Audiovisual information affects informed choice and experience of information in antenatal Down syndrome screening – A randomized controlled trial

doi:10.1016/j.pec.2011.07.004

Patient Education and Counseling

Volume 86, Issue 3, March 2012, Pages 390-395

https://doi.org/10.1016/j.pec.2011.07.004 Get rights and content

Abstract

Objective

To evaluate the effects of an information film on making an informed choice regarding Down syndrome screening, and women's knowledge and experiences of information.

Methods

Randomized controlled trial including 184 women in the intervention group and 206 controls recruited from maternity units in Stockholm, Sweden. The intervention was an information film presented as a complement to written and verbal information. Data were collected via a questionnaire in gestational week 27. Three different measures were combined to measure informed choice: attitudes towards Down syndrome screening, knowledge about Down syndrome and Down syndrome screening, and uptake of CUB (combined ultrasound and biochemical screening).

Results

In the intervention group 71.5% made an informed choice versus 62.4% in the control group. Women in the intervention group had significantly increased knowledge, and to a greater extent than the control group, experienced the information as being sufficient, comprehensible, and correct.

Conclusions

An information film tended to increase the number of women who made an informed choice about Down syndrome screening. Participants were more satisfied with the information received.

Practice implications

Access to correct, nondirective, and sufficient information is essential when making a choice about prenatal diagnostics. It is essential with equivalent information to all women.

Introduction

Until 2006 screening for Down syndrome (DS) was not routinely offered in Sweden. From a Swedish review in 2006 [1], it was concluded that CUB (combined ultrasound and biochemistry) [2], [3] was the best method for Down syndrome screening (DSS) in early pregnancy. Another conclusion was that the information before screening was inadequate for the women to make informed choices. Information about DSS is complex in many aspects [1], [4]. A screening test cannot diagnose DS, but presents a risk figure. The cut-off level in CUB, for a high risk, is larger than 1:200. The false positive rate, i.e. a high risk without DS, is 5%. Women receiving a high risk have to decide about an invasive test which could lead to miscarriage. Women receiving a low risk must be aware that the baby may have DS [3]. Information must include all those aspects.

In 2001 Marteau and Dormandy developed a multidimensional measure of informed choice to undergo prenatal screening for DS [5]. The definition of informed choice was adapted from O’Connor and O’Brien-Pallas's: “an informed choice is one that is based on relevant knowledge, consistent with the decision maker's values and behaviorally implemented” [6]. The multidimensional measure of informed choice (MMIC) consisted of an eight-item knowledge scale, a four-item attitude scale, and the two alternatives – uptake or not uptake. MMIC was further validated in 2002 [7], and verified as reliable and a valid measure of informed choice. In a study aimed to more specifically understand knowledge regarding DSS, additional questions about DS were suggested [8]. The MMIC was further modified in a study from 2006 aimed to evaluate informed consent in antenatal DSS, comparing combined versus separate visit testing. Two questions about knowledge; concerned abilities and life expectancy for people with DS and two questions about attitudes; whether the screening was worthwhile/not worthwhile and whether it was a bad thing/not a bad thing, were added [9].

The prevalence of informed choice based on MMIC has been studied in different types of visit routines [8], [10]. One study indicated higher levels of informed choice when screening was conducted as a part of a routine visit [10]. This result was not repeated in a cluster-randomized study where information at the routine visit was compared to information at a separate visit [8]. Both studies showed that less than 45% of the women made an informed choice. When comparing informed choice using MMIC between different socioeconomically and ethnic groups, the conclusion was that white women from socially advantaged groups to a higher extent made informed choices [9]. Written information about DSS differs a lot between the European countries, China, and India. The United Kingdom and the Netherlands emphasize the choice and the presence of available balanced information including different aspects of DS [11]. Informed choice regarding DSS has also been studied outside Great Britain. A Greek study and one from Australia also showed that less than 44% and 37%, respectively, of the women made an informed choice [12], [13]. However, some studies show higher proportions of informed choice. An Australian study from 2005 showed that 68% of the women made an informed choice measured before screening. The demographic characteristics of the study group differed from the general population. Women in the study group were older, more well-educated and most of them had health insurance for care within the private sector. The study population was recruited among women having first-trimester screening for DS and 99% of these women had a positive attitude towards DSS. MMIC consequently is based on knowledge alone [14]. Results from a Dutch study from 2005 [15] reported that 68% of the women had made an informed choice. When this study was performed, prenatal screening for DS was not routinely offered to pregnant women in the Netherlands. It is known that routinization of prenatal screening leads to less informed choices [16]. From two reviews [17], [18], one conclusion was that pregnant women favored prenatal examinations, but the choice of participation did not seem to be based on insight to enable fully informed consent. Further, the information about DS and screening tests did not give relevant knowledge to empower an informed consent.

A review from 2009 concluded that patient decision aids increase people's involvement and is more likely to lead to informed, values-based decisions, but the effect varies across studies. The degree of detail that patient decision aids require for positive effect on decision quality should be explored [19].

Hewison et al. assessed the effect of a video about DSS. The intention was to assess how a video with information about DS and the screening method would affect womeńs knowledge, anxiety and the uptake of screening. Two thousand women referred for antenatal care were allocated to two groups. The study group had an information video sent home. The level of knowledge increased without causing more anxiety or affecting the uptake. MMIC was not used in this study [20].

This is the first Swedish study using the multidimensional measure of informed choice to evaluate decision aids for DSS. The introduction of an information film about prenatal examinations might improve knowledge, but also encourage reflection about values and attitudes, and thereby facilitate an informed choice.

The aim of the study was to evaluate the effects of an information film on making an informed choice regarding Down syndrome screening, and the women's knowledge and experiences of the given information.

Section snippets

Study design

The study was a randomized controlled trial with allocation to two groups: the intervention group and the control group.

Participants and randomization

The trial took place at nine maternity units in Stockholm, Sweden, during the period March to July 2009. The trial ended when all women for each maternity were recruited, or according to the agreed end date – July 31, 2009. Women who wanted information about prenatal screening were informed verbally and in writing about the trial. Non-Swedish-speaking women were excluded, as

Participant flow

All women booked for antenatal care at nine selected clinics were the inclusion group. Of these women 483 consented to participate in the study. The 483 women comprised 18.7% of the inclusion group. Of the participants, 236 were randomized to the intervention group and 246 were randomized to the control group (Fig. 1). For ethical reasons, women who had had a miscarriage or an induced abortion were excluded from the study. After one reminder sent per post, a total of 184 women in the

Discussion

The film is the only one of its kind in Sweden, as well as this comparing study. One of the purposes with the film was to stimulate an integration of relevant knowledge about DS and the screening test with a process reflecting the personal implications of prenatal screening. Potter (2008) showed that the interplay between knowledge and values was different for each woman [21].

Conclusion

An information film as a complement to verbal and written information tended to increase the number of women who made an informed choice about Down syndrome screening. The women in the intervention group were more satisfied with the information in different aspects.

Acknowledgements

This study was supported by grants from Sophiahemmet University College and from Södersjukhuset, Department of Obstetrics and Gynecology, Stockholm, Sweden.

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409 participants (96%) had post-intervention data. Mean age was 41.3 years, 44.2% were female. There was no between-group difference in post-intervention treatment intention (MD −0.2, 95% CI: −3.3 to 2.8) and likelihood of intending to have shoulder surgery (OR 0.7, 95% CI: 0.3–1.5). The decision aid slightly improved knowledge (MD 4.4, 95% CI: 0.2–8.6), but not any other secondary outcomes. The display of options did not influence any outcome.
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Interestingly, eight of the twelve interventions used SMS, likely due to its efficiency and cost-effectiveness in information dissemination. Eight studies focused on prenatal medical procedures, including genetic testing [6,9,11,20,51,52], or invasive procedures such as fetoscopic surgery [7], and termination of pregnancy [10]. Tools described the processes, risks and benefits, and care instructions of procedures, with primary benefits of improved knowledge and informed decisions [6,9,11,51].
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To evaluate the knowledge of pregnant women and provide information about Down syndrome (DS) screening, including non-invasive prenatal testing (NIPT).
A prospective unicenter study of pregnant women recruited during their first trimester foetal ultrasound was carried out. Single pregnancies from 11 to 17 + 6 weeks of amenorrhoea (SA) without a history of DS were included. “Pre” and “post” questionnaire were fulfilled before and after the consultation. Patient characteristics, prior information, information provided during the consultation, and patient satisfaction were also analysed.
A total of 273 were included in the study, and 147 completed surveys (pre and post) were examined. In pre-consultation, 82 % of women know that integrated screening includes maternal serum markers and nuchal translucency (n = 103). Concerning NIPT for DS, 8% (n = 11) of women declare having been informed before the ultrasound. A minority of patients know modalities of reimbursement (n = 33, 26 %) and invasive sampling is mandatory for diagnosis when NIPT is positive (n = 37, 28 %). Significant improvement in right answers was obtained for three questions: “nuchal translucency is included in the combined screening test for DS” (p = 0,007); “blood serum markers is included in the combined screening for DS” (p = 0,009) and advanced maternal age increases risk for DS” (p = 0,004). Total score in the post questionnaire was significantly higher than the “pre” consultation questionnaire (14,7 ± 2.8 versus 14,1 ± 2.9; p = 0.01).
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Nonetheless, the decision aid did significantly improve maternal knowledge scores compared with the control group. In other clinical settings ranging from parents facing decisions about prenatal screening to patients with cancer facing different medical and surgical treatment options, randomized studies show that decision aids consistently improve knowledge and accuracy of risk perceptions.33-42 There was no correlation between improved knowledge scores and decisional conflict.
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Among decision aids designed for choosing between medical decisions, most were designed for patients with either screening for or genetic testing for the following conditions: prostate conditions (n = 18),15-32 cardiovascular disease (n = 11),33-43 colorectal cancer (n = 14),44-57 breast cancer (n = 13),58-70 endocrine disorders (n = 11),1,71-80 and women's health conditions (n = 10).81-90 Few studies assessed decision aids for medical decisions in other categories such as screening for congenital disorders,91-97 infectious diseases,98-102 orthopedic conditions,103-106 diabetes,107-112 psychiatric conditions,113-115 neurologic conditions,116,117 dental health conditions,118,119 and health behaviors.120 Among those designed for choosing between a medical and surgical interventions, most were targeted toward patients with breast cancer (n = 9),121-129 orthopedic conditions (n = 9),130-138 prostate conditions (n = 8),139-146 and women's health conditions (n = 6),147-152 whereas few assessed decisions regarding cardiovascular conditions,153-155 vasectomy,156 obesity,157 pulmonary conditions,158 and end-of-life care.159
With continuous advances in medicine, patients are faced with several medical or surgical treatment options for their health conditions. Decision aids may be useful in helping patients navigate these options and choose based on their goals and values. We reviewed the literature to identify decision aids and better understand the effect on patient decision-making. We identified 107 decision aids designed to help patients make decisions between medical treatment or screening options; 39 decision aids were used to help patients choose between a medical and surgical treatment, and five were identified that aided patients in deciding between a major open surgical procedure and a less invasive option. Many of the decision aids were used to help patients decide between prostate, colorectal, and breast cancer screening or treatment options. Although most decision aids were not associated with a significant effect on the actual decision made, they were largely associated with increased patient knowledge, decreased decisional conflict, more accurate perception of risks, increased satisfaction with their decision, and no increase in anxiety surrounding their decision. These data identify a gap in use of decision aids in surgical decision-making and highlight the potential to help surgical patients make value-based, knowledgeable decisions regarding their treatment.

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InterventionAudiovisual information affects informed choice and experience of information in antenatal Down syndrome screening – A randomized controlled trial

Abstract

Objective

Methods

Results

Conclusions

Practice implications

Introduction

Section snippets

Study design

Participants and randomization

Participant flow

Discussion

Conclusion

Acknowledgements

Patient Educ Couns

Patient Educ Couns

Patient Educ Couns

Midwifery

Genet Med

Soc Sci Med

Patient Educ Couns

A screening program for trisomy 21 at 10–14 weeks using fetal nuchal translucency, maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma protein-A

Ultrasound Obstet Gynecol

Screening for Down's syndrome in the first trimester: combined risk calculation, methodology, and validation of a web-based system

Acta Obstet Gynecol Scand

Informed consent to undergo serum screening for Down's syndrome: the gap between policy and practice

Brit Med J

Intervention
Audiovisual information affects informed choice and experience of information in antenatal Down syndrome screening – A randomized controlled trial