The importance of lay summaries – Conversis’ Patient Centricity series

March 18, 2024 | Process

Welcome to the third and final article in Conversis’ patient centricity series.

If you haven’t yet read articles 1 and 2 on patient centricity as a concept and on developments in patient-centric technology, we’d recommend going back and reading those first. Otherwise, on with article 3 – the importance of lay summaries, where you can expect to meet María, our favorite fictional patient, again.

What is a lay summary?

In a clinical trial context, a lay summary is a plain language synopsis of the results of a trial. It is intended to “inform trial participants and the public about clinical trial results in an easy-to-understand manner”.[1] Lay summaries are integral to a patient-centric trial in a number of ways. They offer a tangible benefit to patients (something which, as discussed in our first article in this series, has historically been lacking), as well as being an important part of showing gratitude (something we also discussed in the same article). Plus – possibly the most important factor to take into account when thinking about patient centricity: patients want them! Remember our description of María, back in article 1? Learning more about her health and the outcomes of the trial for herself and her community was a huge part of why she wanted to participate in the first place. And she is not unusual in this! According to one CISCRP study,[2] 84%  of patients said it was ‘very important’ or ‘somewhat important’ to receive the results of their trial. And given the issues facing clinical research (especially in recruitment and retention), the stats around future participation are resounding, with up to 91% of patients stating that, without receiving these results, they would not take part in future trials![3]

How are summaries currently implemented?

Considering the obvious benefits, it may surprise you to learn that the number of trials actually providing lay summaries varies widely. According to estimates, depending on the sponsor, the rate of summary provision can run from 7% of studies to 20%. And according to CISCRP, 61% of patients don’t receive any results reports at all! However, this trend should be poised to change in the relatively near future. Under EU-CTR, lay summaries have become a regulatory requirement for all clinical trials within the EU and EEA. And based on the timelines associated with the regulation, the first of these summaries should be coming due right about now (end of 2023), so we should soon see the effects. However, it’s worth noting that some countries are enforcing lay summary requirements a lot more than others. Some have introduced national laws to ensure summaries are mandated, while others fail to enforce their production in any meaningful way. So – while likely to be a net improvement – only time will tell exactly how much impact EU-CTR will have on the adoption of lay summaries in practice.

How do we get the most value from lay summaries?

So, if we’re clear that lay summaries are beneficial to patients and the entire clinical research enterprise, and we’re reasonably confident that they’re set to increase, the question becomes how do we ensure we get the most from them?

The first thing to consider is: what should a good lay summary include? The actual endpoints to be included will vary based on the study in question, so the important thing is to establish criteria up-front in each case for the data you will provide. The EU-CTR lays out the basic requirements of a lay summary in its Annex V, but the best practice suggestion is to go beyond regulatory requirements and really dig in to what will be the most valuable information you can provide in each context. In the spirit of patient centricity, the best way to determine the information that will be most useful to your patients is to ask them! Previous studies suggest that, in an ideal world, patients want a summary of aggregate results as well as a summary of their own results; something which – through improvements in technology, data collection and segmentation, is becoming increasingly possible. In all cases, as discussed elsewhere in these articles, it is also essential to include a Thank You, and show your appreciation for the participants’ contribution to the study and to medical science as a whole.

Just as important as the content of the summaries is how that content is communicated. From the Conversis perspective, this is a particularly interesting question when viewed from a multicultural/multilingual perspective. For example, much of the best practice guidance for creating lay summaries refers to an average reading age of about 11-14 years for the US and UK. However, that would obviously need to be considered on a population-by-population, study-by-study basis, as reading levels can vary significantly by country, demographic, age, and so on.[4]

When it comes to communication, translation and cultural localization are also essential. For our patient, María, for example, non-availability of materials in her native language is a disqualifying factor. It’s pointless sending summaries at all if the recipient cannot understand the information they contain, as they won’t be in a position to action it. Lay summaries then become yet another checkbox exercise, don’t show value and – as a result – are not implemented going forward. Format, too, is highly important, with best practice recommending a focus on elements that improve understanding (rather than hitting a certain wordcount). This can mean including sections of whitespace, using conversational language, and ensuring the content makes visual sense to the reader[5]; something that can vary based on cultural context and the structures of a given language. This is where a multilingual DTP service can be invaluable, advising on where certain text should be placed, how it should be framed to improve readability, etc.

As different people process information differently, there is no one-size-fits-all solution here, a trend we are seeing over and over again when it comes to true patient centricity. This thinking could be extended even further to embrace more innovative formats, like comic book content for kids, or video summaries for those who would process that better than text.[6] The key is to ensure that the recipients of the information understand it as fully as possible and can utilize what they learn meaningfully.

The final key thing to think about when it comes to lay summaries is when and how you disseminate them. It’s important to remember that these summaries are NOT a promotional tool. They are not an opportunity to advertise your company or product, or to cherry pick results to show either in a deliberately positive light. The purpose of a lay summary, as we mentioned above, is to provide patients with useful and usable information. As such, the context in which it is provided is relevant, as is the point in time – e.g. within a reasonable period of the end of a trial, such that data is still relevant to an individual’s current health and care. It’s also generally accepted that the best place for this information to come from is the site (rather than e.g. directly from the sponsor), as the former is where the relationship with the patient sits.

“sponsors should […] consider partnering with the investigator to ensure a proper results communication”

Good Lay Summary Practice[7]

María, for instance, has a great relationship with her main contact at the site, who speaks Spanish, so to get her results from them would make this step much more personal and meaningful. Referring back to the previous article in this series – on technology – the ability of the sites to dedicate the necessary time for this could be facilitated by technologies that save on admin and data entry, thereby freeing up time for this type of softer, patient-facing, and incredibly valuable work.

Lay summaries are an essential tool in the patient centricity toolkit; one for which the benefits are exceedingly obvious, and to which any historical barriers are decreasing rapidly through technology and legislation. The key to success is in ensuring the data you provide is meaningful and useful to all patients, and that it is communicated in a way that offers the best chance of complete understanding.

For those that are struggling with how to communicate complex information simply, there are companies out there who specialize in lay summary consulting, as well as patient advocacy groups who can speak to the needs of certain populations. And when it comes to communicating those results in terms that make linguistic and cultural sense to all audiences, speak to Conversis – we’d be delighted to help!

 

[1] https://globalforum.diaglobal.org/issue/may-2022/new-requirements-for-lay-language-summaries-of-clinical-trials-are-here-are-you-prepared/

[2] https://www.ciscrp.org/after-the-trial-using-lay-language-summaries-to-close-the-loop-with-study-volunteers/

[3] https://pubmed.ncbi.nlm.nih.gov/19252111/

[4] https://ourworldindata.org/literacy

[5] https://health.ec.europa.eu/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf

[6] https://www.iconplc.com/insights/blog/2022/07/20/clinical-trials-through-a-childs-eyes

[7] https://health.ec.europa.eu/system/files/2021-10/glsp_en_0.pdf