www.emwa.org Volume 27 Number 1 | Medical Writing March 2018 | 51

Danielle Yuill1, Rachel Barron1, andJennifer Preston2

1 GW Research Ltd, Cambridge, UK2 NIHR Alder Hey Clinical Research Facility,

Liverpool, UK

Correspondence to:Danielle YuillTechnical WriterGW Research LtdSovereign HouseVision ParkHistonCambridge, UK CB24 9BZ+44 (0) 1223 266800dyuill@gwpharm.com

AbstractWriting for lay audiences is recognised as adifficult task for medical writers, whosespecialised knowledge can often hindereffective lay communication. This task is evenmore challenging when preparing clinical trialinformation for a paediatric population.Involving advisory groups in the developmentof clinical trial materials improves theirquality and ensures that they are fit forpurpose. This article describes how medicalwriters can build successful partnerships withadvisory groups in developing assent formsfor children being approached to participatein clinical trials.

Research involving children has more complexconsiderations than research with adults.Although children are dependent ontheir parent(s)/legal guardian toprovide written informedconsent for their partici -pation in clinical trials,they should beinvolved in thed e c i s i o n -ma k i ng

process if they have the capacity to assent.1–4

Assent is, therefore, given by children withcapacity, in addition to consent by the legalrepresentative(s), and indicates their unsder -standing of the trial procedures and willingnessto participate.2 In the European Union, whilethere is consensus regarding the need for assentforms to be adapted in accordance with the ageand level of understanding of the childrentargeted for inclusion, there is discordanceregarding the appropriate age of assent and therequirement of a child’s signature to confirm theiragreement to participate.5 A medical writertasked with developing assent form templates foruse across multiple countries and multiple trialsis, therefore, presented with challenges innegotiating national laws and local practices, aswell as trying to ensure the use of appropriatelanguage to aid a child’s understanding of aclinical trial.

We advocate partnering with children’sadvisory groups to overcome some of thechallenges of writing for paediatric populations;such partnering is a concept that is newly

emerging in the pharmaceutical industry andoften daunting for medical writers to undertake.This article describes the process of assessing thesuitability of assent forms and how the supportof advisory groups can aid medical writers inpreparing clinical trial materials that are fit forpurpose.

Where to startAs medical writers, how do we write assent formsto adequately inform children of differing levelsof maturity about participation in clinical trials?How do we know that what we produce providesadequate information to enable a child to make achoice? The internet is an abundant source ofinformation, and there are several examples ofethically approved informed assentforms, which medical writerscould use to develop theirown company-specifictemplates. Most ofthese examples, how -ever, are outdatedand do not describethe involvement ofchildren and youngpeople in theirdevelopment.

We aimed to developtwo new assent formtemplates for use in ourpaediatric clinical trials that providesufficient information for children and youngpeople to make informed decisions aboutparticipation.

Our original assent form templates (cate -gorised as being suitable for younger childrenand older children) had been developed in 2013when we conducted our first clinical trial inpaediatric patients. On review in 2016, we

determined that there was scope toimprove the design and overall com -

prehensibility of the templates.Having prior experience with

lay writing and theinvolvement of patient

and public groups

Lay writing: Strategies for improvingassent forms for children and adolescentparticipation in health research

Animportantelement of

involving laygroups in clinical

research isacknowledgingthe value of the

reviewers’input.

52 | March 2018 Medical Writing | Volume 27 Number 1

in research placed our working groupin a good position for carrying out thistask.

ReadabilityThe first step in the redevelopment ofthe templates was to assess the currentreadability of the assent forms.Readability tests are designed tomeasure how difficult a passage of textis to understand, using a formula basedon the number of syllables per wordand the number of words per sentence.Flesch-Kincaid readability tests are oneof the most widely used measures ofreadability.6 Using the Flesch-Kincaidgrade level (Table 1), our assent formfor younger children had a readinggrade level score of 6 and our assentform for older children had a readinggrade level score of 6.7. Although thesereadability outputs suggested that our assentforms were easy or fairly easy to read (i.e.accessible to an average 11- to 12-year-old), thedifference in grading between younger childrenand older children was thought to be inadequate,suggesting younger children, in particular, wouldfind our assent forms challeng ing. Furthermore,as many of our clinical trials involve children andyoung people with diminished capacity, we felt ascore of 6.7 was too high, even for older children.

The importance of designReadability tests can only provide a mathematicalassumption of under standing and do not takeinto account other important factors thatcontribute to a person’s ability to comprehendwritten text. Such factors include the motivationof the reader, the style of the writer, and thedesign and layout of the written material.7 Whendesigning materials for children, we recommendusing smaller pieces of information, illustrationsor pictures that have meaning, and lots of colour.8Although this seems like common sense, few

examples of assent forms available for downloadon the internet use these basic elements ofdesign.

A key skill in lay writing is the ability of thewriter to understand the audience and how theaudience interprets information. This isparticularly challenging for medical writers whenpreparing material for children and young people,as they are required to disregard their scientificknowledge as well as best practice in writing foradults, optimising their work for a differentgeneration. This task has added complexities formedical writers with limited personal interactionwith children and young people. To overcomethese challenges, the involvement of children’sadvisory groups is recommended.

From theory to practiceWe revised the language and overall design of ourassent forms using the guidance produced by theNational Institute for Health Research (NIHR)Medicines for Children Research Network ondesigning patient information leaflets8 and thetop tips for researchers published by INVOLVE,9

a national advisory group supporting publicinvolvement in research.

The revised templates had a Flesch-Kincaidreading level grade score of 4.4 for youngerchildren and 6.1 for older children, animprovement on the previous scores. Regardingdesign, for younger children we opted forsimplicity, using illustrations to make the contentappealing. For older children, we used a series ofarrows and illustrations to guide users aroundand down the page to different elements ofinformation regarding the clinical trial (Figure 1).

Involving lay groupsRecognising that, as adults, we are not experts inunderstanding how children and young peoplethink and process complex information, we thencontacted the NIHR GenerationR YoungPerson’s Advisory Group (YPAG) to ask for theirsupport in reviewing the revised assent forms. Set up in 2006, GenerationR YPAGs support thedesign and development of clinical research andhave several groups across the UK includingLiverpool, Birmingham, London, Bristol, andNottingham. Each group consists of approxi -mately 10 to 15 members aged 8 to 19 years. Thegroups meet every 6 weeks during weekends,evenings, or school holidays; researchprofessionals are encouraged to attend themeetings to discuss their findings.

We attended the YPAG at the NIHR AlderHey Clinical Research Facility, Liverpool, UK, onDecember 3, 2016. Thirteen children and youngpeople aged 13 to 19 reviewed the assent forms,

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What will happen to me? You�will�visit�us�<<X>>�times.��Each�time�you�visit�you�will�spend�around�<<2>>�hours�with�us.��A�doctor�or�nurse�will�<<e.g.,�check�to�see�how�you�feel,�listen�to�your�heart,�take�blood�and�wee�from�you,�and�ask�you�some�questions.>>�

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Why are you doing this study?

We want to find out if a new medicine helps children and young people

with <<condition>> <<e.g. have fewer seizures>>. <<We also want to

e.g. make sure the new medicine is safe for children and young people to

take.>> <<To test this, some people will get the new medicine, and others

will get a pretend one, but you won’t know which one you’ve been given.>>

Is it okay to change my mind?

Yes. If you change your mind then just

tell an adult looking after you, or any of

the doctors and nurses at the <<study

centre>>.

Do I have to take part?

No. If you do not want to

take part then just tell an

adult looking after you.

Will I be safe?

<<enter information here>>

That might sound like a lot, but we need to do more

studies to make sure it is safe for children and young

people like you to take.

How many times will I need to visit?

About <<X>> times over <<period>>.

Each time you visit you will spend around

<<X hours>> at the <<study centre>>.

Sometimes it isn’t possible for the

same doctor or nurse to see you

every time you visit us. We

will try our best to make sure

you see people who you

recognise each time you come

to the <<study centre>>.

Who else is taking part?

We are looking for <<X>>

children and young people

with <<condition>> to

help us with our study.

Will I see the same Doctor when I visit?

Figure 1. Assent form templates pre-YPAG review

Lay writing – Yuill et al.

Table 1. Flesch-Kincaid grade level scoringFlesch-Kincaid grade level score Age Reading difficulty5th 10–11 Very easy6th 11–12 Easy7th 12–13 Fairly easy8–9th 13–15 Standard10–12th 15–18 Fairly difficultCollege 18–22 DifficultCollege graduate >22 Very difficult

www.emwa.org Volume 27 Number 1 | Medical Writing March 2018 | 53

Yuill et al. – Lay writing

during which the overall comprehension of thetemplates was assessed, including design, format,clarity, and readability. Although all reviewers felt

that the information presented in both assentforms was sufficiently lay for children andyoung people to understand, drasticimprovements to the designs were suggestedby the reviewers to aid overall comprehensionand make them more user-friendly. We haddetailed discussions with the children andyoung people on how to achieve this.

Acting on advice For younger children, the YPAG suggested“cute animals instead of people” to make theinformation more reader-friendly (Figure 2).As adults with several years of experience inclinical research, we initially felt that thiswould be suggestive of animal testing.However, on discussing these concerns withthe group, they explained how youngerchildren would not necessarily be aware ofanimal testing. For older children, the YPAGthought that the “layout [was] confusing witharrows” and suggested a design based oncolourful sticky notes and stickers pinned toa notice board. During our meeting, the group raised an issue

regarding the need for a child’s signature on theassent form, as per the International Conferenceon Harmonisation E11 guidelines (clinicalinvestigation of medicinal products in the

paediatric population).2 On both assent forms,our initial design used a traditional consent formtemplate with the ethical elements for signaturetailored for assent (e.g., “I understand I can stopthe study at any time”). For older children, theYPAG altered some of the wording on thesignature page to ensure it was understandable.For younger children, however, the YPAG wasconcerned that they would be unable to under -stand the elements of assent and provide asignature. To overcome this issue, the groupsuggested the use of a happy face with acorresponding tick box to acknowledge assent,and a sad face to acknowledge dissent.

Acknowledging adviceAn important element of involving lay groups inclinical research is acknowledging the value of areviewer’s input.9,10 Once we had completed theredesign of both assent form templates, we senta copy of these to the YPAG to show the youngpeople who took part in the review process howwe had incorporated their ideas and suggestions(Figure 3).

ConclusionThe input of children and young peoplehighlighted the value of involving YPAGs orsimilar groups in clinical trial design and

Figure 2. Completed YPAG review form basedon assessment of assent for younger children

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Why are you doing this study? We want to find out if a new medicine helps children and young people with <<condition>> <<e.g., have fewer seizures>>. <<We also want to e.g., make sure the new medicine is safe for children and young people to take.>> <<To test this, some people will get the new medicine, and others will get a pretend one, but you won’t know which one you’ve been given.>>

What will I need to do? An adult looking after you will give you the medicine <<X>> times a day

for <<X>> weeks.

When you visit the <<study centre>>, a doctor or nurse will <<check to see if you are well, listen to your heart, take blood and urine (wee) samples, and ask you some questions about how you feel.>>

Figure 3. Assent form templates post-YPAG review

54 | March 2018 Medical Writing | Volume 27 Number 1

development. Although the initial feedback gavetestament to our ability to write for lay audiences,and indeed the Flesch-Kincaid scores of ourrevised templates were aligned with this finding,the overall design of the draft templates affectedtheir suitability. As such, had we not involved theYPAG, although it could be assumed thatyounger and older children would be able tounderstand our clinical trials, it is plausible thatthey would not have engaged with the material,resulting in dissent or potentially subsequentwithdrawal post-enrolment.

It should be recognised that there is notnecessarily a one-size-fits-all model of assent, asa child’s level of understanding will differ on anindividual basis. While it is possible to createtemplates to aid the development of trial-specificassent forms, the decision regarding thesuitability of clinical trial materials is ultimatelyin the hands of the ethics committees fromwhom approval is being sought. As such,adaptations should be made to templates basedon feedback from ethics committees andevidence-based learning and research.

Although writing for children and youngpeople can be difficult, and involving advisorygroups can be daunting, medical writers shouldnot be discouraged from pursuing this importantarea of work. The involvement of advisory groupsbenefits the paediatric clinical trial processthrough an improved understanding of clinical trial materials by potential participantsand can, in turn, improve medical writers’ laywriting skills.

AcknowledgementsThe authors would like to thank all the youngpeople at Liverpool YPAG for their continuedsupport in improving the information that weprovide for children and young people takingpart in clinical trials.

Conflicts of interestThe authors declare no conflicts of interest.

References 1. World Medical Association Declaration of

Helsinki. JAMA. 2013;310(20):2191–4.2. International Conference on Harmonisation

of Technical Requirements for Registrationof Pharmaceuticals for Human Use. ICHHarmonised Tripartite Guideline. ClinicalInvestigation of Medicinal Products in the

Pediatric Population (E11). 2000. 3. US Department of Health and Human

Services. Code of Federal Regulations, Title 21 (Food and Drugs) Food and DrugAdministration, Part 46 – Protection ofHuman Subjects, Subpart D, Section46.408. Accessed 26 July 2016.

4. Giesbertz N, Bredenoord A, van Delden J.Clarifying assent in pediatric research. Eur J Hum Genet. 2013;22(2):266–9.

5. Lepola P, Needham A, Mendum J, SallabankP, Neubauer D, de Wildt S. Informedconsent for paediatric clinical trials inEurope: Table 1. Arch Dis Child.2016;101(11):1017–25.

6. Calderón JL, Morales LS, Liu H, Hays RD.Variation in the readability of items withinsurveys. Am J Med Qual. 2006;21(1):49–56.

7. National Institute of Adult ContinuingEducation. Readability: how to produceclear written materials for a range of readers.Leicester: NIACE; 2009.

8. National Institute for Health Research.Medicines for Children Research Network.Guidance document for researchersdesigning patient information leaflets.Available at: http://www.hra-decisiontools.org.uk/consent/docs/MRCNYPAG – Guidance for Researchersdesigning Patient Information Leaflets.pdf.

9. INVOLVE. Involving children and youngpeople in research: top tips for researchers.Eastleigh: INVOLVE; 2016.

10. INVOLVE. Briefing notes for researchers:involving the public in NHS, public healthand social care research. Eastleigh:INVOLVE; 2012.

Author informationDanielle Yuill is a technical writer at GWPharmaceuticals. She has a Master of Researchdegree in clinical research and experienceinvolving patients and members of the publicin the development of clinical trials. She hasextensive experience writing and designingclinical trial materials for lay audiences.

Rachel Barron is a senior medical writer atGW Pharmaceuticals with an interest inwriting for lay audiences. She is a qualified vetwho transitioned to medical writing 12 yearsago. As such, she has considerable previousexperience of communicating medicalinformation to lay audiences (pet owners!).

Jennifer Preston is the Patient and PublicInvolvement (PPI) Manager for the NIHRAlder Hey Clinical Research Facility and PPIPriority Lead for the NIHR Clinical ResearchNetwork Coordinating Centre. She set up thefirst YPAG in Liverpool in 2006, followed by groups throughout the UK, Europe, andthe US.

Lay writing – Yuill et al.