Literature Search Report for SOTA
For
[Device Name]
Manufacturer Name: [Manufacturer name]
Document Number: XXXX
Revision: XXXX
Approval
Author
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Approval
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Name:
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Date:
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Title:
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Signature:
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Evaluator
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Approval
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Name:
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Date:
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Title:
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Signature:
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Approval
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Name:
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Date:
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Title:
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Signature:
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Revision History
Table 1: History of revision
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Revision
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Date
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Change History
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Table of ContentS
Approval 2
Revision History 3
Table of ContentS 4
Acronyms 5
1. Objective 6
2. Deviation to the protocol 6
3. Search period 6
4. Search databases 6
4.1. Literature search database 6
4.2. Clinical trials database 6
4.3. Clinical evidence from the previous CER 6
4.4. Inclusion and exclusion criteria 7
5. Summary of literature search results 7
5.1. Introduction 7
5.2. Overall Search limitations 8
5.3. Search queries 8
5.4. Search results 10
5.5. Reasons for exclusion 10
6. Detailed literature search results 10
7. List of retained citations for SOTA 11
Acronyms
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CER
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Clinical evaluation report
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EBM
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Evidence based medicine
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EEA
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European economic area
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EU
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European union
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LVL
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Level
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MEDDEV
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Medical Devices Documents
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N/A
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Not applicable
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SOTA
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State of the art
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Objective
The literature search report has been carried out according to the protocol [protocol number and revision]. A systematic approach has been applied to collect clinical literature articles that support the SOTA of [Device Name], hereafter named [device short name] (Objective 1).
Deviation to the protocol
No deviation to the protocol described in Section 1.
All deviations need to be justified for their impact on the results.
Search period
The SOTA literature search report is defined to cover the period from [start date (DD Month YYYY)] to [end date (DD Month YYYY)].
As described in the protocol indicated in Section 1, Include a justification for how the period selected is appropriate (copy/paste justification from the protocol)
Search databases
Literature search database
The following literature databases have been selected to collect the published literature articles that support the SOTA of [device short name].
Table 2: Search databases for published literature
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Literature Database
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Justification (copy/paste the justification from the protocol)
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Embase
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Embase is a recognized database for literature described in Section A4 of MEDDEV 2.7/1 rev.4.
Embase will be used as a primary medical literature database for the collection of clinical data using dedicated search terms.
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PubMed
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Pubmed is a recognized database for literature described in Section A4 of MEDDEV 2.7/1 rev.4.
Pubmed will be used as a primary medical literature database for the collection of clinical data using dedicated search terms
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NICE
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NICE means National Institute for Health and Care Excellence and has the purpose to help healthcare professionals via guidance documents, recommendations.
NICE is used as secondary database for the collection of clinical data missed in the primary databases to establish the SOTA.
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Clinical trials database
No clinical trials database has been selected for the collection of SOTA clinical evidence.
Clinical evidence from the previous CER
To be removed if not applicable
Literature articles included in the previous clinical evaluation report (CER) will be screened against the inclusion/exclusion criteria to verify their continuous suitability.
Table 3: Searches in previous CER
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Previous CER
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Number of articles to be screened
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Document Number and revision
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Inclusion and exclusion criteria
For the identification of relevant literature articles, the results from the literature search implementation have been reviewed for inclusion based on the titles and abstracts (Level-1 screening) and the full articles (Level-2 screening). The decision to retain each article has been defined based on the inclusion/exclusion criteria described below.
Table 4: Inclusion/exclusion criteria for SOTA (copy/paste from the protocol)
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Code
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Description
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Inclusion criteria
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I1
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The article includes data that represent the SOTA of the medical condition treated/diagnosed by the subject device
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I2
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The article includes data on benefits/risks, advantages/disadvantages of alternative treatments
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I3
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The article includes data on benefits/risks, advantages/disadvantages of similar devices
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IX
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Exclusion criteria
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E1
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The article does not include data:
on the current knowledge/state of the art relevant to the medical condition treated/diagnosed by the subject device (e.g., clinical background, clinical condition, prevalence)
on the current knowledge/state of the art relevant to similar devices and medical alternatives available for the target population and medical condition (e.g., benefits/risks/advantages/disadvantages of similar devices and alternative treatments)
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E2
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Conference article, protocol, survey, position paper, case report, case series, XXX (to be adapted depending on the quality and quantity of expected results)
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E3
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Not in English
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E4
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Not in humans
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E5
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Article outside the period of search
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E6
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Duplicated reference
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E7
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Full text not accessible
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EX
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Summary of literature search results
Introduction
The literature search has been implemented according to the protocol described in Section 1 to detect the published articles related to the SOTA of the medical condition treated/diagnosed by [device short name].
Overall Search limitations
The search limitations, such as types of articles, language, etc. differ from a database to another. Hence, this section describes the overall search limitation strategy that has been applied in the literature search.
Table 5: Overall search limitations (table adapted from the protocol)
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Type of search
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Objective
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Type of limitation
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Description
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Literature search
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SOTA
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Search period:
Article type:
Language:
Population:
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See Section 3
guidelines/meta-analysis/systematic review
English
Humans
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Search queries
The literature search has been carried out by: John Doe
The literature search has been implemented on: DD/MM/YYYY
The following table describes the search queries that have been used for the identification of literature articles relevant to the SOTA of the medical condition treated/diagnosed by [Device short name].
Table 6: Search queries for SOTA (table adapted from the protocol (removal of strategy column))
The queries need to be as detailed as possible with all limitations, start/end dates of search, exact keywords, connectors, etc. to be reproducible later by another author and to be modified easily for an update
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Literature database
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Detailed limitations
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#
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Detailed query
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Embase
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EBM:
- Guidelines/de,
- Systematic review,
- Meta-analysis
Date: Publication years from YYYY to YYYY
Quick limits:
Publication types: Article
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PubMed
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Publication type:
- Practice Guidelines
- Meta analysis
- Systematic review
Date – publication:
YYYY/MM/DD to YYYY/MM/DD
Language: English
Filter: Humans
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All Text:
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All Text:
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NICE
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Filter:
- Type : Guidance
- Last updated : Last 3 years
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Previous CER: XXX rev.1
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N/A – all articles included in the previous CER will be re-screened to confirm their suitability.
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Search results
The following table describes the total number of articles collected after the implementation of each literature search query as well as the number of excluded/included articles after level-1 and level-2 screening processes.
Table 7: Search results
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Literature database
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Query
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Number of results
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Total number of results without duplicate
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Total number of results
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Level 1 screening
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Level 2 screening
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Number excluded
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Number included
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Number excluded
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Number included
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Embase
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PubMed
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NICE
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Previous CER: XXX rev.1
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Reasons for exclusion
The following table describes the summary of reasons for inclusion/exclusion for all articles collected via the literature search strategy implemented.
Table 8: Summary of reasons for inclusion/exclusion
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TOTAL number of results
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Level 1 screening
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Level 2 screening
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Reasons for inclusion/exclusion
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Number of results
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Reasons for inclusion/exclusion
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Number of results
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E1
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E1
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E2
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E2
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E3
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E3
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E4
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E4
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E5
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E5
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E6
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E6
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E7
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E7
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E8
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E8
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I1
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I1
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I2
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I2
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Detailed literature search results
The following table describes the reasons for inclusion/exclusion of all individual articles collected via the literature search strategy implemented.
Table 9: Justification for inclusion/exclusion
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#
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Citations
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Screening
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LVL 1
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LVL 2
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List of retained citations for SOTA
- XXX
- XXX
