Where are biomedical research plain‐language summaries?

Abstract Background and Aims Plain‐language summaries (PLS) are being heralded as a tool to improve communication of scientific research to lay audiences and time‐poor or nonspecialist healthcare professionals. However, this relies on PLS being intuitively located and accessible. This research investigated the “discoverability” of PLS in biomedical journals. Methods The eLIFE list of journals/organizations that produce PLS was consulted on July 12, 2018, for biomedical journals (based on title). Internet research, primarily focusing on information provided by the journal websites, explored PLS terminology (what do the journals call PLS), requirements (what articles are PLS generated for, who writes/reviews them, and at what stage), and location and sharing mechanisms (where/how the PLS are made available, are they free to access, and are they visible on PubMed). Results The methodology identified 10 journals from distinct publishers, plus eLIFE itself (N = 11). Impact factors ranged from 3.768 to 17.581. Nine different terms were used to describe PLS. Most of the journals (8/11) required PLS for at least all research articles. Authors were responsible for writing PLS in 9/11 cases. Seven journals required PLS on article submission; of the other four, one required PLS at revision and three on acceptance. The location/sharing mechanism for PLS varied: within articles, alongside articles (separate tab/link), and/or on separate platforms (eg, social media, dedicated website). PLS were freely available when they were published with articles; however, PLS were only included within conventional abstracts on PubMed for 2/11 journals. Conclusion Across the few biomedical journals producing PLS, our research suggests there is wide variation in terminology, location, sharing mechanisms, and PubMed visibility. We advocate a more consistent approach to ensure that PLS have appropriate prominence and can be easily found by their intended audiences.


| INTRODUCTION
Many patients and caregivers are eager to read about new treatments, be better informed regarding treatment choices, and get involved in making decisions about care. 1,2 In line with this, industry trends point to the public being increasingly embraced as valuable contributors to medical research, 4 with the establishment of the Patients Included charters and the BMJ spearheading patient involvement in the journal editorial review process through their Patient and Public Partnership strategy. 5,6 Research shows that some journal editors feel that patient reviewers are beneficial to the peer-review process, 7 and that patient and public reviewers can assess the relevance and importance of research to patients and caregivers, and determine whether a treatment or intervention being studied is practicable and acceptable to patients. 8 In addition, it has been reported that public involvement can enhance the design and implementation of clinical trials, for example, by increasing the quantity and quality of patient-relevant priorities and outcomes. 9 Enrolment, funding, and dissemination of trial data are other aspects of clinical trials that can reportedly be enhanced by public involvement. 9 However, in order to support the moves toward patient and public involvement in medical research, scientific information needs to be more accessible, as the dense technical language of journal articles can be challenging for nonscientific audiences to understand. 10 In recognition of the need to communicate research to lay audiences, some journals are starting to publish plain-language summaries (PLS) as a component of full research articles. PLS help to make scientific research understandable and accessible by describing complex research using nontechnical language that can be easily understood.
PLS are also important for transparency and enable greater reach, as a means to having an impact on the lives of patients, caregivers, and families affected by illness. 11 As well as being of benefit to lay audiences, PLS are also likely to be used by time-poor and nonspecialist healthcare professionals (HCPs) and researchers. Although experts may be used to reading technical scientific language, they may refer to PLS before deciding whether to read the full article, and PLS may help HCPs to quickly get an overview of large volumes of literature.
With the increased uptake of online platforms and open-access publishing, it is also likely that more patients will want to access specialized health-related information. 12 Therefore, PLS might in the future, if more ubiquitous, become vehicles that bring together HCPs, researchers, patients, caregivers, and the public.
A survey in 2018 has supported the value of PLS for both patients and physicians. After general internet searches (61%) and patient-specific websites (57%), articles in scientific journals (47%) were the third most important online source of health-related information for patients. 12 Of the physicians who were surveyed, 60% indicated that they would use PLS, with 46% rating PLS as valuable.
Interviews with patients highlighted that knowledge creates empowerment and that it is important that information is made accessible.
Moreover, physician interviews indicated that PLS help generate dialog with patients and streamline communication whilst saving time, as patients are not solely dependent on them for information. 12 Beyond journal article PLS, the value of summaries for lay audiences is also being evidenced by the emergence of clinical trial summaries. The European Union Trials Registration 536/2014 (Article 37) requires that a summary of clinical trial results understandable to a layperson be developed along with the clinical study report and be made publicly available on the EU database. 13 In addition, in 2017, the United States Food and Drug Administration provided draft guidance on the provision of PLS for clinical trials. 14 However, a publication in 2019 highlighted that at this time, less than 2% of all clinical trials completed or terminated within the past 3 years had returned PLS to study volunteers. This was below the forecast made 10 years previously when a pilot effort evaluated the feasibility and efficiency of a process for communicating summary results to patients. Nevertheless, a tightening of the regulatory environment and the growing appetite for PLS of clinical trial data is expected to push research sponsors to adopt PLS. 15 While PLS are being heralded as a tool to improve communication of research to lay audiences and time-poor HCPs, this will only be achieved if PLS are intuitively located and accessible. The aim of our research was to investigate how the "discoverability" of PLS is being handled by biomedical journals; the PLS for this article is presented in Box 1.

| METHODS
A cross-section of journals was identified based on the freely available eLIFE list of journals and other organizations that produce PLS. 16  BOX 1 Plain-language summary for this article "Plain-language summaries" (PLS) are short, easy-to-read summaries of medical research articles for lay readers. PLS are meant to be helpful to patients and the general public, but finding them can be hard, which will limit their use. We found that a range of names are used for PLS, which will make them hard to search for on the internet. Some names do not make it clear to lay readers, including patients, that the PLS are for them to use. Also, PLS are not available for all research articles, and when they are available, they are shared in different ways, such as on websites or via social media. Overall, we were pleased to find that PLS are free to read, but we recommend that ways of naming and sharing should be the same for all articles so that PLS are easier to find.
The eLIFE list was consulted on July 12, 2018 for journals that we deemed relevant to the biomedical field (based on the journal titles). Internet research, primarily focusing on the information provided by the journal websites, explored PLS terminology (what do the journals call PLS), requirements (what articles are PLS generated for, who writes/reviews them, and at what stage), and location and sharing mechanisms (where/how the PLS are made available, are they free to access, and are they visible on PubMed). Internet research was conducted by one researcher (with findings populated in a data collection sheet), and subsequently checked by a second researcher. Separate follow-up with specific journals was considered where key information was missing. The research was completed over the period July

| PLS terminology
Across the 11 journals, nine different terms were used to describe PLS: lay summaries (n = 3); lay abstracts (n = 2); plain-language summaries (n = 2); patient summaries (n = 2); author summaries (n = 1); eLIFE digests (n = 1); plain English summaries (n = 1); scientific summaries for families with ASD (n = 1); and significance statements (n = 1). Moreover, two journals used more than one of these terms: Annals of the Rheumatic Diseases referred to PLS as both "lay summaries" (on the main journal website) 17 and "patient summaries" (on the PLS archive website), 18 and Autism Research had changed their term from "lay abstracts" to "scientific summaries for families with ASD," and more recently to "lay summaries" (Table 1).

| PLS requirements
PLS were a requirement for all articles, or at least all research articles, in 8/11 journals. For the remaining journals, PLS were only developed for articles that were selected by the editors (n = 2) or authors were encouraged to provide PLS but these were not mandatory (n = 1) ( Table 1).
For 9/11 journals, authors were responsible for writing PLS.
Health Technology Assessment recommended that PLS development be supported by a Patient and Public Involvement representative, to ensure that language is appropriate for nonacademics. For the remaining journals, the journal editors developed PLS based on the authors' responses to questions (n = 1), or PLS could be developed by either the editorial team or the authors (n = 1) ( Table 1).
Some journals provided details of additional review/editing steps for PLS: PLS in Annals of the Rheumatic Diseases were reported to be checked for accuracy and readability by expert rheumatologists and People with Arthritis and Rheumatism (PARE), which is the patient organization of the European League Against Rheumatism (EULAR); PLS in Autism were reported to be reviewed by a social media editor to ensure that they would be accessible to the target audience; PLS in Cochrane Database of Systematic Reviews, eLIFE or PLOS Medicine were reported to be edited by in-house editorial team members.
Most journals required PLS upon submission (n = 7); however, for some journals, this was only necessary following article acceptance (n = 3) or during article revision (n = 1) ( Table 1).
The required format for PLS was not a focus of this research, but there appeared to be broad variation in the level of instruction provided and where this could be found. For example, where word limits were specified, these ranged from 60-80 words (Autism Research) to 250-500 words (FACETS); meanwhile, the instructions to authors for

| DISCUSSION
Our research suggests that there are few biomedical journals inviting PLS for publication, which is in line with previous observations. 22 Moreover, amongst the few biomedical journals that were identified, we found wide variation in PLS terminology, requirements, and locations/sharing mechanisms.
Ultimately, our methodology relied on the eLIFE list of journals producing PLS. However, we had previously found that the variation in PLS terminology made it challenging to define a systematic and robust sampling methodology for identifying a representative crosssection of biomedical journals that publish PLS. As "PLS" is not a term used universally across journals, there were no logical search criteria that could be inputted into databases of biomedical literature (eg, PubMed), without potentially introducing bias by focusing on the terms that were already known to us. If standard internet search engines were used, this would have been further compounded by the fact that the term "PLS" is not exclusive to the biomedical field. By extension, we envisage that this terminology issue could also hamper the efforts of target audiences to find PLS as well.
We also found that PLS terminology did not necessarily clearly reflect the target audience. For example, lay audiences who come across "lay abstracts/summaries" or "patient summaries" may suspect these could be relevant for them to read, but we suggest they might overlook "author summaries" or "significance statements." In our experience, some journals require authors to develop bulleted "key points" or "significance statements" to provide a bite-sized overview of articles for time-poor HCPs. These are not typically developed with lay audiences in mind but, given the evolving journal article PLS landscape, sometimes appear to be categorized under the "PLS" umbrella, which is confusing. So beyond the need for more consistent PLS terminology, we also believe that there needs to be better distinction between, and clearer naming of, summaries intended for broad use, including by lay audiences, vs those bite-sized overviews specifically designed for time-poor or nonspecialist HCPs and researchers. The two serve different purposes and the medical communications industry needs to help lay audiences find content that could be helpful to them, by naming it consistently while differentiating it clearly from content directed solely at specialist HCPs and researchers. PLS for broad use need not only to be pitched appropriately but should also consider points that are relevant from the patient perspective (without deviating from the content in the published article); this will be another differentiator vs the bite-sized overviews directed at HCPs and researchers. Overall, our research begs the question of why, in a time when the value of the patient voice is being embraced, and time-poor and nonspecialist HCPs need more "snackable" content, PLS are not being offered by more journals-or even becoming a mandated part of article requirements in journal instructions to authors. Obstacles to PLS uptake could include the possibility that, where PLS focus more on points of relevance to patients, they may appear to have a different balance of content compared with the article's abstract, which could prompt criticism or even perceptions of direct-to-consumer promotion. Perceived duplicate publication is another challenge, but requiring that PLS do not generalize findings, are peer-reviewed alongside all other elements of an article, and are published within that article or on a linked platform referencing the original citation, will make these issues surmountable. 23 A key limitation of this research is the reliance on the eLIFE list of journals that produce PLS. Given the above challenges relating to

PLS requirements varied between journals in terms of
To standardize approaches and optimize reach to intended audiences, we recommend that: journals publish PLS for all articles all journals use the term 'plain-language summaries, PLS' when referring to summaries for lay audiences, particularly to make PLS easier to find using standard internet search engines PLS are signposted with a recognizable icon to help readers locate them easily (Figure 2) PLS, plain-language summary/summaries. PLS are also located outside the article, on a separate platform or shared on social media including a hyperlink to the original full article location to avoid PLS being categorized as a duplicate publication F I G U R E 1 Our recommendations for PLS for journal articles. PLS, plain-language summary/summaries F I G U R E 2 Our recommended icon to identify PLS in journal articles. PLS, plain-language summary/summaries terminology, use of the eLIFE list was deemed the most practical methodology for identifying an unbiased sample for exploring PLS accessibility. However, we had no assurance that this list was complete, and suspect that some relevant journals will not have been captured. For example, we were aware that Adis journals support publication of PLS, but these were not included in the eLIFE list (perhaps because the Adis journals are among a growing number of journals that do not mandate PLS but will publish PLS when requested by authors). 24 Since conducting this research in the summer of 2018, other possible methodologies have come to light, as we have become aware of the PubMed feature to filter for articles that include information for patients (via the search term "hassummaryforpatientsin"). 25 Moreover, in February 2019, PubMed announced that when PLS are supplied by the publisher, these will appear below the abstract 26 ; they also introduced the "plain-language-summary" meta-tag, although so far uptake appears to be low amongst journals publishing PLS. 27  Based on our research, and our knowledge of the field, a summary of our own recommendations for PLS is presented in Figure 1. To increase the reach of biomedical research to lay audiences, we advocate that journals mandate the requirement for PLS for all articles.
The 11 journals studied in this research referred to PLS using nine different descriptors between them, so another key recommendation would be that all journals refer to summaries for lay audiences by the consistent plain-language summaries (PLS) descriptor to make them easier to find using standard internet search engines, and so audiences know that they are looking for the same thing whatever the journal.
Using a standard, instantly recognizable icon, such as that in Figure 2 Hannah FitzGibbon, the corresponding author, confirms that she had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

TRANSPARENCY STATEMENT
As corresponding author, Hannah FitzGibbon confirms that the manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

DATA AVAILABILITY STATEMENT
Some of these results have been presented as posters at the Interna- The two Elsevier journals were similar, except that one referred to "lay summaries" (Journal of Hepatology) and the other "patient summaries" (European Urology), and one required PLS to be submitted at journal article revision (Journal of Hepatology) rather than at submission (European Urology).