Plain Language Summary: Taking Science and Clinical Research to Lay audience

Introduction

Plain language is grammatically perfect, with an entire sentence structure and precise word usage. Clear, to-the-point writing improves communication and takes less time to read and comprehend. There is an increasing desire for non-technical audiences to have access to current medical research in simple language formats(1). Thus, to communicate clinical research to a non-technical audience, best-practice approaches in the form of plain language summaries (PLSs) are necessary(2).

Clinical trial results that are presented in simple, stand-alone factual summaries have the potential to improve public awareness and participation in pharmaceutical research (3). PLSs, in particular, are intended to improve research participants' comprehension of trial processes and outcomes to improve their overall clinical trial experience(4). According to research spanning a variety of therapeutic indications, people who have taken part in clinical trials want to know the outcomes as soon as possible.

Furthermore, the PLS process could provide a significant opportunity for sponsors, contract research organizations (CROs), and sites to express their gratitude to patients for participating in their studies regularly, potentially increasing patients' trust and confidence that the study sponsor will actively protect their privacy and maintain the confidentiality of their data(5).

Policies and guidelines

A PLS is not simply a modified or rephrased version of the paper abstract. There are few policies and guidelines specified, to make scientific data accessible to the general public and develop their knowledge about ongoing research and its outcomes. Some of the very basics are as follows:

·         Be clear and concise.

·         Break documents into separate topics.

·         Use short paragraphs.

·         Use shortlists and bullets to organize information.

·         Use more headings with fewer sub-headings.

Need for PLS in science communication

u  Simplifying science through PLS

Simplicity, clarity, and transparency are the keys to communicating science effectively (1).PLS use non-technical language to explain the motivation, methods, and findings of a scientific investigation, allowing non-expert audiences to appropriately comprehend scientific findings(6). Scientific abstracts, on the other hand, are written for an audience of experts. Sharing a PLS with study participants has been found to improve public desire to participate in clinical trials.PLS has received endorsements from several international working groups and professional organizations. Even though the legislation has not yet been implemented, several sponsors have already begun to produce these documentations. The motivation has been altruistic rather than regulatory compliance.

u  Disseminating clinical trial data in PLS

The dissemination of study data is essential for clinical trials to be completed, and it is primarily intended to aid in the translation of evidence into policy and practice(7). Other academics and healthcare professionals, policymakers, funders, and the general public are among the audiences to whom scientists convey their findings(8). The possible advantages and burdens of research involvement must be considered at each stage of the trial procedure to improve the trial experience. Clinical trial research burdens entail psychological, physical, and financial consequences that occur both during follow-up and after participation is completed(7),(8). Failure to foresee or minimize the negative consequences of participation may have an impact on future clinical research participation and the desire to give time to longitudinal cohorts.

u  PLS in improving health literacy and vaccine awareness

Vaccines have demonstrated their ability to prevent vaccine-preventable diseases from causing illness, disability, and death(9). Vaccination and immunization are supported by a large body of evidence, the most recent examples being the COVID-19 vaccines. "The capacity of individuals to obtain, process, and understand basic health information and services needed to make appropriate health decisions" is defined as health literacy (10). It is a comprehensive notion that refers to people's abilities to handle the complicated demands of modern health(9). Plain language summaries can be used to inform the general public either directly or indirectly (via healthcare professionals) and may aid in the development of trust and vaccine confidence(11), (12).

Recommendations for plain language summaries for the following types of publications

u  Peer-reviewed medical journal publications

PLSs of peer-reviewed medical journal papers are a way to share research with a wide range of audiences, and they may promote medical research transparency, accountability, accessibility, discoverability, and inclusion(13). There is currently an industry-wide effort underway to establish consensus on plain language summaries, and initiatives have already been put in place to provide detailed guidance on plain language best practice, co-creation methods, patient-focused content, graphic and digital considerations, and publisher-specific guidelines(14). However, a basic set of suggestions is still needed to supplement existing projects and specify the minimal procedures required to provide PLSs that are trustworthy, credible, and of high quality.

u  Publications of company-sponsored medical research

Lay audiences are interested in medical advancements. Evidence supports the use of PLS for effectively communicating research to these broader lay audiences and demonstrates that PLS can improve understanding of research results(15). Understanding the implications of new data can help patients and their healthcare teams put research into context and can facilitate shared decision-making. Effective communication via PLS may broaden the scope of medical research by assisting in the avoidance of misunderstanding and misinterpretation of complex data, as well as the combating of misinformation.

u  Abstract plain language summary for Scientific congress

Many individuals are interested in learning about the most recent scientific advancements in the field of medicine. Clinical data, on the other hand, is often complex and difficult to comprehend if one is not a scientist. Developing plain-language summaries for research results given at medical conferences to enable interested non-scientists better comprehend the newest research. These are referred to as "abstract plain language summaries" (APLS).

  Benefits and challenges of PLSs

Future of PLS: Prospects and Perspectives

u  Scope of improvement

Plain language summaries (PLS) can spread medical knowledge to a wider audience and combat health misinformation, which is a major issue highlighted by the COVID-19 pandemic(11). Open Pharma guidelines(13), a 'how-to' guide for multi-stakeholder insights from Patient Focused Medicines Development, and PLS of Publication (14), a new journal article type from the Future Science Group, are examples of the recent breakthrough in PLSs. Despite these advancements, PLS have been reluctant to gain traction as supplements to medical papers, and there are no standardized methods for their creation or dissemination.

u  Key questions to address

The following questions need to be addressed to ensure formulating a proper PLS(15):

1.      What information must, and must not, be included in a PLS?

2.      Who are the target audiences for PLSs, and why are they important?

3.      What format(s) for a PLS is/are the best?

4.      What is the best process to design, review, and approve a PLS?

5.      What must be done to guarantee that PLSs are regarded as proper vehicles for accompanying scientific articles beyond medical education or promotional materials?

6.      To achieve maximum reach and discoverability, where and how should PLSs be published?

7.      How can the reach, quality, and value of PLSs be quantified?

8.      To avoid the sponsor's perception of selection bias, what approach should be used to choose articles that will have a PLS?

9.      What requirements should be followed while creating a PLS for a previously published article?

u  Scope of PLS according to geographical location

Assuming that every PLS and relevantquery submitted to an information retrieval (IR) system is geography-dependent is a significant concept(15). If the geographical scope of an article can be determined, this information can be utilized to improve the precision with which persons, places, and organizations named in the article can be located(16). More crucially, by tuning relevance ranking and query expansion algorithms using scope metadata, geographical scopes of documents can be used to reach out to readers against geography-dependent user queries.

Conclusion

PLSs are meant to give readers a clear, nontechnical, and easily accessible overview of medical and scientific literature; nevertheless, audience preferences for specific PLS formats have yet to be completely studied. By optimizing content and structure, the PLS can improve health literacy and, as a result, raise pharmaceutical knowledge and confidence as part of a larger integrated communication strategy(11). An industry-wide effort is underway to create consensus on PLSs. Even though the legislation has not yet been implemented, several sponsors have already begun to produce these documentations. The motivation behind simplifying science is more altruistic rather than regulatory compliance.

 References

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7.         Dormer L, Walker J. Plain Language Summary of Publication articles: helping disseminate published scientific articles to patients. Future Oncol. 2020 Sep 1;16(25):1873–4.

8.         Degaga TS, Weston S, Tego TT, Abate DT, Aseffa A, Wayessa A, et al. Disseminating clinical study results to trial participants in Ethiopia: insights and lessons learned. Malar J. 2020 Jun 8;19(1):205–205.

9.         Lorini C, Santomauro F, Donzellini M, Capecchi L, Bechini A, Boccalini S, et al. Health literacy and vaccination: A systematic review. Hum Vaccines Immunother. 2017/12/06 ed. 2018 Feb 1;14(2):478–88.

10.       Biasio LR. Vaccine hesitancy and health literacy. Hum Vaccines Immunother. 2016/11/03 ed. 2017 Mar 4;13(3):701–2.

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12.       Michel J-P, Goldberg J. Education, Healthy Ageing and Vaccine Literacy. J Nutr Health Aging. 2021 May 1;25(5):698–701.

13.       Rosenberg A, Baróniková S, Feighery L, Gattrell W, Olsen RE, Watson A, et al. Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications. Curr Med Res Opin. 2021 Nov 2;37(11):2015–6.

14.       Smith R. Improving and spreading plain language summaries of peer-reviewed medical journal publications. Curr Med Res Opin. 2021 Nov 2;37(11):2017–8.

15.       Lobban D, Gardner J, Matheis R. Plain language summaries of publications of company-sponsored medical research: what key questions do we need to address? Curr Med Res Opin. 2022 Feb 1;38(2):189–200.

16.       Andogah G, Bouma G, Nerbonne J. Every document has a geographical scope. Data Knowl Eng. 2012 Nov 1;81–82:1–20.