Writing the Literature section in PSUR

2

November, 2018

The Literature section is one of the vital organs of PSURs. Most information you’ve accumulated plays a big part here. This is the section where you distill all the monitoring and screening you’ve done up to now and produce significant insights.

Condensing all relevant information from literature is no easy feat

You combine and summarize data in the most effective way. And to do it right, you have to possess thorough understanding of its relevancy. To know more about judging the relevancy of findings, take a look at our previous article.

However, can there be universal guidelines?

PSURs can never be a “one-size-fits-all”. Even less so in the Literature segment. The complexity of PSUR writing depends on the complexity of the molecule in question.

The process is very individual, from one PSUR to another. Yet their composition is always grounded by the same unwavering rules and follows the same underlying logic.

I.  Collecting information:

Check literature databases again

If you have a tendency to save relevant articles while performing weekly literature searches, be sure to do the additional literature search with as much care as if you’re doing it for the first time. Especially because many databases, such as PubMed, include articles in retrograde.

Investigate

Although literature findings and SmPC are your two main referring points in writing, they could still leave you with gaps. And you’ll have to fill these gaps yourself.

Collect and group information. Be thorough. Organize all of your findings before you even pick up your pen. This way, it will be easy to see what to include and where to include it.

For example, you may find a study that mentions how, out of all of the medicinal products used for a specific indication, yours is the one that induced a side effect with the least severity.

This information is significant and good to include but could be easily overlooked if you don’t broaden your research. If you notice a frequent pattern or some implications that could lead to less apparent conclusions, follow those leads. This way, you can be sure you’ve covered everything.

Check information on substances of the same class

Literature searches for PSURs should also include studies reporting safety outcomes in other products containing the same active substance.

Information on other active substances of the same class should be considered to see if they’re relevant and applicable.

II.  Before you start writing:

Determine what is relevant

Once you get to know your material, distill what is important, and in what context is it important. What facts show up often, and why? If you don’t have the answers to these questions, it’s time to retrace your steps until you’re sure you do. If you want to go deeper into what makes a specific study relevant, read all about it in our study checklists.

Explain why is it relevant

Writing Literature is not simply listing findings. You have to elaborate on why are these findings relevant and in what way are they relevant.

Know what to include

When determining the literature you need to include, start from the broadest angle possible. What studies are relevant? What exactly is relevant in them?

Group studies into segments

Depending on the period a PSUR covers and the usage of the substance, your literature search might end up with a whole list of diverse studies.

It’s best to group them by adverse effects, affected population (i.e. elderly, children, pregnancies). This way you start to make sense of the information you accumulated.

Organize the hierarchy of segments

With the studies neatly grouped into a kind of mindmap, you get to see the exact nuances of their importance.

It’s easy to see what should be prioritized, and what data complement each other. Organizing this hierarchy before diving into writing will give you a steadfast idea of the final report’s shape.

Sympto® can help you immensely to put heaps of information into order. You can link all literature you’ve found, and extract it with detailed filters. Use comments to mark what’s relevant in a literature entry – later it will be easy to see where can you use it.

Special types of safety information

You should keep an eye out for special types of safety information, such as:

  • pregnancy outcomes (including termination) with no adverse outcomes;
  • use in pediatric populations;
  • compassionate supply, named patient use;
  • lack of efficacy;
  • asymptomatic overdose, abuse or misuse;
  • medication error where no adverse events occurred;
  • important non-clinical safety results.

III.  The writing process

Structure each segment

Start with what you’ve found about a specific literature finding. Give it a general introduction. Then, describe in broad strokes what is it all about. What have you found?

Finally, summarize the relevant information and recount everything vital from it. If there are more studies you can include in one segment, combine them.

Be objective

In the Literature section, you describe every positive and negative thing you encounter. Broaden your perspective. You have to present all relevant facts from every angle possible.

Be concise

Although it could seem like the easiest thing about composing PSURs, writing information in a clear and concise manner can be elusive.

Write Vancouver references

The Vancouver reference style is a numbered citation style often used in scientific and medical writing.

You’re probably well acquainted with it from various papers, and you can see it in any article or study you find on PubMed. Keep in mind that it’s not the only referencing system used in medicine: you’ll come across articles using the Harvard system.

When including a citation, number it to match the source’s number in the list. Name the source in the following order:

  • Author surname
  • Initials
  • Title of article in double quotation marks
  • Title of journal (abbreviated)
  • Date of publication
  • Volume Number
  • Issue Number in brackets
  • Page number
  • DOI (Digital Object Identifier), if applicable

And there you have it. A step-by-step guide of writing the tricky literature section. Feel free to ask us more about this topic. Also, if you want to know how Sympto® helps with PSUR writing, contact us for a free demo.

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.

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