Women sample characteristics
All of the GPs managed to invite at least one woman to participate. A total of 59 pregnant women were initially invited to take part. Of these, 22 did not meet the eligibility criteria and 8 were not interested. A total of 29 eligible women agreed to participate.
The mean age of the women was 32 years (range 25–40 years) (Table
3). Seventeen of the 29 women (59%) had a university education, 7 (24%) had a trade or technical qualification, and 5 (17%) had completed high (secondary) school education (aged between 15 and 16 years) or had achieved a Higher School Certificate. The Higher School Certificate (HSC) is the qualification awarded to senior high school students in Years 11 and 12 (aged between 16 to 18 years) who successfully complete high school. Participants were divided into two groups – (i) Higher education (
n = 17, 59%) – undergraduate or postgraduate degree and, (ii) Lower education (
n = 12, 41%) – completed secondary/ high school education or had successfully completed a Higher School Certificate, or trade/technical/vocational qualifications.
Table 3
Characteristics of the women (n = 29)a
Socio-demographic characteristics |
Age (years) |
Mean | 32 |
Range | 25–40 |
Marital Status |
Married | 24 (83) |
Living with partner | 4 (14) |
Not living with partner | 1 (3) |
Educational level |
Year 10 or belowb | 3 (10) |
Year 12 Higher School Certificate (HSC)c | 2 (7) |
Trade or technical certificate | 7 (24) |
Bachelors/Undergraduate degree | 10 (35) |
Postgraduate degree | 7 (24) |
Country of birth |
Australia | 22 (76) |
Other | 7 (24) |
Language/s spoken at home |
English only | 19 (66) |
Bilingual | 10 (34) |
Current employment status |
Full-time employed | 14 (48) |
Part-time employed | 7 (24) |
Self-employed | 3 (10) |
Homemaker | 4 (14) |
Student | 1 (3) |
Has private health insurance |
Yes | 22 (76) |
No | 6 (21) |
Obstetric variables |
First pregnancy |
Yes | 13 (45) |
No | 16 (55) |
Previous pregnancy outcomes |
Previously experienced a miscarriage | 7 (24) |
Previously experienced a termination of pregnancy | 2 (7) |
Previous screening tests |
Yes | 9 (31) |
No | 5 (17) |
Unsure | 3 (10) |
Previous diagnostic tests |
No | 16 (55) |
Unsure | 1 (3) |
Acceptability of the DA
GPs
Most GPs felt that the information was ‘very’ clear (
n = 13, 72%), ‘very’ easy to read (
n = 13, 72%), ‘very’ useful (
n = 16, 89%), and ‘very’ appealing (
n = 14, 78%) (Table
4). All GPs described the DA as ‘very’ informative (
n = 18, 100%). The majority of GPs felt that the DA presented a balanced view of prenatal screening (
n = 16, 89%), and would ‘very much’ assist women/couples in helping them to better understand about screening (
n = 15, 83%) and facilitate their decision-making (
n = 16, 89%).
Table 4
GP responses regarding the acceptability of the DA (n = 18)
How clear was the information? |
Very | 13 (72) |
Somewhat | 5 (28) |
How informative was the DA? |
Very | 18 (100) |
How easy to read was the DA |
Very | 13 (72) |
Somewhat | 3 (17) |
Not at all | 2 (11) |
How useful was the DA? |
Very | 16 (89) |
Somewhat | 2 (11) |
How appealing was the DA? |
Very | 14 (78) |
Somewhat | 4 (22) |
How would you describe the amount of information? |
Just right | 9 (50) |
Too much | 9 (50) |
How balanced did you find the information? |
Completely balanced | 16 (89) |
Encouraging prenatal screening | 2 (11) |
Will the DA make it easier for you to communicate with patients? |
Very much | 8 (44) |
Somewhat | 8 (44) |
Not at all | 2 (11) |
Do you think the DA will assist women/couples in helping them to understand about prenatal screening? |
Very much | 15 (83) |
Somewhat | 3 (17) |
Do you think the DA will assist women/couples in making decisions? |
Very much | 16 (89) |
Somewhat | 2 (11) |
How feasible would it be to implement the DA into routine practice? |
Very | 10 (56) |
Somewhat | 5 (28) |
Not very | 3 (16) |
Most felt the DA would make it ‘somewhat’ or ‘much’ easier to communicate to women about screening (n = 16, 88%). Just over half of GPs (n = 10, 56%) thought it would be ‘very’ feasible to implement the DA into practice, whereas the remaining GPs felt it would be ‘somewhat’ more challenging (n = 8, 44%). Half of the GPs described the information in the DA as just the right amount (n = 9, 50%), and the other half thought it would be ‘too much’ for women (n = 9, 50%).
Women
Overall, women reacted positively towards the DA (Table
5). The majority of participants reported reading all the information (
n = 25, 86%), and that it took them less than 30 min to read (
n = 23, 79%). Around half of the women reported that ‘all’ or ‘most’ of the information was new to them (
n = 15, 51%). Most women felt the DA presented a balanced view of screening (
n = 21, 72%), although a slightly higher proportion of women with higher education thought it was encouraging screening (
n = 6, 35%) compared to those with lower education (
n = 2, 17%). Most women thought the amount of information was ‘just right’ (
n = 20, 71%), with only a few finding it to be ‘too much’ information (
n = 3, 11%).
Table 5
Women’s responses regarding the acceptability of the decision aid by higher and lower education groupsa
How much of the DA did you read? |
I read all of it | 14 (82) | 11 (92) | 25 (86) |
I read part of it | 0 (0) | 1 (8) | 1 (3) |
My GP went through it with me | 1 (6) | 1 (8) | 2 (7) |
How long did it take you to read it? |
Less than thirty minutes | 14 (82) | 9 (75) | 23 (79) |
More than thirty minutes | 3 (18) | 3 (25) | 6 (21) |
What about the amount of information? |
Not enough | 3 (18) | 2 (18) | 5 (18) |
Just right | 12 (71) | 8 (73) | 20 (71) |
Too much | 2 (12) | 1 (9) | 3 (11) |
How balanced was the information? |
Encouraging prenatal screening | 6 (35) | 2 (17) | 8 (28) |
Completely balanced | 11 (65) | 10 (83) | 21 (72) |
Order of topics presented |
I liked the order | 13 (89) | 11 (92) | 24 (89) |
I’m not sure | 2 (13) | 1 (8) | 3 (11) |
How much of the information was new? |
All or most | 10 (59) | 5 (41) | 15 (51) |
Some | 7 (41) | 6 (50) | 13 (45) |
None | 0 (100) | 1 (8) | 1 (3) |
Did you show the booklet to anyone? |
Yes | 11 (65) | 7 (58) | 18 (62) |
No | 6 (35) | 5 (42) | 11 (38) |
Who did you show the booklet to? |
Husband/partner | 9 (53) | 6 (50) | 15 (52) |
Friend who is pregnant | 0 (0) | 1 (8) | 1 (3) |
GP + husband/partner | 2 (12) | 0 (0) | 1 (7) |
Would you recommend the DA? |
Yes I would | 14 (82) | 9 (75) | 23 (79) |
I’m not sure | 2 (12) | 2 (17) | 4 (14) |
No | 1 (6) | 1 (8) | 2 (7) |
How worried you felt after reading the DA? |
Not at all | 8 (47) | 7 (58) | 15 (52) |
A little bit | 5 (29) | 5 (42) | 10 (35) |
Somewhat | 4 (24) | 0 (0) | 4 (14) |
Did you use the worksheet? |
Yes | 5 (29) | 5 (42) | 10 (34) |
No | 12 (71) | 7 (58) | 19 (66) |
Please indicate if you thought the booklet was… |
Clearly presented | 12 (71) | 10 (83) | 22 (76) |
Informative | 13 (77) | 10 (83) | 23 (80) |
Easy to read | 13 (77) | 11 (92) | 24 (83) |
Useful | 14 (82) | 10 (83) | 24 (83) |
Appealing to look at | 10 (59) | 9 (75) | 19 (66) |
How helpful was the DA in terms of… |
Increasing understanding of options | 15 (88) | 10 (83) | 25 (86) |
Clarifying the benefits of each option | 9 (53) | 9 (75) | 18 (62) |
Clarifying the risks of each option | 12 (71) | 8 (67) | 20 (69) |
Clarifying your decision-making | 8 (47) | 8 (67) | 16 (55) |
Helping you reach a decision | 8 (47) | 6 (50) | 14 (48) |
Most women found the booklet ‘very’ clearly presented (
n = 22, 76%), ‘very’ informative (n = 23, 80%), ‘very’ easy to read (
n = 24, 83%), and ‘very’ useful (n = 24, 83%) (Table
5). Slightly fewer women described the DA as ‘very visually appealing to look at’ (
n = 19, 66%). The majority of women felt the booklet was ‘very’ helpful in increasing their understanding of the options (n = 25, 86%). Around half of the women reported it being ‘very’ helpful in clarifying their decision-making (
n = 16, 55%) and reaching a decision (
n = 14, 48%). Just over a third of women reported completing the personal worksheet (
n = 10, 34%).
Women’s responses to the open-ended questions
All of the women found the font size appropriate. The colours were described as ‘bright’, and ‘consistent’. The illustrations and diagrams were generally well received; being described as ‘appropriate’, and ‘a good mix of cultures’. However, a few women did not like the illustrations and found them ‘condescending’ and too ‘upbeat’ considering the serious nature of the topic.
The summary sheet, timeline, worksheet and glossary of medical words were described as ‘useful’, and helping to ‘put it into perspective’. The 100 dot-diagrams (Fig.
1) received mixed responses – some described them as ‘a clever visual representation’, whereas others thought they were ‘difficult to grasp’ in terms of what they were representing (i.e. pregnant women carrying a baby with Down syndrome).
Women’s screening knowledge – Conceptual and numeric
Overall, there was a difference in women’s knowledge before and after exposure to the DA, with mean scores increasing from 12.7 (out of 22) to 18.3 (Table
6). Conceptual knowledge scores improved from 12.0 to 14.4 (out of 16), and numeric knowledge scores increased from 0.7 to 3.9 (out of 6). Women’s knowledge about NIPT also improved from 2.1 to 4.1 (out of 5) after receiving the decision aid. Both education groups showed improvements, and a slightly higher proportion of women with higher education had increased knowledge compared to women with lower education (77% versus 58%, respectively).
Table 6
Women’s conceptual and numeric screening knowledge before and after receiving the decision aid by education group
Pre Knowledge Scores, Mean (SD)a |
Conceptual (maximum score 16) | 12.1 (1.7) | 11.9 (2.2) | 12 (1.9) |
Numeric (maximum score 6) | 0.9 (1.4) | 0.3 (0.7) | 0.7 (1.2) |
NIPT knowledge (maximum score 5) | 2.1 (1.2) | 2.2 (0.6) | 2.1 (1.0) |
Total knowledge score (max score n) | 13.1 (2.3) | 12. 2 (1.8) | 12.7 (2.1) |
Adequate knowledgeb (total score ≥ 17 out of 22), n (%) | 1(6) | 0 (0) | 1(4) |
Post Knowledge Scores, Mean (SD) |
Conceptual (maximum score 16) | 14.7 (1.4) | 14.1 (1.5) | 14.4 (1.4) |
Numeric (maximum score 6) | 4.2 (2.4) | 3.4 (2.4) | 3.9 (2.4) |
NIPT knowledge (maximum score 5) | 4.3 (1.0) | 3.8 (1.1) | 4.1 (1.09) |
Total knowledge score (max score 22) | 18.9 (3.2) | 17.5 (3.4) | 18.3 (3.3) |
Adequate knowledge (total score ≥ 17 out of 22), n (%) | 13 (77) | 7 (58) | 20 (69) |
Key revisions to the DA based on participant feedback
Both women and GPs had useful suggestions on how to improve the booklet. The following revisions were made in accordance with their feedback. We included a summary page comparing the accuracy and potential risks (i.e. miscarriage) of the different types of screening and diagnostic tests so the reader had all the information in one to which they could refer to in their decision-making. Both women and GPs wanted more practical information on where NIPT could be done and who to ask about it; we included a list of questions about NIPT that women could ask their GP, or other antenatal health professional. Some women were interested to know where they could find more information on the practicalities or impact of raising a child with Down syndrome. As such, in our revisions, we provided details of several resources produced by Down syndrome Australia. Some GPs felt the booklet should explain that screening requires medical referral, and clarify that screening identifies other chromosomal conditions. Throughout the booklet, we made some wording changes in accordance with Down syndrome Australia protocol on how to communicate with the public about Down syndrome. For example, we replaced the term ‘risk’ with ‘chance’, and ‘problem’ or ‘disease’ with ‘condition’. Based on GP feedback, we described diagnostic tests as ‘definite’ tests and replaced ‘detecting Down syndrome’ with ‘identifying Down syndrome’. We also reworded the 100-dot diagrams to clarify that the diagrams represented 100 pregnant women carrying a baby with Down syndrome.
Discussion
This article describes the development and acceptability of a low literacy DA about Down syndrome screening. The DA was well received by women with different education levels and GPs. Women’s knowledge of the different types of screening tests, including NIPT, increased after exposure to the DA. Most women felt the information was very clearly presented, easy to read, informative, and rated the amount of information and length favourably. The DA was considered to be relevant, with most reporting they would recommend it to others. Similarly, most GPs reported the DA as clear, and that it would assist women in decision-making.
Although conceptual and numeric knowledge increased for both higher and lower education groups, a slightly higher proportion of women with higher education were found to have adequate knowledge compared to those with lower education. Although this is a small sample, it nonetheless echoes previous work showing that women from lower education groups experience greater difficulties making an informed decision [
32]. Similarly, women with higher education have shown to benefit more from decision aids than those with lower education, possibly because they are more familiar with the engaging in decision-making and critically appraising health information [
33,
47,
52].
Both women and GPs reviewed the DA positively, and there were few discrepancies in their views towards it. However, they did differ with regard to the amount of information, with half of the GPs thinking there was too much information, yet most women thinking it was just about right. Women expressed the need for more experiential information about living with a child who has Down syndrome. The final version includes website links with information about this. It is not uncommon for health professionals to underestimate how much information patients want to receive, possibly through fear of overloading patients, or underestimating their understanding [
53].
Not all GPs agreed that the DA would be easy to implement and some felt it would not necessarily facilitate communication. The challenges of implementing DAs in clinical practice are widely reported [
54‐
56]. Although DAs have proven to be effective, they are not commonly used in practice because of communication, cultural, ideological, organisational, and practical barriers [
57]. Lepine et al. (2016) identified a number of factors influencing whether health professionals would use a prenatal screening DA, ranging from whether the tool was positively appraised, considered relevant, or being readily accessible to having enough time and colleagues endorsing the tool [
58].
Our results showed that around two-thirds of women reported not using the values clarification worksheet. Perhaps the information on its own without a values clarification exercise might be enough to improve knowledge and enhance decision-making [
27,
59,
60], or women found it difficult to complete. There is debate about whether DAs interfere with intuitive forms of information processing, and exercises that encourage deliberative (slow and analytic) decision-making may not always lead to better decisions. Clearly, more research is needed as to explore the factors that influence people using values clarification exercises, who might benefit more from such methods, and whether information alone might be enough to clarify values.
We note that GPs were the only health professionals involved in the study. Including other health professionals (e.g. midwives, obstetricians, and genetic counsellors) would have been useful to explore the diversity of perspectives. One study observed that health professionals varied in their attitudes towards using prenatal screening DAs; midwives seemed more positive about using DAs compared to GPs and obstetricians [
58].
At the time of the study, NIPT was on the cusp of being implemented into the Australian healthcare system, predominately in the private health care system with test results being sent to offshore laboratories on a user pays basis with no reimbursement. At present, NIPT is more widely available in both the private and public healthcare system, and although it is less expensive than it used to be, it is still offered with no reimbursement. It is possible that discussions with health care professionals about NIPT may have influenced women’s knowledge and understanding about NIPT, and women may have paid less attention to the decision aid because NIPT was too expensive for women to consider a viable option. However, we note that some GPs in our study were not fully aware of the availability of NIPT and found the decision aid to be informative in improving their own knowledge. Further, our results showed that women’s knowledge of NIPT increased after exposure to the decision aid and they were able to correctly answer questions about accuracy of the NIPT that would have required reading the decision aid.
This study has a few limitations. Firstly, despite efforts to recruit partners to the study we were not successful. However, most women in the current study reported showing the DA to their partners, indicating that they valued their involvement. Similarly, previous research has shown screening decisions are often made by couples together [
27,
36,
61,
62]. Others have also highlighted the challenges of recruiting men to participate in health research. Strategies have been proposed to help overcome men’s resistance to participation, these include; emphasising the personal benefits and altruistic elements of the research, simplifying technical information, and using humour [
63]. Future research should consider these recruitment strategies to ensure partners’ perspectives are taken into account.
Secondly, although we made efforts to recruit women with varying education levels to ensure the tool was acceptable to different education groups, we encountered difficulties recruiting women from lower education groups. The length of recruitment was extended due to difficulties recruiting this group. This is perhaps not surprising given that lower socioeconomic groups are generally under-represented in health and medical research [
64]. In addition, we did not measure participants’ health literacy skills. While educational attainment is associated with literacy and health literacy, they are not synonymous. Further testing with higher and lower health literacy groups would be an important next step to identify whether the decision aid is suitable and understandable to different health literacy groups.
Thirdly, given the aims of the study were to provide descriptive data on the acceptability of the DA, the results should therefore be considered as preliminary. The small sample size in each education group meant that we were underpowered to perform statistical analyses to detect any statistical differences between the two groups. At this stage, it is not possible to make conclusive statements about the actual effect of the decision aid without a randomised controlled trial with a larger sample, to evaluate the efficacy of the DA compared to standard information. This will provide valuable evidence on the effect of the decision aid on informed decision-making (knowledge, attitudes, uptake, values consistency and deliberation), and enable us to generalise the findings to populations with different education levels.
Finally, in line with previous work [
65], there was a very low response rate from GPs creating problems of non-response bias. GPs who responded may have had a stronger interest in prenatal screening and reactions to the DA may have been different among GPs who did not respond. Furthermore, although we asked GPs to invite all eligible pregnant women to participate, GPs may have selected women whom they thought had the necessary health literacy skills to read and understand the DA. We had considerable difficulties recruiting women with lower education levels throughout the study which subsequently delayed recruitment.
Practice implications
This is one of the few prenatal screening DAs to provide information about NIPT. It has the potential to provide prospective parents with clear and easy-to-read information, and complement existing information presented by health care professionals. A formal evaluation of the efficacy of the tool (compared to standard information) is necessary before it is made available.
Although all participants spoke English, around one-third of participants were bilingual. If translated into different languages, the DA could provide culturally and linguistically diverse (CALD) populations with a tool that is accessible in their own language and help to address the potential communication challenges. Future work could also focus on translating the DA into different languages to address the needs of those from CALD backgrounds.
Future work is also needed to identify and overcome the barriers to implementing DAs, with studies focused on identifying the contextual and facilitative mechanisms that could influence the implementation of the DA [
66]. The potential use of social marketing, (the use of commercial marketing strategies to enhance public health and well-being [
67], has also been suggested [
57]. Future work could be directed towards identifying social marketing strategies (e.g. social media) to support the long-term implementation of DAs. We also note that this DA was developed in the context of the Australian healthcare system and the risk information presented is based on Australian data. The DA would need modification if tested in other countries.