A Company’s Approach to Developing Publication Plain Language Summaries

Angela Sykes, MA, MPhil, Pfizer Inc., New York, NY; Beth Whann, BA, ISMPP CMPP^TM, Pfizer Inc., Collegeville, PA; Stephanie Dooley, PharmD, Pfizer Inc., Collegeville, PA

Scientific publications tend to be written with a specialized audience in mind, using complex and technical language that may not be easily understood by a lay person. Plain language summaries (PLS) of publications represent a way to communicate research more broadly using everyday language. Pfizer, along with many others working in medical communications and publications, recognized this, and in early 2020 implemented a company-wide process for developing PLS. This initiative supports the company’s value of equity by ensuring that information from Pfizer’s clinical studies is understandable and accessible to all. Here we share how we successfully integrated PLS into the company’s publications standard operating procedure (SOP).

Why are plain language summaries important and why now?

A survey exploring global attitudes about science found that 88% of people think that scientists should share information in language that is easy to understand.¹ Due to the global COVID-19 pandemic, the general public’s thirst for scientific knowledge may be greater now than ever. Governments, public health experts, and individuals rely on rapidly emerging scientific data to make decisions that have major economic, public health, and personal impact. In addition, a survey of patients with chronic diseases found that nearly 50% of respondents use scientific journals as a source of disease information.² These trends underscore the importance of delivering scientific information not only rapidly and openly, but also in a manner that is understandable and accessible to readers without scientific expertise.

We believe that scientific research, especially when it relates to new advances in medicine and public health, is relevant to an audience much broader than just the specialists in a particular field. Patients and their advocates, as well as non-specialist healthcare professionals (HCPs), journalists, healthcare policy experts, and the public, can all benefit when medical research is made easier to understand. PLS describe the results of research studies presented in a scholarly manuscript, abstract, poster, or presentation in a manner that can be easily understood.

When is a PLS needed?

When deciding which publications should have a PLS, publication teams should consider the type of research, where it will be published, and the perceived usefulness of the information to a general audience. We see value in prioritizing PLS for publications reporting the results of clinical trials for approved treatments and vaccines and those related to patient preference studies and patient reported outcomes, given the relevance to patient care. However, PLS of publications related to investigational products can also be considered, as they may help to make patients with limited treatment options aware that newer therapies may one day be available. PLS of systematic literature reviews and meta-analyses may also be useful as they provide a broader perspective than a PLS of a single study. Ultimately, every scientific publication can be considered a candidate for a PLS because they all will promote broader understanding.

The development of PLS requires time and resources, meaning that they cannot be done for all publications. We recommend to our publication teams that the intent to develop a PLS be decided on as early as possible during the publication planning process, ideally when the original publication is identified. The type of PLS (infographic, text only, video) should also be considered during planning because the PLS type will impact the overall cost. Pfizer has negotiated fixed fees for the development of PLS with our publication agencies. If resources are limited, then we suggest prioritizing manuscript PLS over abstract PLS since they are accessible to a wider audience and are more enduring than congress PLS.

What process did Pfizer adopt for developing PLS?

Our path to developing a company-wide PLS process began with a congress abstract PLS pilot in Pfizer Oncology and was described in a poster presented at the 2020 ISMPP Annual Meeting.³ Collaboration with Medical, Legal, Corporate Affairs and Publications was essential and, during the 18‑month pilot, feedback was gathered from patients, congress organizers, HCPs and internal stakeholders. The learnings from the pilot were incorporated into the company’s PLS process and requirements. Figure 1 highlights recommended steps for implementing a company-wide PLS SOP.

To address the fact that individuals vary in their ability to understand and process health information, Pfizer’s SOP supports using health literacy best practices when developing PLS. The goal of health literacy principles is to create content that is organized and understandable. This can include defining the target audience, limiting the content to essential information only, ensuring the information is easy to understand and using appropriate white space and infographics to highlight key information.  

Health literacy is defined as the degree to which individuals have the “capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”⁴

To ensure that PLS are developed according to health literacy principles and in a consistent manner, Pfizer partnered with health literacy experts at Northwestern University to develop an internal best practices manual for publication PLS. The manual explains how to apply health literacy best practices to PLS and includes a PLS template, plain language glossary of scientific terms and a checklist. The health literacy experts at Northwestern University trained hundreds of Pfizer colleagues and our agency partners on this manual. Pfizer recommends use of the United Health’s JustPlainClearGlossary for plain language definitions of terms not included in the Northwestern Manual.

Pfizer’s SOP requires that PLS content be non-promotional and consistent with the original publication. Not allowing additional content to be included keeps the process streamlined and avoids compliance or quality concerns that could arise from introducing new information beyond what had been approved by the publication authors.

Pfizer’s PLS are written by trained medical writers at our publication agencies. Translating medical content into plain language is a unique skill that not all scientific medical writers are comfortable with. We aim for the equivalent of United States 4^th-6^th grade reading level, but with the need to include some more complex terms, such as drug names, up to an 8^th grade reading level is acceptable. Some of our publication agencies include the involvement of lay reviewers in their PLS process, which helps to ensure the intended meaning is delivered. Recommendations for what to include, and not to include, in PLS content are outlined in Figure 2.  

Other Pfizer PLS best practices include:

• Involving all authors of the original publication in the review of the PLS
• Review of the PLS by internal non-author subject-matter experts to ensure that the content is clear, consistent with the publication on which it is based and accurately reflects the overall conclusions
• Optional review by lay persons to ensure that the content is understandable and relevant to a non-specialist audience
• Inclusion of all applicable disclosure statements (e.g., study sponsorship and funding of the development of the PLS)
• Use of a customized automated tool to assess draft PLS for more than 50 health literacy criteria
• Review of a foreign-language translation of a PLS by a Pfizer colleague fluent in the language the PLS is being translated to and knowledgeable in the subject area
• Final approval of the PLS only after completion of the underlying publication
• Publishing PLS simultaneously with, or after, the publication on which the PLS is based
• Linking the PLS to the original publication on which it is based

Who was trained on Pfizer’s PLS process and requirements?

Colleague and agency training on Pfizer’s PLS requirements was an integral step for the successful implementation of our PLS process. Live training sessions were provided, and a recording of the sessions is made available on a dedicated PLS SharePoint page – accessible to all Pfizer colleagues and our publication agency partners – along with other resources. A trained team of Publication Specialists review all manuscript PLS prior to submission to ensure that they comply with the SOP requirements and health literacy principles. In addition, for each PLS, a quality control checklist must be completed by the Pfizer Publication Owner and Publications Specialist to ensure all SOP requirements are met before submission.

What’s the best type of PLS?

PLS may be developed in various lengths and formats, such as text only, text with images, infographic, audio and video. Journals that publish PLS may have specific requirements; some require that all research manuscripts include a plain language paragraph of a few hundred words that summarizes the paper. There is limited research comparing how PLS type impacts comprehension, understanding and enjoyment achieved by various audiences and the findings have been inconsistent, so more investigation needs to be done to determine the best format for each audience.^5-7

Below are links to some examples of Pfizer-sponsored PLS published in various formats.

Where should PLS be published?

It is essential that PLS are freely accessible and not hidden behind a paywall. Pfizer’s SOP requires that all manuscript PLS are available open access upon publication. Abstract PLS are accessed by congress attendees through scanning a QR code on a congress poster or presentation. The QR code directs the reader to the PLS, which is housed on an external microsite for up to 1 year, meaning that accessibility is restricted to congress attendees for a limited period. Pfizer has taken steps to improve the discoverability of abstract PLS, such as compiling QR code booklets that are shared upon request at the congress booth. QR code booklets may require additional internal company reviews for compliance, and their use must be approved by the congress. Oncology abstract PLS are also posted on the HCP section of the Pfizer Medical Information website for 1 year after the congress.

Some journals that do not have a current policy on publishing PLS are open and willing to discuss PLS and consider the option. For manuscript PLS, target journals should be contacted early on to inquire about whether they publish PLS. If the PLS cannot be hosted on the journal’s website, consider other options to host the PLS, such as publishing the PLS as a standalone secondary publication and link to the original manuscript. A standalone PLS may be published by the journal alongside the publication as supplementary material; posted on an information-sharing platform, such as Figshare; or published as a standalone article. PLS that are published as a standalone manuscript and not as supplemental material may be more discoverable because they have their own digital object identifiers (DOIs) and are indexed in bibliographic databases.

Future Science Group is an example of one publisher that publishes PLS versions of manuscripts from other journals, and they publish PLS in various formats. At Pfizer, we recently launched a Figshare portal (Pfizer.Figshare.com) where we can disseminate standalone manuscript PLS when the journal in which the paper was published does not host PLS. Pfizer has embraced many different options and opportunities to publish PLS in various formats. So far in 2021, 116 PLS have been included in Pfizer publication plans for 46 products across the company.

Summary

Scientific research is important and relevant to not only the specialists in a particular field, but also to patients, caregivers and non-specialist HCPs. PLS allow for transparent communication of scientific research to a lay audience and assist patients and HCPs with understanding clinical results. By applying health literacy best practices and helping to ensure discoverability and accessibility of PLS, we as scientific communication professionals have the opportunity to share important scientific research to a broader audience with a consistent approach.

Acknowledgements

We would like to thank J.R. Meloro from Pfizer for his review of this article.

Helpful Resources

‘How-to’ guide for the development and dissemination of PLS –
https://www.plainlanguagesummaries.com/pfmd-how-to-guide/

Health Literacy Principles –
https://ismpp-newsletter.com/2020/02/25/what-is-health-literacy-in-clinical-research-communications-and-why-is-it-important/

Enhanced Publications Options Navigator (EPON) –
https://www.mpip-initiative.org/transparencymatters/epon.html

eLife – list of journals and other organizations that publish PLS –
https://elifesciences.org/

Just Plain Clear Glossary –
Home | Just Plain Clear® Glossary | UnitedHealth Group

Readability formulas*:
https://www.wyliecomm.com/2018/11/10-free-readability-calculators/
http://www.hemingwayapp.com/
https://www.wordrake.com/

Plain Language Expectations for Author of Cochrane Summaries (PLEACS) https://methods.cochrane.org/sites/default/files/public/uploads/PLEACS_0.pdf

Summaries of Clinical Trial Results for Laypersons: Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use – https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2017_01_26_summaries_of_ct_results_for_laypersons.pdf

Workgroup of European Cancer Patient Advocacy Networks (WECAN) online publications training course for patients –
https://wecanadvocate.eu/patients-in-publications/

_{*Use caution when using these online tools, especially regarding confidential company information. It is unknown whether information is stored and/or saved on these sites.}

References

1. State of Science Index. (2019). https://multimedia.3m.com/mws/media/1665444O/3m-sosi-2019-global-findings.pdf. Accessed July 22, 2021.
2. Pushparajah DS, Manning E, Michels E, Arnaudeau-Bégard C. Value of developing plain language summaries of scientific and clinical articles: a survey of patients and physicians. Ther Innov Regul Sci. 2018 Jul;52(4):474-481. DOI: 10.1177/2168479017738723.
3. Sykes A, Chari D, Meloro JR. Developing a company-wide process for publication plain language summaries. Poster presented at ISMPP Annual Meeting 2020. 
4. Institute of Medicine. Health literacy: A prescription to end confusion. Washington DC: National Academy Press; 2004.
5. Bujlan I, Malicki M, Wager E, et al. No difference in knowledge obtained from infographic or plain language summary of a Cochrane systematic review: three randomized controlled trials. J Clin Epidemiol. 2018;97:86-94. DOI: 10.1016/j.jclinepi.2017.12.003.
6. Buljan I, Tokalić R, Roguljić M, et al. Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial. Trials.2020;21:426. DOI: 10.1186/s13063-020-04360-9.
7. Bredbenner K, Simon SM. Video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts. PLoS ONE.2019;14:11. DOI: 10.1371/journal.pone.0224697.