





































 V37 N2 / 2022 

©2022 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     4

ABSTRACT 
Peer-reviewed scientific publications are written by scientists 

with peers in mind. However, there is a growing demand of 

patients and other nonspecialists to understand the poten-

tial implications of clinical and medical research. Research 

summaries of scientific articles in easy-to-read language—

called plain language summaries (PLS)—are currently being 

developed to broaden the reach of scientific articles beyond 

expert audiences. While PLS can help nonexperts to under-

stand and be informed about scientific articles, there is a risk 

that PLS contribute to publication bias and hence misinfor-

mation of patients and the public and thus achieve the oppo-

site of their intention. Potential issues are an unbalanced 

selection of the scientific source articles for which a PLS is 

initiated, lack of alignment of the data presented in the PLS 

and in the source article, unbalanced reporting of efficacy 

and safety data, absence of reporting the primary endpoint, 

or over- or underreporting of secondary endpoint results. 

To objectively inform patients and to become a trustworthy 

source of information, the writing of PLS needs to be firmly 

embedded in a set of ethical principles. To safeguard bal-

anced and fair PLS writing, the cocreated “How-To” Guide 

on PLS writing developed by the Patient Focused Medicines 

Development initiative comprises a set of 15 ethical consid-

erations. These include the necessity for objective reporting, 

the need for balanced presentation, the importance of audi-

ence focus, the need to apply health literacy principles, and 

the importance of using inclusive and respectful language. 

The “How-To” Guide was developed in a stepwise process 

with several rounds of cocreation, public consultation (two 

rounds), internal review, and a final external review. The iter-

ative development process ensured input from a wide variety 

of stakeholders (patient representatives, industry members, 

publishers, researchers, medical communications agencies, 

and public officials involved in research bodies). The final 

“How-To” Guide is a standalone, practical, ready-to-use tool 

to support multistakeholder cocreation of PLS. 

Peer-reviewed scientific publications are the established 

channels through which researchers share results and data 

with their peers. These communications are typically writ-

ten by scientists with peers and fellow experts in mind and 

are characterized by extensive use of technical language 

and complex graphical representations. Scientific articles 

are therefore often impenetrable for nonspecialist audi-

ences. On the other hand, patients, patient organizations, 

and other nonexperts want to be informed about scientific 

research results that may impact on them or to whose gen-

eration they have contributed, eg, as participants in clin-

ical trials or by anonymously being a included in health 

resource use study. Patients and their caregivers want to 

know what the research activity may mean for them and the 

conditions they are living with.1-3 

 Plain language summaries (PLS) are summaries of 

scientific articles written in easy-to-read, nontechnical 

language. They have the potential to increase the under-

standing of scientific data by making complex information 

more accessible to wider audiences. This includes patient 

organizations, patients, caregivers, healthcare profession-

als from different fields, and the public.4-6  By improving 

knowledge and understanding of clinical research, PLS 

may facilitate patient–physician communication that could 

contribute to shared decision-making. Importantly, PLS 

are only of value when facts, numbers, and conclusions are 

conveyed truthfully and objectively, without promotional 

intent or spin. PLS can only fulfil their objectives if readers 

can fully trust that all relevant data—including informa-

tion on the uncertainty of research conclusions—have been 

made available to them. Thus, the writing of PLS needs to be 

based on ethical considerations and requires a documented 

institutional framework. 

 The number of PLS associated with peer-reviewed  

publications is still relatively low, and there is currently  

wide variation in content, format, quality, and location  

(i.e., where people can access them) of PLS.7 Efforts are 

Generating Plain Language Summaries of Scientific Publications with Ethical 
Foundations: A Practical “How-To” Guide Cocreated with Patients

Thomas M. Schindler, PhD / Boehringer Ingelheim Pharma GmbH & Co KG and Lay & Regulatory Writing, 
Biberach a. d. Riss, Germany 

THEME ARTICLE

http://www.amwajournal.org


AMWAJournal.org     5Generating Plain Language Summaries of Scientific Publications

ongoing to provide guidance, and minimum standards for 

PLS have recently been proposed.8-10 However, previous 

guidelines do not address the need of ethical considerations 

for the generation of PLS nor do they provide guidance on 

cocreation with the target audience. 

 In line with key ethical principles formulated in the 

Declaration of Helsinki11 that have become the basis for all 

clinical research in humans, members of the science com-

munication continuum, ie, researchers, authors, sponsors, 

editors, and publishers, share the obligation to appropriately 

and ethically share the results of research (principle 36).

 An ethical key consideration for PLS writing that 

expresses respect for potential and enrolled subjects of clin-

ical research is the aspect of cocreation. PLS should be pre-

pared in collaboration with members of the target audience 

to achieve an optimal outcome in respect to adequacy of 

content and presentation.12 However, in current practice, 

patient involvement is often restricted to the late stages of 

PLS development, for example the review process. 

 The need for a practical “how-to” guidance that will 

ensure both ethical considerations and early involvement 

of patients was recognized by Patient Focused Medicines 

Development (PFMD).13

 PFMD is a collaboration of health stakeholders, includ-

ing publishers, patient organizations, and pharmaceutical 

companies, whose aim is to facilitate patient engagement 

(PE) across the medicine development lifecycle.

COCREATION OF THE “HOW-TO” GUIDE
For the development of the “How-To” Guide on PLS, an 

international working group was established, and mem-

bers were required to have PE experience and/or expertise 

in generating PLS. The “How-To” Guide was developed in 

a stepwise approach using established cocreation meth-

odology.14-16 This included several rounds of cocreation, 

public consultation, internal review, and an external review. 

Feedback from each step in the review process was used to 

refine the draft “How-To” Guide, which was then validated 

through additional consultation. The first round of public 

consultation focused on the content, while the second 

public consultation gathered feedback on the usability and 

the associated user experience; a detailed description of the 

process is provided by Dormer et al.17

Ethical Considerations for PLS Writing
According to the Declaration of Helsinki,11 a universally 

accepted ethical standard for medical research in humans, 

researchers, editors, and publishers have ethical obliga-

tions regarding the publication and dissemination of the 

results of research (principle 36). These actors in the bio-

medical communication continuum are accountable for 

completeness and accuracy of their reports and that neg-

ative and inconclusive as well as positive results are pub-

lished or otherwise made publicly available (principle 36). 

Compliance with ethical principles is particularly relevant 

for PLS because they are intended for patients and nonex-

perts who are likely lacking the expertise to detect poten-

tial methodological flaws in scientific publications. In this 

regard, patients, caregivers, and other nonexperts constitute 

a vulnerable group that needs to be protected from harm 

inflicted by misinformation. While scientists are trained 

in presenting research in a structured way, the common 

format is alien to most patients and nonexperts. Hence, 

authors, editors, and publishers have the obligation to mini-

mize the potential for misunderstanding of scientific results 

that are presented in PLS. This is supported by the 15 ethical 

considerations included in the “How-To” Guide.

 The considerations cover the necessity for objective 

reporting, the need to apply health literacy principles, the 

importance of audience focus and the absence of any pro-

motional intent, the need for balanced presentation, and 

the importance of using inclusive and respectful language. 

It is also essential for both sponsors and journals to have 

a consistent policy for the development and publishing 

of PLS. This means there should be transparent, prospec-

tive, and objective selection criteria for choosing publica-

tions from which to develop PLS and for deciding how and 

when they will be published to prevent publication bias. For 

example, one criterion from a sponsor could be a commit-

ment to producing PLS for all phase 3 trials, regardless of 

outcomes. PLS on single trials need to include a disclaimer 

on the limitations and generalizability of the results. Details 

on the ethical principles are provided in Table 1.

Table 1. Ethical Considerations for PLS Writing

Any statement in the PLS should be objective and aligned with the 
data provided in the scientific publication.

Health literacy and numeracy principles should be applied in the 
writing and design of the PLS.

The choice of words should be neutral and factual. Superlative and 
emotional words, phrases, and metaphors should be avoided.

The PLS should be free of any commercial bias and must be strictly 
nonpromotional.

For PLS linked to primary scientific publications of clinical trials, there 
should be a balanced presentation of efficacy and safety data.

The overall objective (ie, the primary objective) of the research that 
is reported needs to be described in the respective PLS.

All data provided in the PLS should also be given in the scientific 
article. The data presented in a PLS should not go beyond the data 
provided in the scientific article.

Table continued on next page

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AMWAJournal.org     6Generating Plain Language Summaries of Scientific Publications

 Cocreation of content expresses respect for the target 

audience and hence is an important aspect in generating 

PLS of peer-reviewed scientific publications. The methodol-

ogy proposed in the “How-To” ensures adequate represen-

tation of the target population. 

Seven Steps for Generating a PLS: Proposed Algorithm
The generation of PLS was broken down into seven steps 

that serve the overall aims of maximum audience focus and 

full cocreation with members of the target audience. A sum-

mary is provided in Table 2 below; a more detailed descrip-

tion is available in Dormer et al.17

DISCUSSION AND CONCLUSION
The field of PLS writing is evolving as more and more 

journals provide the opportunity for PLS.5-7 Some guidelines 

for the content of PLS have been published by collaborative 

networks such as Cochrane8,9 and Open Pharma.10 Although 

these guidelines are applicable to all PLS, they do not 

explicitly provide ethical considerations, and they provide 

no methodology for cocreation of PLS with members of 

the target audience. It is very important to realize that PLS 

Table 2. Seven Steps of Creating a PLS 
Step Action Content

1 Have a rationale 
and scope for 
developing  
the PLS

The selecting criteria for the source scientific publication for a PLS must be clear before the writing is initiated. It is 
important to have a transparent process, such as a standard operating procedure, across an organization, to avoid 
publication bias by selectively providing PLS. Reasons for a PLS could be the impact of the data, the uniqueness of the 
scientific approach, or the needs of a certain audience.

2 Identify the 
target audience

The target audience should be defined before the start of the writing process. This choice will impact the resource 
needs in the cocreation process and will determine the administrative and operational complexity of the PLS writing.

3 Consider the 
dissemination 
channels

It is essential to consider the dissemination of the PLS based on the identified target audience. Free access is 
important to optimize distribution. The method of dissemination will influence the amount of aggregation and 
summarization of data from the source article. For example, if a manuscript and its PLS appear in the same issue of 
a journal, certain details may be omitted from the PLS and provided solely as reference to the source. Some journals 
may allow the inclusion of supplementary material, eg, for additional infographics.

4 Identify key 
stakeholders for 
cocreation

It is important to identify the key stakeholders for their engagement in cocreation before a PLS is written. It is desirable 
to have a broad range of stakeholders, including patients, caregivers, and others. The PLS cocreators should determine 
whether they have the appropriate reach into the target audience or whether new cocreation relationships need to be 
established. Resourcing (eg, contracting, payment, technical infrastructure) and any applicable legal requirements need 
to be considered to ensure that relationships can be maintained throughout the process.

5 Write PLS PLS cocreators should establish an appropriate infrastructure and should agree on roles and interaction in the writing 
process. Based on the target audience, the PLS cocreators need to decide on the literacy level and the structure of 
the PLS and the use of visuals or infographics. It is highly recommended to have a member of the target audience 
review the draft PLS. The PLS must reference the source scientific article or contain a link to it.

6 Disseminate 
PLS

Once the PLS is published, it may be shared in print, in online repositories, or on relevant websites; the channels 
should be chosen based on target audience preference. The use of social media for dissemination depends on the 
legal restrictions in some countries and the corresponding compliance rules in large organizations.

7 Track 
dissemination 
and measure 
success

Ways to monitor the impact of the PLS should be developed to gauge future efforts. Various metrics may be available 
depending on where a PLS is located/hosted. The journal site/website/repository that hosts the PLS might provide 
metrics such as the number of views or downloads. Another measure is the attention the PLS or the source article has 
received on social media or in other commentaries. Posts on social media that link to the PLS may be liked or shared, 
and monitoring this activity can provide an indication of the reach of the PLS. It should also be measured whether the 
PLS is shared by patient organizations and healthcare providers in the respective disease area.

The results of the primary endpoint need to be described and ex-
plained in the PLS when reported in the scientific publication. Results 
of key secondary endpoints could be included if they have been 
prespecified in the study protocol or analysis plan, are statistically 
powered and analyzed, and are of particular relevance to patients.

The PLS needs to mention the important limitations of the research or 
study that is reported in the scientific article.

To make PLS accessible for patients whose native language is not 
English, appropriate translations should be done that faithfully reflect 
the content of the PLS. Translations need to be mindful of the cultur-
al diversities between audiences and ideally reviewed by members of 
the target audience for each language.

The PLS should be inclusive of all genders, nationalities, and 
ethnicities.

The PLS should be reviewed by members of the public and/or by 
patients or patient representatives ideally with the condition that 
was studied in the scientific article.

The PLS should be approved by the lead author (the author 
who is named first in the author list) of the scientific article, as a 
minimum. All authors of the scientific article on which the PLS is 
based should be given the opportunity to review and comment 
on the PLS.

The authors of the PLS as well as the funding source of the 
research work and the funding of the PLS should be disclosed in 
the PLS.

Links to the scientific publication should be included in the PLS.

Table 1. Ethical Considerations for PLS Writing (continued)

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AMWAJournal.org     7Generating Plain Language Summaries of Scientific Publications

written without strict consideration of ethical principles 

bear the risk of contributing to misinformation rather than 

providing insight and understanding to nonexperts. To 

make this new format a trustworthy source for patients, 

caregivers, and others, a firm commitment to ethical 

conduct in PLS writing is mandatory. However, while not 

being explicit about their ethical considerations, the existing 

guidelines8,9 stipulate a number of requirements that are in 

line with the recommendations of the PFMD guidance. For 

example, the Cochrane collaboration mentions consistency 

between the source and the PLS and the need to report the 

primary outcome as well as balanced reporting of efficacy 

and safety data as mandatory requirements.8 Interestingly, 

in the latest version of the Cochrane guidance published in 

January 2022, the ethical considerations in regard to content 

of PLS, are substantially less explicit than in the previous 

version.9 The Open Pharma collaboration mentions that 

PLS need to be nonpromotional and unbiased and that 

PLS need to include a link to the source publication.10 

In a recently published modified Delphi approach of 

stakeholders’ perceptions of issues in generating PLS,18 a 

number of items emerged as “important” that are in line 

with the ethical considerations put forward in the PFMD 

guidance. Stakeholders considered it “important” that the 

primary endpoint results are included in the PLS as well as 

mentioning the limitations of the study. Other obligations 

related to ethical conduct, such as having the authors of the 

source article approve the PLS, are only to be “considered” 

in PLS generation, according to this stakeholder group.

 In summary, the “How-To” Guide developed by PFMD is 

the first one to more explicitly require compliance with a set 

of ethical considerations. The value of these stipulations was 

corroborated by the fact that the “How-To” Guide had been 

developed using an iterative and robust co-creation meth-

odology with substantial public consultation.14-16 

 To ease implementation, selected resources for PLS 

development, complementary tools, and good-practice 

examples are available directly in the “How-To” Guide. The 

“How-To” Guide19 has been uploaded onto the PFMD PE 

Management Suite, a central repository that allows open 

access to all PFMD tools. 

Acknowledgment

I take full responsibility for the content and the presen-

tation. However, I thankfully acknowledge the discus-

sions within the PFMD PLS working group on the topic. 

The members of the PLS guidance core team were Laura 

Dormer, Lauri Arnstein Williams, Dawn Lobban, Sheila 

Khawaja, Amanda Hunn, Daniela Luzuriaga Ubilla, and 

Anne-Marie Hamoir.

Author declaration and disclosures: The author notes no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article.

Author contact: lay_and_regulatory_writing@gmx.de

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https://doi.org/10.1136/bmjinnov-2018-000317
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