Relevancy in literature monitoring
Literature monitoring is the backbone of all your PV reports. Their compliance depends on your skill to identify relevant literature. Many criteria determine a finding’s relevancy – so how can you recognize them efficiently?
Sometimes, a single finding can be more relevant to your PSUR than thousands of others.
The scope of literature screening varies from one report to another. Searches could yield thousands of results depending on the period you cover.
And determining the relevancy of each and every one of these numerous findings is crucial for a good literature search. If you learn to speed up the process of delivering this judgment without risking its quality, you can meet deadlines with less stress.
In this article, we’ll cover some points that could help you get to the pith of each article on your list with ease, make relevancy judgments with more confidence, and increase the speed of your screening. If you’re interested to get deeper into this topic, download our three checklists to easily filter out what makes a study relevant. Checking them out can really come in handy while doing your weekly or monthly screening.
To determine if an article is relevant, you have to understand every bit of information in the SmPC, and beyond. Investigate. Google. Check regulatory websites.
Summary of Product Characteristics (SmPC)
Before typing in the first keyword related to a given substance, download or print the medicinal product’s product information (SmPC) as available (e.g. from the European Medicines Agency’s website).
Get to know it the best you can. Portions of essential information will alert you to what is crucial while screening articles.
Important information will catch your eye with more ease if you read them beforehand – that’s just how our brain works. In cognitive neuroscience, this is called pattern recognition.
Write notes that serve as little reminders of the SmPC’s most important points. You can even write them directly into your PV platform if it enables comments, like Sympto®.
Use a simple Google search to investigate any additional information about the medicinal product. Dig up old information about the substance by browsing through the Pharmacovigilance Risk Assessment Committee (PRAC) and the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) recommendations. Some facts may be less mentioned nowadays, but still relevant.
Things to look for:
A title can immediately tell what information the article will offer, or will it offer any relevant information at all. On the other hand, titles can be misleading, and it’s better to take them with a grain of salt.
In case you don’t check only the relevant fields of interest in your query, most databases will list hits from other scientific areas. These hits could have little to no connection to the safety profile of a drug, rendering them irrelevant to your process. Articles retrieved could be from certain journals pertaining to a strictly chemical or mechanical perspective. Regardless, screen them for mentions of safety profile, benefit or risk regarding a given substance.
Databases such as PubMed offer an option that lists abstracts in the search result list so you can either read them through all at once or open each article separately. The abstract will summarize the main points of an article, showing you what to expect in just a simple glance.
Type of Study
To know the type of study is to know what information it offers. Writing it down in a note for yourself or the PSUR writer will let them know what can be extracted from it. Meta-analyses and systemic reviews are sources of valuable and through information. They are by far the richest and most useful findings, filled with statistically relevant information. For more tips on the types of studies, take a look at our checklists.
Even if an article seems to draw interesting points, its relevancy depends on the number of subjects. It’s a crucial thing to look for in studies on humans. To determine if a number of subjects in a study is enough to make it statistically relevant, you have to consider the type of substance and the indications it is used for. Is it a rare or common indication? What is the medication and how many side-effects have been reported for it?
Keep in mind that it’s always better to include a seemingly non-relevant finding than leave out a relevant one. Especially when it comes to pregnancies, children and the elderly. It’s better to be safe than sorry and include a finding that mentions the use and the effects of a certain substance on a sensitive group. They are always worth a closer look.
Relevant studies have concrete conclusions. If it still hangs in the air, implying that further investigation is needed, it’s possible that the study’s information isn’t substantial enough to be relevant.
- Keep in mind that every search is individual in its kind. Many factors determine the relevancy of literature. This is why taking that extra mile to investigate the substance is so important for the quality of searches. It enables you to zone in on the critical points of literature findings with sharper precision.
- Be fast and efficient. Get a feeling of the underlying point, of the study’s results and conclusion.
- Use a simple CMD or CTRL+Find to lead you through all of the mentions of the substance. It’s an easy way to check if there is something you’ve missed, and you can get a quick look at the context it’s mentioned in.
- Double check everything.
- And always be alert.
To make it easier for you to recognize relevant literature, we put together three study checklists you can consult during screening. So if you want to dig deeper into the relevancy of literature, take a look at our whitepaper.
Now that we’ve dealt with collecting literature, you can read on about processing these findings in our article on Writing the literature section in PSUR.
Want to know more about this topic or about Sympto®?
We invite you to connect with us or download our study checklists to make your literature screening easier.
Getting started with PSUR writing
10 October, 2018
Writing the literature section in PSUR
2 November, 2018
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