The literature review is a critical part of any clinical evaluation. It’s where you collect all of your clinical data, analyze it, weigh it, and use it to evaluate the acceptability of your device’s risk-benefit profile.
For lower-risk devices, most, if not all, of your clinical data will come from the scientific relevant literature and your literature review.
Depending on the project, you might collect hundreds of journal articles. Keeping track of that many citations comes with its challenges.
This article will review how to keep track of your scientific literature and references during your literature review using EndNote.
What is EndNote?
EndNote is a reference management tool that lets you collect references and citations, import PDFs, and create bibliographies and reference libraries.
It lets you format your citations and bibliographies with more than 6900 formatting styles from journals and professional associations. It also connects to more than 6000 online databases.
EndNote is basically a one-stop shop-shop for references and citations.
EndNote is a paid program,m and it is not cheap – the full license will cost you $275, while the student license is $150. If a new version of EndNote is released, upgrading will cost you $125 even if you have previously purchased the full license.
There are other citation managers on the market, both paid and free.
Menderley by Elsevier is our (free) favorite as it has many of the same basic functionalities of EndNote, such as direct citations in Word and PDF upload.
Some prefer Excel, which is alright for smaller or simpler literature reviews without many citations or searches. Handling extensive searches and references in Excel can quickly become complex.
Lastly, some professional companies specializing in literature reviews have developed their own software to deal with large amounts of references and citations. At Citemed, our proprietary software helps us deal with thousands of references simply and quickly.
Research process with EndNote
Your search and research process does not change when using EndNote compared to other citation managers or Excel.
Your research question and searches should be performed in precisely the same manner.
However, when it comes to scientific database search results, this is where EndNote shines. Exporting your search results from the database and importing them directly into your EndNote library makes collecting your references in one place a breeze.
Almost all the major literature databases offer citation export. With more than 700 import options, you are sure to find the optimal way to import your references to your citation manager.
The EndNote library
One of the quirks of EndNote is that you must maintain an EndNote library on your computer. It should not be stored on network drives or the cloud but on the computer.
Because your EndNote library is not stored in a cloud-based drive, we highly recommend backing it up several times during your literature review.
Your backups will act as a safety net in case you need to revisit previous searches or if your library (or, God forbid, your computer) is damaged or corrupted in the midst of your literature review.
We recommend doing library backups at the following stages of your literature review:
- After importing all your references into EndNote and before duplicates are removed
- After you’ve removed your duplicates
- At any point after you’ve screened a large chunk of references or done other major work on your references, such as editing references in case of incomplete citation data
- Before doing any large pieces of work on your references, such as finding full texts for the majority of your references
- Some might like to do daily backups at the end of each work day (or at the beginning, we won’t judge you). In this case, it becomes important to name your backups correctly and archive or overwrite previous versions to avoid hundreds of backup files
Keeping track of references during your literature reviews
It can be helpful to track which databases references were originally downloaded from.
We recommend including a listing in your clinical evaluation report of every reference, where it was found, and whether it was included in the clinical evaluation.
Likewise, most notified bodies will expect tables showing the number of search results per search and database, so having an overview of where a reference was exported from is critical.
Sometimes references already include the name of the database it was found in. This is especially true for larger databases, such as PubMed or Embase.
However, citations might not include the source, and then what do you do?
You have two options, and we recommend using both:
- Edit your references to include the source database
- Create groups in EndNote for each database
Doing it this way will give you an easy overview of the database results with the groups. Still, you will also see the source in the individual reference, which will be valuable when you review references in your document and not in the EndNote user face.
Integration with Word
EndNote integrates seamlessly with Word.
The “cite while you write” feature allows you to add references while you, well, write.
Once installed, EndNote will have its own toolbar in Word. The toolbar lets you cite, edit, and manage citations and references.
You can update or configure your citations and annotated bibliography according to your referencing style.
Overall, the EndNote Word interface is easy to use, and you can get citing as soon as you have it installed.
It also includes more advanced features, which take a while to learn. The advanced features might not be needed for basic users, but for professional medical writers or other heavy literature review writers, they are a necessity.
So, what are the downsides to EndNote?
While EndNote is a fantastic citation manager and literature review tool, it does have a few cons.
First, the price tag can deter even the most hardened professional, especially considering the (free) alternatives out there. However, some companies require references and citations formatted to EndNote and delivery of the entire EndNote library along with the literature review, so not all medical writers can avoid the expense.
Second, the learning curve with EndNote is steep. It is not a simple program, and becoming proficient can take a while.
Third, if you switch between devices frequently, the local EndNote library can quickly become irritating. It requires some extra planning if you primarily use a stationary computer at home or work but sometimes work from a laptop or a tablet when you are out and about.