Evidence generation shouldn't end with publication: Why every HEOR and RWE publication needs a plain language strategy

As healthcare decision-making becomes increasingly patient-centered, the audiences for HEOR and RWE continue to expand. Here Joanne Walker and Laura Dormer argue that every HEOR and RWE publication should have a plain language strategy, ensuring findings are communicated effectively to researchers, patients, policymakers, and other stakeholders through Plain Language Summaries and, where appropriate, standalone Plain Language Summaries of Publications.

When we introduced the first Plain Language Summary of Publication (PLSP) in 2020, our aim was to create a standalone, peer-reviewed article that communicated published research in language that could be understood by people beyond the traditional scientific and medical audiences. Our intention was to make published scientific articles more accessible while maintaining the accuracy, transparency, and rigor of the original publications.

Six years on, this has evolved considerably. Recently we’ve co-authored a paper that brings together Becaris Publishing, Sage, Taylor & Francis, and Open Pharma to establish, for the first time, a cross-publisher agreement on the defining principles of PLSPs. In doing so, it provides a formal definition of a PLSP and establishes a shared set of principles to support greater consistency in how these articles are authored, peer reviewed, published, indexed, and discovered.

Reaching agreement across several publishers is an important milestone for the evolution of PLSPs as a recognized publication format. However, we believe the significance of this publication extends well beyond publishing standards. It reflects a broader shift taking place across healthcare research.

For those working across health economics and outcomes researcher (HEOR), real-world evidence (RWE), market access, medical affairs, and regulatory science, this reflects the growing recognition that, as healthcare decision-making becomes increasingly multidisciplinary and patient-centered, generating robust evidence is no longer enough. It is equally important to ensure that evidence can be understood by the people who need to use it.

Evidence is no longer written solely for researchers

The role of healthcare evidence has changed significantly over the past decade. HEOR studies now inform reimbursement decisions, value assessments, and pricing negotiations. RWE and comparative effectiveness research is contributing to regulatory submissions, supports health technology assessments (HTAs), and increasingly complements clinical trial data throughout the product lifecycle. Patient-reported outcomes are also becoming central to understanding the value of new interventions from the perspectives of patients, caregivers, clinicians, and healthcare systems.

At the same time, the audiences using the evidence have expanded considerably. Alongside researchers and specialist clinicians, HEOR and RWE are now informing decisions made by HTA bodies, regulators, payers, policymakers, multidisciplinary healthcare teams, patient organizations, and increasingly, patients themselves.

These developments are also reflected in the evolving policy landscape. One important catalyst has been the European Union Clinical Trials Regulation, which requires sponsors to produce lay summaries of clinical trial results, acknowledging that research participants should have access to study findings presented in language they can understand. Similarly, the new EU Health Technology Assessment Regulation embeds patient involvement throughout the Joint Clinical Assessment process, where patients, carers, and clinical experts can contribute directly to assessments, bringing perspectives on outcomes, treatment burden, and quality of life that cannot be captured through clinical data alone.

Elsewhere, as part of the Medicare Drug Price Negotiation Program in the US, the Centers for Medicare & Medicaid Services (CMS) actively invites patients, caregivers, clinicians, and other stakeholders to share their experiences and perspectives during negotiations. Their contributions help inform discussions around unmet need, clinical benefit, and therapeutic alternatives.

The same trend is evident in real-world data (RWD) as patients are becoming active contributors rather than passive participants. Through patient-reported outcome measures, disease registries, digital health technologies, and mobile applications, patients are generating data that increasingly forms part of the evidence base used by regulators, HTA agencies, and healthcare systems.

We have seen this evolution reflected in publishing as well. As patient involvement has become increasingly embedded throughout the research and healthcare ecosystem, it has also changed the types of conversations taking place within scientific publishing. Earlier this year, we launched the Journal of Patient Centricity in recognition of the growing importance of patient-centered research and the need for a dedicated forum to explore how patient perspectives are shaping healthcare innovation, evidence generation, and decision-making. Importantly, the journal reflects these principles in practice, with patients contributing as members of the Editorial Board as well as authors and reviewers.

“For us, this reflects a much broader change taking place across healthcare: patients are no longer simply recipients of care or participants in research; they are increasingly partners in generating, interpreting, communicating, and applying evidence.”

These multiple developments all point to the same trend. If we are asking people to contribute to evidence generation and healthcare decision-making, shouldn't we also ensure they can understand the evidence itself?

Publication planning should be part of integrated evidence planning

Integrated evidence generation is now well established. Increasingly, organizations plan evidence strategies across the product lifecycle, bringing together regulatory, clinical development, HEOR, market access, and payer evidence needs much earlier in the process. Rather than generating evidence for individual stakeholders in isolation, the emphasis has shifted towards developing evidence packages that can support multiple decision-makers.

As evidence generation has become more integrated, publication planning has also evolved. Scientific publications, congress presentations, posters, videos, infographics, and digital content are increasingly viewed as linked, complementary outputs, each designed to communicate evidence to different audiences.

We believe the next step is to adopt the same approach to plain language communication. Rather than asking whether a publication should have a Plain Language Summary (PLS) once the manuscript has been accepted, publication teams should consider a plain language strategy from the outset. That strategy should identify who the evidence is intended to reach, what those audiences need to understand, and which publication formats will best support those objectives.

Developing this strategy should not sit solely with publication teams. Integrated evidence generation already requires close collaboration between clinical development, HEOR, regulatory, market access, and medical affairs. Publication professionals and experts in scientific communication should also be involved from the outset to ensure that evidence is generated not only for its intended audiences, but communicated effectively to them as well.

Why every publication should include a PLS

We believe there is now a strong case for every HEOR and RWE publication to include, at a minimum, a PLS. abstract, be that text-based or graphical. This is an approach we have adopted in the Journal of Comparative Effectiveness Research, where all original research articles must include a PLS as part of the main manuscript.

The benefits extend beyond making research more accessible to patients. A well-written PLS helps readers quickly understand the purpose of a study, the methods used, the main findings, and what those findings mean in practice. Importantly, it also benefits specialist audiences. Healthcare professionals working outside a particular disease area, multidisciplinary research teams, journalists, policymakers, and even time-constrained clinicians often value clear summaries that allow them to assess whether a paper is relevant before exploring the full publication.

One of the most encouraging developments has been the response from our authors. While some initially view plain language writing as an additional step in the publication process, we have found that it resonates strongly once they begin developing a PLS. Many recognize the value of communicating their research more effectively and are keen to ensure their findings reach audiences beyond the immediate scientific community. Increasingly, authors see a PLS not as a publishing requirement, but as an opportunity to maximize the reach and impact of their research.

Authors are also better supported than ever before. Journal guidance, editorial expertise, professional medical writers, and the rapid evolution of AI-assisted technologies mean there are now multiple ways to develop a high-quality PLS.

“Expert oversight of PLS remains essential to ensure scientific accuracy, appropriate language, transparency, and adherence to publication ethics, but the practical barriers to including a PLS alongside a publication are now considerably lower than they were just a few years ago.”

When should authors consider a PLSP?

While a PLS should become standard practice for every HEOR and RWE publication, authors should also consider whether their study would benefit from a standalone PLSP.

“For many studies intended to influence healthcare policy, reimbursement, HTA, regulatory decision-making, clinical practice, or patient care, we believe the answer will increasingly be yes.”

A PLS provides readers with a concise overview of a study. A PLSP goes considerably further. As a standalone, peer-reviewed article, it allows authors to explain the background to the research, study design, methodology, results, and their implications in much greater detail, while presenting the information in clear, accessible language.

The format also provides far greater flexibility to communicate complex research visually. Meaningful graphics, infographics, study schematics, treatment pathways, patient journeys, and key findings can be integrated throughout the article, helping readers understand concepts that may be difficult to communicate through text alone. This is particularly valuable for HEOR and RWE studies, where complex methodologies, RWD sources, comparative analyses, or health economic models often require additional explanation.

The recently agreed cross-publisher definition reflects these strengths. A PLSP is:

“… a standalone summary of a peer-reviewed article written according to plain language principles and published in a peer-reviewed journal. PLSPs are designed to meet the needs of diverse audiences, including different groups of readers to those of the original article and those with limited time to find and digest scientific content. As peer-reviewed standalone articles with a unique digital object identifier (DOI), PLSPs differ from other types of research summaries, such as text and graphical PLS published within or alongside a peer-reviewed article and lay summaries of clinical trial results developed for regulatory purposes.”

Unlike a PLS, a PLSP becomes a citable, discoverable publication in its own right, extending the reach of the original research while helping ensure that complex evidence is communicated in a way that is understandable, credible, and ultimately more likely to inform healthcare decision-making.

A stronger future for evidence communication

The publication of the cross-publisher agreement marks an important step towards establishing PLSPs as a recognised publication format. More importantly, we hope it encourages a broader conversation about the role of communication in evidence generation and more journals and publishers to embrace plain language content.

As HEOR and RWE continue to inform increasingly important healthcare decisions, every publication should have a plain language strategy. That starts with including a PLS as part of the primary publication and, where appropriate, extends to developing a standalone, peer-reviewed PLSP. Communicating evidence clearly should no longer be viewed as an optional enhancement to publication planning – it should be considered an integral part of evidence generation itself.