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

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)

3

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

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

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

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

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

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

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

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

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

Indexing medical device items (cont’)

6. The appropriate medical device subheadings (qualifiers) are indexed:

• Adverse device effect

• Device comparison

• Device economics

• Clinical trial

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

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

In-depth indexing of medical device

(subheadings, triple-linking, trade and manufacturer name)

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.

Clinical Evaluations –

Gather information for successful

regulatory submissions

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

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

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

Device Clinical Performance

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)

24

Example of a result

Device Comparison

26

Device Comparison

1. Focused search using subheadings

'everolimus eluting coronary stent'/'device comparison' (171 hits)

27

Example of a result

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

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

Device Safety

(finding Adverse Device Effects)

31

Device Safety

1. Focused search using subheadings:

'everolimus eluting coronary stent'/'adverse device effect'

32

Example of a result

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:

Export search strategies and

full search results

35

Search strategies, full search results and a clear and

functional list of references must be included in the CER

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*))

Set up an

email alert

Thank you!

Any questions?

Dr. Ivan Krstić

Senior Product Development Manager

Embase

i.krstic@elsevier.com