In December 2022 we launched our Medical Plain Language Summary style. It’s launched in beta as a living document, and we hope that the medical writing community will continue giving us feedback so that we can keep making it more useful for medical communicators working with plain language summaries.

It’s free for all PerfectIt subscribers (and it always will be). So if you just want to get started running it in PerfectIt, you can download it here.

Keep reading if you want to learn about how we built it.

Why Plain Language Summaries?

We knew plain language summaries were important. We heard about the Clinical Trials Regulation (EU) No 536/2014 and the growing emphasis on improving patient involvement. We built our Medical Plain Language Summary Style in PerfectIt in response to feedback and requests from our many customers working in medical communication. Our motivation was to help the medical writers and editors we work with to cope with the demands of a changing regulatory environment. However, it was only when we came to present the style at AMWA 2022 that we realized the significance of what we had become involved in. Plain language summaries aren’t just a regulatory requirement: They matter.

This realization was crystallized for us in a conversation with the team at ICON Clinical Research. They pointed out the great sacrifice that many trial participants make when suffering from serious, or even terminal, conditions. The plain language summary is the key document that ensures the patient’s family members can read and understand what that sacrifice was for.

Plain language summaries inform participants about the results of the study and can ensure that they feel respected and fully understand the value of their contribution to improving public health. The people engaged with plain language summaries care passionately about democratizing information and improving health literacy. We wanted to be even a small part of that.

Getting Started

There is a wealth of information and resources on plain language summaries. Review boards, university libraries, government agencies, pharmaceutical companies, and working groups of volunteers have all created resources. Some have put together toolkits and guidance for creating plain language summaries; others have compiled links to relevant websites or have created glossaries or word lists. The resources list at the end of this article shows a sampling of what we found.

Our hypothesis was that we could use those resources to help medical writers use simpler terminology in their summaries. We worked with Shelley Reinhardt to review those resources and build a list of complex medical terms that could be simplified into PerfectIt.

The List of Complex Terms

We built in more than 500 complex medical terms that we might expect to appear in plain language summaries. The list is not intended to be comprehensive. The goal is only to build a starting point upon which others can build. It breaks down into three types:

Suggested replacements
Phrases to consider
Introducing complex vocabulary

Below are examples of each.

Suggested Replacements

Since the style is only designed for one particular document (plain language summaries), we were confident enough about the context to suggest direct replacements in many cases. These include:

"Reasonable" is a more accessible and more immediately understandable term in the context of a plain language summary.
Although people may understand "approximately," it is a longer and more complex term than this simple replacement.
Replacing industry jargon with a simpler alternative will help in most cases.

Phrases to Consider

Even knowing that the context is a plain language summary, language is so varied that it isn’t always possible to find a straightforward replacement. Examples like this are shown below.

This can have multiple meanings such as “giving a medication,” “dosing,” “a route of dosing,” or even “conducting the study”.
In many cases, the word “check” will be easier to understand. However, it won’t apply everywhere, so the style simply flags the term and prompts the user to look closer.

Introducing Complex Vocabulary

There are also times when a word should be explained rather than replaced to maintain flow. For example, having the phrase “narrowing or hardening of the artery walls” appearing again and again in a document would make the text less accessible to the reader because of the impact on flow, so in a case like this it is better to explain what “arteriosclerosis” means the first time it appears. PerfectIt scans a document and, when it finds a word on its first use that may need an explanation, it highlights the word and shows the relevant instruction.

Real-World Application

The ultimate test of whether the list of terms would be useful to medical writers working in the field is running the document on published plain language summaries. We decided that we would only release the style if it found complex terminology creeping into published documents.

We tested more than 200 published summaries from online public domain repositories for a range of pharmaceutical companies. To try to avoid biasing the suggestions to a specific field, we chose samples from as many specialties as possible—oncology, psychiatry, neurology, endocrinology, immunology, and many more.

We wish we could tell you that the style was useless and that published documents are already pitched at just the right level. Sadly, that wasn’t the case. Even with our limited list, the style found lots of complex terminology that could easily be simplified with a little bit of thought and the touch of a button.

We know that this is just a small contribution to a vast and incredibly important field. But we also know it’s a contribution that will be valued by everyone working on plain language summaries who wants to save time.

Why It Works

Writing plain language summaries is a sophisticated job. It requires a mind that understands extraordinarily complex science and also has the communication skills to explain it to a non-specialist audience. Most medical writers have advanced degrees. How can they be expected to identify complex terminology when it’s not complex to them?

Glossaries are useful. But they’re just lists. By building complex terminology into PerfectIt, the software actively looks for terms. It provides a second set of eyes, enabling the writer to focus on the wider challenge of communicating the science.

While the focus of the style is broad, like all PerfectIt styles, it can be customized. So you can use it as a base and build the rest of your specialist vocabulary on top. If you have a glossary, you can build it directly in.

Download It Now

We hope that our new style is a useful starting point in helping medical communicators create plain language summaries more efficiently and effectively for the benefit of patients, their families, and wider public health. We know it’s just a starting point. But we hope it will help you with your next summary.

Our Medical Plain Language Summary style is free and will remain free for all PerfectIt subscribers. Due to its specialist nature, it’s not currently built into PerfectIt, but you can download it easily from our website.