Establishing the information needs of pregnant women and their partners to support informed choice about Patau’s syndrome (trisomy 13), Edwards’ syndrome (trisomy 18) and non-invasive prenatal testing (NIPT) to the Scottish pregnancy screening programme

Authors

Rachel Bishop, Scott Porter Research and Marketing Limited Alison Miller, Scott Porter Research and Marketing Limited

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Contents

Contents .................................................................................................... 1 Abbreviations ............................................................................................ 2

Glossary .................................................................................................... 3 Executive summary ................................................................................... 5

Introduction ............................................................................................. 18 Methodology ............................................................................................ 23

Results .................................................................................................... 33

Discussion ............................................................................................... 80 Conclusions and recommendations ......................................................... 83

Appendix 1: Discussion guide ................................................................. 89 Appendix 2: Initial screening information sheet ..................................... 100

Appendix 3: Alternative front cover ........................................................ 102

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Abbreviations

DNA: deoxyribonucleic acid

ISD: Information Services Division

NIPT: Non-Invasive Prenatal Testing

NES: NHS Education for Scotland

NHS: National Health Service

NSD: National Specialist and Screening Services Directorate

SEG: Socio-economic groups

SIMD: Scottish Index of Multiple Deprivation

SSC: Scottish Screening Committee

T13: Trisomy 13: Patau’s syndrome

T18: Trisomy 18: Edwards’ syndrome

T21: Trisomy 21: Down’s syndrome

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Glossary Amniocentesis: is a diagnostic test that may be offered during pregnancy to

check if a baby has a genetic or chromosomal condition, such as Down's

syndrome, Edwards' syndrome or Patau's syndrome.

Chromosomes: carry genes that determine how people develop. People usually have 46 chromosomes, 23 from the mother and 23 from the father.

DNA: The material that carries all the genetic information about a living thing.

NIPT: Non-Invasive Prenatal Testing can identify pregnant women at higher chance of having a baby with certain genetic and chromosomal conditions such

as Down’s syndrome (T21), Patau’s syndrome (T13) and Edwards’ syndrome

(T18). The test detects DNA fragments from the baby’s placenta in a sample of

blood taken from the mother and carries no risk of miscarriage.

SEG: These enable the classification and measurement of people of different social grade and income and earnings levels, for market research, targeting,

social commentary, lifestyle statistics, and statistical research and analysis. The

different classifications are based on the occupation of the head of the household

(or chief income earner) and are:

Grade A (Upper middle class) - Higher managerial, administrative or professional

• Grade B (Middle class) – Intermediate managerial, administrative or

professional

• C1 (Lower middle class) – Supervisory or clerical and junior managerial, administrative or professional

• C2 (Skilled working class) – Skilled manual workers

http://en.wikipedia.org/wiki/Upper_middle_class

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• D (Working class) – Semi and unskilled manual workers • E (Non-working) – Casual or lowest grade workers, pensioners, and

others who depend on the welfare state for their income

SIMD: SIMD is the Scottish Government’s official measure for identifying areas of deprivation within Scotland. It identifies small area concentrations of multiple

deprivation across all of Scotland in a consistent way.

Trisomy (T): a condition in which there are three instances of a particular chromosome, instead of the usual two, causing developmental abnormalities –

this report references T13: Patau’s syndrome, T18: Edwards’ syndrome and T21:

Down’s syndrome.

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Executive summary

Background In Scotland, pregnancy screening programmes are offered to all pregnant women

with tests and scans assessing whether mother or baby has, or has a higher

chance of having, a particular condition, thereby allowing more informed

decisions to be made on the management of pregnancies. NHS Scotland is

planning to introduce a more accurate genetic test to the Scottish pregnancy

screening programme from 2020, Non-Invasive Prenatal Testing (NIPT). NIPT

can identify pregnant women who are at higher chance of having a baby with

certain genetic and chromosomal conditions, Down’s syndrome (T21), Patau’s

syndrome (T13) and Edwards’ syndrome (T18). The test detects DNA fragments

from the baby’s placenta in a sample of the mother’s blood, with no risk of

miscarriage. This change will also involve the introduction of Patau’s syndrome

(T13) and Edward’s syndrome (T18) testing during the existing first trimester

screening. Currently first trimester screening can only test for Down’s syndrome.

Reporting to the T13, T18 and NIPT Implementation Board, the Training,

Education and Communications workstream is responsible for producing material

to support patient choice and to guide front line professionals. The findings of this

research will be used to support the Communications and Engagement Plan for

the changes in the pregnancy screening programme, including development of a

set of messages that can be used consistently across various communications

channels, updating the current suite of information materials and creating new

materials to support the programme.

Aims and objectives The study aim was to establish the information needs of pregnant women and

their partners in relation to T13, T18 and NIPT testing to ensure information

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provided is sufficient to enable pregnant women (and their partners) to make

autonomous, informed choices. Specific objectives were to:

• explore understanding of proposed changes to the pregnancy screening programme and the introduction of T13, T18 and NIPT

• identify any factors that may improve understanding of and engagement with implementation of T13, T18 and NIPT: establishing preferences for receiving information; communication channels; and language

• explore how the introduction of T13, T18 and NIPT could be best communicated to those eligible

• identify improvements to communication of the introduction of T13, T18 and NIPT.

Method A qualitative method was used involving focus groups, individual depth

interviews and paired depth interviews (where two people take part). 42 women

took part across Scotland and 6 of their partners. Fieldwork took place between

30 April and 30 May 2019. Women were invited to participate through local third

party recruiters in urban and rural locations across six Health Board areas:

Greater Glasgow and Clyde, Forth Valley, Lothian, Lanarkshire, Tayside and

Grampian. A discussion guide outlined necessary question areas.

Twenty-four depth interviews with pregnant women 24 weeks or more, six depth

interviews with partners (all male, five conducted as paired depths) and four

focus groups with new mums with babies up to 4 months old were conducted,

across a mix of ages, parental experience and areas of deprivation.

Respondents signed a written consent form confirming their willingness to take

part and all were reassured that the research was not intended to focus on their

choices made regarding pregnancy screening. They were offered £40 to thank

them for their time. An information sheet on initial screening information and a

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draft booklet (Your pregnancy your choice) for use at the point of receiving a

higher chance result from initial screening were used as research stimulus.

Summary of key results

Current information provision Most screening information was said to come verbally from the midwife. All

respondents said they received leaflets at their booking appointment or first scan,

however the majority could not recall what was given. Most also said they were

not signposted towards anything specific at any point throughout the pregnancy.

In Grampian most were accessing their maternity records and resources online

using the BadgerNet maternity portal, but the level of interaction varied among

respondents.

Respondents felt health professionals made assumptions that if the booklet had

been given to them, it had also been read and understood. In other words, when

professionals requested and received consent from women, they assumed it to

be ‘informed’ consent when this was not always the case.

The female respondents said they tended to talk about pregnancy screening to

those with experience, such as their own mothers or friends. They talked to their

partners, but more to inform them rather than to discuss details. Some also

looked online for information. The partner respondents reported being less likely

to talk to anyone other than their own partner but may look for information online.

Some experienced parents said they relied on knowledge from previous

pregnancies.

Preferred format for information on pregnancy screening Personal preference led the choice for preferred formats for information on

pregnancy screening. A paper format was described as expected, and

accessible, but large amounts of different leaflets were overwhelming. Online

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formats were praised by those who use their smart phone ‘for everything’.

However, respondents said, this is not accessible for all. Some respondents also

said they did not want to look for information online. Many watched videos, but

not for pregnancy screening information, which was felt to be more serious then

general information related to pregnancy.

When prompted about the format for information on NIPT they reiterated that a

mix of formats should be available to account for all preferences and abilities.

Video (after prompting) did not seem obvious for this topic but was felt to be

useful for those who needed it. If developing information in video format, it was

felt the video should show a life-like scenario of parents receiving the information

face to face from a health professional. It was felt that the video could be longer

than might be usual for health information, perhaps between 2 and 5 minutes,

because parents having receiving a higher chance result during pregnancy would

be likely to feel engaged with the information.

When asked about improvements to information, the spontaneous reaction from

respondents was that information should be delivered to allow sufficient time to

discuss screening with the midwife. If appointments are too busy, then the

midwife should signpost to information and give instructions as needed. Above all

information must be easy-to-take-in and offered in different formats to allow for

people to be able to choose their preferred format.

When booklets about the choices available after a higher chance result from

initial screening tests should be made available depends on how higher chance

results are given out. Booklets should be easily and quickly available. Electronic

versions could be signposted to from a phone call, or paper copies sent or given

out. Respondents felt it vital each person is asked what is best for them and

actioned accordingly, and that information is available prior to making a decision.

All reiterated this would be secondary to discussing it with the midwife.

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Spontaneous knowledge of the new test for Edwards’ syndrome (T18) and Patau’s syndrome (T13) and NIPT All respondents were asked spontaneously about awareness of a pregnancy

screening test that included Down’s syndrome, Edwards’ syndrome and Patau’s

syndrome. On prompting there was very little knowledge with only a few

individuals aware of such a test. Whilst Down’s syndrome was ‘known’, most

respondents admitted specific knowledge of this was limited.

Views on information for the new initial screening test that will include Edwards’ syndrome (T18) and Patau’s syndrome (T13) An A4 information sheet on the new initial screening test was shown to all

respondents. A few said they would need to read it a couple of times to digest the

information, but most deemed the language and tone acceptable.

It was clear to respondents that the new initial test was for all three conditions

(Down’s syndrome, Edwards’ syndrome and Patau’s syndrome) and that the

individual could choose which condition to be tested for (all three conditions, just

Down’s syndrome, or just Edward’s syndrome and Patau’s syndrome) as this

was mentioned very specifically within the text. All respondents had one vital

query, namely what Edwards' syndrome and Patau’s syndrome are. There was

mixed awareness of the ‘You’re Pregnant! Scans and Tests’ booklet

(www.healthscotland.com/documents/30532.aspx). All respondents assumed the

midwife would tell people about all pregnancy screening tests and that the details

of the new test would go into this booklet, including background information on

Edwards' syndrome and Patau’s syndrome and an explanation of why they are

being introduced into the pregnancy screening programme. All respondents

confirmed this information would be vital to know when the first decision is made

regarding the initial screening test.

http://www.healthscotland.com/documents/30532.aspx

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Views on NIPT and the new ‘Your pregnancy, your choice’ booklet All respondents were shown the draft ‘Your pregnancy, your choice’ booklet (see

Figures 1 to 13 of main report) for use after a higher chance result at initial

screening. Generally, the booklet was deemed by respondents to contain

sufficient information to aid further decisions about screening. It was also said to

be approachable and easy to read, but appropriately serious.

The Edwards’ syndrome and Patau’s syndrome information had most impact on

respondents during the first read of the booklet. Finding out that both conditions

are life-limiting was felt, by some respondents, to change the thought process

when deciding about screening. Some who had not had screening for Down’s

syndrome said they would have reconsidered their screening decisions if the new

test for Edwards’ syndrome and Patau’s syndrome had been available.

Choice

Respondents said the ‘Your pregnancy, your choice’ booklet made it clear there

was a choice whether to take the screening test or not, but many said it was not

clear what all the choices were, and this could lead to the conclusion that the

booklet was principally saying people should have NIPT, rather than presenting

unbiased information about alternatives.

The information about NIPT was clear on what it is, how it is done and what it

measures. It was described by respondents as ‘just a blood test’, something they

were used to.

Benefits of NIPT

The benefits of NIPT as taken from the booklet were described by respondents

as ‘you’ll have more information to know if the baby has one of these

syndromes’. All respondents saw NIPT as a more accurate and a safe test and a

good idea to have instead of a more risky diagnostic test at this point.

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Language

Overall the language in the ‘Your pregnancy, your choice’ booklet was felt to

work well, being neither too medical, nor too simplistic, but with sufficient depth

for what the reader needed. The only request from respondents was to be

consistent with terms when health professionals speak with pregnant women.

Most said they would add in the names Edwards' syndrome and Patau’s

syndrome next to the T18 and T13 so descriptors were consistent, and all felt it

would be more useful to use syndrome names throughout, being more

appropriate and approachable, and matching how Down’s syndrome is referred

to. Having a specific name like NIPT was acceptable and something to

differentiate it from other blood tests. It was also assumed from the description to

be a genetic test, so seemed sensible to use this to describe the test. ‘Your’ baby

was preferred to ‘a’ baby to focus on the individual concerned. Whilst

respondents acknowledged that people might not know exactly what

chromosomes are, most would know the term is linked to genetics, but a brief

definition would help confirm this.

Tone

The tone was described as being factual and informative, getting across a

difficult topic, without scaremongering. It was seen as serious, important and the

right tone for this booklet. It was also felt to be approachable enough to allow the

reader to decide what to do.

Design

The overall design of the ‘Your pregnancy, your choice’ booklet was seen

positively. It was thought to be easy to read, with mostly small blocks of text and

headings aiding reading, especially as questions. The design felt approachable

and the colours helped guide the reader through, but some pages were too text

heavy and could be broken out more.

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Respondents viewed the ‘You’re Pregnant! Scans and Tests’ booklet design as a

comparison. Most decided the graphics used in this booklet were not right for the

‘Your pregnancy, your choice’ booklet and would not recommend using them.

Order of information

The order of information within the ‘Your pregnancy, your choice’ booklet was

deemed as acceptable on a first read, but respondents then questioned the flow

of information, namely whether the booklet should have separate sections for

each choice; giving all the details first before talking about making a decision.

Respondents also questioned whether this booklet is about NIPT as the next

step, or about presenting unbiased information about alternatives.

Fathers-to-be and their thoughts

There was very little difference in views from mothers to fathers (partners). The

fathers felt they could read the booklet and even though they felt it was not

written directly for them this was the norm for pregnancy information and

acceptable. However, they noted that if the pregnancy was planned the topic of

pregnancy screening was likely to have been raised at the planning stage. They

also said most men (in their opinion) tended to defer to the fact their partners are

carrying the child and felt they were more likely to be ‘told’ than to look for

information. A few fathers would welcome information as to what to expect and

how they might feel on receiving a higher chance result after initial screening.

One also wanted to ensure single fathers-to-be also received information on

pregnancy screening.

Conclusions Many women and partners in the sample had limited knowledge of the pregnancy

screening tests offered currently. This knowledge is based on information from

various sources, but often not the NHS. Knowledge of Down’s syndrome was

limited among the respondents. The midwife was seen as the primary source of

correct information, with only a few respondents engaging with the written

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information provided. Consent (for screening) was recognised but often seen by

respondents as not fully informed. Preferred formats for pregnancy screening

information were mixed, with some preferring paper based, some preferring

electronic information and others preferring a mix of channels. Respondents

stated that formats must be accessible and inclusive.

Only a few respondents had heard of either of the new screening tests – initial

screening or NIPT. There was no spontaneous knowledge among respondents of

what NIPT entails and almost no knowledge of either Edwards’ syndrome or

Patau’s syndrome unless someone had come across them during a previous

pregnancy or knew someone who had. Both the new tests (initial screening and

NIPT), and crucially knowledge of Edwards' syndrome and Patau’s syndrome,

are therefore likely to be seen as new information.

The information needs for the new tests – both initial screening and NIPT – were

not necessarily primarily about the actual test as blood tests were familiar to

respondents. However, safety and accuracy were seen by the respondents as

important factors to emphasise, so as to alleviate any possible worries for

individuals. Given the lack of knowledge about Edwards' syndrome and Patau’s

syndrome the key need, confirmed by all respondents, was information about the

two conditions.

The A4 sheet showing information about the initial screening test did not highlight

any major obstacles to understanding for respondents. The initial screening test

was known and all that was new, was adding in another thing to be tested for to a

blood test that is already done. Therefore, other than information about Edwards'

syndrome and Patau’s syndrome no other information was needed by the

respondents at this point. All respondents did assume however that they would

be told all of this information by the midwife in good time to decide about

screening tests and that the information would be added to the ‘You’re Pregnant!

Scans and Tests’ booklet.

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Once respondents read about Edwards' syndrome and Patau’s syndrome they

were perceived as much more serious than Down’s syndrome. These conditions

were felt to bring with them many more considerations for the baby, the parents

and the wider family. Knowing that the initial screening test is for these conditions

changed some respondents’ views of the decision making process.

The new booklet, ‘Your pregnancy your choice’, was seen to have all the

necessary information and to be easy to understand and clear on a quick read. A

more detailed read raised several questions, as respondents became more

aware of the considerations and decisions involved. However, this may depend

on the focus of the booklet. If this is to be that NIPT is the next test, then not

much needs to be changed as the booklet’s focus is seen to be on NIPT. It is

important to note that some respondents felt the booklet currently leads to NIPT

as the expected choice. If, on the other hand, the booklet is to present unbiased

information about alternatives, then it needs to work harder to ensure these are

more clearly structured and explained. Another important point to note is that all

respondents assumed that the booklet is secondary to a full discussion with the

midwife. Deciding on the purpose of the booklet to be given out after a higher

chance result at initial screening will help define its content.

Recommendations

Initial screening information In terms of where the information should be, information on the changes to

screening and new tests – both at initial screening and NIPT – must be in the

‘You’re Pregnant! Scans and Tests’ booklet. The information here needs to focus

on details about Edwards’ syndrome and Patau’s syndrome (as described

below), not necessarily the actual blood test. If this is added, initial information

would be considered to be complete.

However, having said this, the main task will be to signpost people to the

information. This will be imperative to gaining not just consent, but informed

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consent, with midwives ensuring people: know changes are happening

(especially if experienced parents); know about Edwards’ syndrome and Patau’s

syndrome and their nature; and know about the new screening tests themselves,

both at initial stage and NIPT.

Information provision will need to be in good time of being asked for consent and

checks made that the parent-to-be has understood the information provided to

them.

Information on Edwards’ syndrome and Patau’s syndrome The information on Edwards’ syndrome and Patau’s syndrome needs to include

what the conditions are; how prevalent they are; how they are identified, either

via screening or at birth if no screening is chosen; how the conditions will affect

the babies through their lives with likely day-to-day scenarios, for example

hospital versus home time; and linked to this, what it may mean for the families,

what they need to be aware of, practically and emotionally, such as the impact on

home, work, other children. The information should set out the reality to ensure

the decision-making is fully informed. It must be available at the point of initial

screening and again if there is a higher chance result.

The ‘Your pregnancy, your choice’ booklet Consider replicating information from ‘You’re Pregnant! Scans and Tests’ into

the ‘Your pregnancy, your choice’ booklet as the reader’s frame of mind if they

have received a higher chance result may not be conducive to referencing back,

so it is advantageous to have all the information needed in the booklet.

Recommendations for the content include:

• The right elements are included in the content, but the decision must be made as to the focus: is this to be NIPT as the next test, or to present unbiased information about alternatives.

• If all three alternatives are to be detailed, present them in separate sections.

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• All possible outcomes should be noted, for example what happens if someone chooses not to have further tests after a higher chance result, and what happens when the baby is born?

• Review the flow chart to make it flow, including information as appropriate for above decision on the overall contents for the booklet.

• Review the information on the conditions – keep to percentage figures and take out mentions of many or some babies, add in details of daily life with the conditions, explaining how they would be diagnosed at birth, and so on.

• Review the questions in ‘Your questions’ if the diagnostic section is to be given more emphasis and place this information in that section instead.

• Be very clear with questions, for example, ‘Are the diagnostic tests painful?’

• Consider a note to dads or partners with regards to how they might feel, what they may need to think about and how to talk about this with their partner.

• Offer reassurance that there is sufficient time for the tests, and to think about them, in other words time will not ‘run out’.

• Make the information flow clear with specific sections: e.g. from background information on syndromes, to NIPT, to diagnostic testing, to no further tests, to making the decision, to other questions, and then to support information.

Recommendations for the language and tone include:

• Be consistent with terms throughout.

• Call the conditions Edwards' syndrome, Patau’s syndrome and Down’s syndrome, add in T numbers for reference only.

• Be aware of new medical terms, provide links for definitions or further details.

• Add in a definition for chromosomes as a useful reminder.

• Use NIPT to describe the test as there are no issues with this, everyone will get used to it and it differentiates it from the initial screening test.

• Consider adding in ‘blood test’ to further clarify if desired (not vital).

• Again, if deemed necessary, use ‘genetic’ as it defines the test further.

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• Use ‘your baby’ not ‘a baby’, it might be hard reading for some but all felt it needs to be specifically personal at this point.

Recommendations for the design include:

• A more formal approach works, most do not want a more graphic format, but this is with the assumption the midwife will review the contents in detail.

• Use the front cover of the draft booklet – keep it plain, with no image, giving a more formal and serious look, but highlight, or make bold the ‘after a higher chance screening result’ to emphasise the information pertains to this.

• Review putting information on the front inside cover as it gets lost and the eye is drawn to NIPT benefits (making the booklet emphasis all about NIPT).

• Consider more headings to break up some sections (or bullet points), for example the condition information pages.

• Use question headings as they work well by leading the reader through the information and keeping them engaged.

Recommendations for format and communication include: • Allow for personal preference of format, ideally enabling a communication

preference to be noted, and with a channel mix of paper and online as the principal formats.

• A video format is not vital and would be most useful for general screening information, not specific information after a higher chance result and the next steps. If used, a real-life (two people talking) format is suggested.

• In terms of communication it all depends on how results are delivered, via a

call from the midwife or a letter (most felt this should be a phone call to schedule an appointment). Whichever route is taken the information must then be available quickly and as preferred, paper or online, and before or after the discussion, again as preferred.

• Allow for sufficient time for the information they receive at this point (both verbally and in print regarding the higher chance result and the choices now available to them) to be understood before a decision is required to be made.

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Introduction Background

Screening and Immunisation programmes and policy Screening tests, which are non-compulsory, are offered to groups of the population to

identify the risk of certain conditions detrimental to health. They are offered to help

people make informed choices about their health. Screening policy in Scotland is set by

the Scottish Government Health Directorates on the advice of the UK National

Screening Committee and other appropriate bodies. The National Specialist and

Screening Services Directorate (NSD) commissions and co-ordinates various important

elements of national screening programmes to ensure consistent, effective, coordinated

national screening programmes for the people of Scotland. Pregnancy screening programmes Pregnancy screening programmes are offered to all women during pregnancy to help

them make informed choices about their own or their baby’s health. A variety of tests

and scans provide the opportunity to assess whether someone has (or has a higher

chance of having) a particular condition, enabling earlier treatment for some conditions.

They allow for more informed decisions to be made on the management of the

pregnancy, including reproductive choice.

NHS Health Scotland produce pregnancy screening information which is provided to all

pregnant women at the start of their antenatal care. The information aims to support

them by providing information to make an informed decision regarding the screening

tests they will be offered during pregnancy.

Information on pregnancy screening is provided to women at an early stage in

pregnancy (ideally before the initial booking visit with the midwife). Whilst pregnant

women in Scotland are advised to book an appointment with a midwife as soon as

possible, the timing of this first midwife visit (and thus the provision of the information

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leaflet regarding screening tests) can vary. A leaflet is either posted to them before their

booking visit or is given at this first interaction with the midwife. Although fathers and

partners (and other significant family members) can influence the woman in her decision

making, the decision is ultimately taken by the pregnant woman. A decision to accept or

decline each of the screening tests is recorded in the relevant maternity record, but

irrespective of her decision the woman will continue to receive the full range of

pregnancy (and then post-natal) care.

The pregnancy screening programme in Scotland currently consists of:

1) Sickle cell and thalassaemia screening, offered ideally before 10 weeks.

2) Blood tests (includes full blood count, blood group, Rhesus antibodies) and

screening for infectious diseases (includes tests for syphilis, hepatitis B, and

Human Immunodeficiency Virus), offered between 8-12 weeks.

3) Early blood test for Down’s syndrome (screening for Down’s syndrome), which is

offered between 11-14 weeks.

4) Early pregnancy scan (a pregnancy scan to estimate the stage of pregnancy,

confirm whether having one baby or more, assess growth and development, and

to check the baby’s heartbeat). This also provides the nuchal translucency1

measurement for Down’s syndrome (which, when combined with the results from

the early blood test provides a measurement assessing the chance of the baby

having Down’s syndrome). This is offered between 11 (+2 days) and 14 (+1 day)

weeks.

5) Later blood test for Down’s syndrome which is offered between 14 (+2 days) and

20 weeks – offered if the earlier test was not performed.

6) Fetal anomaly screening – a mid-pregnancy ultrasound scan which is offered

between 18 and 21 weeks.

1 For information on nuchal translucency: www.nhsinform.scot/healthyliving/screening/pregnancy/early- pregnancy-scan-booking-or-dating-scan

http://www.nhsinform.scot/healthyliving/screening/pregnancy/early-http://www.nhsinform.scot/healthy-living/screening/pregnancy/early-pregnancy-scan-booking-or-dating-scan

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The introduction of new testing – T13, T18 and NIPT Following a recommendation from UK National Screening Committee, NHS Scotland

are planning to introduce an additional, more accurate genetic test to the Scottish

pregnancy screening programme in early 2020; this is Non-Invasive Prenatal Testing

(herein referred to as NIPT). NIPT can identify pregnant women who are at a higher

chance of having a baby with certain genetic and chromosomal conditions such as

Down’s syndrome (T21), Patau’s syndrome (T13) and Edwards’ syndrome (T18). The

test is designed to detect DNA fragments from the baby’s placenta in a sample of blood

taken from the mother. Importantly it carries no risk of miscarriage.

This change to pregnancy screening will also involve the implementation of Patau’s

syndrome (T13) and Edward’s syndrome (T18) testing during the existing first trimester

screening, before NIPT is offered. Currently first trimester screening can only test for

Down’s syndrome.

The recommendation to proceed with NIPT proved controversial with some individuals

and groups expressing concerns regarding the ethics in the use of NIPT in the NHS as

it was felt that it could lead to an increase in the number of terminations following a

diagnosis of Down’s, Edwards’ or Patau’s syndrome. As such the Nuffield Council on

Bioethics was commissioned to produce a report to consider the ethical, legal and

regulatory implications of recent and potential future scientific developments in NIPT,

with regard to its use in both NHS and private services. Their report2 was published on

1 March 2017 and concluded that women and couples should be offered NIPT, but only

within an environment that enables them to make autonomous, informed choices.

NIPT is available to women in Wales (as part of the NHS Fetal Anomaly Screening

Programme – FASP), usually at screening tests given between 10 and 14 weeks of

pregnancy. Whilst the tests are not currently available in the NHS in Scotland or

2 Nuffield Council on Bioethics Report: http://nuffieldbioethics.org/wp-content/uploads/Nuffield-Council- NIPT-review-of-activites.pdf

http://nuffieldbioethics.org/wp-content/uploads/Nuffield-Council-NIPT-review-of-activites.pdfhttp://nuffieldbioethics.org/wp-content/uploads/Nuffield-Council-NIPT-review-of-activites.pdf

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England, they have been available via the private sector in the UK since 2012.

However, individual tests can cost between £300 and £600 per test and this is reported

to have now led to inequalities in screening choices available to women based on ability

to pay.

It is imperative that the planned introduction of T13, T18 and NIPT in Scotland is

accompanied by accurate, balanced and non-directive information for pregnant women

and their partners about NIPT and the conditions for which it tests. Implementing the changes in Scotland An Implementation Board has been created to provide overall project governance for

the introduction of T13, T18 and NIPT testing in Scotland and will report to the Scottish

Screening Committee via the NSD. Three different workstreams have been set up to

support its implementation: Training, Education and Communications; Laboratory

Solution; and Data capture and local implementation. The Training, Education and

Communications workstream, co-chaired by NHS Health Scotland and NHS Education

for Scotland (NES) are responsible for producing solutions (such as patient-facing

leaflets) to support patient choice. They are also responsible for enhancing staff

knowledge and the skills of those professionals who are in the position of supporting

patients. The purpose of this study NHS Health Scotland, wished to commission a qualitative study to establish the

information needs of pregnant women (and their partners) in relation to T13, T18 and

NIPT testing to ensure that the information provided is sufficient to enable pregnant

women (and their partners) to make autonomous, informed choices.

The findings will be used to support the Communications and Engagement Plan for the

changes in the pregnancy screening programme in NHS Scotland which will include

developing a set of clear messages that can be used consistently across various

communications channels, updating the current suite of information materials and or

creating new materials which support the pregnancy screening programme. This is

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expected to include the information sent to women inviting them to participate in

pregnancy screening.

Aims and objectives The overall aim of the study therefore was to establish the information needs of

pregnant women (and their partners) in relation to T13, T18 and NIPT testing to ensure

that the information provided is sufficient to enable pregnant women (and their partners)

to make autonomous, informed choices. The specific objectives were as follows:

• explore understanding of proposed changes to the pregnancy screening programme and the introduction of T13, T18 and NIPT

• identify any factors that might improve understanding of and engagement with the implementation of T13, T18 and NIPT including:

o establishing preferences for how information about pregnancy screening is received

o establishing the preferred communication channels and form of engagement about getting screened

o establishing preferences in language used to explain the introduction of T13, T18 and NIPT

• explore how the introduction of T13, T18 and NIPT could be best communicated to those eligible

• identify learning to further improve information on the introduction of T13, T18 and NIPT.

Report structure The report will firstly highlight the method and sample used before looking at the main

research findings. The main findings will review reactions to pregnancy screening

information currently, review the information provided in the initial screening information

that highlights the introduction of the new initial screening test and the draft booklet

designed for those who have received a higher chance result at initial screening to

ascertain what information is needed at this point. This will all be followed by a

discussion of the findings, conclusions and recommendations.

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Methodology Study design A qualitative approach was chosen due to the evaluative nature of the research and the

need to establish the health information needs of pregnant parents in relation to

pregnancy screening choices. Given the potentially sensitive nature of the topic, a more

intimate interviewing approach was required to help tease out the emotive nuances and

any issues in relation to pregnancy screening and the related communications.

Method Face-to-face depth interviews were recommended as the main route to combine a

sufficiently large number of interviews in the funding available with a method that

provided respondents with the necessary comfort levels and gave sufficient data to

allow for meaningful analysis. The majority of the depth interviews were conducted with

individuals, but to gain the views of parents-to-be together, some were convened as

paired interviews where both partners took part. A limited number of focus groups (with

around 4 to 5 respondents per group) were also convened to allow for a wider

discursive element to be included. Depth interviews were conducted in respondents’

homes and groups in a local hotel venue. Interviewing in the respondent’s home gave

respondents a level of comfort to allow them to privately discuss the potentially sensitive

topic of pregnancy screening in known surroundings. Interviews were set at 60 minutes

duration, but it should be noted that total time with each respondent ranged between 60

and 90 minutes, longer interviews coming into play where both partners were included

as a paired depth. Each focus group lasted 90 minutes. The specific details of the

sample can be seen in section 2.4.

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Data collection Recruitment Recruitment was completed by third party freelance recruiters in the relevant areas

using free-find methods, e.g. on street. Using local recruiters ensured their knowledge

and understanding of the area could be leveraged and they could capitalise on

assistance from existing contacts, using word of mouth and snowballing techniques to

identify possible respondents.

All recruitment was undertaken using research instruments designed by Scott Porter in

conjunction with the T13, T18 and NIPT Education and Communications Working

Group. The screening questionnaires were the primary resource for sourcing the most

appropriate respondents. Recruiters used these to ascertain potential respondent’s

details and these were then matched against the specification they were given in order

to ensure the achieved sample recruited reflected that proposed for the project.

All recruiters were briefed verbally, then given a written briefing pack; including briefing

letter with their specification for who they needed to find (by all appropriate variables,

including gender, age, SEG etc.), screening questionnaires, participant information

sheets, consent forms, formal invitation letters and Market Research Society thank you

leaflets. Recruited respondent details were quality checked by the Scott Porter team to

ensure all were recruited to the correct specification prior to respondents receiving a

final invitation informing them of the date and time of interview, and venue for focus

groups.

As is standard practice, it was imperative to gain informed consent from individuals prior

to taking part in the research. All recruitment questionnaires contained an introduction

which was read to prospective respondents, letting them know the purpose of the study,

what it was about and asking for consent to proceed with the full recruitment

questionnaire. All those who then expressed a willingness to take part were given the

participation information sheet and then asked to provide consent in writing by

completing a consent form. They were all re-contacted after 24 hours to confirm that

25

they were happy to take part and only then were they considered a ‘firm recruit’. A final

contact was made 24 hours before interview to offer a reminder and ensure everything

was still suitable.

All respondents were given a monetary incentive of £40 cash as a gesture of

appreciation for their time – a standard procedure for research of this nature. Questioning approach An audio recording of each interview was made (with respondents’ permission). The

data collected during each session was the output of conversations which followed a

guide (Appendix 1) to facilitate the discussion. This outlined all the necessary areas of

enquiry and was developed by Scott Porter in consultation with the T13, T18 and NIPT

Education and Communications Working Group.

It was decided by the Working Group and the research team that respondents would

probably not know many details about the new tests – at initial screening and NIPT –

and as such would need to review information about the screening tests in question to

ensure they could contribute views about what information they might need about these

and if they were in the situation of receiving a higher chance result after initial

screening. If no stimulus had been shown to respondents, it was felt, that they might not

have been able to articulate what information they might need.

The stimulus that was used was designed by the Working Group and included an A4

information sheet on the initial screening information (see Appendix 2) and a draft

booklet for use at the point of receiving a higher chance result from initial screening.

These two pieces of stimulus formed the basis for discussion about information needs

and the current ‘You’re Pregnant! Scans and Tests’ booklet3 was also used as a

3 NHS Health Scotland You’re Pregnant Scans and Tests booklet: www.healthscotland.com/documents/30532.aspx

http://www.healthscotland.com/documents/30532.aspx

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reference and point of comparison. Sensitive questioning approaches were used given the delicate nature of the subject of

pregnancy screening. All respondents were reassured that the research was not

intended to find out their choices made regarding pregnancy screening. Researchers

provided the opportunity for respondents to express concerns and feelings that may not

be have been directly related to the information content, but may have stemmed from

more emotional responses to the topic. Any reluctance to discuss certain points was

always respected and researchers adapted their interviewing manner and style as

necessary to accommodate sensitive situations.

Sample The following were the key variables in the sample for this study:

• Pregnant women and mothers with newborn babies o Pregnant women were included as they had needed to consider

pregnancy screening most recently – and all were recruited to be past 24 weeks in their pregnancy to avoid sensitivities with respect to scans and the timings of those.

o Mothers with newborn babies up to 4 months old were included as they also had recent experience of pregnancy screening, but could review their thoughts from a post-natal timepoint – those with newborn babies under 2 weeks were excluded on the basis it was too soon to expect such mothers to participate.

o Any who expressed strong negative views towards pregnancy screening or diagnostic testing during pregnancy were screened out at recruitment stage as it was deemed that their views would have been too fixed to openly review the information provision for something they would not have considered.

• A mix of first time and experienced families were included to assess any differences in views from those going through pregnancy for the first time versus those who had been through previous pregnancies.

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• Six fathers(-to-be) were included to ensure views on pregnancy screening were gained from both parents-to-be, and each father(-to-be) was given the option to be interviewed as a couple or individually, five of six opting to take part with their partner.

• SIMD profile included those who live in more deprived areas as defined by the SIMD (Scottish Index of Multiple Deprivation) quintiles 1 and 2, as well as those in SIMD areas 3, 4 and 5, the more affluent areas. In terms of social grade, the SIMD 1 and 2 sample was specified to include social grades C2, D and E, and

the SIMD 3 to 5 sample specified to include social grades C1, B and A.

• The depth sample was split into three age groupings: 16-24 years, 25-34 years and 35+ years, with a focus towards women in the oldest age band (35+) to ensure their information needs were prioritised given they are often classified as a ‘higher risk’ pregnancy.

• The NHS Health Board areas included: Greater Glasgow and Clyde, Forth Valley, Lothian, Lanarkshire, Tayside and Grampian.

• Urban, semi-urban and rural locations were chosen to ensure respondents were included from different areas. The broad areas were located by using the definitions of the Scottish Government Urban Rural Classification 2016.4 This provides a consistent way of defining urban and rural areas across Scotland and is based upon: population, as defined by the National Records of Scotland (NRS), and accessibility, based on drive time analysis to differentiate between accessible and remote areas in Scotland. The classification is available in multiple forms. The 6-fold classification was used to check and choose locations:

1. Large Urban Areas: Settlements of 125,000 people and over.

2. Other Urban Areas: Settlements of 10,000 to 124,999 people.

3. Accessible Small Towns: Settlements of 3,000 to 9,999 people, and within a

30-minute drive time of a Settlement of 10,000 or more.

4 Scottish Government urban rural classification: www.gov.scot/publications/scottish-government- urban-rural-classification-2016/pages/2/

http://www.gov.scot/publications/scottish-government-https://www.gov.scot/publications/scottish-government-urban-rural-classification-2016/pages/2/

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4. Remote Small Towns: Settlements of 3,000 to 9,999 people, and with adrive

time of over 30 minutes to a Settlement of 10,000 or more.

5. Accessible Rural Areas: Areas with a population of less than 3,000 people,

and within a 30-minute drive time of a Settlement of 10,000 or more.

6. Remote Rural Areas: Areas with a population of less than 3,000 people, and

with a drive time of over 30 minutes to a Settlement of 10,000 or more.

Whilst recognising it is important to mainstream equalities in research and to consider

the experiences and needs of different groups, it was beyond the study scope to include

specific quotas on different equality groups. However, no respondent was excluded

from the study on the basis of nationality, race, sexual orientation, marital status,

disability or religion.

A total of 30 depth respondents and 18 group respondents took part in the research. Fieldwork was conducted between 30 April and 30 May 2019. The final

sample is as described in Table 1 overleaf.

Table 1: Achieved sample structure

Age Pregnant women

24 weeks +

Partners

(all male)

New mums babies

up to 4 months old

- 24 depths 6 depths

(5 as couples)

4 focus groups

16-24 years 3 1 mix of ages

25-34 years 9 - mix of ages

35+ years 12 5 mix of ages

First time 12 3 mix of 1st time and

experienced

Experienced 12 3 mix of 1st time and

experienced

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Age Pregnant women

24 weeks +

Partners

(all male)

New mums babies

up to 4 months old

SIMD 1-2 14 3 2 groups

SIMD 3-5 10 3 2 groups

Location NHS Boards: GGC (5),

Forth Valley (8), Lothian

(6), Tayside (5),

Grampian (6)

Urban (12), semi-urban

(12), rural (6)

Same as pregnant

women 24+ weeks +

2 Grampian

2 Lanarkshire

Analysis On completion of fieldwork the moderators reviewed each of their own audio recordings

or transcripts. An informal framework was designed to do this and used by each

moderator to develop their notes. Detailed notes were therefore made with analysis

transcending mere reportage of respondents’ comments. After this preliminary stage,

the moderators convened to explore, discuss and debate the data. Not only did this

offer greater sensitivity in identifying and interpreting nuances in the findings but

subjected the data to theoretical yet pragmatic modes of thinking. By working as a team

it was possible to retain an objective perspective and ensure a systematic and rigorous

analysis approach.

The process of analysis started therefore with a review of the transcriptions and audio

files from the interviews by the individual moderators, followed by a meeting, usually

lasting around a day of all moderators to review the findings as a team, before the

project leader then took all the data to work on the final analysis process. Here the data

was mined from different routes, overall and by each of the sample variables to look at

the findings thematically and review the similarities and differences as they appear.

Learnings were therefore reviewed thematically in isolation and in combination with

interpretative analysis based upon the required output of the study as defined by the

research objectives.

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The findings were therefore analysed as follows:

• review of views/attitudes to pregnancy screening, specifically

o how information about screening programmes was accessed o what communication channels were preferred to receive information about

pregnancy screening

o preferred forms of engagement • review of previous experiences of pregnancy screening

o extent and nature of discussion with others (midwife, partner, etc.) o perceived gaps in information provision

• review of awareness of and reactions to the information on the new tests and their introduction

o identification of information needed (including language preferences) o any additional or different communication channels required to receive

information about T13, T18 and NIPT specifically

o any additional forms of engagement required to receive information about T13, T18 and NIPT

• review of factors that would further improve information of the introduction of T13, T18 and NIPT in the future.

Throughout this process consideration was given of any contextual factors that may

have influenced attitudes and behaviour towards considering the pregnancy screening

programme which needed to be considered when implementing the delivery of T13, T18

and NIPT testing in Scotland and also any key patterns or differences in attitudes

between sample variables such as the older and younger age groups, and between first

time and experiences mothers (to be) as well as SIMD 1 and 2 groups versus SIMD 3, 4

and 5 groups.

Limitations and solutions The potential limitations within the study lay first and foremost with the fact that

pregnancy screening is a sensitive subject, which people may not wish to engage with

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in an in-depth one-to-one interview, or indeed in a focus group. To minimise the

potential for people not wishing to engage with this, the recruitment instruments were

designed to clearly explain the research process, what was needed from the respondent

and that the research was not to focus on their own personal decisions regarding

pregnancy screening. By being clear, open and transparent about the process, there

was more chance of potential respondents feeling reassured to take part.

There may have been a risk as a result of this that some respondents looked for

information prior to their taking part in the research but the findings show very few

respondents had prior knowledge of the topic to be researched.

Given the sensitive nature of the subject it would have been remiss not to fully explain

to the respondent about the subject of the research. Whilst it could be said that this may

have led people who feel strongly about the subject to be more likely to take part, again

the findings have shown that views ranged from those very interested to those with only

limited knowledge or interest in pregnancy screening. As with any qualitative research,

the nature of the method is not to provide findings that are statistically robust, so careful

design of the sample frame and ensuring a mix of pertinent respondents were recruited

mitigated this risk.

It could also be said that the choice of methodology might mean respondents could be

influenced by others in a focus group or paired depth setting. However, the risk was

mitigated by experienced moderators who ensured all respondents were given a chance

to speak (or if needed diplomatically limited a more dominant respondent). By including

these methods alongside individual depth interviews any bias was reviewed and

addressed accordingly during fieldwork.

Another limitation of the study related to sampling. As a qualitative study the sample

was indeed not designed to be representative demographically or geographically, but to

encompass a mix of different women and their partners.

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Indeed, time and funding constraints prevented fieldwork from being conducted across

all NHS Boards. They also prevented the inclusion of specific sample groups such as

ethnic minorities and those who had received higher chance results in their pregnancy.

To facilitate a geographical spread a decision was made to interview in a range of

Health Board areas, making good economic sense in terms of venue and travel

expenses to maximise the funding available.

Finally, as the materials were only available in English, the sample frame did not include

a specific quota of those for whom English was not their first language, but no one was

excluded from taking part if they could converse in English with all respondents

approached at random during recruitment.

Ethics approval Review of NHS assessment criteria for research ethics confirmed that the study did not

require NHS research ethics committee approval. However, the study was reviewed and

approved by the NHS Health Scotland Research Development Group.

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Results The following sections of the report show the findings from the interviews with thirty

depth respondents and four focus groups conducted. The results section starts with a

review of the respondent’s background and their thoughts on pregnancy screening

currently, followed by a detailed analysis of the initial screening information and the draft

booklet for NIPT, which would be received after receiving a higher chance result at

initial screening.

Notes:

• All reporting is done by exception. This means specific audiences are only mentioned if they differ from the majority. If no mention is made to a specific audience, then the response illustrated is relevant across all audiences and there

was no difference between audience groups. In other words, if there were no differences across demographics, then they are not referenced within the findings.

• The method used for this study is qualitative, which by definition is used to

understand and interpret the thoughts and views of respondents, not to add up how many respondents gave an answer to a specific question, as would be the case for quantitative research (such as responses given in a questionnaire). The analysis of responses for qualitative research groups them into relatively broad

areas, which, for the purposes of this report mean:

o all – a view reflected across all the research sessions conducted (depths and groups – note focus group dynamics mean it is not useful or indeed sometime feasible to break down groups into individual respondent responses)

o virtually all / almost all – around 90% o most – around 66% or more o the majority – at least over 50% o some – around a quarter to a half

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o a couple / a few – 2 research sessions, up to 4 or 5 o one / someone – something mentioned by one individual.

Views of the current screening process This section of the report presents respondents’ thoughts on the current pregnancy

screening process in order to set the scene with regards to their background knowledge

prior to reviewing the new tests and their material. Respondents’ background There was a good mix of women across the sample in terms of their age, social grade,

urban and rural locations, and first time or experienced parents (ranging from those in

their second to fourth pregnancy). The partners interviewed within the sample were also

from a good range of demographic backgrounds, including first time and experienced

fathers. There were very consistent views across the sample groups and overall little

difference in views in terms of the main sample groups of age, socio economic

grouping, urban or rural locations, pregnant women, new mums and fathers-to-be.

Personality seemed to bring out the most differences. For example those who said they

would be more likely to worry about things said they were likely to read everything they

could, whilst others who said they tended to let things just happen said they probably

would not read anything. Experience also showed differences in views, by age, or by

the number of children the respondents had. Most felt that they had learned and

changed as they got older and, or as they had more children. Who delivers current pregnancy screening information Most screening information was reported to come through the midwife, mostly given

verbally at one of the first appointments. All respondents said they received ‘something’

at their booking appointment or their first scan in terms of printed material. However the

majority could not recall exactly what they were given and indeed quite a few stated that

the information they had been given was still in the folder they had been given by the

midwife at their booking appointment.

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Most respondents also said they were not signposted towards any specific publications

to read or take note of at any point throughout the pregnancy.

In Grampian most of the respondents were on BadgerNet,5 the new online system for

pregnancy monitoring. However, the level of interaction with the system appeared to

vary across individuals interviewed, both in terms of what people were being given, or

being told about the system. Some had received paper booklets as well as the online

information, whereas others had been told that everything was now on the BadgerNet

app and therefore they would not receive any paper-based information. As a

consequence, some felt that the app was their main source of information about their

pregnancy, whilst others had not even logged in, assuming that it was more a nice to

have if they wanted it. A couple of the respondents who had not registered on

BadgerNet as they didn’t want to use an app said they had not been given paper copies

so they had not received any information on pregnancy screening at all.

You don’t have to have the app… “No, I was told, that was it, it’s just the app now and

you have to have it.” (Group, New mum, 16-35+ years, SIMD 3-5)

Perceptions of assumptions made about pregnancy screening information The respondents felt that assumptions were being made by health professionals about

pregnant women and their partners in terms of taking in information. These included:

that if information had been given out, it had been read; and that someone had read and

understood the information when asked if they wanted the screening test. This,

respondents concluded, meant that there was perhaps an assumption being made that

informed consent was being given, when consent may not, in fact, have been informed.

It seemed that no, or very few checks were being made to ensure any information given

was read and understood as the question that respondents reported being asked in

5 BadgerNet: www.pregnotes.net/

http://www.pregnotes.net/

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regard to the screening tests was ‘do you want this?’. A response to this meant consent

was given, but some respondents did not feel they had necessarily been fully informed.

Whilst some said their midwives were good and they could ask about anything, many

said they did not feel able to ask about screening, indeed some felt they could not ask

any questions at all. Some also stated they felt screening was something they were

‘supposed to do’. A couple of respondents questioned whether screening was in fact

mandatory at this point as they had assumed this to be the case.

“I felt it was more, not pushed upon me but just this is the way things go. It’s not like

how do you feel about that, are you comfortable doing this. It was basically 1, 2, 3. And

don’t get me wrong, you do get asked, and obviously to consent, but it wasn’t a case of

a proper understanding.” (Depth, Pregnant, 16-24 years, SIMD 1-2) Sources of advice about pregnancy screening information currently The female respondents said they tended to talk to those they know who have

experience of being pregnant and the pregnancy screening tests such as their mother,

sister, other family members or friends. They said they were looking for information, but

they were not necessarily looking for help to decide (they would do that with their

partner). They also said they would indeed talk to their partners, although many

qualified that they did this more in order to inform their partner, rather than to discuss

the details of screening. However, some did also say that they had discussed screening

when deciding whether to get pregnant and a few noted that decisions about whether to

undertake screening or not were a very private discussion, ‘ours alone’ as they

described it.

Some women also looked for information online, stating that they had Googled it. It

appeared that this was more about what and how screening was carried out than why it

was done. Searching for information seemed to be personality dependent, with those

who were more likely to worry, or those who felt they needed to know more searching.

Often it was said, this search for information was to fill in the background information

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about screening to help them be able to make their final decision.

38

Partners reported being less likely to talk to anyone other than their own partner about

pregnancy screening, although they stated they were more likely to look online privately.

It should also be noted that some experienced mums (and dads) said they had not

bothered to talk, or read about anything during their most recent pregnancy as they felt

they knew it all and had no need to review any information, relying on knowledge from

previous pregnancies. Preferred information formats for pregnancy screening information There were mixed views regarding whether paper or online were the best formats for

pregnancy screening information, with personal preference leading the decision for

each individual.

Paper formats were described as being ‘proper’ and expected from the NHS. They were

also seen as accessible to all but were felt to be less than ideal in a busy household

where there was the chance of them getting lost. Some respondents also felt that

getting a large amount of information at the start of their pregnancy was overwhelming

and that it therefore became simply too much go through and read. Paper formats were

also not always available to everyone, for example one respondent (a single dad-to-be)

said only one copy per couple was distributed and that his partner had the information.

“They probably gave us the booklets, one set, because we looked like we were

together, but we weren’t, so she’s got all the booklets… You know why I maybe thought

they were mandatory, ‘cos my ex said we need to go to these things. So maybe she

thought the same? I was just following like a wee sheep. I said to her that I kind of feel

left out. I do, I feel really left out.” (Depth, Father-to-be, 16-24 years, SIMD 1-2)

Online formats were praised by those who used their smart phone ‘for everything’ and

these respondents stated that information in this format was therefore ‘on my phone so

in my hand’. They felt everything was sourced online these days. Some also stated that

39

information in this format seemed like it was less to read. However, respondents noted

that an online format was not accessible for all, either in terms of having a suitable

device, or in terms of having sufficient data allowance.

Some also felt they would not look for information online. For others, going online was

more for happening across information than searching for something specific or going to

a specific website, or indeed using a specific app.

In terms of watching information and videos online, many respondents did this, but this

was more likely to be done for other pregnancy related information rather than

specifically for pregnancy screening information, for example like how to get to sleep

when pregnant, or other people’s experiences of pregnancy.

Views on how information on NIPT should be provided did not change after all the

information used as research stimulus had been reviewed.

Respondents still felt that a paper format was needed for those who preferred this or

had no internet access and to allow midwives to have a source of reference to go

through and hand out. An online version, such as a PDF of the same booklet they said,

would be useful for those who preferred to access information online or on their phones

and again to also allow midwives to signpost to this information to read if the need was

urgent, for example, before a paper copy can be sent out (and assuming someone had

internet access).

Respondents were prompted to think about a video format for information on NIPT. This

did not seem to them to be an obvious choice for a serious topic such as this stage in

pregnancy screening, but it was nevertheless deemed useful for those that like watching

information online, or those who are not good at reading, or who take in verbal formats

better than written ones.

If there was to be a video about NIPT, all respondents felt a real-life discussion would

be the best format to get across such information as it makes it real and ensures the

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subject is taken seriously, for example a midwife talking to a mother-to-be (respondents

did not mention including a father-to-be at this point). In terms of length, the shorter the

better was the main thought, from around two to five minutes. However, as many

respondents pointed out, viewers will be much more engaged with the information at

this point in their pregnancy screening process, therefore would probably watch for

longer than they would usually. Spontaneous improvements to current pregnancy screening information When asked the question most respondents could not think of any spontaneous

improvements to the pregnancy screening information. However, many realised on

speaking about this that they either had not got information, or they had not received it

at the right time.

“There’s more information than there used to be, but they make less fuss. Before they

really made sure you read it and made an informed decision, now they just say it’s

available if you want to look it up, so there’s more paper, but it’s discussed a hell of a lot

less, it’s up to you to read and they don’t check.” (Depth, Pregnant, 35+ years, SIMD 1-

2)

After this consideration many then said they would like to have information that is

delivered in time to allow sufficient time to discuss screening with the midwife, time

which the respondents felt they didn’t usually get, as their midwives were reported as

being too busy.

“I got my pack at the booking appointment. They asked me if I wanted them (the tests)

at my first appointment, but they didn’t give me the information then. So probably it

would be better if they sent the You’re Pregnant booklet out to you prior to that, because

they gave me the blood test there and then.” (Depth, Pregnant, 25-34 years, SIMD 3-5)

The respondents also suggested that, if appointments are too busy to do this, the

midwife should signpost to specific information so that they then know what information

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they need to engage with prior to needing to make the decision on screening tests.

Respondents suggested it would be helpful if they were given ‘to-do’ instructions as

necessary, for example, ‘read this and think about what you want to do so you can

decide’.

“If there are or have been changes to the screening programme since your first

pregnancy then it’s important that they kind of bring that to the fore, that they point that

out to you… for example I was told this time to avoid haggis which is new guidance

apparently.” (Depth, Pregnant, 35+ years, SIMD 3-5)

Most importantly, the pregnancy screening information they needed, they felt, must be

in an easy-to-understand, preferred format.

“You get the information on the Badger system, so you can look. You get the results,

but there’s no meaning to them, no interpretation.” (Paired depth, Father-to-be, 35+

years, SIMD 3-5)

Spontaneous knowledge of the new test for Edwards’ syndrome (T18) and Patau’s syndrome (T13) and NIPT Prior to reviewing the information about the new test at initial screening and NIPT and

the information needed for them it was necessary to understand any background

knowledge about these tests that the respondents may have had.

All respondents were therefore asked spontaneously about any knowledge they had

about the new pregnancy screening tests – initial screening and, or NIPT – or the three

specific conditions in question. On prompting it became clear that there was very little

knowledge of these among respondents.

A few, individual respondents, had the following knowledge:

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• two depth respondents said the name NIPT was vaguely familiar

• one depth and one group respondent said they had heard of ‘Harmony’ (the name often given to NIPT by private providers of the screening test)

• one group respondent was aware of ‘new screening tests’ for Down’s syndrome, Edward’s syndrome and Patau’s syndrome

• one depth and one group respondent were aware of Edwards’ syndrome, and another five depth respondents thought they knew the name

• two depth and 1 group respondent knew the name Patau’s syndrome.

In terms of Down’s syndrome, 24 of the 30 depth respondents said they knew of Down’s

syndrome, but 21 of these said they just knew the name and were able to recognise

someone with Down’s syndrome. This was similar within the group discussions. So,

even whilst Down’s syndrome was recognised by virtually all respondents, most

admitted that their specific knowledge of Down’s syndrome was limited.

Views of information on initial screening, now including Patau’s syndrome (T13) and Edward’s syndrome (T18) All respondents were shown an A4, double sided sheet of information about the new

initial screening test for Edwards’ syndrome and Patau’s syndrome that would be

included within the initial screening information in the ‘You’re Pregnant! Scans and

Tests’ booklet.

There were no major issues with the information shown. A few respondents said they

would have needed to read the information through a couple of times to fully understand

the new language. However, although there were a couple of respondents who found a

few words such as ‘amniocentesis’ new and therefore they did not know exactly what

they meant, overall the general language and tone were deemed acceptable by

respondents.

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It was clear to respondents that the new initial test was for all three conditions (Down’s

syndrome, Edwards’ syndrome and Patau’s syndrome) and that the individual could

choose which condition to be tested for (all three conditions, just Down’s syndrome, or

Edward’s syndrome and Patau’s syndrome) as this was mentioned very specifically

within the text. Some respondents did however query about the tests being completed

between 11 and 14 weeks, or then in a later test. Many were not aware of this, due to

their lack of knowledge of the current pregnancy screening programme.

The information sheet left all respondents with one immediate and vital query – what are

Edwards' syndrome and Patau’s syndrome? This information was determined by

respondents to be essential to enable an informed decision to be made at the first

screening test (especially as there was very limited knowledge of the three conditions

prior to the study).

There was mixed awareness and knowledge of the current ‘You’re Pregnant! Scans and

Tests’ booklet among respondents. Most said they had not read it and some said they

hadn’t received it. All respondents assumed that the midwife would and should inform

people about any tests, including new tests, telling people what they are, why they are

important and therefore why someone should have them.

All respondents assumed too that the information about the new tests – both initial and

NIPT – would go into the ‘You’re Pregnant! Scans and Tests’ booklet, and that it would

include background information on Edwards' syndrome and Patau’s syndrome, with an

explanation of why this change to the pregnancy screening programme is being made.

Indeed, some respondents said there should also be an explanation provided as to why

the initial test is still being done if NIPT is more accurate. To some respondents it

seemed sensible to just use NIPT for the initial test.

Adding the information on the two conditions in initial pregnancy screening information,

they said, would lessen the impact if a higher chance result comes back and parents-to-

be needed to read the ‘Your pregnancy, your choice’ booklet, thereby focusing the

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information in this booklet on the choices to be made, namely to test further or not, and

if so, which test to undertake.

Views of the information in ‘Your pregnancy your choice’ NIPT booklet Following a review of the initial screening information on the A4 sheet, all respondents

were then shown the new draft booklet including NIPT – ‘Your pregnancy, your choice’–

which would be given to someone if they had a higher chance result at initial screening.

Initial impressions Respondents’ first thoughts on reading through the booklet were that it was good,

detailed information, but also that the information on Edwards’ syndrome and Patau’s

syndrome was hard to read. Some commented that it was quite scary information, but

also necessary information.

Generally everything in the booklet seemed clear in terms of the language and the

information covered. On a first read through the booklet was deemed by respondents to

be sufficient information to aid further decision making about screening, and to answer

any questions raised.

On first view the booklet was felt to be approachable, but also serious, which

respondents felt was appropriate at this point in the process, as it is designed to be

information received after a higher chance result from initial screening tests.

“People who get this will be invested in it, so will read it slowly, but it’s not complicated,

it’s ok to read, although they are difficult things ….” (Paired depth, Father-to-be, 35+

years, SIMD 3-5)

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Impact of the information on the respondents The information on Edwards’ syndrome and Patau’s syndrome had the most impact on

the respondents’ first read of the booklet. It was seen by them as very hard-hitting

information (for this audience) and as new information that all wanted to take note of.

This meant that information on NIPT being a new, safe, accurate blood test now

available prior to diagnostic testing was perceived to be good to know, but almost

incidental information to them. The emphasis of the booklet, at this point, was seen to

be the new information about Edwards' syndrome and Patau’s syndrome.

Indeed finding out that both syndromes are life-limiting conditions was generally felt to

change the thought process when deciding about pregnancy screening. Some

respondents who stated they had not had screening for Down’s syndrome said they

would have reconsidered their screening decisions if this information had been available

for Edwards’ syndrome and Patau’s syndrome and if they could have chosen to screen

for these conditions at initial screening.

“I didn’t do any tests, but if I’d read that about the syndromes I’d have had the tests.

…Down’s syndrome …wasn’t an issue. But I didn’t know about the details. Or about the

other 2 syndromes and they’re a different ballgame.” (Group, New mum, 16-35+ years,

SIMD 3-5) Clarity regarding choice When asked if the booklet made it clear that someone has a choice whether to take the

screening test or not, all respondents said the booklet was clear that any test is the

patient’s choice, with multiple references to this throughout the booklet, that they know

this to be the case and that this is rightly so. A few respondents did however point out

that it does not say what should happen if two partners do not agree and the question

on what, or who would take precedence was raised, with these respondents assuming

that the woman’s decision would prevail.

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However, many respondents said that what was not necessarily clear was what all the

choices were in detail and this could lead to the conclusion that the booklet was

principally saying that people should have NIPT. The focus was therefore seen to be on

NIPT, rather than presenting unbiased information about choices when an initial test

has come back showing a higher chance result.

Clarity of all potential outcomes On closer review of the booklet some respondents also noted that it does not seem to

follow through on all the possible outcomes for each option noted. It was stated that

whilst the inside cover shows there are three choices after an initial higher chance

result, the booklet appeared to focus on what happens for NIPT. In addition, the flow

chart on page four only flowed down from NIPT, it did not show routes to all outcomes.

It was felt by respondents that all the outcomes of the choices would be needed in this

information. This would include for example outcomes such as what happens if

someone goes straight to diagnostic tests. Likewise, some respondents questioned

what would happen if someone decides not to do anything. For example, how would

their care continue and then what would happen at the birth after a higher chance

result? How are the babies tested at birth for each of the syndromes if no further testing

is completed? These questions from the respondents highlighted the types of

‘outcomes’ that were currently missing from the information in the new (draft) booklet. NIPT and its benefits In terms of the information about NIPT all respondents felt that the test itself was

described well, being clear what it is, how it is done and what it measures. In their view,

it is, another blood test, something all respondents said they were used to.