Elizabeth Dormandy

A measure of informed choice

Objective To develop a measure of informed choice.

The multi-dimensional measure of informed choice: a validation study

The aim of this prospective study is to assess the reliability and validity of a multi-dimensional measure of informed choice (MMIC). Participants were 225 pregnant women in two general hospitals in the UK, women receiving low-risk results following serum screening for Down syndrome. The MMIC was administered before testing and the Ottawa Decisional Conflict Scale was administered 6 weeks later. The component scales of the MMIC, knowledge and attitude, were internally consistent (alpha values of 0.68 and 0.78, respectively). Those who made a choice categorised as informed using the MMIC rated their decision 6 weeks later as being more informed, better supported and of higher quality than women whose choice was categorised as uninformed. This provides evidence of predictive validity, whilst the lack of association between the MMIC and anxiety shows construct (discriminant) validity. Thus, the MMIC has been shown to be psychometrically robust in pregnant women offered the choice to undergo prenatal screening for Down syndrome and receiving a low-risk result. Replication of this finding in other groups, facing other decisions, with other outcomes, should be assessed in future research.

Will the introduction of non-invasive prenatal diagnostic testing erode informed choices? An experimental study of health care professionals

OBJECTIVE Informed choice is a fundamental concept within prenatal care. The present study assessed the extent to which the introduction of non-invasive prenatal diagnosis (NIPD) of Downs syndrome may undermine the process of making informed choices to undergo prenatal testing or screening for Downs syndrome by altering the quality and quantity of pre-test counselling. METHODS 231 obstetricians and midwives were randomly allocated one of three vignettes, each describing a different type of test: (a) invasive prenatal diagnosis (IPD), (b) non-invasive prenatal diagnosis (NIPD) or (c) Downs syndrome screening (DSS). Participants were then asked to complete a questionnaire assessing (1) the information considered important to communicate to women, (2) whether test offer and uptake should take place on different days, and (3) whether signed consent forms should be obtained prior to testing. RESULTS Across the three test types, five out of the seven presented topics were considered equally important to communicate, including the information that testing is the womans choice. Compared with participants receiving the IPD vignette, those receiving the NIPD and DSS vignettes were less likely to report that counselling and testing should occur on different days (IPD 94.7% versus 74.1% and 73.9% for NIPD and DSS respectively, p=.001) and that written consent was a necessity (IPD 96.1% versus 68.3% and 75.4% for NIPD and DSS respectively, p<.001). CONCLUSION This study provides the first empirical evidence to demonstrate that practitioners may view the consent process for NIPD differently to IPD. There is potential for the introduction of NIPD to undermine women making informed choices in the context of prenatal diagnostic testing for conditions like DS. PRACTICE IMPLICATIONS Given the importance of informed choice in reproductive decision-making, implementation of any programme based on NIPD should be designed to facilitate this.

Informed choice: understanding knowledge in the context of screening uptake

This study evaluates a scale measuring knowledge about a screening test and investigates the association between knowledge, uptake and attitudes towards screening. One thousand four hundred ninety-nine pregnant women completed the knowledge scale of the multidimensional measure of informed choice (MMIC). Three hundred forty-five of these women and 152 professionals providing antenatal care also rated the importance of the knowledge items. Item characteristic curves show that, with one exception, the knowledge items reflect a spread of difficulty and are able to discriminate between people. All items were seen as essential or helpful by both women and health professionals, with two items seen as particularly important and one as unimportant. There were some differences between health professionals, women with low risk results and women with high risk results. Knowledge was not associated with uptake, attitude, or the extent to which uptake was consistent with womens attitudes towards undergoing the test.

Attitudes and uptake of a screening test: The moderating role of ambivalence

This study examined the extent to which ambivalence moderates the relationship between attitudes and screening behaviour in a clinical setting using an objective measure of behaviour. For this study 979 pregnant women eligible for prenatal Down syndrome screening completed questionnaire measures of attitudes, ambivalence and intentions towards undergoing the test. Screening behaviour, assessed by test uptake, was determined from medical records. Attitudes predicted intentions to undergo the test and screening behaviour. The correlations between attitudes and intentions and between attitudes and behaviour were greater in women with lower levels of ambivalence (r = 0.85 and r = 0.58, respectively) than in those with higher levels of ambivalence (r = 0.50 and r = 0.27, respectively). Regression analyses revealed that ambivalence moderated the relationships between attitudes and intention and between attitude and behaviour. In addition, a three-way interaction was found between ambivalence, attitudes and intention when predicting behaviour. Given that behaving consistently with attitudes is central to making an informed choice, ambivalence appears to undermine the making of such choices.

Maximising recruitment and retention of general practices in clinical trials: a case study

BACKGROUND There is limited evidence regarding the factors that facilitate recruitment and retention of general practices in clinical trials. It is therefore pertinent to consider the factors that facilitate research in primary care. AIM To formulate hypotheses about effective ways of recruiting and retaining practices to clinical trials, based on a case study. DESIGN OF STUDY Case study of practice recruitment and retention to a trial of delivering antenatal sickle cell and thalassaemia screening. SETTING Two UK primary care trusts with 123 practices, with a high incidence of sickle cell and thalassaemia, and high levels of social deprivation. METHOD Practices were invited to take part in the trial using a research information sheet for practices. Invitations were sent to all practice managers, GPs, practice nurses, and nurse practitioners. Expenses of approximately pound 3000 per practice were available. Practices and the research team signed research activity agreements, detailing a payment schedule based on deliverables. Semi-structured interviews were completed with 20 GPs who participated in the trial. Outcome measures were the number of practices recruited to, and completing, the trial. RESULTS Four practices did not agree to randomisation and were excluded. Of 119 eligible practices, 29 expressed an interest in participation. Two practices withdrew from the trial and 27 participated (two hosted pilot studies and 25 completed the trial), giving a retention rate of 93% (27/29). The 27 participating practices did not differ from non-participating practices in list size, number of GPs, social deprivation, or minority ethnic group composition of the practice population. CONCLUSION Three factors appeared important in recruiting practices: research topic, invitation method, and interest in research. Three factors appeared important in retaining practices: good communication, easy data-collection methods, and payment upon meeting pre-agreed targets. The effectiveness of these factors at facilitating recruitment and retention requires assessment in experimental studies.

Undergoing prenatal screening for Down's syndrome: presentation of choice and information in Europe and Asia

To date, studies assessing whether the information given to people about screening tests facilitates informed choices have focussed mainly on the UK, US and Australia. The extent to which written information given in other countries facilitates informed choices is not known. The aim of this study is to describe the presentation of choice and information about Downs syndrome in written information about prenatal screening given to pregnant women in five European and two Asian countries. Leaflets were obtained from clinicians in UK, Netherlands, Spain, Italy, Czech Republic, China and India. Two analyses were conducted. First, all relevant text relating to the choice about undergoing screening was extracted and described. Second, each separate piece of information or statement about the condition being screened for was extracted and then coded as either positive, negative or neutral. Only Downs syndrome was included in the analysis since there was relatively little information about other conditions. There was a strong emphasis on choice and the need for discussion about prenatal screening tests in the leaflets from the UK and Netherlands. The leaflet from the UK gave most information about Downs syndrome and the smallest proportion of negative information. By contrast, the Chinese leaflet did not mention choice and gave the most negative information about Downs syndrome. Leaflets from the other countries were more variable. This variation may reflect cultural differences in attitudes to informed choice or a failure to facilitate informed choice in practice. More detailed studies are needed to explore this further.

Using the theory of planned behaviour to predict screening uptake in two contexts

Given current policy that decisions about screening should be based on informed choice, such decisions should reflect peoples values and attitudes. This prospective study compares the attitudes and other cognitive predictors of screening uptake in two contexts: when conducted as part of a routine visit and when it is conducted at a separate, test-specific visit. It was conducted in two hospitals in England, differing in method of screening organisation. 1499 pregnant women offered serum screening for Down Syndrome completed a questionnaire assessing theory of planned behaviour constructs: attitude towards undergoing the test, subjective norms of others, perceived behavioural control and intention to undergo the test. Intention predicted screening uptake in both screening settings, but more strongly when screening was part of a routine visit. Perceived behavioural control was not predictive of uptake, and only weakly predictive of intention in both settings. Subjective norm predicted intention more strongly when it referred to partner and friends than when it referred to health professionals, in both settings. Attitude was more strongly predictive of intention to attend screening when screening was organised as a part of routine screening, rather than requiring a separate visit. These results suggest that offering a screening test at a routine visit compared with a separate visit is more likely to facilitated uninformed choices, given the stronger association between attitudes and intention and the absence of an association with the perceived influence of health professionals.

Is informed choice in prenatal testing universally valued? A population‐based survey in Europe and Asia

Objective  Informed choice has become an integral part of healthcare provision. We investigated the extent to which informed choice in the context of prenatal testing is universally valued.

Offering antenatal sickle cell and thalassaemia screening to pregnant women in primary care: a qualitative study of women’s experiences and expectations of participation

Objective To describe the acceptability to women of being offered antenatal Sickle cell and Thalassaemia (SC&T) screening in primary and secondary care at the visit to confirm pregnancy; and to explore the implications of their views for participating in decisions about their health care.