Quality by Digital Design for Developing Platform RNA Vaccine and Therapeutic Manufacturing Processes.

Quality by digital design (QbDD) utilizes data-driven, mechanistic, or hybrid models to define and optimize a manufacturing design space. It improves upon the QbD approach used extensively in the pharmaceutical industry. The computational models developed in this approach identify and quantify the relationship between the product's critical quality attributes (CQAs) and the critical process parameters (CPPs) of unit operations within the manufacturing process. This chapter discusses the QbDD approach in developing and optimizing unit operations such as in vitro transcription, tangential flow filtration, affinity chromatography, and lipid nanoparticle (LNP) formulation in mRNA vaccine manufacturing. QbDD can be an efficient framework for developing a production process for a disease-agnostic product that requires extensive experimental and model-based process-product interaction characterization during the early process development phase.

An exploration of migrant women's perceptions of public health messages to reduce stillbirth in the UK: a qualitative study.

BACKGROUND: Stillbirth is a global public health priority. Within the United Kingdom, perinatal mortality disproportionately impacts Black, Asian and minority ethnic women, and in particular migrant women. Although the explanation for this remains unclear, it is thought to be multidimensional. Improving perinatal mortality is reliant upon raising awareness of stillbirth and its associated risk factors, as well as improving maternity services. The aim of this study was to explore migrant women's awareness of health messages to reduce stillbirth risk, and how key public health messages can be made more accessible. METHOD: Two semi-structured focus groups and 13 one to one interviews were completed with a purposive sample of 30 migrant women from 18 countries and across 4 NHS Trusts. RESULTS: Participants provided an account of their general awareness of stillbirth and recollection of the advice they had been given to reduce the risk of stillbirth both before and during pregnancy. They also suggested approaches to how key messages might be more effectively communicated to migrant women. CONCLUSIONS: Our study highlights the complexity of discussing stillbirth during pregnancy. The women in this study were found to receive a wide range of advice from family and friends as well as health professionals about how to keep their baby safe in pregnancy, they recommended the development of a range of resources to provide clear and consistent messages. Health professionals, in particular midwives who have developed a trusting relationship with the women will be key to ensuring that public health messages relating to stillbirth reduction are accessible to culturally and linguistically diverse communities.

Digestive health in pregnancy.

Women experience the physiological changes of pregnancy in a variety of ways. Changes in pregnancy are associated with changing hormone levels. These hormonal changes have an impact on all body systems. Midwives need to have an understanding of the changes so that they can enable women to manage their digestive health effectively. The midwife needs to be vigilant in history taking to understand the woman's experiences and to be able to offer appropriate support and advice. There are a number of conventional and alternative treatments that can help to prevent and alleviate symptoms. This article will consider the impact on the gastro-intestinal system and how changes can be managed.

Clinical hypnosis for labour and birth: a consideration.

Labour pain is one of the most important factors in shaping women's experiences of birth. Choice around pharmacological relief can be complex. Clinical hypnosis is a non-pharmacological option which a number of women have chosen to use, often paying privately to do so. Self hypnosis allows women the opportunity to take control of this technique. Research findings relating to the therapy vary; some trials have found positive effects by way of a reduction in use of pharmacological pain relief, oxytocin use and shortened first stage of labour. Inclusion of the therapy as a means to invoke relaxation and counter the effects of stress and anxiety alone may be valid reasons for consideration of its use. This article outlines the framework used in clinical hypnosis and discusses some of the issues relating to the evidence base for it.

Changes in the NHS.

The NHS is no stranger to restructure and change. Further restructure is currently taking place with the introduction of clinical commissioning. Moving to clinical commissioning will transfer responsibility for commissioning maternity services from primary care trusts (PCTs) working in collaboration with local maternity service providers and acute trusts to clinical commissioning groups (CCGs) working in partnership with health and wellbeing boards and the NHS commissioning board (NHSCB). This restructure aims to increase consultation with clinical service providers and to move service planning nearer to the service user. Maternity care provision is complex and challenging. Despite these challenges, restructures must enable services to reduce morbidity, increase efficiency and improve safety and women's experiences of maternity services.

Exploratory randomized controlled trial of hybrid obstetric simulation training for undergraduate students.

BACKGROUND: Introducing novel methods in undergraduate teaching of obstetrics and gynecology has been recommended. High-fidelity simulation of shoulder dystocia has been shown to improve skills of qualified maternity staff. We aimed to assess whether simulation is also useful for improving medical students' skills. METHODS: Twenty-four medical students were recruited. Training consisted of a high-fidelity simulation teaching session for all 24 students and a refresher session for which the same students were randomly allocated to two groups. Half attended a small-group tutorial (SGT) and half a simulation session with a patient-actor (hybrid simulation, HYB). Afterward, they were asked to deliver a baby with simulated shoulder dystocia. We assessed their practical skills and compared communication skills between SGT and HYB. Primary outcome measure was their communication score, using a validated scale. Secondary measure was the students' ability to deliver the baby appropriately. RESULTS: Posttraining, all students managed delivery appropriately. Group HYB had significantly higher median total patient perception scores (11 simulation versus 9 tutorial, P = 0.0239, Mann-Whitney) than SGT. CONCLUSION: High-fidelity simulation can be used to train and evaluate learning. The use of patient-actors during simulation improves students' communication skills. Future research should assess whether this translates into better communication with real patients.

Risk management standards in midwifery are no substitute for personal knowledge and accountability.

Integration of complementary therapies in maternity practice is an ever growing field. Midwives have burgeoning interest in and are increasingly using complementary therapies within their practice. Issues regarding knowledge and safety remain essential within midwifery care. It is possible that the use of complementary therapies during pregnancy is not always based on a foundation of adequate knowledge and therefore may not be completely safe. Risk management is essential, both within conventional maternity care and where there is integration of new practices, to ensure that client safety is paramount. In order for integration of complementary therapies into maternity care to be safe and effective policies must be developed based on a sound evidence base, parameters of practice must be clear institutionally and for individual practitioners, and education and training needs must be met.