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Lay Summary
Writing for Lay Audiences - Questions & Answers
Astrid Gross
May 2015
Content
Preface
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The New Clinical Trial Regulations on Lay Summary
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When is a person to be considered lay?
What is a lay summary?
How are lay summaries used?
What are the quality principles for a lay summary?
How are patients’ information needs evaluated?
How do we measure if a summary is lay or lay enough?
Long or short? – Different requirements on the length of lay documents
and the impact on information quality
Information Sheets and Consent Forms
What is needed to achieve common ground?
a. Why is the interest of patients/general public/lay people into research important?
b. Charities versus Universities – a comparison of current stage on lay
involvement and lay document writing
c. Bridgebuilding to improve communication to selected lay audiences
Basic checklist example for lay summary in clinical research
Conclusion
Reference
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Preface
I am an independent health and research professional and have extended my services with the translation of
health and research documents into lay language.
My own experience of using and translating into lay language lasts for the entire 29 years of my professional
career. During the last 3 decades, I have been communicating written and verbally with other health
professionals, academics, researchers, scientists, nurse students, and patients or other groups of lay people
which required a permanent adaption of expression, wording, sentencing, phrasing and even thinking.
As a clinical Nurse I permanently was in demand to translate medical information to patients and their
relatives. This extended into my private life where I had to explain medical and health issues to family and
friends in an appropriate style and lay wording, using different every day plain formulations. As a Nurse
educator, during practical guidance, I experienced the challenge of communicating with three parties at
once: nurse student, patient, and doctor or other health professional. I had to express myself lay enough so
that both the patient and student1 could follow my explanation, and professional enough to keep existing
conventions of language required by my status.
In clinical research operations I worked in the role of a clinical trial specialist responsible for study start up
activities for global clinical research organisations. The integrated research application system IRAS required
a lay summary about the purpose of the study for the general public. Many of the numerous application
system questions also contained a requirement of lay language. Conflict arose, when the lay summary and
the application form were sent to the sponsor or investigator for review. They often were unaware of the
requirement of lay expression. Even when aware, they changed or corrected the lay content back to
scientific language unsuitable for the lay reader.
The customization of Patient Information Sheets and Informed Consent Forms (PISICF) from master versions
provided by the Sponsor into country specific lay language documents compliant with UK Ethics Committee
requirements implicated a similar challenge. Sponsors outside the European Union unfamiliar with the
requirements of European and country specific regulations insisted on changing back wording or other
patient/lay reader friendly adaptions such as tables which altered the appearance of the PISICF away from
the original master version, partially because the review of those alterations against the master version
became impossible for the sponsor delegates when the document became amended – consequently each
change on the PISICF had to be tracked in detail from the moment the study was approved by an Ethics
Committee until the moment the study ended.
The creation of this paper Writing for lay audiences – questions and answers was the result of research on
current approaches of lay summary writing. I have studied and compared the content of several UK
documents (see reference) on the topic to enhance my already existing knowledge and writing expertise,
and to preserve my conclusions. I hope this document may support the discussion about lay summary
writing between stakeholders and patient organisations and may encourage basic agreements on a (EU)
guideline for researchers and other professionals who write lay documents.
1
Pre-registration, with changing knowledge level from year 1 to year 3
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The New Clinical Trial Regulations on Lay Summary
The new EU Clinical Trial Regulation 536-2014 contains information about the content of the summary of the
results of the clinical trial for laypersons. The summary results must include a summary understandable to
lay person.
Patients participating in a trial must be informed that, irrespective of the outcome of the clinical trial, both a
summary of the results of the clinical trial in scientific language and a lay summary of those results will be
available in the EU database, and where and when they will be able to obtain those results (Article 29 (6)).
This document approaches the new clinical trial regulations on lay summary with questions concerning the
term lay summary (summary presented in terms understandable to a layperson) to clarify culture,
understanding and use.
1.
2.
3.
4.
5.
6.
7.
When is a person to be considered ‘lay’?
What is a lay summary?
How are lay summaries used?
What are the quality principles for a lay summary?
How are patients’ information needs evaluated?
How do we measure if a summary is lay or lay enough?
What is needed to achieve common ground?
Above main points are amended by occasional additional sub-topics and other questions. This is an evidence
based approach to answer those questions based on the research of publications by relevant UK
organisations. It also involves the view of the author on current approaches.
1. When is a person to be considered ‘lay’?
An English Dictionary defines a lay person or layperson as
1) A person who is not a member of the clergy
2) A person who does not have specialized or professional knowledge of the subject.
Lay people play a significant role in the English legal system which uses this term to describe the use of
ordinary, non-qualified people. Using ordinary people in courts intends to create a fairer legal system in
which ordinary citizens are more likely to trust.
A similar principle is used within the consistence of Ethics Committees according to ICH GCP E62 which
describes a lay person as <<….. non-medical members, whose responsibility it is to ensure the protection of
the rights, safety and well-being of human-subjects involved in a trial and to provided public assurance of
that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial
protocol, the suitability of the investigator(s) facilities, and the methods and material to be used in obtaining
and documenting informed consent of the trial subjects...>> UK NHS Research Ethics Committees consist of
up to 18 members, 1/3 of whom are lay (broadly this means their main professional interest is not in the
2
Page 4, 1.27 Independent Ethics Committee (IEC)
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research area, nor are they a registered healthcare professional). They safeguard the rights, safety, dignity
and well-being of research participants, independently of research sponsors3.
Whom we consider a lay person is obviously highly dependent on the task or role of this person and the
connected responsibility. A lay person in the role of a scientific document reader can be assumed to have
little or no knowledge about the professional and highly specialised topic and language used in this
document. It therefore makes sense to answer this question under the focus of the activity of the lay person
and the expectation connected with this activity. These may vary from culture to culture.
2. What is a lay summary?
Lay summaries are short accounts of research4 that are targeted at a general audience. Many charities and
other organisations have created their own guidelines on lay language to support their members and
researchers on criteria how to write a lay summary:
A lay summary is a brief summary of a research project or a research proposal that has been written for
members of the public, rather than researchers or professionals. It should be written in plain English5, avoid
the use of jargon and explain any technical terms that have to be included6.
The UK Digital Curation Centre in collaboration with the UKOLN7 has published guidance on
characteristics/elements of a lay summary8:
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Appropriateness for readership (audience): the author should be aware of (and indicate) the
intended audience for the text (e.g. potential study participants or the general public)
Grammar and punctuation should be accurate, and spelling should follow appropriate conventions
Level of difficulty of text (words and structure): the text should be written in an easily readable
style. The author should use short, clear sentences broken up into paragraphs for readability, and
avoid complex grammatical structures where possible. The author should use every-day English
words9 in place of complex words
Structure: the text should be ordered logically and flow naturally
Avoid complex or meaningless terms and phrases: many terms used in academic English are either
overcomplicated or contain no useful information. Examples include terms such as ‘virtually’ or
‘literally’ or archaic language (e.g. amidst, whilst), as well as verb choices such as ‘purchase’ used in
place of the simpler ‘buy’.
3
http://www.hra.nhs.uk/about-the-hra/our-committees/research-ethics-committees-recs/
Very tight definition – lay summaries may also appear in other areas of interest to the public
5
CT Regulations: publication language is decision of each individual country.
6
Digital Curation Centre (DCC) ‘working level’ guide: How to write a Lay Summary by Monica Duke in collaboration with
the Patients Participate! Project.
7
Formerly known as the United Kingdom Office for Library and Information Networking
8
DCC How-to Guides, Duke, M. (2012). How to write a Lay Summary, page 4
9
Everyday words in the relevant language of the country of the summary audience
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Expressing ideas in the active voice: text should be written in the active voice (“I”…”You”) and
second person (“you”) should be used in place of third person (“he/she”). For example: “You will
have chemotherapy” rather than “Chemotherapy will be given to you.”
Positive phrasing. Sentences should be phrases positively, rather than negatively. For example, “You
will have repeat appointments at least once a fortnight”, rather than “The usual practice is not to
schedule repeat appointments more frequently than once a fortnight”.
Adhering to convention: the text should have the correct word count and the author should
structure it according to relevant guidelines (such as funder’s guidelines).
Straightforward to read: the writer should limit the memory load on readers – don’t ask them to
remember too much jargon/abstract information.
Clear theme. A good and relevant title should be provided, and the first sentence should offer a
concise introduction to the text.
Content. The text should provide answers to the essential questions: Who, What, Where, When,
Why, How? For example, the reader should easily be able to find answers to questions such as “By
whom was the research funded, and why?”
Relevance, application and benefits. Aims and objectives should be clearly signalled. For example,
the ‘point’ – the impact – of the work should be clearly understood.
Everyday examples. Give concrete everyday examples wherever possible.
Timescales, if relevant, should be clearly defined.
Risks. If it is relevant to the activity you are summarising, make sure that any risks attached to the
activity are clearly identified and described.
Person-centred language. The language used should be person-centred, rather than focusing on
circumstance, illness or disability. For example: ‘people with a disability/illness’ is preferable to ‘the
disabled/invalids’; a person ‘has cerebral palsy’ rather than ‘is a victim of cerebral palsy’.
Appropriate tone. The text should not be written to entertain.
In general, any guidance requires a deeper investigation on the audience and relevant needs and
expectations of the reader or consumer.
3. How are lay summaries used?
Keel University10 has released a lay summary poster with the title question << The Lay Summary in medical
research proposals – is it becoming more important? >>. The introduction reads as follows:
One of the skills every researcher must learn is how to present complex ideas and medical or scientific terms
to a “lay” audience. That audience includes carers, long-term users of services, organisations representing
consumers’ interests, members of the public, who are the potential recipients of health promotion
programmes, or researchers from a different clinical or academic background to their own.
The authors further claim that a lay summary has three purposes for grant funders:
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10
Grant application and ethical review processes
Mark Smith and Claire Ashmore, Research Institute Managers, Faculty of Health, Keele University, United Kingdom
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Public understanding of science, particularly important for fundraising charities
Raising and justifying funds from governments in healthcare
The DCC How-To Guide11 outlines the following:
Lay summaries serve the general purpose of explaining research to the non-expert. There are different ways
in which lay summaries can be used, both by members of the general public and by other researchers who
are not specialists in the field of research.
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Research grant applications often contain a lay summary or abstract which helps to explain why the
research is being suggested, what researchers aim to achieve, and how this may impact on the rest of
the research community.8
Patients12 taking part in a research study, or Patients9 or carers9 directly involved in research funding
decisions, or the design of a study will have a direct interest in the outcome of the research.
Charities use lay language on their websites and lay summaries to communicate research progress to
individual audiences.
Public information and engagement is a new role for researchers to communicate and raise awareness
of their research to the public and make it accessible for them.
Lay summaries are used to raise awareness about, present, promote, justify, and review a theory, topic or
event, and to interest, involve, inform, recruit, report and communicate to a targeted lay audience13.
4. What are the quality principles for a lay summary?
Many researchers, who in the majority are academics and communicate within their particular professional
language code, find writing a lay summary difficult. They often continue to provide summaries that are
impenetrable14 to patients and the public15. Therefore, standards are necessary to train and guide individuals
(researchers and other persons involved in research) to deliver a target audience orientated lay summary
outcome. Derived from the characteristics listed by the Digital Curation Centre on page 3 and 4, the
following principles of a lay summary may be considered as core principles:
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The lay document author must have knowledge16 about the audience/target population, and their
information and language needs
The lay document author must have knowledge17 about lay terminology or where to obtain
The lay document author must be aware of possible issues and conflicts18and address them
11
DCC How-to Guides, Duke, M. (2012). How to write a Lay Summary, page 3
In the UK
13
Clinesco Limited, A. Gross, 2015
14
incomprehensible, non-understandable, unclear
15
AMRC Natural Ground report
16
Can be obtained from charity websites; University of Iowa has published a page ‘lay language for medical terms’:
http://hso.research.uiowa.edu/medical-terms-lay-language
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Can be obtained by collaboration with the audience
18
If the document is edited, the editor may be an academic person unwilling/unable to adapt to new regulations
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The lay document author must possess good language and grammar, punctuation and spelling skills
applying to the language the document is presented to the target audience
The document text requires
o a clear structure with a clear theme and relevant easy to understand content19
o a straight forward and fluent text flow marked by short sentences
o avoidance of complex or meaningless terms and phrases
o person-centred language and an appropriate tone adhering to conventions
o an active voice and positive phrasing
o (when appropriate) information about risks, benefits, everyday examples and time scales as well
as other information relevant to the information needs of the target audience.
A quality review of the document by lay person(s) of the target audience is recommended.
The produced lay document must be easily accessible by the target audience.
5. How are patients’ information needs evaluated?
The Patients Participate - Case Study Report20 was a feasibility study project in June 2011 with the aim to
explore the potential of developing a useful body of lay information for patients and those interested in
biomedical and health research.
Key finding of this case study was a set of recommendations produced by the workshop participants on how
to enhance the communication of biomedical research.
If patient involvement is to increase, biomedical research needs to be made more accessible, alongside more
extensive production of easy-to-understand, plain English21 information relating to research.
Basically, a lay summary should be produced to every scientific report, article or other document of public
interest22.
In the DCC How-To Guide23, examples are to be found on easy to understand information for the public
relating to biomedical research, and how patients’ information needs can be met:
PLOS24 is a non-profit organization of scientists and physicians committed to making the world’s scientific and
medical literature a freely available public resource. All research articles are accompanied by an Editors’
Summary – a comprehensible summary for physicians in all specialities, as well as patients and their
advocates.
The DCC points out that the journal provides lay summaries alongside research articles which are written by
the journal’s editors prior to the publication of the submitted article. Those lay summaries are easy to
understand by the general public without scientific, medical or biomedical background knowledge.
19
Orientation on the needs of the target audience
http://www.bl.uk/reshelp/experthelp/science/eventsandprojects/Patients-Participate_Case-Studies.pdf
21
Or relevant language of the lay document
22
Clinesco Limited, A. Gross, 2015
23
DCC How-to Guides, Duke, M. (2012). How to write a Lay Summary, page 7
24
http://journals.plos.org/plosmedicine/
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Charities are also valuable contributors on evaluation of patients’ needs as they regularly consult patients or
work together with patient groups.
Last but not least, prefabricated lay information may be given to random lay people representing the target
audience for review to answer questions about the documents’ style and content. In general, the feedback
of a lay audience connected with the overall topic of the lay document will serve immensely to make the
document a truly lay and audience centred document but also can provide valuable information on new
important questions.
6. How do we measure if a summary is lay or lay enough?
This is indeed a difficult question. I think that various factors have to be contemplated to answer this
question.
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Target audience
The key question prior to starting lay document writing is Who is my target audience? The result on
research of this question will decide about medium, format, and content. Certain audiences may be
familiar with details of a study by having been involved in the design. They may experience or may have
experienced the trial as a participant and have read the information in the participant information sheet
available in lay language. The general public on the other hand may take a more remote role by missing
theoretical/physical involvement and has to be addressed in a different way. Appropriate research of the
target audience is one of the key points for the success of the message or information. The fact that
people use pre-existing schemata as interpretive tools has also influence on the effect of the lay
document read by the targeted social group25.
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Age
Age may bring restrictions regarding information (e.g. limited access to digital and with this to overall
research-information, or minors up to a certain age have information only via their parents) and
understanding. Members of a younger age group may be more interested to research the background of
the information themselves while older or old age groups may be dependent on the detailed
information provided to them in understandable language.
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Culture and Education
It must be considered that individuals of the target audience addressed with the lay document, no
matter which gender or age, have varying education levels. This means that the greater the diversity of
this target audience group is, the greater varies the education level – subsequently a higher grade of lay
language (very lay) is needed. In particular in health and research, the overall health experience of
individuals plays a role: people with chronic diseases who live with their condition for decades are more
or less experts on the disease/topic. The health education level of the population may vary from country
to country, and dependent on culture. Depending upon the culture, poor health may be perceived as the
25
See low information rationality and concept of framing under point 5a page 8
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result of stress, disease or malign spirits28. The perceptions of a cultural group guide the interpretation
of the document.
The majority of European countries have now multicultural societies. This brings new challenges. If
individuals of the group addressed by the lay document have the same cultural and educational
background, the addressed group may be evaluated on limited or targeted requirement of lay wording.
If the cultural and educational background differs significantly, a higher level of lay expression is needed
to reach all.
The general public as an audience of different age, education and culture makes it impossible to satisfy every
individual reader with one document. For such a big audience, a high grade of lay language is required. Thus,
for the one reader, even an excellent written truly lay document is still difficult to comprehend while
another person will feel outraged about being addressed in a style understandable to school children.
Measurement by checklist is a method which may aid researchers and other people who are trusted with the
production of a lay document. Such a checklist may be useful to meet criteria set by individual organisations
concerning a group of readers with tightly defined criteria yet will have restrictions to meet overall
expectations. A basic example of such a checklist is integrated at the end of this document and can be
adapted and expanded as needed.
7. Long or short? – Different requirements on the length of lay documents and the impact on information
quality
Another factor has a significant impact on the quality of lay documents, in particular grant or other
applications. The question of the required length measured in characters poses a challenge for researchers
and any person writing a lay document. Different organisations require a variety of characters or words,
sometimes due to restrictions with electronic application systems or databases26. In practice this means for
the researcher that under circumstances they have to rewrite one document several times to fulfil different
requirements. Apart from the increase in workload, the variations in character/word limitation have a direct
impact on the style, phrase, wording and expression and with this on the quality of the document. The
shorter the length of the document is, the greater is the limitation on content when complex scientific terms
require lay explanation. As a consequence of compliance with such limitations, a document may not fulfil the
expectations on information by the lay reader audience to whom the document is addressed. More
discussion is needed to assess if harmonisation in this area is possible.
Low information rationality27 is based on the assumption that human beings are cognitive misers and
minimise the economic costs (time and effort) of making decisions and forming attitudes. Subsequently, they
only collect as much information as they think is necessary to make any given decision. The less expertise
citizens have on an issue initially, the more likely they will rely on cognitive shortcuts or heuristics. Difference
26
The UK Research Councils permit 4,000 characters (approx. 600 words) in a grant application lay summary; charities
use varying word limits down to the British Heart Foundation limiting words to 100.
27
Sam L. Popkin, Political Scientist, The reasoning Voter, 1994
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in information seeking is largely a function of costs, benefits involved, the anticipated use of a product, and
the relevance of the topic in daily life28.
It is unrealistic to expect people to sift through masses of information to draw up a reasoned conclusion. We
are mostly ‘cognitive users’, drawing upon a minimum amount of information. What is crucial is how an issue
is ‘framed’ – the context in which it is communicated and how it fits with peoples’ pre-existing thinking.
Understanding these aspects is crucial to effective science communication29.
The concept of framing is based on the theory that people carry interpretive schemata in their heads as an
economical way of making sense of things that happen in the world around them. How a message is framed
influences which schemata in peoples’ minds are activated and therefore how they process information.
Framing therefore involves two separate concepts: media frames and audience schemata. Media frames
provide audiences with cognitive shortcuts or heuristics for efficiently processing new information, especially
for issues that audience members are not very familiar with. In (clinical) research, audience schemata such
as moral values, trust in scientists, prior knowledge or any other interpretive schema assist people to make
sense of the information.
These conclusions are immediately transferrable to addressing a lay target audience in (clinical) research. It
is to be discussed if a headline and newspaper style lay summary would achieve an increased understanding
and processing of research trial results by the lay target audience.
8. Information Sheets and Consent Forms – the possibility of new tools to achieve lay communication
The EU Clinical Trial regulation in chapter V article 29 points out in the second paragraph that
Information given to the subject or, where the subject is not able to give informed consent, his or her legally
designed representative for the purposes of obtaining his or her informed consent shall:
(b) be kept comprehensive, concise, clear, relevant, and understandable to a layperson;
4. The information referred to in point (c) of paragraph 2, special attention shall be paid to the information
needs of specific patient populations and of individual subjects, as well as to the methods used to give the
information.
5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood
the information.
6. The subject shall be informed that the summary of the results of the clinical trial and a summary presented
in terms understandable to a layperson will be made available in the EU database, referred to in Article 81
(the ‘EU database’), pursuant to Article 37(4), irrespective of the outcome of the clinical trial, and, to the
extent possible, when the summaries become available.
28
Derived from Wellcome Trust Engaging Science –Thoughts, Deeds, Analysis and Action, 2007, pages 23 - 26
Quote Dietram A Scheufele, Professor at the Department of Life Sciences Communication, and the School of
Journalism and Mass Communication, University of Wisconsin, Madison
29
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The regulations have the aim to protect the rights, safety, dignity and well-being of subjects, caution to
generate reliable and robust data, and prioritise the interests of the subjects over all other interests. The call
for publication of trial results in lay language is only a consequence to fulfil the interests of the subjects.
Usually, when there are new or amended clinical trial regulations, the interpretation mostly is one of
restrictions or barriers rather than benefits and possibilities. As we are living in a highly innovative digitalised
age, more and more possibilities arise to present information in this way. Language is not more the only
channel of communication, and the methods used to present the information can be tightly adapted to the
individual audience. Using audio, video, presentation, webinar and e-consent, the palette of serious
information submission literally is endless, under the consideration that it is understood by the target
audience. Yet, one thing will not change: the single participant is entitled to ask questions concerning
details, this means a person appropriately trained in the speciality of the study (medically trained person or
delegate) must be present to answer those questions in language understandable to a lay person. The
inability of many academic medical professionals to transfer content of scientific information verbally to a
lay person is most likely the reason why such tasks are often delegated to a Research Nurse who may be able
to talk lay but may lack a deeper knowledge about medical consequences of treatment to answer questions
in this direction. Here, the use of supportive digital information for the health professional is a possibility to
compensate this and amend the information already given to the participant. The participant is also entitled
to have a copy of the provided trial information and consent, in which ever way this information is presented
– under circumstances this will require more than one medium (e.g. study information video and PISICF
document).
9. What is needed to achieve common ground?
The below graphic shows an overall picture of criteria30 from the viewpoint of patients, patient advocates
and lay readers.
Criteria for a single agreed standard
Patient oriented, design consultance by
patients, understandable to lay readers
Reviewed by lay readers
Straightforward, unbiased, evidence based,
objective, reliable information
Comprehensive, relevant, up to date, well
presented, audience orientated
Userfriendly, accessible and transparent
platform(s) for readers
30
Based on ‘EU Core quality principles for patient information on diseases and treatment options’, EPF lay summary
position paper March 2015, and own experience.
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9a - Why is the interest of patients/general public/lay people into research important?
The National Co-ordinating Centre for Public Engagement states that evidence is growing that there are
benefits to universities, to students and staff, and to society when they can demonstrate the impact,
relevance and responsiveness of their research. Various methods of public engagement such as consulting,
collaborating and informing can be applied through media and writing for non-specialist audiences31.
INVOLVE is a UK national advisory group funded by the UK National Institute for Health Research. Their
reports show that the direct benefit of involving service users in all stages of a research project evolves in
the following way26:
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It increases the relevance of the research.
It increases the recruitment to clinical research.
It improves the design of the research to address ethical concerns, improves the research tools and
makes it easier for the people to take part.
It makes it more likely that the findings of the research will be used to make a difference to service
users’ lives.
Lay summaries are one form of writing intended to help communicate research to a non-specialist audience.
They describe research to a non-specialist audience. They describe research in non-specialist language and
are meant for people who are not the immediate peers of the research….Lay summaries are useful to the lay
public but can also make research accessible to professionals in nearby fields26.
9b - Charities versus Universities versus Pharma – a comparison of current stage on lay involvement and
lay document writing
I have reviewed website information and policies of several UK research organisations, universities and
charities on lay summary/writing to investigate similarities and distinctions of expectations and
understanding on lay person involvement and lay writing.
This comparison is necessary to evaluate if the expectations of service users and service providers drift apart
or provide some common ground for a basic EU recommendation. The metamorphosis of the current
research culture into an environment in which service providers32, researchers and service users33 work
alongside as a standard will take another decade or more - both parties need to make this possible by
education, transformation and activation. Demand/expectation has to be compromised on both sides. A lack
of understanding of the professional demands and timely resources in clinical research by the population is
acompanied by an unwillingness of some service providers to share ideas and viewpoints on research
questions with those they are supposed to benefit. The current visualization of the role of the study
participant/patient as a person with no influence on scientific research procedures has to change generally
and internationally. People will generally be more interested into clinical or other research if their role is
shifted from passiv to activ. In recent years, many opportunities have been created by selected countries to
31
DCC How-to Guides, Duke, M. (2012). How to write a Lay Summary, page 2
Sponsor organisations, research services and other organisations
33
Patients, patient organisations, charities, and the public
32
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change the status of a person from study participant (passiv) to study consultant (activ). More research is
necessary on how this activ status can be extended to the benefit of greater public interest.
The following table shows the diversity between organisations concerning the involvement of lay
contribution. The table is split into funding application lay information, which type of lay writing is exercised
by the organisation, and how they handle currently the involvement of lay persons.
Organisation
Asthma UK
(UK Charity)
Cancer
Research UK
(UK Charity)
Muscular
Dystrophy UK
(UK Charity)
Wellcome Trust
(Global charitable
foundation)
University of
Manchester
Funding application
Requires scientists
to include a lay
description of their
research in all
funding applications
and provides tips
for writing.
Provides writers’
guidelines for
Cancer Research
UKs’ patient
information which
includes style guide,
words and phrases
to avoid, and tips
on improving
writing.
Application process
involves rigorous
peer review and a
panel of “lay
experts”.
Mandatory
completion of a
scientific and a
short lay application
with a less detailed
proposal written in
lay English – lay
application consists
of questions.
Expects all major
research groups to
engage with the
public about their
work.
Provides
funds for public
engagement within
research grants.
Has published a pdf
with tips for writing
a lay summary in
bullet points, and a
paper investigating
the question: What
do UK research
funding bodies look
for
in
a
lay
summary?
Lay involvement in

Identifying & prioritising research
topics

Being part of research advisory groups
and steering groups

Undertaking research projects

Reporting
and
communicating
research findings.

Science funding committee




Assessment of lay applications for
readability
Feeds back to the Medical Research
Committee
Two members of the Lay Research
Panel sit on the Medical Research
Committee
Lay Research Panel votes on funding
may present as much as 20 percent of
the total.
Has no lay person involved in any
committee. In their paper Developing a
strategy for clinical trial transparency Oct
2013, the section Patient and public
involvement points out the intention of a
collaborative interaction between patient
groups and funders to establish principles
on patient/participant involvement and
research data made available for the
public.
Not known
© This is a Clinesco Limited genuine document.
Lay review
Lay review tag
exists on website
without content
(not published).
Types of lay writing

Lay wording in
website
Lay review of web
content and all
writing is part of
the editorial policy.

Lay wording in
website

Lay wording in
website
Semi-lay
wording
on
social media
(Twitter,
Facebook)

Lay summary on
grant applications,
and lay summary of
discoveries,
achievements,
implications in end
of grant form


Research grant
applications
Lay summary
for the general
public
Page 13 of 17
Organisation
Keele University
University of
Sheffield
Novartis
Pfizer
Funding application
Published a poster
exploring some of
the purposes and
current
tensions
surrounding the use
of a lay summary.
Published an author
produced version of
Lay summaries of
open access journal
articles under the
title: Engaging with
the general public
on medical
research.
No policy on lay
writing. Committed
to transparency of
clinical
trials,
recognised benefits
making clinical trial
information more
publicly available.
Statement on
website that Pfizer
will provide
summaries of the
trial findings to
participants in easyto-read, nontechnical language,
in countries where
regulations will
allow it.
Lay involvement in

University council

Research

Interviews of prospective medical
students at school of medicine

School of medicine committees
Not known
Lay review
Types of lay writing

Research grant
applications

Lay summary



Interactions with Patient Organisations as a
source of knowledge aim at the exchange
of information on disease and treatment
experiences, engages patients as
consultants and/or members of patients
advisory boards.


Summaries are prepared in partnership
with the Centre for Information & Study on
Clinical Research Participation (CISCRP) – a
US non-profit organization dedicated to
educating and informing the public and
patients about clinical research. CISCRP has
patient advocates in their board. Pfizer has
no policy yet on the involvement of
patients in trial design.




Research grant
applications
Participant
Information
Sheets
Lay summary
of research
study
PISICF
Lay summary
as part of trial
application
Lay summary
trial report
PISICF
Lay summary
as part of trial
application
Lay summary
trial report
9c – Bridgebuilding to improve communication to selected lay audiences
More than 70,000 deaf people in the UK use British Sign Language (BSL), a rich marriage of hand shapes,
hand movements and facial expressions, to communicate meaning. However, sign language for scientific
words barely exists; what does is cumbersome, slow and limited. It is easy for insiders to forget how
exclusive the language of science can be. Important steps are now being taken to generate an entirely new
biological sign language, bringing everyone into the discussion34.
The communication between scientists and lay audiences required mediators in the past and most likely will
require them in the future. Those mediators may be a new professional group of appropriately trained
people to communicate scientific language to lay audiences, both verbally and in writing. Mediators may
also be new technological/digital inventions assisting researchers and health professionals in this task.
Mediators may be databases or special online dictionaries, platforms where scientists and lay population
meet and discuss, and/or journals specifically focused on providing research information to a lay audience.
Mediators may be Patient Advocates employed by research companies to consult on lay communication.
34
Taken from Engaging Science:Thoughts, deeds, analysis and action under Silent Science, page 29. More details to be
found under www.biology.ed.ac.uk/public/sibe/signingbiotechnology/MMOV
© This is a Clinesco Limited genuine document.
Page 14 of 17
Information provision regarding scientific research must overstep existing traditional and formal rules,
policies and operation procedures to find new methods of satisfying relevant communication needs between
researchers and lay audiences35.
Scientific
Message
Mediator
Lay audiance
10. Example of a basic checklist for a research study lay summary:
AUDIENCE
Question:
1.
Who will read
my document?
Audience size
Education
Culture
Religion
Age
Location
Health situation
Pre-existing
information
Involvement in
lay summary
Relation to topic
general public
authority
2.
group
3.
very large
academic
multi-culture
diverse
diverse
world
healthy
guaranteed
large
higher E.
European
single
same
continent
disease
maybe
small
average
country
non
age span
country
impairment
non
co-writes
reviews
non
public
patient
service user
Other/Describe
CONTENT
1.
2.
3.
4.
5.
Check:
Check:
Check:
Information
35
Describe the answer to each question in as few sentences as possible.
What is the topic of the study?
Where was the study performed?
When was the study performed?
Why was the study performed?
How was the study performed?
Tailor each answer to your audience information above. Check word count.
clear structure
straight forward
appropriate tone
adhering to
conventions
unbiased
relevant
clear theme
relevant
fluent
short sentences
avoids complex or meaningless
terms and phrases
easy to understand
good grammar
positive phrasing
active voice
good punctuation
person-centred
language
evidence based
up to date
reliable
quality checked
comprehensive
reviewed/approved
objective
well presented
In respect of data protection rules concerning both parties
© This is a Clinesco Limited genuine document.
Page 15 of 17
11. Conclusion
This document intended to investigate some questions around writing for lay audiences, and to research and
find answers which can serve to move the topic in the direction of clarification and harmonisation. However,
the document mirrors the situation in one country only, and it can be assumed that additional questions are
existent regarding the needs of lay writers and readers in other countries. More research has to be done
around the topic lay document writing as well as into the possibilities of communicating and/or presenting
scientific research results to lay audiences.
There certainly is more public interest in science and research today as there was a decade ago. People are
more interested in health issues and ongoing research due to promotion by the media. But the fascinating
world of discovery is still locked up in the golden tower by selected academic researchers who consider
insight in their world as the violation of the Holy Grail. It is no question that the professionals working in
science and research require exceptional skills and have to undergo long pathways of education to be able to
deliver the demanded results of current research questions. Their importance is in no danger to be
discredited or disrespected. However, for too long, patients have been in the role of the enduring ‘subject’, a
participant included in a clinical trial with no influence on design, execution, conduct and conclusion report.
At the end of the study, they often are dismissed into the unknown. Information has been restricted to what
they should know from the perspective of the sponsor. As a result, years ago recruitment numbers have
gone back to a minimum and will not recover significantly until there is integration instead of insertion by
inclusion/exclusion criteria. The moment, participants are involved in the entire birth of a new study project,
this project will become alive. With their assistance, research can be re-shaped to be truly efficient for the
patient, and not just for business. If this becomes a normal procedure, communication between researchers
and participants may move to a more advanced and even level as the population may develop over time a
more skilled approach to research topics.
To write lay language documents currently requires flexible qualities which, for many reasons, are not
always met by writers. Particular training in the topic does not exist to my knowledge. Prior to establishing
efficient training courses, the qualities of potential trainers have to be specified, and the criteria for the
training goals agreed to interest various parties. A basic training course may achieve an increased sensibility
of participants for expectations of different audiences and how to develop working criteria within their
institution to develop Standard Operating Procedures for lay summary or lay report writing.
I am looking forward to become involved in the development of such a training course.
Horsham, West Sussex, May 2015
Astrid Gross
Independent Health Professional and Researcher
Member of the EFGCP Education Working Party
www.clinesco.co.uk
© This is a Clinesco Limited genuine document.
Page 16 of 17
Reference:













EU core quality principles for patient information on diseases and treatment options (pdf document):
http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/itp_quality_en.pdf
EFP position: Clinical trial results – communication of the lay summary (pdf document):
http://www.eu-patient.eu/globalassets/policy/clinicaltrials/epf-lay-summary-position-march2015.pdf
University of Manchester: What do UK research funding bodies look for in a lay summary? (pdf
document):
http://www.researchsupport.eps.manchester.ac.uk/documents/pe/Funding%20Bodies%20Lay%20Su
mmaries.pdf
DCC working level guide: How to write a Lay Summary, Monica Duke (DCC) in collaboration with the
Patients Participate! Project (pdf document):
http://www.bath.ac.uk/marketing/public-engagement/assets/HowToWriteLaySummariesUKOLN.pdf
Asthma UK – Writing a lay summary: http://www.asthma.org.uk/research-writing-a-lay-abstract
Asthma UK – Lay involvement: http://www.asthma.org.uk/research-lay-involvement
Cancer Research UK – Writers’ guidelines (The house style and Lay review):
http://www.cancerresearchuk.org/about-cancer/utilities/cancers-in-generalhelp-uk/cancerhelp-ukpolicies/editorial-policy/writers-guidelines
Keele University poster: The lay Summary in medical research proposals – is it becoming more
important? (pdf document):
https://www.keele.ac.uk/media/keeleuniversity/ri/istm/documents/posters/Lay_summary_poster_fi
nal.pdf
Keele University, Mark Smith, Research Manager, Institute for Science & Technology in Medicine, The
Lay Summary in Medical Research – Why and Wherefore
https://www.keele.ac.uk/media/keeleuniversity/ri/istm/documents/publications/The%20Lay%20Su
mmary%20in%20Medical%20Research%20%20Mark%20Smith%20Midlands%20Medicine%2025%205%20pp191-195.PDF
White Rose university consortium, University of Leeds, Sheffield & York, Nunn, E. and Pinfield, S.
(2014): Lay summaries of open access journal articles: Engaging with the public on medical research
http://eprints.whiterose.ac.uk/79609/1/Lay%20summaries%20LP%20final.pdf
Patients Participate – Bridging the gap between information access and understanding in health
research (pdf document summary report):
http://blogs.ukoln.ac.uk/patientsparticipate/files/2011/09/WebPatientsParticipateSummaryReport.p
df
Imogen Evans, Hazel Thornton, Iain Chalmers and Paul Glasziou, Testing Treatments – Better Research
for Better Healthcare, Second Edition, 2011 (pdf document):
http://www.testingtreatments.org/wp-content/uploads/2012/09/TT_2ndEd_English_17oct2011.pdf
Wellcome Trust, Engaging Science – Thoughts, deeds, analysis and action (pdf document for
download):
http://www.wellcome.ac.uk/About-us/Publications/Books/WTX032706.htm
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