OHDSI Talk by Jon Duke on developing product labeling incorporating diverse evidence sources.

1. Evidence-Enhanced
Product Labeling
(EPLs)
Jon Duke
April 15, 2014

2. What Are We Trying to Solve?
A Problem with Labeling
• While considered the official source of drug
safety information
– Labels are infrequently read by patient or providers
– The evidence for a given ADR is often scant
– They are one-size-fits-all and do not support
personalized decision-making

3. What Are We Trying to Solve?
A Problem with OHDSI
• While we are developing superb methods and
brilliant tools to convey evidence on drug safety
– Driving use of external tools requires significant
activation energy
– Awareness of the evidence being generated by
OHDSI may diffuse slowly even to those who would
be extremely interested (e.g., drug knowledge
vendors)
– Users will generally need to know what they are
looking for (e.g., what drug-outcome pairs)

4. The EPL Big Picture
4
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~ ~~
~~ ~~~ ~~ ~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~
~~ ~~~ ~~ ~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~
~~ ~~~ ~~ ~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
~~~ ~~ ~~ ~~
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
Structured
Product Label
Enhanced
Product Label

5. Evidence-Enhanced Product Labeling
• EPL is a platform for injecting approved product
labeling with evidence from external sources
• Evidence may manifest as
– visual emphasis / de-emphasis of label content
– on-demand display of data and visualizations
• EPL is a trojan horse for getting people to see
the incredible work of OHDSI while using a
standard reference

6. Enhanced Product Labeling:
Framework vs App
• EPL is fundamentally a framework that can
work with any web application
• Two Reference Apps
– Embedding of HOMER-like content within SPL
(DOI_HOI evidence base)
– Embedding of PLATO-like content within SPL
(requires mechanism to capture patient data-manual
inputs, CCD, blue button, etc)

7. JS
Library
OHDSI
APIs
OHDSI
KB
OHDSI
PLATO
Services
Other
Evidence
Sources
SPL

8. Potential OHDSI KB Content

9. What’s in an SPL?
Part 1: XML (the content)
9
XML/XSL/CSS
 HTML

10. What’s in an SPL?
Part 2: XSLT (the format)
10

11. What’s in an SPL?
Part 3: CSS (the style)
11

12. What’s in an SPL?
Roll them together  HTML
12

13. What’s in an SPL?
HTML
13

14. What’s in an SPL?
HTML
14

15. EPL
Javascript
SPL
XML/XSL/CSS
 HTML
EPL / OHDSI
APIs
OHDSI
KB
OHDSI
PLATO
Services
Other
Evidence
Sources

16. Web App
Structured Product
Label
~~~ ~~ ~~ ~~ ~~
~~ ~~ ~~ ~~~ ~~
~ ~~ ~~~ ~~ ~~~
~~ ~~ ~~
~~~ ~~ ~~ ~~ ~~
~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~
EPL.js
From SPL to EPL
Tell me all the known
ADRs for this drug
EPL / OHDSI
APIs

17. EPL / OHDSI
APIs
Web App
Structured Product
Label
~~~ ~~ ~~ ~~ ~~
~~ ~~ ~~ ~~~ ~~
~ ~~ ~~~ ~~ ~~~
~~ ~~ ~~
~~~ ~~ ~~ ~~ ~~
~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~
EPL.js
From SPL to EPL

18. Web App
EPL.js
From SPL to EPL
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~

19. Web App
EPL.js
From SPL to EPL
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~

20. Web App
EPL.js
From SPL to EPL
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~

21. Web App
EPL.js
From SPL to EPL
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~

22. Web App
EPL.js
Detail On-Demand
Tell me the specific
evidence for this HOI
DOI_HOI_id=234515
Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~
~~ ~~ ~~~
EPL / OHDSI
APIs

23. EPL / OHDSI
APIs
Web App
Structured Product
Label
~~~ ~~ ~~ ~~ ~~
~~ ~~ ~~ ~~~ ~~
~ ~~ ~~~ ~~ ~~~
~~ ~~ ~~
~~~ ~~ ~~ ~~ ~~
~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~
EPL.js
From SPL to EPL

24. Adverse Reactions
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ns
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~
~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~ ~~~ ~~ ~ ~~ ~~~ ~~ ~~~ ~~
~~~ ~~ ~~ ~~
Advanced Jquery Tooltips support
AJAX calls, visualzations, full HTML5

25. Example EPL Prototype
25

26. Example EPL Prototype
26

27. Final Thoughts
• Evidence-enhancement not limited to SPLs,
could be applied to SPCs or any other web
content with identifiable drugs and outcomes
• Designed to be flexible in terms of novel
evidence sources and presentation layers
• Will develop in parallel with OHDSI KB and
APIs
27

28. Thanks!
Questions?
28