Use of Literature databased in CERs Optimal database combinations for literature searches of a CER

Combination of systematic searches in different databases with (potential) additional hand searches is the optimal approach to identify literature data for an MDR-compliant CER. When possible, searches for the State of Art should be limited in reviews, systematic reviews, meta- analyses and Clinical Practice Guidelines further delimited by data derived from studies in humans. On the contrary, device-specific searches should proceed without any filters.

Keep in mind that in both cases (SoTA and device-specific searches), it might be required to identify and discuss data of biomechanical, pre-clinical and/or technical nature depending on the special features of a medical device and/or an in-vitro diagnostic medical device.

In this context, the most appropriate databases to use are PubMed, Embase, and Google Scholar. Watch out for overlapping and make sure you are excluding all duplicates!

Pubmed Embase CENTRAL Google Scholar  MEDLINE® is the  EMBASE is an  Cochrane Library is a  Google Scholar National Library of database with > 32 million collection of databases that retrieves an extremely ® (NLM®) citations from almost 3,000 contain different types of wide range of journal citation database, indexed journals unique to evidence, namely the interdisciplinary results. including citations from > EMBASE and > 2.4 million Cochrane Central Register of  It searches the full 5,600 scholarly journals, conference abstracts indexed Controlled Trials (CENTRAL), text of articles and is also which are subject to from > 7,000 conferences. the Cochrane Database of likely to retrieve clinical review by a NIH- Systematic Reviews and the data from non-peer- chartered advisory Health Technology Assessment reviewed sources. committee before (HTA) Database.  Results are sorted by acceptance.  The library lies into the relevancy and number of Cochrane Database Systematic times cited. Reviews (CDSR), a database of  Search strategies peer-reviewed systematic are limited to a maximum reviews in health care of 256 characters, which prepared by Cochrane Review means that creating a Groups. thorough search strategy can be laborious.

MeSH Emtree

 The Medical Subject  The EMTREE function is Headings (MeSH) a collection of standardized thesaurus is a controlled keywords within Embase, vocabulary or depository which allows organization of terms produced by of biomedical terms in a NLM used for indexing, broader sense. Emtree cataloging, searching terms are added to articles and organizing to describe the content of information in the an article in a uniform way. Medline database. It Articles entered in Embase consists of sets of terms are automatically assigned naming descriptors in a Emtree via an algorithm, hierarchical structure that which is later manually permits searching at checked and corrected by various levels of Embase indexers. Watch specificity. Watch this to this to know how to use it: know how to use it: https://www.youtube.com/w https://www.youtube.co atch?v=-6hMmclhzSE m/watch?v=ycfCoy6RW3 Q&feature=emb_logo

Use of Literature databased in CERs

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 Although Clinical Trial Database (e.g. Clinicaltrial.gov) is NOT peer-reviewed, it represents a potential useful source of clinical data especially in situations where data is limited and publication bias might emerge. However, its use in SotA section might not be necessary if a thorough systemic search of the above-mentioned databases is executed. →Searches in Cochrane library will also retrieve results from clinicaltrials.gov.

 Looking for extra resources to help you retrieve data on clinical trials? Check these: . Clinical Trials Register: https://www.clinicaltrialsregister.eu/ . ISRCTN Registry: http://www.isrctn.com/ . International Clinical Trials Registry Platform (ICTRP): https://www.who.int/ictrp/en/

 CENTAL is your database of interest when looking to retrieve randomized and/or quasi-randomized controlled trials. When in doubt, do a pilot, basic search on CENTRAL to see what is retrieved.

 Changes in the new PubMed result in higher number of returned hits compared with the legacy version due to automatic term mapping, removal of the previous limit to 600 iterations when using a wildcard (*) search, and the default search now ignoring Boolean operations (AND, OR, etc.). This will have a major regulatory implication: replication of searches by Auditors and/or Competent Authorities will eventually not be possible although legacy PubMed is currently still available (new citations are NOT added) and can be accessed here: https://pmlegacy.ncbi.nlm.nih.gov/ →Make sure you have kept copies of all your searches in legacy . →Prepare a rationale for the expected discrepancies. Most probably your search strategy will need revision!

 Searching with MeSH terms excludes citations from MEDLINE journals that have not yet been fully indexed, as well as other PubMed citations that are not indexed for MEDLINE (e.g. citations that are out of scope for MEDLINE).

 Want to search the new pubmed for a specific date range? Try this : “your search string” AND YYYY/MO/DAY:YYYY/MO/DAY[dp]

 Embase has featured a special section for medical devices with comprehensive content and search strategies indexing, among others, trade names linked to Manufacturer names and related procedures. Use it here: https://www.embase.com/search/medicalDevice (registration required).

 If you are looking to manage Google Scholar hits, consider using Publish or Perish, a software program that retrieves and analyzes academic citations from a variety of data sources including Google Scholar. Get it here: https://harzing.com/resources/publish-or-perish Keep in mind it might require a few pilot searches before finalizing the features that serve your literature search

database, developed by Elsevier, includes Cited References and incorporates searches of scientific web pages through . It indexes Medline. However, it covers a very wide range of disciplines and this may result in increased “noise” when focusing on Medicine/. . Looking specifically for proceedings of abstracts? Consider starting your search in Scopus

 If you are searching Gray literature, remember there are two spellings and search for (gray OR grey) literature

 Looking for Grey Literature Resources? Start with these . Pubmed’s dedicated site to Grey Literature: https://www.ncbi.nlm.nih.gov/books/NBK518693 . GreyNet: http://www.greynet.org/ . Grey Literature Report: http://www.greylit.org/ . Open Grey: http://www.opengrey.eu/ . OpenDOAR: http://v2.sherpa.ac.uk/opendoar/

 Found an interesting article? . Use “view similar articles” function in Pubmed to retrieve similar articles . See who cited the article using the “cited by” function in Google Scholar