Finding the right medical device information in embase 11 2016
1. 1
Embase Webinar:
Finding the right
Medical Device
information in Embase
Dr. Ivan Krstić
Senior Product Development Manager Embase
Elsevier R&D Solutions
Date: 16th November 2016
2. 2
Agenda
In this webinar, we will discuss:
• New European Medical Device Clinical Evaluation Report guidelines
(MEDDEV 2.7/1)
• How Embase addresses these requirements
• How to design effective literature searches for Clinical Evaluation reports
using the PICO search form in Embase (demo)
• How to build a more comprehensive search using Emtree terms and
synonyms (demo)
4. 4
Medical Device Clinical Evaluation Report (CER)
guidelines
Revision 4 of MEDDEV 2.7/1: Clinical Evaluation: Guide for Manufacturers
and Notified Bodies (June 2016)
Includes detailed information on:
• Where to search for literature
• How to search for literature
• How to record the process of collecting, appraising and analyzing the
items found.
The relevant guidelines should be applied to all medical devices sold in
European Union, including those manufactured elsewhere.
5. 5
Guidelines for systematic reviews of biomedical
literature in CER creation
Sources
Appendix A4, Sources of Literature, highlights the important literature
databases to be used as sources, specifically stating:
- MEDLINE® or PubMed® can provide a good starting point for a search.
However, with potentially incomplete coverage of European journals and
reduced search features, comprehensiveness is not necessarily
guaranteed.
- Additional databases may need to be used to ensure adequate coverage of
devices and therapies in use in Europe, to identify relevant clinical trials
and publications of user experience, and to facilitate searches by device
name and manufacturer. Listed additional databases include Embase®
and the Cochrane Central Trials Register.
6. 6
Guidelines for systematic reviews of biomedical
literature in CER creation
Types of search
Objective, non-biased, systematic search and review methods should be used:
• PICO (patient characteristics, type of intervention, control and outcome
queries)
• Cochrane Handbook for Systematic Reviews of Interventions
• PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-
Analyses) Statement
• MOOSE Proposal (Meta-analysis Of Observational Studies in Epidemiology)
Items for inclusion and protocol
The objectives of the CER must be linked to specific safety, performance and
risk–benefit endpoints.
7. 7
How Embase addresses these requirements
Embase is the most comprehensive biomedical database. It contains over
2,900 journals that cannot be found in MEDLINE.
Embase
Embase
MEDLINE
• In-depth device indexing with
>2x as many index terms as MEDLINE
• Unique search features to find results based on
Booleans, proximity, wildcards and dozens of filters
• Ability to save, share and edit complex search
strategies with a group
• Unique coverage of over 2.2m conference
abstracts from >6,600 conferences (added since
2009)
• Much more coverage of non-English content and
RCTs
2,900 journals not available
on MEDLINE
Over 8,600 Journals/
32 Million Records
Embase contains
all of MEDLINE
8. 8
How Embase addresses these requirements
Embase covers all the content contained in MEDLINE and unique coverage,
including conference abstracts and European journals.
49.7%
33.4%
9.5%
7.4%
North
America
Europe
Asia
RoW *
* RoW = Rest of the World (esp. Australia & New Zealand, Africa, South America)
9. 9
Indexing for Embase is a manual process
performed by trained indexers with a biomedical
background, with the exception of articles designated
for automatic indexing.
Indexers read and analyze the full text of articles in
order to identify relevant concepts, and index them with
the most specific Emtree terms.
Index terms are controlled by the Emtree thesaurus
resulting in consistent coverage of concepts that
may be expressed in many different ways in the
literature.
Indexing principles
10. 10
How Embase addresses these requirements (con’t)
Crucially for medical device CERs, Embase has a specific focus on medical
devices. Emtree®, the Embase thesaurus used for indexing, includes over
3,000 medical device terms.
2,168,297 records about
medical devices indexed
in Embase
Comprehensive and in-depth
indexing of medical devices
11. 11
Indexing medical device items
1. All medical devices for which device-related information is given in the item are
indexed. To find medical devices, the whole record is read, including “materials
and methods”.
2. A medical device is indexed using the most specific term available in Emtree
to cover the device.
3. If an appropriate specific term to index the medical device is missing from
Emtree a new term (candidate term) is proposed/used.
4. Device trade names are indexed.
5. Device manufacturer names are indexed.
12. 12
Device manufacturer names are indexed
Manufacturer Embase Not in MEDLINE
Abbott 8,202 2,046
Medtronic 16,746 3,776
Boston Scientific 12,361 2,838
Siemens 31,747 7,262
Philips 17,192 4,329
Toshiba 5,362 1,281
Olympus 12,458 5,413
Indexing shows what’s relevant and what might be missed…
13. 13
Indexing medical device items (cont’)
6. The appropriate medical device subheadings (qualifiers) are indexed:
• Adverse device effect
• Device comparison
• Device economics
• Clinical trial
14. 14
How Embase addresses these requirements (con’t)
Dedicated medical device search form and device subheadings can be
used to retrieve records which contain these useful qualifiers (e.g., adverse
device events, device comparison, device economics).
15. 15
In-depth indexing of medical devices (cont’)
If medical device links are relevant, the appropriate device (triple) link/s are
indexed (triple-indexing) based on semantic relationship.
16. 16
In-depth indexing of medical device
(subheadings, triple-linking, trade and manufacturer name)
17. 17
How Embase addresses the new requirements (cont’)
Ability to build searches in Embase.com using a structured PICO framework
which also allows easy incorporation of Emtree terms and synonyms, supports
manufacturers in the creation of comprehensive CERs, enabling them to get
regulatory approval faster and accelerating the time to market.
19. 19
The clinical evaluation is based on
a comprehensive analysis of
available pre- and post market
clinical data relevant to the
intended use of the device in
question, including clinical
performance data and safety
data.
This includes data specific to the
device in question as well as any
data relating to devices claimed as
equivalent by the manufacturer.
What is clinical evaluation?
20. 20
Clinical Evaluations –
Gather information for successful regulatory submissions
Potentially relevant
literature identified
Literature excluded,
with reasons
Literature excluded from clinical
evaluation, with reasons
Literature retrieved for
more detailed assessment
Literature with relevant useable data
included in the clinical evaluation:
Device performance
Device safety
Device comparability
(if applicable)
Comprehensive
search
21. 21| 21
Scenario: Device manufacturer wants to market a new coronary
stent - everolimus eluting coronary stent
Goal: Find critical information needed for successful regulatory
submissions (Clinical Evaluations and Post-Market
Surveillance) that includes:
• Device clinical performance
• Comparison of device with existing devices
• Device safety – finding adverse device effects
Case study
23. 23
Clinical performance information
Sensitive search created using PICO search form
('everolimus eluting coronary stent'/exp OR 'promus element' OR 'xience xpedition' OR 'xience-v' OR
'everolimus eluting coronary stent')
AND
('randomized controlled trial'/exp OR 'systematic review'/exp OR 'meta analysis'/exp)
28. 28
Device Comparison (with a specific device)
2. More focused search based on triple-linking (indexed semantic relationships
between two devices):
'everolimus eluting coronary stent'/'device comparison'/'biolimus eluting coronary stent'
29. 29
Device Comparison (with a specific device)
Search based on co-location of terms in
records:
('everolimus eluting coronary stent'/exp
OR 'promus element' OR 'xience
xpedition' OR 'xience-v' OR 'everolimus
eluting coronary stent‘)
AND
('biolimus eluting coronary stent'/exp OR
'biolimus a9 (device)' OR 'biolimus
eluting coronary stent' OR 'umirolimus
eluting coronary stent')
3. Sensitive search using PICO search form
33. 33
Device Safety
('everolimus eluting coronary stent'/exp OR 'promus element' OR 'xience
xpedition' OR 'xience-v' OR 'everolimus eluting coronary stent')
AND
('adverse device effect'/exp OR 'complication'/exp OR (postoperative
NEXT/2 complication*) OR complicat* OR 'risk'/exp OR risk* OR ‘side
effect’/exp OR (adverse OR side OR undesirable OR unwanted OR lack)
NEXT/2 (effect* OR reaction* OR event* OR outcome*))
(1,616 hits)
2. Sensitive search using Emtree and free text:
35. 35
Search strategies, full search results and a clear and
functional list of references must be included in the CER
36. 36
Automatize searching for post-market surveillance
('everolimus eluting coronary stent'/exp OR 'promus element' OR 'xience xpedition' OR
'xience-v' OR 'everolimus eluting coronary stent')
AND
('adverse device effect'/exp OR 'complication'/exp OR (postoperative NEXT/2 complication*)
OR complicat* OR 'risk'/exp OR risk* OR ‘side effect’/exp OR (adverse OR side OR
undesirable OR unwanted OR lack) NEXT/2 (effect* OR reaction* OR event* OR outcome*))
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