The COVID-19 pandemic has bought the scientific community and general public far closer together than ever before. Clinical studies on vaccines and treatments have turned into mainstream headlines. People from all walks of life want to understand how vaccines work, and need to understand how vaccines are developed in order to have confidence in them.
But COVID-19 is just an example. There’s a huge audience that would benefit from plain language summaries across all fields of medical research: patients, patient advocates, caregivers, healthcare professionals, the media and policymakers. Such summaries would encourage discussions around medical research and aid informed and shared decision-making.
And even seasoned healthcare professionals could benefit from such summaries: those who come from another specialism; are not reading in their native tongue; or are simply time-challenged and want to be able to engage quickly and easily with research. This could be especially crucial for rare diseases, of which there is often a limited awareness among non-specialists.
Crucially, the need for plain language summaries comes down to the need to build transparency and trust with the general public: and avoid the all-too-common misinterpretations and misrepresentation of data.
"Public engagement, citizen science and open science are practices and concepts that embody transparency and accessibility – two key elements of building public trust in science and research," says Open Pharma.
"Communicating scientific information in transparent and accessible ways is important to aid in countering the spread of misinformation and media sensationalization. This practice is well established when it comes to clinical trial transparency; many pharmaceutical sponsors already have processes in place to produce lay language trial results summaries.”
Laying the foundations
Open Pharma is a multi-sponsor collaboration of pharmaceutical companies, non-pharmaceutical funders, publishers, patients, academics, regulators, editors, and societies which sets out its mission as identifying and driving positive changes in the publishing of pharmaceutical company-funded research.
It acknowledges ongoing, industry-wide efforts to establish consensus on plain language summaries, with some best-practice and publisher-specific initiatives already in place.
But the group says there remains a need for a foundational set of recommendations for plain language summaries that are trustworthy, credible and of high quality. As a result, it's now set out its recommendations in the journal Current Medical Research & Opinion.
“Standardizing the minimum steps for the development and sharing of index-friendly plain language summaries can help promote the quality and credibility of these types of communications," says Open Pharma.
"The aim of a minimum standard is to build a universal foundation that encourages the accessibility, discoverability, and inclusivity of plain language summaries.
"This standard can then serve as a basis for summaries written for a more specific target audience or that include graphically and digitally enhanced formats that increase understanding and engagement, which we strongly encourage.”
The recommendations have been put together with the input from companies such as Gilead Sciences, GSK, Novartis, AstraZeneca, Pfizer; alongside from a wide range of other organisations including consultancy Oxford PharmaGenesis, patients groups, the BMJ, the American Medical Writers Association; trial centers and universities.
At the base, plain language summaries should be in the style of an abstract; free of technical jargon; unbiased; non-promotional; peer reviewed; and easily accessed. They should also meet the technical requirements to be indexed in directories such as PubMed.
Open Pharma's recommendations are that plain language summaries should be:
- Targeted toward a broad, inclusive and non-technical, non-specialist, or time-challenged audience
- Written in easily understandable, unbiased language that is free of expert or technical jargon and accessible to readers who may have a different first language to that of the summary
- Text based and concise (of 250 words or fewer) – this allows for indexing in directories such as PubMed and facilitates straightforward translation
- Explicitly linked to the source publication citation and relevant clinical trial identifiers, with brief reference to the existing evidence
- Consistent with the same overall key points and conclusions as the scientific publication abstract
- Developed alongside the main content of the manuscript, in line with the International Committee of Medical Journal Editors’ authorship criteria
- Ideally reviewed by a non-expert during development
- Fully peer reviewed alongside the main content. “Plain language summaries should undergo peer review alongside the journal publication. Peer review ensures that accountable validation processes are applied to medical journal publications before entering the literature. Applying the same process to plain language summaries helps ensure they are considered just as reliable and valid as the publication they accompany.”
- Made available to read free of charge alongside the scientific publication abstract
- Tagged with appropriate metadata and keywords to improve discoverability in search engines, directories, and indexes.
Setting the scene
The plain language summary should be in line with the key points and conclusions as the scientific abstract. This should include making sure the information is clearly put in context for the lay reader.
"As with any communication of this type, there is always a risk of plain language summaries getting separated from the main publication and being presented without nuance and context. Therefore, plain language summaries should ideally place any findings, and especially any clinical recommendations, in a wider context," notes Open Pharma.
"They should also explicitly link back to their associated publication to help avoid the spread of misinformation and to be distinct from non-peer-reviewed science journalism and news articles."
What should have a plain language summary?
Open Pharma’s recommendations only cover peer-reviewed medical journal publications: setting the bar that a plain language summary should be peer-reviewed and consequently trustworthy.
As it puts it: “limiting the scope of plain language summary selections to only peer-reviewed publications could help avoid blurring the line between valid plain language communications and other unreliable sources, helping to prevent unvalidated results from spreading among the general public.”
But it also acknowledges: “On the other hand, applying such criteria would exclude most congress materials and conference proceedings, which are often important sources of novel clinical trial data and can be valuable to lay readers.”
Thinking outside the textbox
Text-only summaries are the easiest to find on internet search engines and research websites such as PubMed.
Once text summaries have been embraced, researchers could consider different formats: such as infographics and video summaries as well.
With the huge volumes of scientific content produced, it becomes a matter of selecting where plain language summaries are most useful.
Preclincial and early-clinical phase research, for example, may be of less interest to lay readers: and thus a lower priority than large later-stage trials.
“While we believe that, ideally, every scientific research publication should have an accompanying plain language summary, this is far from practical.
"Plain language summaries represent an additional cost to sponsors, and the pharmaceutical and medical publishing infrastructure for widespread uptake is lacking; the further cost associated with graphical and digital enhancement is also a barrier that impacts cost/benefit assessments.
"Mandating the inclusion of plain language summaries for all scientific publications may not be scalable nor sustainable.”
Ultimately, plain language summaries will be a question of practicality, and publishers will have to prioritize where and how they are used for the time being. But the new guidelines can help make it clearer as to what a good plain language summary looks like, and help pave the way for their wider use.
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