000;105(6):e72. 2. Laine MK Pediatrics 2010;125(5):e1154-e1161.

Home Diagnosis of Otitis Media – Smartphone Otoscope

•By giving parents the ability to digitally image their child’s tympanic membranes at home with a smartphone-based otoscope a substantial percentage of office visits could potentially be prevented with remote image transmission and diagnosis

What our “Best Friends” can Teach Us About Disease Detection.

• Dogs have, on average 170 cm2 of olfactory epithelium relative to 10 cm2 in humans.

• They have roughly 200 million olfactory receptors compared to our ~5 million.

• Their sense of smell is estimated to be ~1,000,000 x more efficient than ours.

• Prior studies have found that trained dogs have > 90% accuracy for detecting cancers in exhaled breath.

McCulloch M. Integr Cancer Ther 2006;5:30-39

10 October 2012

Smartphone Breath Analysis for Cancer Detection

Lung Cancer

Colon Cancer

Breast Cancer

Peng G. Nature Nanotechnology 2009;4:669-73

Quantified Earthquakes Northern California Earthquake Aug 24, 2014

Medicine Unplugged: mHealth Beyond the Hype

1.What will it mean for providers?

2.What is mhealth , how did we get here, and why should we care?

3.Examples of how mhealth can transform healthcare.

4.Where is the evidence?

The Evidence for Connected Health May 30, 1996

• 1396 veterans with DM, COPD or HF

• Over 6 months “connected” cohort had 68% more PCP contacts and an average of 7.5 calls with a primary care nurse c/w 0 in control cohort.

• Connected patients were much more satisfied (p<0.001) but no difference in QOL.

• Connected patients experienced significantly greater readmissions (p=0.005) per month and hospital days (p=0.041).

The Evidence to Date

• 179 GP clinics in England, 3230 individuals with DM, COPD or HF

• Intervention clinics incorporated mobile devices; BP, pulse ox, scales, glucometers… plus symptom questions and educational messages.

• At 12 months sig decrease in admissions (OR 0.82, p=0.017) and unadj. mortality (OR 0.54, p=<0.001).

• However, the difference in admissions was limited to only the first 3 months and was due to a marked increase in control admissions.

• No change in PCP contacts, QOL or psychological (anxiety, depression..) outcomes.

“…high quality adequately powered trials of optimised interventions are required to evaluate effects on objective outcomes.”

“The paucity of evidence calls for much needed future research...”

“High quality trials measuring clinical outcomes are needed.”

January 2013

January 2013

Incorporation of mHealth into Existing Systems of

Care Steam Engine Electric Dynamo

David Paul A. American Economic Review 1990;80:355-61

“Productivity Paradox”

Systems of care need to be re-engineered around the capabilities that mhealth tools provide.

Medicine Unplugged: mHealth Beyond the Hype - Summary

• We are at the cusp of a remarkable transformation in our ability to care for individuals, and for individuals to take better care of themselves.

• mHealth technologies, provide a starting point for the complete re-engineering of healthcare that can better engage and empower consumers, improve outcomes, lower costs, and improve satisfaction for all involved.

• The evidence to drive this transformation is currently lacking, requiring thoughtful implementation with surveillance, adaption & dissemination.

Watson is now “…the size of three pizza boxes stacked up. It's also 24 times faster and has seen a 2,400 percent improvement in performance.”

Based on my genotype and sensor data, what is the best treatment for me?

2012

“The doctor of the future will be oneself.”

Albert Schweitzer, MD 1875-1965

Nobel Peace Prize 1952