Updating the Literature Review and Literature Search Protocol
Getting the long-awaited CE mark is certainly something to celebrate, so if you got it, congratulations! Now you just have to make sure to keep it!
While the preparation for the device launch (which is what the CER is mostly about, to be honest) is difficult, the real work comes after the device is placed on the market. There are tons of stuff to be done; analyses to run, clinical data to collect, and reports to update periodically.
One of the big things to take care of is the literature search or literature review. The literature search takes up much of the workload of the CER process. So, it would be great if we could do it once and be done with it. However, the field of medicine is always changing. Whether there are new devices being invented every day or new information regarding existing technology, it all translates to one thing: an update in the literature review.
In this article, we will go through the common questions people have about the process and some tips for you.
Is Your Data Latest and Relevant?
If you are wondering whether you should update the literature review of your CER, the answer lies in this question. A literature review should be updated when new research or material becomes available.
This can include everything from new findings, new theories or even hypotheses, shifts in the field practice, groundbreaking clinical trials, or the implementation of new laws or norms. It makes sense if you think about it. A literature review represents the most recent results and advancements in the subject and retains its relevance and credibility. So, as soon as the current information changes, the literature review should also change to represent it.
Updating a literature review also helps manufacturers ensure that their device design and clinical conclusions are based on the most recent information.
However, it’s not possible to redo the literature review process every day, so we do the next best thing. We update it periodically.
Preparation of Literature Search and Review
The golden key to the regulatory process hides in preparation, plans, and protocols. A well-planned literature search and review strategy works like magic to pave the way for a thorough and focused search, increase the speed of the review process, and, all-around, easier evidence analysis.
The preparation process is pretty simple. The first screening is on what you already have. Create an index or use the previous one if you have one on the contents of your current literature review. Mark and tag what you can. Try to divide the contents into a few groups based on a common theme.
After you have done that, take a look at the recent news and updates of the device in question. Gather as much as you can, keeping the focus on relative and recent info. You don’t have to dig too deep; just the headlines or keywords are enough. These will serve as starting points in your literature search protocol.
Next, list all the adverse effects, complications, or clinical notes you have received so far as part of your clinical evaluation report activity. Also, enquire whether there were any comments on the last literature review from the regulatory people.
After you have enough data on the current status, start your literature review.
EU CER Literature Review Process
The literature review for any medical product is extensive. When it comes to medical devices, since there are so many mechanical and theoretical components that interact together, the literature search is quite extensive.
The literature review process starts as usual, by identifying and choosing relevant scientific material. This involves examining databases, academic journals, conference proceedings, and other reliable sources for studies related to the device under consideration. Selection criteria commonly include research design, sample size, patient population, and desired outcomes.
While gathering the scientific literature, the selected studies must be critically appraised and analyzed. This entails evaluating the research’s quality and dependability, taking into account criteria such as study design, methodology, sample size, and potential bias.
The outcome of the literature review depends on the literature search process. There are several ways to go about it, really. You can choose to dive blindly into the sea of journals and take your chances. But, for us, a systematic approach has always worked best.
Systematic Literature Search Protocol
A systematic literature review protocol means having a methodical approach that combs through the databases to find the best and most relevant literature. The outcome you get is worth the time and effort it takes to build a well-thought-out protocol.
The best protocols for a systematic review update will reflect its purpose. Choose and define inclusion and exclusion criteria based on the data you collected in the preparation step.
You will get better results for different databases by customizing the literature search strategy. Also, remember the search results depend largely on search terms, especially on platforms like google scholar. Term refinement in literature search in itself is a great tool to filter out the most usable literature. Focus on relevant clinical evidence and equivalent device in the search terms.
After you go through the major scientific databases, you will have to filter them out. Have a screening and quality assessment process. Determine how you will extract the clinical data for clinical evidence at this stage. This will come in handy later while updating the clinical evaluation report.
Apart from these, you will also need to choose the ideal method of data synthesis suitable for your literature review.
Review It All: The Favorable…and the Not So Favorable Data
After you are done with the first few sessions of literature searches, you should have enough to start. Start with the statistical analysis of the clinical data extracted from various sources. The literature search, when done correctly, will provide an ample amount of clinical data to go on.
The clinical evaluation process is about knowing where your strength and weaknesses lie. Sure, it is tempting to present only good data and avoid all potential adverse reactions. But you will feel the full effect at the post-market surveillance stage.
Expert Advice on Literature Search
In the field of literature review and technical documentation, pieces of advice are always welcome. Here are some of the hand-picked ones from our staff for you.
MDCG Documents
Before you complete your new and shiny literature review, go through the MDCG documents on this. These are guidance documents from official authorities and are tremendously useful.
Hiring a clinical evaluation report writer?
If you are considering hiring someone to write your literature review, look for the specific qualifications that mark a good CER writer.
Automate the process
There are several tools at your disposal now that can help streamline the literature search. While most will help in only certain parts of the process, they were worth a try.
Grey literature
We often skip these while searching for the perfect scientific literature. However, you may find some gems within government papers or clinical trials you would otherwise miss.
