Visual and video formats for a lay summary
A lay summary of trial results can carry its content in visual and video forms as well as in text: figures and visual structure within the summary, a graphical abstract that opens it, and a video version that accompanies it. Whether visuals improve a lay reader's comprehension is disputed. These forms need to stay objective, and the people they depict should be drawn so that readers can identify with them.
What visuals do for a lay summary
Some sponsors have invested significant time in communicating lay regulatory documents in alternative visual formats, including graphics, comics and videos. The European Commission's guidance on lay summaries of January 2017 mentions visuals and infographics. The Recommendations of the Expert Group on lay summaries (the expert recommendations), published in February 2018, encourage well-chosen and clearly designed visual aids, in line with the general public being the primary audience of lay summaries.
Sources disagree on whether visuals improve a lay reader's comprehension. Sponsor staff who produce visual lay summaries hold that visual displays enhance understanding. Visual displays let information be processed faster and more effectively, communicate complex information efficiently by giving an immediate understanding of a trial concept, and improve the accessibility of trial information for anyone, including readers with lower health literacy or a lower reading level. For most people, visuals have a broader impact than text for communicating information. Visual aids are easier and faster to understand than text alone, increase memorability and recall, make comparisons and the relations between elements easier to perceive, and enable quick comprehension of data. They also help people with lower health literacy understand health information. Visual displays have been shown to greatly support the understanding of complex data. People with low literacy levels find processing text challenging, and graphic displays greatly help their understanding. Research on medical instructions for patients has underlined the importance and helpfulness of visual aids.
An article on writing lay summaries, citing published research, states the opposite: visuals such as infographics do not improve comprehension, although they are more enjoyable and user-friendly. To avoid misinterpretation, visuals should be simple and accompanied by text.
A second article, also citing published research, takes a middle position: graphics do not always increase comprehension and need care, but they may make a summary more user-friendly, and used appropriately they can be a powerful tool to help understanding. It holds that graphics can enhance a lay summary to a certain extent.
Figures, tables and visual structure within the summary
Numerical data are always difficult to comprehend when presented as text, and to improve comprehension and presentation they can instead be given in tables and figures. In the main part of the summary, graphics help readers compare two groups and quickly see and understand the data, as in a results figure that used a bar chart with a clear description and explanation.
It is important to establish which data suit an infographic, chart or table, and which formats readers are most likely to understand. In a user-testing study of lay summaries, one participant asked why a bar chart was upside down, which shows that some figure formats may confuse readers who are not used to them. Formatting also matters, and accessibility standards such as those for font size, colour, bullet points and layout need some consideration to improve comprehension. The text itself can also be improved with visual elements such as headings, subheadings, bullet points and sidebars.
In an online search of pharmaceutical companies' web pages carrying lay summaries of the trials they sponsored, some used graphics and tables to an extent, but most summaries still contained too much text, and tools such as bullet points and lists, which would make a summary easier to read, were underused. One company's summaries contained only text, and although each was only about a page long, they were extremely difficult to read and understand. Even where companies used graphics, charts and tables, these would sometimes have been better used for different content in the document.
The graphical abstract
A graphical abstract is a single-page graphical overview of the whole clinical trial. It summarises the key information of the lay summary, so that readers have everything on one page and can read it in more detail on the following pages. It serves a lay summary as an abstract serves a scientific publication. That purpose limits its content to highly aggregated data and statements. A graphical abstract is not a requirement, but select sponsors have taken it on to further improve understanding of clinical trials. One sponsor opens most of its lay summaries with a graphical abstract, and developed its template from considerable feedback from the patient representatives and patient groups it engages with. It regularly tests its lay summaries and often gets very positive feedback from patients.
Going beyond Annex V of the EU Clinical Trials Regulation, the expert recommendations propose that a lay summary have an abstract describing the purpose of the study, what was tested, who took part, the main results and the safety information, to help readers decide whether to read the whole summary. One graphical abstract was developed from the expert recommendations with the support of patient organisations. Its developers first identified the information items that make up a study's key information for a general audience, then determined the appropriate level of data aggregation, fine-tuning their conclusions in discussions with internal stakeholders, patient representatives and patient organisations, and finally transferred the items into graphical representations on a single page preceding the summary. A template was developed to ensure a harmonised format across different trials and therapeutic areas. Representatives of different patient organisations reviewed a first version made from the initial template, and review and feedback from them and other stakeholders shaped the final template for all lay summaries across therapeutic areas, so that it aligned with the needs of patients. Patient representatives from various disease areas who tested the graphical abstract responded positively to the idea of an abstract preceding the summary and found the graphical display helpful and attractive. This generally positive feedback emphasises the usefulness of the graphical abstract in conveying the key information of clinical trials. Its developers believe the format can increase the attractiveness of lay summaries and so help inform the public more adequately about the results of clinical studies.
The graphical abstract's design
The graphical abstract developed from the expert recommendations rests on the principle that a graphical abstract must be strictly non-promotional, in line with those recommendations and the requirements of the EU Clinical Trials Regulation. So its appearance, feel and content should be distinctly different from any marketing material for the medicine under study, and it aims at a sketchy, non-glossy look, like something a clinical investigator might draw to illustrate a study's results in conversation with a patient or participant. It is meant both to invite readers and to give them a high-level summary of the study, so it is limited to one page and placed at the beginning of the lay summary, where a publication's abstract sits. After viewing it, readers should be able to decide whether to read the full lay summary.
It should be visually appealing enough to attract readers and also hold their attention, so its content is divided into distinct panels with as much white space as possible. Each panel presents one aspect, such as demographics, the disease, the study aim, efficacy or safety, and can be understood without the others. The panels follow a logical order but no fixed sequence, so readers are free to go through them as they choose. Shapes, line styles and background colours vary between panels for visual appeal, but with care, because too much playfulness might be associated with a non-serious, non-scientific intention. Text is cut to a minimum, and variations in font style, size, colour and highlighting make certain words stand out as focal points and headings for the panels, so that readers can skim to the panel they care about most.
What the graphical abstract carries
The page opens with the study's lay title, which lets a reader judge quickly whether the study is relevant to them. The panels, which encompass the suggestions of the expert recommendations, then carry:
- a short description of the disease, complementing the title
- the study aim
- the demographics: key inclusion criteria, age range, gender distribution as a pie chart, and where participants came from, with sketches of human age characteristics depicting the age requirements
- the medicines studied, with name, dose and mode of administration
- the safety outcomes, which are the adverse reactions Annex V requires, labelled "unwanted effects" because the regulatory term is unfamiliar to lay readers, with their frequencies in all treatment groups as pie charts
- the result of the protocol-specified primary endpoint for all treatment groups, as bar charts
All text is in plain language, in short, simple and neutral sentences, and abbreviations are avoided, because lay readers usually do not know them.
Objectivity and aggregation in the graphical abstract
The information in lay summaries and graphical abstracts needs to be presented objectively. To keep lay summaries credible with the public, anything promotional must be strictly avoided, and the expert recommendations strongly emphasise this. To ensure objective scientific content, the internal guidance of the sponsor that developed this graphical abstract sets these rules:
- The content is strictly factual.
- Efficacy is limited to the protocol-specified primary endpoint, in line with the expert recommendations.
- Numbers are given for the primary endpoint and the key safety observations, so that readers can link the page to the scientific summary or the results posted on ClinicalTrials.gov.
- The graphics follow the standards of ethical publishing, with the axes of bar charts and pie charts appropriately labelled and the results of all treatment groups shown.
- All statements are in neutral language, and emotional words, expressions and superlatives are avoided.
- Content elements such as efficacy and safety results are presented in a balanced way.
- Only whole numbers are shown, rounded by conventional rules wherever possible and supported by graphics, because decimals are hard for readers with limited numeracy.
Choosing the appropriate level of aggregation is one of the challenges of designing and writing a graphical abstract. To be useful for the general public, a lay summary is limited in the amount and depth of information it can give, and its graphical abstract even more so. The sponsor tries to meet this challenge by following clear rules and by involving patient representatives in reviewing its lay summaries. Its template, used with clear instructions, ensures high-quality graphical abstracts, although a complex trial or one with unclear results may need to depart from it.
The sponsor treats the graphical abstract and the full lay summary as one document, posted as a single PDF. The abstract's highly aggregated data are complemented by the summary's more detailed data and descriptions, and the single file matters because the summary's disclaimer, called "Important notice", also applies to the abstract.
Example graphical abstracts
One graphical abstract is for a study comparing nintedanib with placebo in patients with scleroderma-related lung fibrosis. It explains that scleroderma, also called systemic sclerosis, is a rare disease that can affect the skin and other organs and in some people causes lung fibrosis, and asks whether a medicine called nintedanib helps patients who have lung fibrosis due to scleroderma. It shows that 576 patients from 31 countries in Europe, Canada and the USA, Asia and other regions took part, 25% men and 75% women, and that each patient took 150 mg nintedanib or placebo twice a day. It reports that on average, after 1 year of treatment, nintedanib slowed down the loss of lung function by 44%, charted as the yearly decrease in FVC in mL, and that 83% of patients who took nintedanib and 43% who took placebo had unwanted effects, diarrhoea being the most common: 68% of patients taking nintedanib and 20% taking placebo had it.
Another graphical abstract, for a trial in a skin disease called GPP, starts with the lay title, then gives a short introduction to the health condition on the left and the study's main question on the right. Below them come who took part and a box for the study treatment, and at the bottom one box for the unwanted effects and one for the primary endpoint, with icons, pie charts and bar charts used to try to make the content easy to read and understand and more appealing than text alone.
The video version
One sponsor produces a video of the lay summary for select trials, to increase accessibility for participants and the public. These videos aim to offer a different way to communicate the same content as the lay summary, to give a more smartphone-friendly way to view the results and, in general, to give participants and the public their preferred format. Video is a visually appealing format, and because many people have limited reading ability, it is always good to provide the same content in a different format. Patients and patient organisations have also requested additional formats for presenting results, which is why one sponsor began creating lay summary videos.
A lay summary video never appears alone: not all of the required content fits into it, so it always comes in addition to the written summary. A website is also always needed where the lay summary can be posted and shared with trial participants or the public, and this may vary from country to country. The sponsor that produces videos for select trials posts them, like its written lay summaries, on its trial-results website, where the public and anyone interested can access them.
In drafting the video's storyline, it is good to stay close to the content of the written lay summary. Where the information is embedded in a story, the story should not be too emotional, because there is always a risk that it is perceived as promotional, so consulting a legal colleague is advised.
An example lay summary video
The narration of an example lay summary video, for a study of empagliflozin added to insulin in Chinese adults with type 2 diabetes, puts each part of the trial into lay language. It begins by explaining why the trial existed: clinical trials are often done globally because researchers want to know how well a medicine works in different populations worldwide, and national authorities sometimes ask for additional studies in a single country to make sure the medicine works in a specific group of people. It defines the condition and explains why controlling blood sugar matters. It states eligibility as plain criteria, being between 18 and 75 years of age with type two diabetes and having taken insulin for at least three months, and defines insulin as a common medicine for that condition. It describes the population concretely: 219 people, 119 men and 100 women, average age 60, youngest 33 and oldest 75. It explains randomisation without using the word, as three groups of almost equal size with every participant having an equal chance of being in each. It explains blinding and placebo the same way: participants and doctors did not know the group, and placebo tablets looked like the medicine but contained none. It gives the comparison's purpose and the 28 weeks participants were in the study, and reports that after 24 weeks of treatment both empagliflozin groups showed a greater decrease in blood sugar levels than the placebo group, which shows that empagliflozin added to insulin helps Chinese people with type 2 diabetes lower their blood sugar. It defines unwanted effects as health problems the doctors think were caused by the medicine or the placebo, reports them as counts out of the group total, names the most common ones, and explains that serious means a hospital stay or a longer one was required. It thanks the participants for helping answer important questions, and closes by naming the written lay summary the video is based on and where it can be found.
Depicting the people in images, comics and videos
It is crucial that visuals depict a diverse population, because that lets people identify with the characters in images, comics and videos. Patients may perceive how they want to be depicted completely differently from the producer, so it is always good to ask them directly how they want to be drawn, to make the depiction as accurate and respectful as possible. Especially where trial results are involved, what a visual shows needs care, because overdoing it risks the material being perceived as promotional.