Ethical considerations for choosing between possible models for using NIPD for aneuploidy detection

Recent scientific advances mean the widespread introduction of non-invasive prenatal diagnosis (NIPD) for chromosomal aneuploidies may be close at hand, raising the question of how NIPD should be introduced as part of antenatal care pathways for pregnant women. In this paper we examine the ethical implications of three hypothetical models for using NIPD for aneuploidy in state-funded healthcare systems and assess which model is ethically preferable. In comparing the models we consider their respective timings; how each model would fit with current screening and diagnostic tests offered to pregnant women; the implications of offering NIPD at different stages of pregnancy; and the potential for each model to support reproductive autonomy and informed decision-making. We conclude by favouring a model that would be offered at 11-13 weeks gestation, alongside existing combined screening, provided that this is accompanied by measures to maximise informed decision-making, for example provision of adequate pre- and post-test counselling. Key words: Genetic Screening/Testing, Genetic Counselling/Prenatal Diagnosis; ethics; aneuploidy; Down syndrome.This article was written by Dr Ainsley Newson during the time of her employment with the University of Bristol, UK (2006-2012). Self-archived in the Sydney eScholarship Repository with permission of Bristol University, Sept 2014

Ethical considerations for choosing between possible models for using NIPD for aneuploidy detection

Recent scientific advances mean the widespread introduction of non-invasive prenatal diagnosis (NIPD) for chromosomal aneuploidies may be close at hand, raising the question of how NIPD should be introduced as part of antenatal care pathways for pregnant women. In this paper we examine the ethical implications of three hypothetical models for using NIPD for aneuploidy in state-funded healthcare systems and assess which model is ethically preferable. In comparing the models we consider their respective timings; how each model would fit with current screening and diagnostic tests offered to pregnant women; the implications of offering NIPD at different stages of pregnancy; and the potential for each model to support reproductive autonomy and informed decision-making. We conclude by favouring a model that would be offered at 11-13 weeks gestation, alongside existing combined screening, provided that this is accompanied by measures to maximise informed decision-making, for example provision of adequate pre- and post-test counselling. Key words: Genetic Screening/Testing, Genetic Counselling/Prenatal Diagnosis; ethics; aneuploidy; Down syndrome.This article was written by Dr Ainsley Newson during the time of her employment with the University of Bristol, UK (2006-2012). Self-archived in the Sydney eScholarship Repository with permission of Bristol University, Sept 2014

Informed Consent and Trisomy Screening: Delineating Parent and Professional Interests

The landmark decision of Montgomery established that patients’ right to self-determination and autonomy underpins the doctrine of informed consent. However, a growing body of medical research routinely conclude that consent for trisomy screening is less than informed. Consent for trisomy screening is not a ‘one-off event’: it is a multistage and multifaceted process, requiring the involvement and integration of interprofessional practices across the pathway. However, Mordel exposed systemic frailties and disconnects in terms of the processes for securing parent consent for trisomy screening: a dimension often missed by medico-legal studies in this field. With the recent introduction of non-invasive prenatal testing (NIPT) and additional trisomies (Edwards’ and Patau’s Syndrome) to the traditional Down’s Syndrome screening programme, this has exacerbated existing concerns around parent decision-making and consent for screening. Using empirical methods, this study seeks to delineate parent and professional interests for providing and securing consent for trisomy screening

Ethnographic study of ICT-supported collaborative work routines in general practice

<p>Abstract</p> <p>Background</p> <p>Health informatics research has traditionally been dominated by experimental and quasi-experimental designs. An emerging area of study in organisational sociology is routinisation (how collaborative work practices become business-as-usual). There is growing interest in the use of ethnography and other in-depth qualitative approaches to explore how collaborative work routines are enacted and develop over time, and how electronic patient records (EPRs) are used to support collaborative work practices within organisations.</p> <p>Methods/design</p> <p>Following Feldman and Pentland, we will use 'the organisational routine' as our unit of analysis. In a sample of four UK general practices, we will collect narratives, ethnographic observations, multi-modal (video and screen capture) data, documents and other artefacts, and analyse these to map and compare the different understandings and enactments of three common routines (repeat prescribing, coding and summarising, and chronic disease surveillance) which span clinical and administrative spaces and which, though 'mundane', have an important bearing on quality and safety of care. In a detailed qualitative analysis informed by sociological theory, we aim to generate insights about how complex collaborative work is achieved through the process of routinisation in healthcare organisations.</p> <p>Discussion</p> <p>Our study offers the potential not only to identify potential quality failures (poor performance, errors, failures of coordination) in collaborative work routines but also to reveal the hidden work and workarounds by front-line staff which bridge the model-reality gap in EPR technologies and via which "automated" safety features have an impact in practice.</p

IDEAS Phase 2 project – Village Health Worker Scheme sustainability study in Gombe State, Nigeria: Protocol and topic guides

The IDEAS project sought to improve the health and survival of mothers and babies by understanding the factors that would contribute to making a Village Health Worker Scheme sustainable at scale across Gombe State, northeastern Nigeria, where survival rates for mothers and babies are low compared with many other low and middle-income countries, in part due to a shortage of trained health care workers and to low levels of community awareness about health care services available. The scheme was initially introduced by the Gombe State Primary Health Care Development Agency with implementation support from a national NGO, Society for Family Health, and external financial support. This collection comprises the protocol and semi-structured topic guides for three rounds of qualitative, in-depth interviews with key stakeholders from the Gombe State Primary Health Care Development Agency, and Society for Family Health in Sept 2017, Jan-Feb 2018 and Nov-Dec 2018. Focus group discussions were also held in Sept 2017 and Nov-Dec 2018 with local government area health service staff who now oversee the day to day running of the scheme, village health workers from two wards in the state, the primary health care staff who supervise them and members of the Ward Development Committees – local leaders responsible for community health. The final round of data collection also included four additional focus group discussions with women who had received support from village health workers and their children’s fathers

Summary care record early adopter programme: an independent evaluation by University College London.

Benefits The main potential benefit of the SCR is considered to be in emergency and unscheduled care settings, especially for people who are unconscious, confused, unsure of their medical details, or unable to communicate effectively in English. Other benefits may include improved efficiency of care and avoidance of hospital admission, but it is too early for potential benefits to be verified or quantified. Progress As of end April 2008, the SCR of 153,188 patients in the first two Early Adopter sites (Bolton and Bury) had been created. A total of 614,052 patients in four Early Adopter sites had been sent a letter informing them of the programme and their choices for opting out of having a SCR. Staff attitudes and usage The evaluation found that many NHS staff in Early Adopter sites (which had been selected partly for their keenness to innovate in ICT) were enthusiastic about the SCR and keen to see it up and running, but a significant minority of GPs had chosen not to participate in the programme and others had deferred participation until data quality improvement work was completed. Whilst 80 per cent of patients interviewed were either positive about the idea of having a SCR or ?did not mind?, others were strongly opposed ?on principle?. Staff who had attempted to use the SCR when caring for patients felt that the current version was technically immature (describing it as ?clunky? and ?complicated?), and were looking forward to a more definitive version of the technology. A comparable technology (the Emergency Care Summary) introduced in Scotland two years ago is now working well, and over a million records have been accessed in emergency and out-of-hours care. Patient attitudes and awareness Having a SCR is optional (people may opt out if they wish, though fewer than one per cent of people in Early Adopter sites have done so) and technical security is said to be high via a system of password protection and strict access controls. Nevertheless, the evaluation showed that recent stories about data loss by government and NHS organisations had raised concerns amongst both staff and patients that human fallibility could potentially jeopardise the operational security of the system. Despite an extensive information programme to inform the public in Early Adopter sites about the SCR, many patients interviewed by the UCL team were not aware of the programme at all. This raises important questions about the ethics of an ?implied consent? model for creating the SCR. The evaluation recommended that the developers of the SCR should consider a model in which the patient is asked for ?consent to view? whenever a member of staff wishes to access their record. Not a single patient interviewed in the evaluation was confident that the SCR would be 100 per cent secure, but they were philosophical about the risks of security breaches. Typically, people said that the potential benefit of a doctor having access to key medical details in an emergency outweighed the small but real risk of data loss due to human or technical error. Even patients whose medical record contained potentially sensitive data such as mental health problems, HIV or drug use were often (though not always) keen to have a SCR and generally trusted NHS staff to treat sensitive data appropriately. However, they and many other NHS patients wanted to be able to control which staff members were allowed to access their record at the point of care. Some doctors, nurses and receptionists, it seems, are trusted to view a person?s SCR, whereas others are not, and this is a decision which patients would like to make in real time

Supporting patient decision-making in non-invasive prenatal testing: a comparative study of professional values and practices in England and France

Background Non-invasive prenatal testing (NIPT), which can screen for aneuploidies such as trisomy 21, is being implemented in several public healthcare systems across Europe. Comprehensive communication and information have been highlighted in the literature as important elements in supporting women’s reproductive decision-making and addressing relevant ethical concerns such as routinisation. Countries such as England and France are adopting broadly similar implementation models, offering NIPT for pregnancies with high aneuploidy probability. However, we do not have a deeper understanding of how professionals’ counselling values and practices may differ between these contexts. Methods In this paper, we explore how professionals in England and France support patient decision-making in the provision of NIPT and critically compare professional practices and values. We draw on data from semi-structured interviews with healthcare professionals. Results Both English and French professionals emphasised values relating to patient choice and consent. However, understandings and application of these values into the practice of NIPT provision differed. English interviewees placed a stronger emphasis on interpreting and describing the process of counselling patients and clinical care through a “principle” lens. Their focus was on non-directiveness, standardisation, and the healthcare professional as “decision-facilitator” for patients. French interviewees described their approach through a “procedural” lens. Their focus was on formal consent, information, and the healthcare professional as “information-giver”. Both English and French professionals indicated that insufficient resources were a key barrier in effectively translating their values into practice. Conclusion Our findings illustrate that supporting patient choice in the provision of NIPT may be held as an important value in common on a surface level, but can be understood and translated into practice in different ways. Our findings can guide further research and beneficially inform practice and policy around NIPT provision

Improving the sustainability of hospital-based interventions: a study protocol for a systematic review

Introduction Sustaining effective interventions in hospital environments is essential to improving health outcomes, and reducing research waste. Current evidence suggests many interventions are not sustained beyond their initial delivery. The reason for this failure remains unclear. Increasingly research is employing theoretical frameworks and models to identify critical factors that influence the implementation of interventions. However, little is known about the value of these frameworks on sustainability. The aim of this review is to examine the evidence regarding the use of theoretical frameworks to maximise effective intervention sustainability in hospital-based settings in order to better understand their role in supporting long-term intervention use. Methods and analysis Systematic review. We will systematically search the following databases: Medline, AMED, CINAHL, Embase and Cochrane Library (CENTRAL, CDSR, DARE, HTA). We will also hand search relevant journals and will check the bibliographies of all included studies. Language and date limitations will be applied. We will include empirical studies that have used a theoretical framework (or model) and have explicitly reported the sustainability of an intervention (or programme). One reviewer will remove obviously irrelevant titles. The remaining abstracts and full-text articles will be screened by two independent reviewers to determine their eligibility for inclusion. Disagreements will be resolved by discussion, and may involve a third reviewer if required. Key study characteristics will be extracted (study design, population demographics, setting, evidence of sustained change, use of theoretical frameworks and any barriers or facilitators data reported) by one reviewer and cross-checked by another reviewer. Descriptive data will be tabulated within evidence tables, and key findings will be brought together within a narrative synthesis. Ethics and dissemination Formal ethical approval is not required as no primary data will be collected. Dissemination of results will be through peer-reviewed journal publications, presentation at an international conference and social media