social media & mobile apps as sources for patient reported information: nabarun dasgupta
TRANSCRIPT
SOCIAL
SOCIAL MEDIA & MOBILE APPS AS SOURCES FOR
PATIENT REPORTED INFORMATION
Nabarun Dasgupta
Epidemico, Ltd.
April 24, 2015
The WEB-RADR project is supported by the Innovative Medicines Initiative Joint Undertaking (IMI JU) under grant agreement n° 115632,resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013)and EFPIA companies’ in kind contribution.
Focus on Liberia
Patients are speakingShouldn’t we be listening?
Beyond informing the public about the
importance of adverse event reporting, we
can take steps to encourage patients to
report.
01 02 03
Meet patients
where they’re at
Protect their
privacy
Give them
easy-to-use
tools
Data flow for detecting adverse drug reactions in
social media data.
6
DATA PROCESSING
Acquire
Filter
Curate
Causation
Describe
Collect social
media data
Detect Proto-
AEs, translate
vernacular
Reduce false
positives
Descriptive
statistics
Synthesis
of
information
Analyzing social media relies on machine- and
human-dependent processes.
7
WORK SEGMENTATION
SOFTWARE AUTOMATION HUMAN SKILL COMMUNITY
Define questions that matter
Take a systematic approach to selectively analyze
data for drugs and disease where there is a lack
of understanding.
Improve data tools for efficiency
Natural language processing (NLP) and machine
learning tools can assist in reducing human
burden.
CAUSATIONDESCRIBECURATEACQUIRE FILTER
Bayesian classifier
identifies posts with
resemblance to adverse
events
Dictionary translates
vernacular to
MedDRA
Multiple copies of
posts are consolidated
and PII removed
01
02
03
50 million posts that mention a medical product
have been collected. The classifier has been
trained with 360,000 manually coded posts.
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AUTOMATED FILTERING
68%
Research-ready data available
daily.
PRECISION
[+ predictive value]
88%
RECALL
[sensitivity]
Vernacular-to-Regulatory
Translation
9
Spelling VariationsCombined or invented wordsImplied phrasesInternet Vernacular Translation
lost their eyesight
seeing weird color
seeing weird colour
doublevision
couldn’t see
double vision
blind
googley eyed
blurry vision
changes in visioncross eyed
seeing weird
vision change
blindness
cross visionvisual snow
googly eyed
seeing double
making me eat like a mouse
anorexic
lost appetite
#notevenhungry
appetite is nonexistent
apetite surpressed
didn’t get hungry
dont want to eat
killed my apetite
miss feeling hungry
killed my appetite
can’t eat
lost apetite
lost my appetite
no appetitey
lack of apetite
stomach small
lost teh appetite
never hungrynever want to eat
cant eat
couldntcrosseyed
blurry
apetite surpressed
killed my apetite
lost apetite
lack of apetite
lost teh appetite
Typos
seeing weird color
seeing weird colour
googley eyed
googly eyed
#notevenhungry
no appetitey
making me eat like a mouse
never want to eat
Visual impairment
MedDRA 10047571
Visual impairment
SNOMED 397540003
Decreased appetite
MedDRA 10061428
Loss of appetite
SNOMED 79890006
making me eat like a mouse
anorexic
lost appetite
#notevenhungry
appetite is nonexistent
apetite surpressed
didn’t get hungry
dont want to eat
miss feeling hungry
killed my appetite
can’t eat
lost apetite
lost my appetite
no appetitey
lack of apetite
stomach small
lost teh appetite
never hungrynever want to eat
cant eat
lost their eyesight
seeing weird color
seeing weird colour
doublevision
couldn’t see
double vision
blind
googley eyed
blurry vision
changes in visioncross eyed
seeing weird
vision change
blindness
cross visionvisual snow
googly eyed
seeing double
couldntcrosseyed
blurry
killed my apetite
• Victoza® - liraglutide [rDNA origin] injection
• Diabetes indication
• (Does not include Dec 2014 US approval for Saxenda® for chronic obesity)
• UK, US, IN, CN, EU, JP, DE, DK, NL, IE, SE, FR, MY, SG
• UK approval: 30 Jun 2009
• Public Social Media (FB & Twitter): Jan 1, 2014 to March 9, 2015
• English language only
• MHRA Drug Analysis Print & FDA FAERS (county-limited, non-duplicated)
12
• DESCRIPTIVE METHODS
10,458
All public mentions
of Victoza or
liraglutide in
Facebook or
Twitter, arising from
7,150 unique posts
ACQUIRE
368
Total number of
posts resembling
adverse events
(Proto-AEs) after
curation.
3.5% of mentions
are Proto-AEs
FILTER
158
False positive posts
removed by manual
curation
30%
CURATE
699
Drug-event pairs at
the MedDRA
preferred term level
DESCRIBE
13
OVERALL RESULTS
14
MENTIONS & PROTO-AEs
6360 4098
29 411
TWITTERAll mentions
FACEBOOKAll mentions
TWITTERProto-AEs
FACEBOOKProto-AEs
01
02
03
04
15
SOC Comparison to UK & US Spontaneous Reports
16
QUANTIFYING EVENTS
2 4 2 10
1
2
3
4
5
Pancreatitis Hypersensitivity Angioedema Haemorrhage
The EMA’s list of Important Medical Events (IME)
can be used to identify posts of greatest medical
consequence
17
IMPORTANT MEDICAL EVENTS
2.0%Posts with IME
18
KNOWN FREQUENCY ADVERSE EVENTS
1:10k+1:1000 1:10k1:1001:10
10
10
0
1k
VERY COMMON
decreased blood sugar
levels, diarrhoea,
nausea
COMMON
bronchitis, constipation,
abdominal distension,
faster heart rate, feeling
dizzy, flatulence,
gastritis, gastro-
oesophageal reflux,
headaches, indigestion,
inflammation of
nose/throat, injection
site problems, loss of
appetite, antibodies to
Victoza, skin rash,
stomach pain, tiredness,
toothache, vomiting
UNCOMMON
dehydration, malaise,
itching, kidney
problems, urticaria
RARE / VERY RARE
anaphylaxis, angioedema, GI
problems; pancreatitis,
hypersensitivity
10
kSOURCE
emc+ Medicine Guide, Jan 16, 2015, Datapharm
medicines.org.uk
Medicine Guide
Preferred terms appearing in social media and not appearing
2
23
21
158
MHRA spontaneous reports
FDA spontaneous reports (w/o multiplicate reduction)
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REPORTING BURDEN PER MONTH
?
True Incidence Rate?
How does social media volume
for Victoza (liraglutide)
compare to traditional pharmacovigilance?
Can patterns be detected sooner?
What does social media contribute?
Twitter & Facebook: Jan ‘14 – Mar ’15
MHRA Drug Analysis Print: Jun ‘09 – Mar ‘15
FDA FAERS: Oct ‘12 – Mar ‘14
20
CLINICAL TRIAL DISCUSSION
I'm in a Pfizer double blind ######### trial and could receive the
placebo up until week 16 at which point I'm guaranteed to receive
the drug.
What I don't understand is that I can't be told if I was on the
placebo for the first 16 weeks. I'm not seeing any positive benefit
from whatever I've been taking for 8 weeks so far, and I would
really like to know at week 16 if it's the drug because then I can
bail from the study at that time and move on to something else…
21
CLINICAL TRIAL DISCUSSION
He started on Thursday. He told me yesterday that he tried to chew a
capsule (I'm not sure why, I think he wanted to see if it had a flavor) & it
was hard as a rock. I'm assuming maybe it was eneric coated or
something. He took the no flavor to mean he's on the placebo, but I
actually wonder if they would bother enteric coating a placebo.
Probably doesn't matter & I know we're not supposed to know anyway,
just wondered if anyone else's was enteric coated.
Why do Patients Report Adverse Drug Reactions?Data from The Netherlands Jan 2008 – Mar 2009, Top 4 responses, N=999
33%Not mentioned in patient information leaflet
The adverse drug reaction was severe
I wanted to share my experiences
The possibility for reporting just exists
54%
48%
35%
Van Hunsel, F 2010. Eur J Clin Pharmacol
CROWDSOURCING
Systematic efforts to collect information from a wide audience, particularly through the use of online tools, that is mutually beneficial to the
participants and activity sponsors
CrowdsourcingHow is this different from routine biomedical research?
Source: Estellés-Arolas, Enrique; González-Ladrón-de-Guevara, Fernando (2012), "Towards anIntegrated Crowdsourcing Definition,” Journal of Information Science 38 (2): 189–200.
Did the pill make you ill?ADR Reporting Mobile Apps
Euro
Asia
Australia
Bahk C, paper under review.
Essure
• Implantable, permanent birth control for women
• Coils made of polyester fibers, nickel-titanium and stainless steel, implanted into fallopian tubes
• US FDA approved 2002
• 5-year fail rate: 0.27%
• 750,000 implanted
• Potential market20% of married women
using birth control
Copyright Conceptus, credit Wikipedia
Knezevic MZ, 2011 Drug Safety
Methods
• Outreach to Facebook group “EssureProblems”– 15,000 members
• Work with group administrators to promote AE reporting via mobile app– Krystal Donahue & Melanie Goshgarian
• 1,349 ICSRs analyzed from publicly redacted versions at medwatcher.org
• WHO-UMC VigiGrade completeness scores
Essure Reports per Month
7 per month
FDA MAUDE
132 months marketing
authorisation
103 per month
MedWatcher Mobile App
19 months collaboration with patient
community
Mobile App vs. Traditional PharmacovigialnceComparison of Essure mobile app submissions with WHO-UMC database
Average Time for Submission
App users submitted in 8.5 minutes
(104 words average) compared to 40
minutes via traditional forms
Average VigiGrade Score
Mobile app submissions were more
complete than the global average in
VigiBase.
“Well-documented” Reports
Reports from mobile app were
considered “well-documented” 3x more
often than global average in VigiBase
40 min0.45
Bergvall T 2013 Drug Safety
8.5 min 0.80 56%
24%
HCP
13%
overall
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LIMITATIONS OF SOCIAL MEDIA & MOBILE APPS
CAUSALITYPatients may not correctly assess
causality. Define methods to
measure probability of real world
significance.
VOLUMEVolume of reports likely to be large.
Reduce false positives and create
automated tools to triage
information.
SIGNAL DETECTIONVery limited statistical methods to
detect problems. Collaborate with
academia, industry and regulators to
refine methods.
PRIVACYPatient privacy expectations and
fear of government oversight. Use
publicly available data only.
REGULATION UNCLEARWhen is there an obligation to
monitor or report? Work with
regulators and industry to clarify
guidance.
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02
03
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QUESTIONS?
web-radr.eu
@WEBRADR
epidemico.com
@epidemico
demo.medwatcher.org
@med_watcher