Structuring a lay summary around the reader's questions
A lay summary of a clinical trial's results can be organised around the questions its readers bring to it: its sections follow those questions, its most important message comes before the background, its explanations work back from the take-home points the reader needs, and its safety terms are defined inside the document.
What a patient needs the summary to answer
In an online search of companies' lay summaries, the content of the summaries generally appeared relevant for a lay audience, but whether all useful information from the original document had been included was difficult to assess. The best summaries in that search answered five questions for a potential patient: whether the trial was relevant to them, how the intervention would be administered and monitored, whether they could fully assess its risks and benefits, whether it would be available to them in the future and what it would mean for them, and where to find further information. Good examples also gave background information and explained the disease and the type of trial, but only some summaries did so, perhaps assuming that patients already had basic knowledge of these.
As a decision-making and educational tool, a summary needs to be relevant: its content should be useful to its intended reader, not just what the sponsor wants to convey. For a patient considering a new intervention, its risk-benefit profile is likely a top concern. Other factors that patients consider important can and should be included too, so that an overall assessment can be made: who took part, so that the reader can judge whether the results apply to them; how the intervention is given, such as by mouth, by infusion or by injection; how often it is given; and what monitoring it needs. Each of these can affect whether a patient pursues the intervention, in a further trial or once it is licensed and available.
The message before the background
A lay summary can be written as an inverted pyramid: it starts with the conclusion and discussion, which carry the most important message, and ends with the introduction or background. A scientific paper runs the opposite way, from the introduction to the discussion and conclusions. Leading with the message captures the lay reader's interest and holds it while the reader learns what happened, how it was found out and other aspects of the background. Answering why and so what can make the writing more compelling than a plain account of what, who, when and where, which can be dry.
Trial summaries have been best received by participants when the results are presented first, in a thorough but simple and relevant way.
Starting from the take-home points
One experienced writer of plain-language summaries of trial results holds that there is no such thing as perfection and that it helps to approach these summaries with a sense of priorities, starting from the most important take-home points. For that writer, these are usually the result of the primary endpoint, maybe a secondary endpoint, and some key safety data. With those points in mind, a writer can work backwards and ask what the reader needs in order to understand them well. A concept critical to that understanding can be given time and really explained, and others can be treated superficially or left out entirely. There will always be trade-offs, and people may not always agree on how to navigate them. Another writer likewise finds it key to remember what readers should walk away with, and finds that writing with this in mind makes it more obvious how best to position data and other information.
The sections and their headings
The European Commission's guidance of January 2017 suggests more lay-friendly headings and a question-and-answer format, and it allows the writer to add subheadings and reorder the headings, both of which can help readers understand and navigate the document.
A summary tested and co-created with patients, for a study of a drug in patients with a flare-up of generalised pustular psoriasis, set out its sections in this order: what the study was about, who was eligible, who actually took part and where they came from, how the study was done, what the results were, the safety results, where to find further information, and whether additional studies were planned.
In a published summary of a pregabalin trial in painful diabetic peripheral neuropathy, the second page explained why the study was done, how it was designed and what happened after it ended. Its third and fourth pages described, in non-technical language, how the study was conducted, how outcomes were assessed and what the results were. Its last page told readers where to learn more.
Opening the summary
The psoriasis summary opened, before its first question, with a lay title, a short disclaimer that these were the results of only one clinical study, and thanks to the participants.
The pregabalin summary opened with a title page giving basic information about the study, such as the sponsor, drug, trial number and study dates, with the study's identifying information at the top of the page. A thank-you note from the sponsor followed. It thanked participants for taking part in the trial, which ran from March 2010 to January 2012, said it was important for them to know the results, and hoped the summary would help them understand and feel proud of their key role in medical research. The note also highlighted the importance of patients in clinical research, building trust and confidence in the study. The summary then introduced the drug in non-technical language, with its brand name, as a prescription medicine used in adults to treat the pain of nerves in the arms, hands, legs or feet damaged by diabetes.
Why and how the study was done
The psoriasis summary's How was the study done? described the design, the groups and the treatment duration.
Under Why was the research needed?, the pregabalin summary explained, in language a layperson can understand, what the disease is and why the study was needed: diabetes can cause painful damage to the nerves in the arms, hands, legs and feet, called diabetic peripheral neuropathy, some treatments for it do not relieve everyone's pain, and treatments sometimes stop working after a while. It then said that the researchers wanted to know how well and for how long pregabalin treated this pain in patients who were taking medicine for it but still had pain, and how safe pregabalin was in these patients.
Because patients and the public will not understand the study design, the pregabalin summary's What kind of study was this? aimed to explain technical terms such as blinded, placebo, randomised and crossover in non-technical language, and used diagrams or figures for terms that are otherwise difficult to understand. It described a placebo as looking like a medicine but containing none, and said that comparing the drug with placebo helps researchers understand how well the drug works and how safe it is. It said the study was done in two parts, first a single-blind phase and then a double-blind phase, and it explained both terms, with a figure for the two parts.
The pregabalin summary's What happened during this study? briefly explained the treatment procedures, the medicines given, how they were given and what participants were asked to do, with an illustration to help. In one phase, half the participants took pregabalin and half took placebo, one capsule three times a day. Each day they rated their pain in a diary from 0 for no pain to 10 for extreme pain, and doctors reviewed the diaries at each clinic visit.
The pregabalin summary's What's happened since my trial ended? gave the study's length and size, almost two years with 665 volunteers at 129 locations in the US, Canada and South Africa, and said that when the study ended, in January 2012, the sponsor reviewed all the data and created a report of the results.
Presenting the results
The psoriasis summary's results section, What were the results of this study?, described the primary endpoints, first in text and then in a figure visualising the results. Its writers usually focus on the primary endpoints in their lay summaries.
The pregabalin summary's What were the study results? gave details such as whether the medicine was effective, how many patients benefited and any additional benefits. In this section, as in any other, numerical data can be presented in tables or figures. This summary presented its results in figures, to aid understanding. The section began with the bottom line: pregabalin did not relieve the pain any better than placebo. Details of each part of the study followed, including the size of each group, what happened to participants and a conclusion for each part. The section closed, on the fourth page, with additional benefits: most participants who finished the study felt better than when they started, and participants had less trouble sleeping and less anxiety and depression.
Defining the safety terms
Apart from whether the treatment worked, patients and the public need to be confident that it was safe. Because their understanding of medical terminology is very limited, the safety section needs special care. It is important that a summary clearly defines its term for unwanted effects, so that readers do not confuse it with the side effects they know from the package inserts of approved medicines. Some sponsors use side effects, and any term that suits the writer can serve if it is clearly defined.
The psoriasis summary headed its safety section Did participants have any unwanted effects? and defined unwanted effects as health problems that doctors think were caused by the study treatment. Its safety table gave lay terms with the scientific terms in parentheses, for consistency with other related documents.
Listing high blood pressure with hypertension in parentheses describes an adverse event better than listing hypertension alone: the summary stays understandable and can also help to educate readers and improve health literacy.
The pregabalin summary presented its safety data in tables. Its safety section began by defining a side effect as any medical problem caused by a drug or treatment. It explained that much research is needed to know whether a drug causes a medical problem, so researchers keep track of all medical problems that patients have while a new drug is studied. A side effect was called serious when it was life-threatening, caused lasting problems or needed hospital care. Some participants had serious side effects, but none died during the study. The safety findings from each part of the study followed. In the single-blind phase, 331 of 665 participants (50%) had a side effect after taking pregabalin, and 45 (7%) left the study because of one. The most common were oedema (tissue swelling), dizziness and sleepiness during the day.
Further information and further studies
The psoriasis summary's Where can I find further information? gave links to further resources, and it also gave the full title for consistency, although that title was complicated and not very lay-friendly. Its last section, Are there any additional studies?, reported the follow-up study that was planned.
The pregabalin summary's last page pointed to an online copy of the summary that linked to the full scientific report, and told anyone with questions about the results to speak to the doctor or staff at their study site. A box repeated the web address and gave a telephone number for listening to the summary.