How to use a developed and validated search history from a published source to obtain information on adverse effects of medical devices

Background

Regulatory frameworks around medical devices require that devices placed on the market or put into service are both safe to use and perform as the manufacturer claims they should. The supply of clinical evidence in support of these safety and performance requirements begins with the initial conformity assessment procedures and, in the context of post-market surveillance, continues for the life cycle of the device. Essential to both the initial evaluation and subsequent post-market surveillance is the identification and accumulation of information pertaining to possible adverse effects of the medical device.

Golder et al (see References below) have developed and validated search filters for adverse effects of medical devices in Ovid MEDLINE and Embase. They have shown that the developed searches are able to achieve over 80% relative recall in both databases. Additionally, that such recall can be extended to 90% where the searches are supplemented with specifically named adverse effects.  

This Focused Search presents the Embase search filter for adverse effects of medical devices in Embase on Ovid. For the equivalent search in Ovid MEDLINE, please see Adverse Effects of Medical Devices – Ovid MEDLINE.

Both of these search filters can be easily viewed and run, as well as imported into your My Workspace area on Ovid. And this, for re-use and further fine-tuning to meet your own specific needs. These search filters can be linked to a medical device of your choosing and further refined. Implemented also as an AutoAlert, the information subsequently delivered from such routinely run searches, will be an important contribution to your post-market surveillance activities.

Strategy

1. co.fs.

2. complicat*.ti,ab.

3. safe*.ti,ab.

4. failure*.ti,ab.

5. exp medical device complication/

6. adverse.ti,ab.

7. failed.ti,ab.

8. exp postoperative complication/

9. problem*.ti,ab.

10. side effect*.ti,ab.

11. discomfort.ti,ab.

12. loosen*.ti,ab.

13. removal*.ti,ab.

14. complications.kf.

15. migration.ti,ab.

16. ae.fs.

17. device related events.ti,ab.

18. adverse effects/

19. device safety/

20. safety/

21. peroperative complication/

22. tolerated.ti,ab.

23. failing.ti,ab.

24. Or/1-23

How to run a simple yet focused search to quickly identify records connecting a drug and a specific side effect

Background

In busy and demanding healthcare environments, practitioners may often be called upon to obtain up to date information on a specific drug and its possible or even known side effects. The large A&I biomedical databases are able to provide such information. However, given the differences in the way they index the source material, the search strategy needs to be constructed with the database specific indexing methods in mind, in order to obtain the best results. 

For its part Embase uses extensive and deep indexing, providing targeted access to over 40 million records. The Embase indexing system is based upon the Emtree thesaurus where special focus is placed on the 3 D’s namely, drugs, devices and diseases.

With respect to deep indexing, Emtree’s understanding of “drug terms” is that of any chemical entity. That said, clinical drugs are indexed in greater depth than other drug terms. The indexing of clinical drugs can also be supplemented or modified using drug subheadings. In Embase the subheadings are specific to each of the 3 D’s; diseases, drugs and devices. One of the 5 key subheadings for drugs, is the subheading Adverse Drug Reaction and for diseases Side Effect. See the reference below for more details on how Embase indexes drugs and chemicals.

The search example demonstrates how in 3 lines, users can make good use of Emtree’s very focused and deep indexing, related to clinical drugs to retrieve specific and authoritative information. In the example Ibrance was submitted as the initial entry term. This, Embase maps to palbociclib, its generic name which in turn, as an Emtree term also covers synonyms and variants. Neutropenia, also submitted as an entry term, was mapped to neutropenia, which also being an Emtree term, similarly covers synonyms and variants.   

1. exp palbociclib/ae [Adverse Drug Reaction]
2. exp neutropenia/si [Side Effect]
3. 1 and 2

The lines of the search can always be supplemented. For example, line #1 could also include the key terms in the form of .mp searches. Similarly with line #2 in respect of the side effect condition.

For recall and teaching purposes the search could also be documented in the form of a MODEL SEARCH,

1. exp < DRUG NAME >/ae [Adverse Drug Reaction]
2. exp < ADVERSE EVENT >/si [Side Effect]
3. 1 and 2

The search as listed here is the Embase focused search for running a simple search to quickly identify records connecting a drug and a specific side effect. For the functionally equivalent search in Ovid MEDLINE, please see Adverse Drug Reactions: Quick Search – Ovid MEDLINE.

Strategy

1. exp palbociclib/ae [Adverse Drug Reaction]

2. exp neutropenia/si [Side Effect]

3. 1 and 2

How to incorporate a search filter from an external, third-party source into your own Ovid search libraries and documents (Part 1).

Background

One of the main drivers behind the OvidGO! / Focused Searches project is to make searches, and especially search filters, discoverable, actionable and useable. Search filters, searches designed to achieve a specific outcome, are particularly challenging. On the one hand they are spread across a large variety of publication vehicles, e.g. journal articles, systematic reviews, websites etc.. A consequence being that many of them are “locked” in analogue formats, most notably print. On the other hand, the role and value of search strategies, filters or otherwise, as the informational foundation of systematic reviews is understated. And as a result, problematic.

An analysis of critically assessed systematic reviews using the KSR Evidence database (also available on Ovid), demonstrates – dramatically – that a large number of currently available systematic reviews have to be marked as having a high risk of bias because they have not at all, or only partially, reported on the search strategies employed for their construction. Ovid’s search strategy construction and sharing functionality, used purposefully and systematically, can help remedy this situation.  

Taking as its reference the Adverse Events (AE) filter published by the European Medicines Agency (EMA), this Focused Search provides an example of what is meant by making search filters, discoverable, actionable and useable.

As part of its pharmacovigilance obligations and activities the EMA is mandated to keep a watching brief over some 300 substance groups and 100 herbal substance groups. Specifically, to monitor medical literature and enter relevant information into the EudraVigilance database. This the EMA does by running search strategies on EMBASE (Embase.com) that combine (a). a comprehensive list of terms describing the target drug or herbal substances, together with (b). an extensive list of terms and phrases that refer to adverse events in a variety of ways. The list of substances and the AE filter used is available from the EMA and is published and updated regularly. A link to the published document is given below.

The current version of the AE filter, displayed below, can be found on page 13.

AND ('adverse drug reaction'/exp OR adverse:de,ab,ti OR 'side effect':de,ab,ti OR 'side effects':de,ab,ti OR 'side effect':lnk OR 'drug overdose'/exp OR overdos*:de,ab,ti OR 'drug misuse'/exp OR misus*:de,ab,ti OR 'drug abuse'/exp OR 'substance abuse'/exp OR abus*:de,ab,ti OR 'pregnancy'/exp OR pregnan*:de,ab,ti OR 'pregnancy complications'/exp OR 'lactation'/exp OR 'breast feeding'/exp OR ('milk human'/exp AND 'secretion'/exp) OR 'fertility'/exp OR 'reproduction'/exp OR 'fetus'/exp OR 'embryo'/exp OR terat*:de,ab,ti OR 'drug efficacy'/exp OR 'drug withdrawal'/exp OR 'medication error'/exp OR 'death'/exp OR death*:de,ab,ti OR fatal*:de,ab,ti OR 'drug interactions'/exp OR 'drug interaction'/exp OR 'carcinogenicity'/exp OR carcinogen*:de,ab,ti OR mutagen*:de,ab,ti OR 'off label drug use'/exp OR 'occupational exposure'/exp OR 'toxicity'/exp OR toxic*:de,ab,ti OR pharmacotox*:de,ab,ti OR neurotox*:de,ab,ti OR cardiotox*:de,ab,ti OR nephrotox*:de,ab,ti OR immunotox*:de,ab,ti OR hepatotox*:de,ab,ti OR cytotox*:de,ab,ti OR immunocytotox*:de,ab,ti OR 'intoxication'/exp OR 'congenital disorder'/exp OR 'drug treatment failure'/exp OR 'case report'/exp OR 'case reports':de,ab,ti OR 'environmental exposure'/exp OR 'treatment contraindication'/exp OR 'drug contraindication'/exp OR 'injury'/exp OR suicide:de,ab,ti OR 'poisoning'/exp OR 'drug tolerance'/exp/mj OR 'treatment failure'/exp/mj OR 'drug resistance'/exp/mj OR 'substance-related disorders'/exp OR 'treatment failure'/exp OR 'drug resistance'/exp OR 'drug resistance':lnk) AND [humans]/lim

So that you can also use this search filter on Ovid, we have translated the Embase.com syntax into Embase on Ovid syntax. Availing of the ABC format options behind Focused Searches, you can display the Ovid rendered version by clicking on ACTIONS / Display. Alternatively, ACTIONS / Launch will run the filter in Embase on Ovid. If you would like to talk to a member of the Ovid Training Team about the filter, select ACTIONS / Ovid Coaching. Once in the database you can combine the filter with substances relevant to your investigation. You can also save the filter in My Workspace for re-use as part of your own or institutional library of searches and search blocks. 

The next Focused Search, Search Blocks in Line Format (EMA AE Filter) – Embase (Part 2), will consider the relative merits of this filter in its paragraph format vis-à-vis a line-by-line format.  

Strategy

exp adverse drug reaction/ OR adverse.hw,ab,ti. OR side effect.hw,ab,ti. OR side effects.hw,ab,ti. OR side effect.fs. OR exp drug overdose/ OR overdos*.hw,ab,ti. OR exp drug misuse/ OR misus*.hw,ab,ti. OR exp drug abuse/ OR exp substance abuse/ OR abus*.hw,ab,ti. OR exp pregnancy/ OR pregnan*.hw,ab,ti. OR exp pregnancy complications/ OR exp lactation/ OR exp breast feeding/ OR (exp milk human/ and exp secretion/) OR exp fertility/ OR exp reproduction/ OR exp fetus/ OR exp embryo/ OR terat*.hw,ab,ti. OR exp drug efficacy/ OR exp drug withdrawal/ OR exp medication error/ OR exp death/ OR death*.hw,ab,ti. OR fatal*.hw,ab,ti. OR exp drug interaction/ OR exp drug interaction/ OR exp carcinogenicity/ OR carcinogen*.hw,ab,ti. OR mutagen*.hw,ab,ti. OR exp 'off label drug use'/ OR exp occupational exposure/ OR exp toxicity/ OR toxic*.hw,ab,ti. OR pharmacotox*.hw,ab,ti. OR neurotox*.hw,ab,ti. OR cardiotox*.hw,ab,ti. OR nephrotox*.hw,ab,ti. OR immunotox*.hw,ab,ti. OR hepatotox*.hw,ab,ti. OR cytotox*.hw,ab,ti. OR immunocytotox*.hw,ab,ti. OR exp intoxication/ OR exp congenital disorder/ OR exp drug treatment failure/ OR exp case report/ OR case reports.hw,ab,ti. OR exp environmental exposure/ OR exp treatment contraindication/ OR exp drug contraindication/ OR exp injury/ OR suicide.hw,ab,ti. OR exp poisoning/ OR exp *drug tolerance/ OR exp *treatment failure/ OR exp *drug resistance/ OR exp substance-related disorders/ OR exp treatment failure/ OR exp drug resistance/ OR drug resistance.fs.

A look at the relative merits of search filters in a paragraph format vis-à-vis a line-by-line format, using as an example the EMA AE Filter (Part 2).

Background

Generally speaking, search filters, whether displayed on screen or reported in scientific literature come in three formats. These are, firstly the “line-by-line” format where search expressions are entered or displayed as a list, one on top of the other, literally line by line. The second format, here referred to as the “paragraph” format has all the search expressions bundled into a single line that appears as a block of text. This provides for a more compact display, and can in turn, be also run as a single line search. Thirdly, the “hybrid” format describes search strategies that contain a mixture of line-by-line and paragraph format search expressions.

Opting for one format over another depends upon many factors. These vary from available screen space to the capacity of the reporting vehicle, e.g. a printed journal, to simply personal choice.

The purpose of this Focused Search is to raise a note of caution when using the paragraph format without firstly verifying whether or not the search expressions (a). run in the target database, and (b). are relevant to the task at hand. The AE Filter as shown above, unpacked, extends to 60 lines listed line-by-line. This way the relative presence of the terms and phrases can be more easily assessed. As too can be the balance between free term and thesaurus-based searches, and with respect to the latter,  whether they have been exploded. Using Ovid’s Edit function (Actions / More / Edit) a thesaurus expression can have the “exp” command function deleted or added to see what a difference this makes.

It is recommended that your key search filters be saved and stored in both paragraph and line-by-line formats. The former for ease of execution and display. The latter for verification, updating and overall knowledge asset management.  

Ovid Trainer Tips

• Command line Syntax: Lists of search expressions can be neatly combined using the OR operator as displayed in line #61 above, i.e. or/1-60.
• Ovid Search History Launcher Tool: Having unpacked a paragraph formatted search using for example, Notepad, the resulting list of search expressions can be easily imported into Ovid using the Ovid Search History Launcher Tool. See https://tools.ovid.com/ovidtools/launcher.html .
• Share Search History: Conversely, searches regardless of format can be exported from Ovid into other applications for eventual re-use, for peer review and reporting purposes. Located in the Search History section of the Ovid interface, the three Share Search History options are, Email All Search History, Copy Search History Link and Copy Search History Details.

Strategy

exp adverse drug reaction/

adverse.hw,ab,ti.

side effect.hw,ab,ti.

side effects.hw,ab,ti.

side effect.fs.

exp drug overdose/

overdos*.hw,ab,ti.

exp drug misuse/

misus*.hw,ab,ti.

exp drug abuse/

exp substance abuse/

abus*.hw,ab,ti.

exp pregnancy/

pregnan*.hw,ab,ti.

exp pregnancy complications/

exp lactation/

exp breast feeding/

(exp milk human/ and exp secretion/)

exp fertility/

exp reproduction/

exp fetus/

exp embryo/

terat*.hw,ab,ti.

exp drug efficacy/

exp drug withdrawal/

exp medication error/

exp death/

death*.hw,ab,ti.

fatal*.hw,ab,ti.

exp drug interaction/

exp drug interaction/

exp carcinogenicity/

carcinogen*.hw,ab,ti.

mutagen*.hw,ab,ti.

exp 'off label drug use'/

exp occupational exposure/

exp toxicity/

toxic*.hw,ab,ti.

pharmacotox*.hw,ab,ti.

neurotox*.hw,ab,ti.

cardiotox*.hw,ab,ti.

nephrotox*.hw,ab,ti.

immunotox*.hw,ab,ti.

hepatotox*.hw,ab,ti.

cytotox*.hw,ab,ti.

immunocytotox*.hw,ab,ti.

exp intoxication/

exp congenital disorder/

exp drug treatment failure/

exp case report/

case reports.hw,ab,ti.

exp environmental exposure/

exp treatment contraindication/

exp drug contraindication/

exp injury/

suicide.hw,ab,ti.

exp poisoning/

exp *drug tolerance/

exp *treatment failure/

exp *drug resistance/

exp substance-related disorders/

exp treatment failure/

exp drug resistance/

drug resistance.fs.

or/1-64

How to locate specific information on mpox quickly on Embase on Ovid

Background

On 13th August 2024, the African Centres for Disease Control and Prevention (African CDC) issued a public health warning, highlighting the spread of a particular strain of the mpox virus (formerly called the monkeypox virus). (1) The next day, the Director-General of the World Health Organisation (WHO) declared the mpox (monkeypox) outbreak to be a public health emergency of international concern. (2)

Wary of the informational challenges presented only just recently by the onset and impact of the covid 19 pandemic, researchers, health care professionals and policy decision makers all have a pressing need to acquire up to date information on mpox. Be it the virus, the disease or the vaccine or vaccines.

Nomenclature Changes
Locating information relating to mpox has its own unique challenges as the description of the virus and disease has undergone a nomenclature change. On 28th November 2022, the World Health Organisation (WHO) recommended a new name for monkeypox disease, namely ‘mpox’. (3) The recommended change was in keeping with the 2015 WHO publication on best practices in naming diseases. 

“According to these best practices, new disease names should be given with the aim to minimize unnecessary negative impact of names on trade, travel, tourism or animal welfare, and avoid causing offence to any cultural, social, national, regional, professional or ethnic groups.”(3)

However, the name of the virus would remain unchanged – for the time being – to reflect its use in scientific literature. And in doing so, to continue to make relevant documents discoverable and retrievable. Biomedical databases, reflecting scientific publications and their terminological use over decades, have also used the term ‘monkeypox’ in their controlled vocabularies. For database searchers, be they novices or experienced searchers, this semantic transition from old to new, has consequences for database search query design.

Search Blocks
This Focused Search presents three search blocks that will help you quickly locate scientific literature on mpox, and that on the virus, the disease and vaccines, respectively. For ease of initial viewing the three search blocks are listed as a single search history which can be viewed via the Actions / Display option. The same search can be run directly in Ovid by clicking on Actions / Launch.

Search Design
Although listed in the Focused Search as a sequence of three searches, the search blocks were individually designed, constructed and tested. Their construction followed the conventional concept search approach of a database thesaurus search followed by a free term search, followed by the combination of the thesaurus and free term search using the Boolean operator, OR.

In all three cases, the thesaurus term’s Scope Note was used as the initial source of free terms. This was done in anticipation of a degree of similar coverage between the thesaurus term and its kindred free terms. However, where the Scope Note omitted terms or listed terms that, when tested were not found in the scientific literature, the free term search expression was amended accordingly. The details for each of the three search blocks are given in the table below.

The search blocks were peer reviewed by members of the Ovid Training Team

Search Assistance
The purpose of this Focused Search is to help kick-start your searches related to mpox, the virus, the disease and the vaccine(s). And this, for your own purposes as well as to help you assist those you advise and teach. By saving these blocks (with your own amendments and changes) in My Workspace you could combine them with Clinical Queries, for example. Or with respect to the vaccine, with the EMA’s search filter on adverse events. If you would like further assistance on or with this Focused Search, as well as on any aspects related to it, please click on Actions / Ovid Coaching and an Ovid Trainer will contact you. Alternatively, please send an e-mail to us at [email protected] .
 

Strategy

monkeypox virus/

(Monkey orthopox virus$ or Monkey pox virus$ or Simian orthopox virus$ or Simian pox virus$).mp.          

(mpxv or monkeypox virus$ or monkey pox virus$ or mpox virus$).mp.

1 or 2 or 3 [THE VIRUS: Thesaurus & Free Terms]

monkeypox/

(benign epidermal monkey pox or chimpanzeepox or monkey pox or Monkeypox virus infection or mpox or monkeypox).mp.

5 or 6 [THE DISEASE: Thesaurus & Free Terms]

monkeypox vaccine/

(monkeypox vaccine$ or monkey pox vaccine$).mp.

(mpxv vaccine$ or monkeypox vaccine$ or monkey pox vaccine$ or mpox vaccine$).mp.

8 or 9 or 10 [THE VACCINE: Thesaurus & Free Terms]