Emesis in pregnancy - a qualitative study on trial recruitment failure from the EMPOWER internal pilot.

BACKGROUND: As part of the internal pilot of the EMPOWER trial investigating the second-line antiemetic therapies in severe emesis in pregnancy ( https://www.isrctn.com/ISRCTN16924692 ), a qualitative study of women's views was carried out, to improve our understanding of why women did, or did not, consent to participation in the trial. Interviews were also conducted with site research staff, to broaden our analysis and explore other factors affecting recruitment. METHODS: The sample comprised women who accepted or declined trial participation (n=21) and site research staff (n=22). A structured topic guide was used, in four email interviews and 17 telephone interviews with women, and semi-structured telephone interviews were carried out with staff. Of the women interviewed, seven had declined trial participation, and of the staff interviewed, 16 were research midwives/research nurses and six were principal investigators. All transcripts were checked for accuracy, anonymised and entered into NVIVO12 for indexing and retrieval. Data was analysed using a reflexive thematic analytic approach. In total, 72 codes were generated from the thematic analysis, and 36 from each sample group. RESULTS: Three key themes based on all the interviews were (a) the diversity of recruitment pathways and boundaries of care, (b) the impact of trial complexity on recruitment and staff morale and (c) the ethics of caring for a patient with emesis. Ethical issues discussed included the use of double dummy and time to treat, particularly those suffering severely from the effects of nausea and vomiting. To illustrate these themes, staff perspectives are given more prominence. CONCLUSIONS: The main reason the trial was stopped related to the high proportion of women ineligible for recruitment due to prior treatment with study drug(s) because of unanticipated changes in clinical practice. The qualitative results also demonstrate the impact of the trial on women and staff and highlight how the diversity of referral pathways, boundaries of care and the complexity of the trial and protocol resulted in additional barriers to successful trial recruitment. Qualitative work in pilot and feasibility studies of a clinical trial is recommended, to evaluate whether recruitment strategies remain viable in unanticipated contexts. TRIAL REGISTRATION: Trial registration number ISRCTN16924692 . Date: 08/01/2018.

How is high quality research evidence used in everyday decisions about induction of labour between pregnant women and maternity care professionals? An exploratory study.

OBJECTIVE: To explore the use of high quality research evidence in women's and maternity care professionals' decisions about induction of labour (IOL). METHODS: A qualitative study underpinned by a social constructionist framework, using semi-structured interviews and generative thematic analysis. SETTING: A large tertiary referral maternity unit in northern England in 2013/14. PARTICIPANTS: 22 randomly selected health care professionals involved in maternity care (midwives, obstetricians, maternity service managers), and 16 postnatal women, 3-8 weeks post-delivery, who were offered IOL in their most recent pregnancy. FINDINGS: Three themes were identified in the data; (1) the value of different forms of knowledge, (2) accessing and sharing knowledge, and (3) constrained pathways and default choices. Findings echo other evidence in suggesting that women do not feel informed about IOL or that they have choices about the procedure. This study illuminates potential explanatory factors by considering the complex context within which IOL is discussed and offered (e.g. presentation of IOL as routine rather than a choice, care pathways that make declining IOL appear undesirable, blanket use of clinical guidelines without consideration of individual circumstances and preferences). KEY CONCLUSIONS: This study suggests that organisational, social, and professional factors conspire towards a culture where (a) IOL has become understood as a routine part of maternity care rather than an intervention to make an informed choice about, (b) several factors contribute to demotivate women and health care practitioners from seeking to understand the evidence base regarding induction, and (c) health care professionals can find themselves ill-equipped to discuss the relative risks and benefits of IOL and its alternatives. IMPLICATIONS FOR PRACTICE: It is important that IOL is recognised as an optional intervention and is not presented to women as a routine part of maternity care. When IOL is offered it should be accompanied by an evidence informed discussion about the options available to support informed decision making. Health care professionals should be supported to understand the evidence base and our findings suggest that any attempt to facilitate this needs to acknowledge and tackle complex organisational, social and professional influences that contribute to current care practices.

A survey of health professionals' views on acceptable gestational age and termination of pregnancy for fetal anomaly.

Termination of pregnancy for fetal anomaly is legal in the UK with no upper limit, if two doctors, in good faith, agree "there is a substantial risk that if the child were born it would suffer from such physical or mental abnormalities as to be seriously handicapped". This is Clause E of the Human Fertlisation and Embryology Act. The most commonly sighted Clause is C, which states "the pregnancy has not exceeded its twenty-fourth week and that the continuance of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman". This study aimed to investigate health professionals' views on gestational age and acceptable termination of pregnancy for fetal anomaly (TOPFA). We undertook a questionnaire survey of UK health professionals working in fetal medicine, obstetrics and gynaecology and neonatology. A study pack consisting of a self-completion questionnaire, an invitation letter, participant information sheet, and a stamped addressed return envelope, were sent to health professionals. We used four fetal anomalies as case study examples in the questionnaire: isolated cleft lip, hypoplastic left heart, spina bifida and trisomy 21. These anomalies were chosen as they differed in terms of the type of anomaly, the type of impairment, and the perceived severity. Forty-one study packs were returned. For anomalies deemed less serious, later gestational ages were an important consideration when deciding acceptable TOPFA. The prognosis of an anomaly was considered an important factor in deciding whether a TOPFA was acceptable alongside gestational age. Clause C of the current UK legislation, which allows a legal termination prior to 24 weeks gestational age if continuing with the pregnancy would impact the mental health of the mother, was deemed a reasonable option for termination when parents are requesting a TOPFA. For each case study example, health professionals responded that TOPFA at '25 weeks and over' was acceptable (cleft lip n = 1; hypoplastic left heart n = 19; spina bifida n = 13 and Trisomy 21 n = 10). Professionals also distinguished between their personal and professional views. These findings offer new insight into how gestational age considerations influence professionals' conceptualisation of acceptable TOPFA.

Negotiating acceptable termination of pregnancy for non-lethal fetal anomaly: a qualitative study of professional perspectives.

OBJECTIVE: This study aims to explore the perspectives of professionals around the issue of termination of pregnancy for non-lethal fetal anomaly (TOPFA). METHODS: Semi-structured interviews were undertaken with medical professionals (14 consultants in fetal medicine, obstetrics, neonatology and paediatrics) and social care professionals (nine individuals with roles supporting people living with impairment) from the Northeast of England. Analysis adopted an inductive thematic approach facilitated by NVivo. RESULTS: The overarching theme to emerge from the interview data was of professionals, medical and social care, wanting to present an acceptable self-image of their views on TOPFA. Professionals' values on 'fixing', pain and 'normality' influenced what aspects of moral acceptability they gave priority to in terms of their standpoint and, in turn, their conceptualisations of acceptable TOPFA. Thus, if a termination could be defended morally, including negotiation of several key issues (including 'fixing', perceptions of pain and normality), then participants conceptualised TOPFA as an acceptable pregnancy outcome. CONCLUSION: Despite different professional experiences, these professional groups were able to negotiate their way through difficult terrain to conceptualise TOPFA as a morally acceptable principle. While professionals have different moral thresholds, no one argued for a restriction of the current legislation. The data suggest that social care professionals also look at the wider social context of a person with an impairment when discussing their views regarding TOPFA. Medical professionals focus more on the individual impairment when discussing their views on TOPFA.

MRI for Fetal Developmental Brain Abnormalities: Perspectives From the Pregnant Patient.

Ultrasound is routinely used as a prenatal screening and diagnostic tool but has limitations. Some anomalies in the developing fetal brain can be difficult to detect, and in utero magnetic resonance imaging (iuMRI) is increasingly used as an adjunct to ultrasound. However, understandings of patient perspectives of iuMRI technology are still developing. Our qualitative study of 41 mothers who experienced iuMRI was embedded in a diagnostic accuracy trial and aimed to inform policy recommendations that might stem from the clinical findings. Our analysis suggests that iuMRI is seen as useful, offering valuable additional information and helping women make decisions about care options at a difficult time. However, patients' experiences demonstrated the uncertainty and anxiety associated with the prenatal diagnosis (PND) process relating to brain anomalies including the challenges of their embodied contributions. Our findings suggest more could be done to reduce the impact on pregnant women during an already difficult, anxious period.

Understanding feticide: an analytic review.

The medical procedure of 'feticide' has been used in clinical practice since the early 1990s in the UK. The procedure constitutes a sensitive aspect of late termination of pregnancy (TOP), an issue that is in itself contentious. The procedure has attracted attention from academic and policy commentators, but recently the medical profession has expressed some uncertainty with respect to the legal position of live birth following TOP, and professional discretion in providing feticide. To understand the meaning of these comments better, we argue that it is helpful to acknowledge the rhetoric that shapes the academic discourse on feticide. In this paper, we review how feticide has been conceptualised within academic discourse, demonstrating that the concept has multiple meanings, some of which could be considered politically charged. We then consider some examples of the comments made about the legal uncertainties of feticide, highlighting assumptions made about the problematic nature of professional discretion. Ultimately, we suggest that a better understanding of the context of feticide is needed to ensure that future research in this area of health care engages adequately with issues of professional discretion.