The COVID-19 pandemic has brought the scientific community and the general public closer together than ever. Clinical studies of vaccines and treatments have grabbed the headlines. People from all walks of life want to understand how vaccines work and need to understand how vaccines are developed in order to be confident.
But COVID-19 is just one example. There is a large audience that would benefit from plain language summaries in all areas of medical research: patients, patient advocates, caregivers, healthcare professionals, media and policy makers. Such summaries would encourage discussions around medical research and help informed and shared decision-making.
And even seasoned health professionals could benefit from such summaries: those who come from another specialty; do not read in their mother tongue; or are simply pressed for time and want to be able to engage in research quickly and easily. This could be particularly crucial for rare diseases, the knowledge of which is often limited among non-specialists.
Basically, the need for plain language summaries comes down to the need to build transparency and trust with the general public: and to avoid the all too common misinterpretations and misrepresentations of data.
“Public engagement, citizen science and open science are practices and concepts that embody transparency and accessibility – two key elements in building public confidence in science and research”says Open Pharma. “Communicating scientific information in a transparent and accessible manner is important in combating the spread of disinformation and sensationalism in the media. This practice is well established in terms of transparency of clinical trials; many pharmaceutical sponsors already have processes in place to produce test results in everyday language. summaries.
Lay the foundations
Open Pharma is a multi-sponsor collaboration of pharmaceutical companies, non-pharmaceutical funders, publishers, patients, academics, regulators, publishers and corporations whose mission is to identify and drive positive changes in the publication of research funded by pharmaceutical companies.
He notes the continued industry-wide effort to build consensus on plain language summaries, and initiatives are already in place on best practices, patient-focused content, and publisher-specific guidelines.
But the group says there remains a need for a core set of recommendations for plain language summaries that are trustworthy, credible and of high quality: leading them to formulate their recommendations. These have been published in the journal Current medical research and opinion.
“Standardizing the minimum steps for developing and sharing clear-language, easy-to-index summaries can help promote the quality and credibility of these types of communications.” says Open Pharma.
“The goal of a minimum standard is to build a universal basis that encourages the accessibility, discoverability and inclusiveness of plain language summaries. This standard can then serve as the 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 were developed with input from companies such as Gilead Sciences, GSK, Novartis, AstraZeneca, Pfizer; alongside a wide range of other organizations including consulting firm Oxford PharmaGenesis, patient groups, BMJ, American Medical Writers Association; testing centers and universities.
Basically, plain language summaries should be in the style of an abstract; free of technical jargon; impartial; non-promotional; Peer reviewed; and easily accessible. They must 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 to a large, inclusive and non-technical, non-specialized or time-limited audience
- Written in language that is easily understandable, impartial, free from expert or technical jargon and accessible to readers who may have a mother tongue different from that of the summary
- Text-based and concise (250 words or less) – this allows indexing in directories such as PubMed and facilitates direct translation
- Explicitly linked to source publication citation and relevant clinical trial identifiers, with brief reference to existing evidence
- Conforms to the same key points and conclusions as the summary of the scientific publication
- Developed alongside the main content of the manuscript, in accordance with the authorship criteria of the International Committee of Medical Journal Editors
- Ideally reviewed by a non-expert during development
- Fully peer reviewed alongside the main content. “Plain language abstracts should be peer reviewed at the same time as publication in the journal. Peer review ensures that responsible validation processes are applied to medical journal publications before entering the literature. Applying the same process to plain language summaries helps ensure that they are considered just as reliable and valid as the publication they accompany.
- Available for free reading with the summary of the scientific publication
- Tagged with appropriate metadata and keywords to improve visibility in search engines, directories and indexes.
The plain language summary should be consistent with the key points and conclusions of the scientific summary. This should include ensuring that the information is clearly put in context for the lay reader.
“As with any communication of this type, there is always a risk that the plain language summaries will be separated from the main publication and presented without nuance or context. Therefore, plain language summaries should ideally place all findings, and in particular all clinical recommendations, in a broader context.
“They should also refer explicitly to their associated publication to avoid the spread of disinformation and to distinguish themselves from science journalism and non-peer reviewed press articles.”
What should have a plain language summary?
Open Pharma’s recommendations cover only peer-reviewed medical journal publications: setting the bar that a plain-language summary should be peer-reviewed and, therefore, trustworthy.
As he says: “Limiting the scope of clear language abstract selections to only peer-reviewed publications could help avoid blurring the line between valid clear language communications and other untrustworthy sources, helping to prevent unvalidated results from being released. spread among the general public. “
But he also recognizes: “On the other hand, the application of such criteria would exclude most congress papers and conference proceedings, which are often important sources of new clinical trial data and may be of value to lay readers.”
Think outside the text box
Text-only summaries are the easiest to find on Internet search engines and search sites such as PubMed.
Once text summaries have been adopted, researchers may consider different formats: such as infographics and video summaries.
With the huge volumes of scientific content produced, it comes down to choosing where the plain language summaries are most useful. Research in the preclinical and early clinical phase, for example, may be of less interest to lay readers.
“While we believe that ideally every scientific research publication should be accompanied by a plain language summary, this is far from practical. Plain language abstracts represent an additional cost to sponsors, and the pharmaceutical and medical publishing infrastructure for widespread adoption is lacking; the additional cost associated with graphics and digital enhancement is also a barrier that impacts cost / benefit assessments. Forcing the inclusion of plain language abstracts for all scientific publications may not be scalable or sustainable. “
Ultimately, plain language summaries will be a matter of practicality, and editors will need to prioritize where and how they are used at this time. But the new guidelines can help clarify what a good plain language summary looks like and help pave the way for their wider use.
Photos: getty / imagesourec; getty / klausvedfelt