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Automate your
literature monitoring
for more effective
Pharmacovigilance
Presented by Robin Fogel and Ian Crowlesmith
June 24, 2015
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Webinar control panel:
• ‘Ask a question’ for
questions and comments
• Option for full screen view
• Q&A at the end
Need to Know
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Presented By
Date
Ian Crowlesmith
24 June, 2015
Finding adverse reactions in Embase
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Setting up Email alerts on Embase for adverse reactions
• Embase content on adverse drug / device reactions
• Using subheadings (with a specific drug or device)
• Using free text to find adverse effects (or toxicity)
• Setting up an Email alert
Agenda
Embase content
on adverse drug /
device reactions
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Searching for "adverse" in Embase
0
20,000
40,000
60,000
80,000
100,000
1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015
In all fields As subheadings
Records
Per year
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Searching for "adverse" or "toxicity" in Embase
Records
Per year
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015
In all fields As subheadings
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Searching subheadings on Embase: how to do it
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Searching subheadings on Embase: results
Using subheadings
with a specific drug
or device
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Searching subheadings for a specific drug
Goal: find records reporting adverse drug
reactions for plavix (clopidogrel)
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Step 1: find the Emtree term for the drug
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Step 2: take the query to drug search
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Step 3: select subheadings (ADR, TOX) and search
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Step 4: review results
Using free text to
find adverse effects
(or toxicity)
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Using free text to find adverse effects
Goal: extend results by searching for
records mentioning adverse drug
reactions that have not been
indexed using subheadings
Background:
(1) Include records that are automatically indexed and for which no subheadings have therefore been indexed
(2) Specifically include adverse effects of interest
(3) Include records which indexers may have missed, or which predate the introduction of subheadings (1987)
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Step 1: find keywords for “adverse” to search free text
You are free to use any terms you wish.
One approach is to scan abstracts retrieved
in a search with subheadings, and to select
relevant keywords.
Some possible terms are shown on the next
slide.
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Representative list of possible terms for “adverse”
Source: Webinar in 2013 - Searching Adverse Events on Embase: http://www.slideshare.net/rocheam/embase-webinar-ard-25-sep-2013
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Step 2: search using free text keywords
Setting up an Email
alert
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Setting up an Email alert
Goal: set up regular delivery of new
content selected by any search
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Step 1: choose Email alert option for selected search
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Step 2: edit Email alert parameters / set the alert
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Step 3: review Email alerts (1)
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Step 3: review Email alerts (2)
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Step 4: export history for an email alert (1)
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Step 4: export history for an email alert (2) This is the history of alert "Whole database" as exported on 24 Jun 2015 12:03 GMT. This alert was originally set up on 06 Oct 2014
06:49 GMT.
Alert name Event Search
query Date & time
(GMT) Records
included Frequency Recipients Status
Whole database Automatic run ? 24/06/2015 04:37 14352 Every day [email protected] On
Whole database Automatic run ? 23/06/2015 04:36 6987 Every day [email protected] On
Whole database Automatic run ? 22/06/2015 04:36 0 Every day [email protected] On
Whole database Automatic run ? 21/06/2015 04:37 0 Every day [email protected] On
Whole database Automatic run ? 20/06/2015 04:37 13995 Every day [email protected] On
Whole database Automatic run ? 19/06/2015 04:37 16107 Every day [email protected] On
Whole database Automatic run ? 18/06/2015 04:37 2 Every day [email protected] On
Whole database Automatic run ? 17/06/2015 04:37 12832 Every day [email protected] On
Whole database Automatic run ? 16/06/2015 04:37 9451 Every day [email protected] On
Whole database Automatic run ? 15/06/2015 04:37 0 Every day [email protected] On
Whole database Automatic run ? 14/06/2015 04:37 0 Every day [email protected] On
Whole database Automatic run ? 13/06/2015 04:37 13227 Every day [email protected] On
Whole database Automatic run ? 12/06/2015 04:37 9150 Every day [email protected] On
Whole database Automatic run ? 11/06/2015 04:37 8624 Every day [email protected] On
Whole database Automatic run ? 10/06/2015 04:37 15967 Every day [email protected] On
Whole database Automatic run ? 09/06/2015 04:38 22358 Every day [email protected] On
Whole database Automatic run ? 08/06/2015 04:38 0 Every day [email protected] On
Whole database Automatic run ? 07/06/2015 04:38 0 Every day [email protected] On
Whole database Automatic run ? 06/06/2015 04:38 19089 Every day [email protected] On
Whole database Automatic run ? 05/06/2015 04:38 7099 Every day [email protected] On
Whole database Automatic run ? 04/06/2015 04:38 6978 Every day [email protected] On
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Presented By
Date
Robin Fogel
24 June, 2015
Using QUOSA to automate the literature and triage process
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Enter your questions in the chat box for Sherry will raise them at the end of the presentation
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We want to address your questions as we go!
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Once Articles Are Captured, the Review and Triage Process Has Additional Challenges
Too much time is wasted
looking at the same article multiple
times
Challenges Needs
Some outsourced systems
are unable to meet the rigid
regulatory demands
Existing in-house systems are
becoming outdated, and
maintenance & replacement
costs are high
Need to be sure all articles are
captured and reviewed
A coordinated workflow to manage
the article pipeline
Capture metrics behind article
reviews in case of audits
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
About QUOSA
A combination of software and services that allows customers to reduce risk, remain compliant and ensure that workgroups have the latest scientific literature
Pharmacovigilance — Monitor literature for adverse drug events
Medical Affairs — Collect and share the latest information for Key Opinion Leaders and healthcare providers
Medical Devices — Conduct post-market surveillance for adverse events reporting and pre-market approval
Information Management — Collect, organize and share key documents for your stakeholders
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Improving biomedical literature search and risk monitoring
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
QUOSA Solution for Pharmacovigilance
• Avoid wasted time looking at the same article multiple times
• Ensure all articles are captured and reviewed
• Automated addition of tagging
and organizing literature from searches
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Receive Alerts as a First Step to Rapidly Identify Adverse Events in Literature
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
QUOSA Captures Literature Alert Emails
Embase
Email Provider
QUOSA Alert Parser
QUOSA Virtual Library
Server
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Same Alert Emails Reviewed Manually Serve as QUOSA Input
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Add the VL Address as an Alert Recipient
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Subject Line Tagging Contributes to Orderly Review Process
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Each Citation will be Captured…
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
As a Robust Fully Populated Record in QUOSA
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Deduplication Merges the Same Record Found by Multiple Alerts
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Deduplication Merges the Same Record Found by Multiple Alerts
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Deduplication Merges the Same Record Found by Multiple Alerts
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Deduplication Also Merges Ahead of Print and “Published” Citation
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Audit Trail of Alert Emails to Validate that No Records are Missed
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
• Captures the citation for re-use and sharing
• Minimizes duplicate reviews while intelligently merging originals, updates and copies coming from multiple searches and databases
• Ahead of print seamlessly updated to print version
• Human and system edits intelligently preserved
• Provides confidence that all articles will be reviewed
• Sets the stage for orderly curation – tags are applied that will be used to organize product literature pipeline
• Flexible support for multiple content sources
Many Benefits to Alert Capture by QUOSA
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Review and Annotate Articles from a Scalable Central Library
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Example of a Coordinated Workflow to Manage the Article Pipeline
Metrics and alerts may be set on any process step but will almost always include alerts for documents needing review and those that are overdue
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Reviewer Process May Begin with Automated Full Text Retrieval
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Reviewer Process May Begin with Automated Full Text Retrieval
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
When in Doubt, Batch Highlighting Saves Time for Article Reviews
"heart infarction" or bleeding "acute coronary syndrome" "coronary artery disease" CAD hypertension thrombosis "diabetes mellitus" "cerebrovascular accident" "stent thrombosis" "cardiovascular disease"
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
When in Doubt, Batch Highlighting Saves Time for Article Reviews
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Reviewer Edits Captured as Document Properties
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
A Different Record:Translation Requests with Clock Date Management
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Benefits of QUOSA Triage Process
• Customized workflow aligned with your organization’s practices
• Make sure that no records are missed
• Ensure compliance
• Improve efficiency with better article backlog management
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Use pre-formatted output to easily create reports
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Audit Trail Presented for Each Record
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Benefits of Storing PV Literature in QUOSA
• Ensure accessibility of safety information in the form of reports and also for direct access (e.g. for signal detection)
• Effortlessly export (avoid reformatting/manual processing)
• In the event of an audit, trail is included in each record
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Embase and QUOSA for Literature Monitoring
• Monitor the most comprehensive source of high-quality biomedical information
• Ensure all articles are captured in a central library
• Automate the process of tagging and organizing literature from searches
• Ensure all relevant articles are reviewed
• Avoid wasted time looking at the same article multiple times
We’d be happy to review more details about QUOSA in a live demonstration. Let us know if you’d like to learn more in the post-webinar survey.
Thank you and
Questions
USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |
Thank you
Robin Fogel
Life Sciences Consultant
Ian Crowlesmith
Senior Product Manager
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