ÐÏࡱá>þÿ úüþÿÿÿøùÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥ÁU@ ø¿á:bjbj¬›¬› "ÞÎñÎñÌ2ÿÿÿÿÿÿˆNNNNNNNbêêê8"d†$b~ŽL¶¶¶¶¶¶¶¶³�µ�µ�µ�µ�µ�µ�$Ê�R“ÞÙ�N¶¶¶¶¶Ù�NN¶¶î�HÆÆÆ¶ÄN¶N¶³�ƶ³�ÆÆâ ~ƒƒ8NN �¶ª Pã'nÚþÄêz»†XW�\6ŽH~އøú“zLú“° �,bbNNNNú“N7� ¶¶Æ¶¶¶¶¶Ù�Ù�bbÄ&ÄÆbb&  Policy Briefing Social and Organisational Implications of One Stop First Trimester Prenatal Screening ESRC Award reference Number L218252042 Sandall,J.1 Lewando-Hundt,G.2 Spencer,K.3 Williams,C.1 Heyman,B.4 1 King’s College, London, 2 University of º£½ÇÉçÇø, 3 Barking, Havering and Redbridge NHS Trust, 4 City University Introduction UK policy guidelines state that the offer of screening for Down’s syndrome is to become a routine part of antenatal care. There may also be a shift to first trimester combined screening technologies, which achieve the greater level of accuracy required in the guidelines. This is accompanied by the move to first trimester combined screening technologies, which achieve a greater level of accuracy. This study of the only NHS site in England offering combined first trimester screening in a one stop clinic has provided the opportunity to look at implications prior to the possibility of wider scale implementation in the UK. The findings of this project are relevant for those using and delivering prenatal screening services, and those responsible for maternal health policy. What is the Innovative Health Technology ? Innovative health technologies (IHTs) – such as new drugs, devices, procedures, hospital delivery systems and wider organisational and socio-technical change present policymakers and the public with major new concerns. The study took place in two district hospitals, one offering innovative first trimester screening (combined Nuchal Translucency and Maternal Serum Screening within a one-stop clinic) and the other, standard second trimester Maternal Serum Sscreening (with results within 1 week). In the one stop clinic, women were screened earlier in pregnancy, and got results back faster, and with greater accuracy. Uptake in the innovative site was higher (95% vs 63%), and screening was integrated with routine antenatal care of booking bloods and the 11-13 week scan,care , thus avoiding a second separate screening visit. Aim, Design and Methods We aimed to explore and compare the risks and benefits of innovative and established models of prenatal screening primarily for Down’s syndrome. Specifically the: impact of new screening technologies on the social management of pregnancy, service delivery and professional roles ; participant’s broader responses to new technologies, and views about the routinisation of screening ; perceptions of self, the fetus, and the management of reproductive risk ; and lay and professional understanding of complex information, and influences on decision-making. A mixed method research design was used to separate out issues generic to all prenatal screening programmes as compared to those specific to the innovative technology. Findings are based on data collected from 2001 to 2004: prospective antenatal and postnatal surveys of 993 and 656 women respectively;; observation of 45 clinic/ultrasound sessions in hospital and the community;; interviews with 24 health professionals and a prospective cohort of 27 women and some partners on a range of screening pathways; and 90 audio-taped consultations. Key Findings Like all healthcare interventions, innovative health technologies offer benefits and harms and often have unintended consequences. These are as follows: What do women value ? * Over 90% of Most women in both sites valued said fast results, and , early screeningknowing results early in pregnancy were very important and having an early scan. In the standard site, 64% of those women who had screeningscreened paid for private screening (compared to 2% in the innovative site). P and payment was associated with social advantage. In addition, 75% of all women were prepared to pay for 1st trimester screening in a future pregnancy if it was not available free. * When women were asked what screening method they would prefer, if they got pregnant again, 79% of women said that combined screening at about 12 weeks was the their option. However, 19% of women in the standard site said none compared to 3% in the innovative site. * The NHS one-stop clinic offering first trimester screening provided what a large percentage of pregnant women in this study valued and wanted, and reduced inequities of access to first trimester screening for those women who wished to have it. Informed decision making Generic issues * Overall, 19% of women said prenatal screening was not fully discussed at booking, with significantly more women who were booked by healthcare assistants or GPs reporting this. * Overall, 30% of women reported that they would have liked more information than they were given, with significantly more women who: were under 21, having their first baby, or those who had no educationalwere either poorly educated qualifications or educated to degree level education reportinging this. Overall, 39% of women said that ‘options after the test’ were not discussed and 84% of women also reported that discussions of ‘what it is like to have a child with Down’s Syndrome’ never happened. * Overall, 39% of women said that ‘options after the test’ were not discussed and 84% of women reported that discussions of ‘what it is like to have a child with Down’s Syndrome’ never took place. * When asked if they felt under pressure to have screening, 6% of all women said yes , and this was associated with processes factors such as: not having as much time to decide;, not being able to discuss tests as much as they wanted;, and and with a positive attitude towards screening expressed by the health professional. Issues associated with Innovativeinnovative sitetechnology Uptake in the innovative site was 95% compared to 63% in the standard site, and screening was tightly integrated into the routine antenatal care of booking bloods and the 11-13 week dating scan. * In the innovative site, The routine and integrated nature of screening in the innovative site was reflected in 27% of women reporteding that they never really made up their mind, but went along with what was offered, compared to 4 % in the standard site. Furthermore, 45% of women in the innovative site answered that they had been “offered a screening test as part of routine care and it was assumed I would be having it” compared to 6% in the standard site. This suggests a tendency to ‘go with the flow’ in a service where screening is integrated into routine antenatal care. * A total of 67% of women in the innovative site, compared to 357% in the standard site reported professionals to be positive encouraging about screening. These positive views were reflected by women and their partners in the innovative site, andpartners reflected this pattern. Fewer women (32%) in the innovative site perceived health professionals as neutral compared to 62% in the standard site. Implications for women * There is little knowledge about the short and long term effects and implications of raised anxiety in women who are screened, and specifically in women who screen positive. * There is little known about how the experience of screening earlier pregnancy affects the ways women feel about pregnancy, birth and parenting, and whether this affects the decisions they make. * It is not known whether the increased routinisation and high uptake of screening makes it harder to opt out of, and whether women who choose not to accept may feel stigmatised. Practice Implications * The introduction of the one stop clinic had a significant impact on the social and organisational management of care, requiring a reorganisation of antenatal care involving GP’s, the hospital, sonographers, laboratory staff and midwives. * The overall impact on women of multiple screening provision needs to be taken into account as new screening systems are implemented. * The information needs of specific groups of women need greater attention, and will require different strategies. This includes a greater understanding of sources of information that women use apart from that provided by the NHS. * More attention needs to be given to the communication of risk information to women. * If the ideal of informed decision making is to be achieved, attention must be paid as to who should provide information, and the training needs of health professionals. Particularly GPs and health care assistants. * Additionally the timing of information giving needs to be reviewed in the light of how antenatal services are staffed and delivered. Wider Policy Implications * In the innovative site, fFirst trimester screening was popular with staff and women, and uptake was very high. However, shifting antenatal , making screening a routineto an ‘opt out’ rather than ‘opt in’ service’. This raises issues for informed choice and non-directive counselling. Staff attitudes are an important influence on uptake of screening tests. In such settings, non-directive information giving may be harder to achieve. * If an ethical screening policy is built on the concepts of informed choice and non-directiveness, then the implementation of routine first trimester screening will may further erode such practices, which are already often more rhetoric than reality. The pace at which first trimester screening is being introduced and the potential consequences of the resulting routinisation for an ethical screening policy need wider debate. * The pace at which first trimester screening is being introduced and the potential consequences of the resulting routinisation for an ethical screening policy need wider debate. * The current debates are dominated by ideals of technical accuracy and individual choice. Further research is needed on the range of social relations that shape how, and what policies are put forward and the social shaping of women’s choices. Practice Implications The information needs of some specific groups of women need greater attention and will require different strategies including a greater understanding of other sources of information that women use apart from that provided by the NHS. The overall impact on women of multiple screening system provision in pregnancy needs to be taken into account as new screening systems are implemented. More attention needs to be given to the communication of risk information to women. It should be considered who should provide information, and to the training of health professionals who provide advice if the ideal of informed consent is to be achieved. In particular, the role of GPs and healthcare assistants needs consideration. Additionally the timing of information giving needs to be reviewed. Implications for service users It is unknown whether there are any short or long term effects of wide scale routine screening in early pregnancy. The wider short and long term effects of raised anxiety are unknown on all women who are screened, and those who screen positive. It is unknown whether screening in early pregnancy affects how women feel about pregnancy, childbirth and parenting and the decisions they make. It is unknown whether the routinisation of screening may stigmatise women who prefer not to accept. Is it worth mentioning here that in terms of anxiety – birth is a bigger worry than screening and that many felt relieved after screening….. Contacting the project team The final report and further publications will be available on the ESRC and project project team websites.  HYPERLINK "http://www.york.ac.uk/res/iht/introduction.htm" http://www.york.ac.uk/res/iht/introduction.htm  HYPERLINK "http://www.regard.ac.uk/regard/home/index_html" http://www.regard.ac.uk/regard/home/index_html? Project leads Gillian Lewando-Hundt  HYPERLINK "mailto:gillian.hundt@warwick.ac.uk" gillian.hundt@warwick.ac.uk, 024765 23543  HYPERLINK "http://www2.warwick.ac.uk/fac/cross_fac/healthatwarwick/" http://www2.warwick.ac.uk/fac/cross_fac/healthatwarwick/ HYPERLINK ""  Jane Sandall,  HYPERLINK "mailto:jane.sandall@kcl.ac.uk" jane.sandall@kcl.ac.uk, Clare Williams,  HYPERLINK "mailto:clare.2.williams@kcl.ac.uk" clare.2.williams@kcl.ac.uk 0207 848 3023  HYPERLINK "http://www.kcl.ac.uk/nursing/research/women.html" http://www.kcl.ac.uk/nursing/research/women.html Kevin Spencer,  HYPERLINK "mailto:KevinSpencer1@aol.com" KevinSpencer1@aol.com 01708 708031Bob Heyman,  HYPERLINK "mailto:b.heyman@city.ac.uk" b.heyman@city.ac.uk 0207 040 5727  HYPERLINK "http://www.city.ac.uk/sonm/hcru/index.html" http://www.city.ac.uk/sonm/hcru/index.html  Gillian Lewando-Hundt  HYPERLINK "mailto:gillian.hundt@warwick.ac.uk" gillian.hundt@warwick.ac.uk, 024765 23543 http://www2.warwick.ac.uk/fac/cross_fac/healthatwarwick/ Jane Sandall,  HYPERLINK "mailto:jane.sandall@kcl.ac.uk" jane.sandall@kcl.ac.uk, 0207 848 3023.  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