Using the Zelen design in randomized controlled trials: Debates and controversies

Background. The use of the randomized consent design (commonly known as the Zelen design) is a controversial issue in randomized controlled trials. In the Zelen design, participants are randomly allocated prior to seeking consent. Those participants allocated to the intervention group are then approached and offered the intervention, which they can decline or accept. Zelen first proposed the design in 1979. It has been used infrequently since this time, although there are some notable exceptions in nursing, midwifery and some medical specialities. Aim. This paper describes the Zelen design, including the two forms used (the single and double consent versions) and discusses the advantages and disadvantages of using such a design. Methods. An explanation of the differences between the Zelen design and a conventional randomized controlled trial is presented. In a conventional design, detailed knowledge of the alternative interventions is given to the prospective participant. The participant gives consent and is allocated to one of the groups. In a Zelen design, participants are randomly allocated and then approached and offered the group to which they were allocated. The Zelen design is used firstly, to reduce disappointment bias in the conventional consent-randomization process, and secondly, to remove subjective bias in the recruitment process. There are concerns relating to the use of the Zelen design, including ethical concerns relating to the timing of random allocation and consent and the collection of clinical data. Conclusion. It is hoped that by presenting issues pertaining to the Zelen design, other nursing and midwifery researchers may be prompted to consider its use when designing clinical research. The Zelen design is controversial, and debate about its merits and shortcomings is useful. This paper contributes to the ongoing debate

Challenging midwifery care, challenging midwives and challenging the system

The purpose of this paper is to generate debate and discussion about the state of midwifery services in Australia today. While numerous reports have been published that highlight what women want in maternity care, widespread change has not occurred. This paper presents the story of Alice (a real woman with a fictitious name). Alice's story highlights the challenges that women face in dealing with a system that is often inflexible. While the health systems, and those who work within them, usually have the best intentions to try to provide the type of care that women want, they are not always successful. The paper summarises the evidence and support for models of continuity of midwifery care and outlines a series of strategies to ensure that change can occur. Finally, the paper challenges all midwives to work towards widespread, system-level change in Australian maternity services. © 2006 Australian College of Midwives

Estimating blood loss after birth: Using simulated clinical examples

Aim: To determine the accuracy of the estimation of blood loss using simulated clinical examples. Setting: Over 100 attendees came together at a seminar about postpartum haemorrhage in June 2006. Five blood loss assessment stations were constructed, each containing a simulated clinical example. Each station was numbered and was made up of a variety of equipment used in birthing suites. Over 5 L of 'artificial' blood was made. The artificial blood was similar to the colour and consistency of real blood. Sample: A convenience sample of 88 participants was given a response sheet and asked to estimate blood loss at each station. Participants included midwives, student midwives and an obstetrician. Results: Blood in a container (bedpan, kidney dish) was more accurately estimated than blood on sanitary pads, sheets or clothing. Lower volumes of blood were also estimated correctly by more participants than the higher volumes. Discussion: Improvements are still needed in visual estimation of blood loss following childbirth. Education programs may increase the level of accuracy. Conclusion: We encourage other clinicians and educators to embark upon a similar exercise to assist midwives and others to improve their visual estimation of blood loss after birth. Accurate estimations can ensure that women who experience significant blood loss can receive appropriate care and the published rates of postpartum haemorrhage are correct. © 2007 Australian College of Midwives

Midwives experiences of removal of a newborn baby in New South Wales, Australia: Being in the 'head' and 'heart' space

© 2015 Australian College of Midwives. Background: A newborn baby is removed from his/her mother into formal care when he/she is considered at risk of serious harm and it is not in the best interests to go home with their parent(s) or carer(s). In New South Wales (NSW), this removal is known as an "assumption of care". This process is challenging for all involved especially when it occurs soon after birth. There is very limited research to inform midwives in this area of practice. Aim: To explore the experiences of midwives who had been involved in the assumption of care of a baby soon after birth or in the early postnatal period. Method: A qualitative descriptive approach was used. Ten midwives involved with the assumption of care of a baby were interviewed. A thematic analysis was undertaken. Findings: There were two overarching themes. "Being in the head space" represented the activities, tasks and/or processes midwives engaged in when involved in an assumption of care. "Being in the heart space" described the emotional impact on midwives, as well as their perceptions on how women were affected. Conclusion: Midwives described feeling unprepared and unsupported, in both the processes and the impact of assumption of care. They were confronted by this profound emotional work and described experiencing professional grief, similar to that felt when caring for a woman experiencing a stillbirth. In the future, midwives need to be provided with support to ensure that they can effectively care for these women and also manage the emotional impact themselves

The role of intermediaries in the transition to district heating

For those countries, such as the UK, in which district heating and cooling has previously played little role in the energy system, the technology often struggles to break through the numerous and complex barriers to its introduction in the context of liberalised energy markets and competition with incumbent technologies such as natural gas networks. Progress is often slow and best practice is yet to be established. ‘Intermediaries’ are actors who facilitate knowledge sharing and build actor networks to enable the introduction of new technologies. This paper uses a case study of the UK to explore where and how the activities of these intermediary actors are currently supporting district heating development. An innovative method called a ‘decision theatre’ was used to collect empirical evidence from a range of local stakeholders involved in district heating projects. This method, which took place in the format of a group workshop, enables understanding of the interactions between stakeholders through each stage of the district heating development process. Lessons are drawn from this case study with regard to how intermediary activities can support the development of district heating in areas with little previous history of such systems. Three geographical scales of intermediary activity are identified (local, regional and national) as having different roles in enabling delivery of new district heating projects. Interactions between the three scales and how their roles might change as the sector develops are explored. The paper will highlight implications of the study for policymakers. In particular, a role is identified for intermediaries in creating a supportive institutional and policy environment that can enable development of large-scale, strategic networks

Initial infant feeding decisions and duration of breastfeeding in women from English, Arabic and Chinese-speaking backgrounds in Australia.

Anecdotally, concerns are often expressed about the varying infant feeding decisions among women from different cultural groups. This paper reports the early infant feeding decisions and duration of breastfeeding in 986 women from English, Chinese and Arabic-speaking backgrounds in Sydney during 1997 and 1998. Data were collectedfrom an audit of medical records and through a questionnaire at eight weeks postpartum. Chinese-speaking women were less likely to express an intention to breastfeed and fewer initiated breastfeeding compared with other women. Arabic-speaking women had significantly longer duration rates compared with other women. A greater proportion of the Chinese-speaking women who initiated breastfeeding were still breastfeeding at eight weeks compared with English-speaking women. This study suggests that there are differences in the infant feeding decisions between English, Arabic and Chinese-speaking women. Clinicians need to further understand cultural differences when providing care, education and support in a multicultural context

Publicly-funded homebirth models in Australia

Background: Publicly-funded homebirth programs in Australia have been developed in the past decade mostly in isolation from each other and with limited published evaluations. There is also distinct lack of publicly available information about the development and characteristics of these programs. We instigated the National Publicly-funded Homebirth Consortium and conducted a preliminary survey of publicly-funded homebirth providers. Aim: To outline the development of publicly-funded homebirth models in Australia. Methods: Providers of publicly-funded homebirth programs in Australia were surveyed using an on-line survey in December 2010. Questions were about their development, use of policy and general operational issues. A descriptive analysis of the quantitative data and content analysis of the qualitative data was undertaken. Findings: In total, 12 programs were identified and 10 contributed data to this paper. The service providers reported extensive multidisciplinary consultation and careful planning during development. There was a lack of consistency in data collection throughout the publicly-funded homebirth programs due to different databases, definitions and the use of different guidelines. Discussion: Publicly-funded homebirth services followed different routes during their development, but essentially had safety and collaboration with stakeholders, including women and obstetricians, as central to their process. Conclusion: The National Publicly-funded Homebirth Consortium has facilitated a sharing of resources, processes of development and a linkage of homebirth services around the country. This analysis has provided information to assist future planning and developments in models of midwifery care. It is important that births of women booked to these programs are clearly identified when their data is incorporated into existing perinatal datasets. © 2011 Australian College of Midwives

The experiences of new graduate midwives working in midwifery continuity of care models in Australia

© 2015 Elsevier Ltd. Background: Midwifery continuity of care has been shown to be beneficial to women through reducing interventions and other maternal and neonatal morbidity. In Australia, numerous government reports recognise the importance of midwifery models of care that provide continuity. Given the benefits, midwives, including new graduate midwives, should have the opportunity to work in these models of care. Historically, new graduates have been required to have a number of years' experience before they are able to work in these models of care although a small number have been able to move into these models as new graduates. Aim: to explore the experiences of the new graduate midwives who have worked in midwifery continuity of care, in particular, the support they received; and, to establish the facilitators and barriers to the expansion of new graduate positions in midwifery continuity of care models. Method: a qualitative descriptive study was undertaken framed by the concept of continuity of care. Findings: the new graduate midwives valued the relationship with the women and with the group of midwives they worked alongside. The ability to develop trusting relationships, consolidate skills and knowledge, be supported by the group and finally feeling prepared to work in midwifery continuity of care from their degree were all sub-themes. All of these factors led to the participants feeling as though they were 'becoming a real midwife'. Conclusions: this is the first study to demonstrate that new graduate midwives value working in midwifery continuity of care - they felt well prepared to work in this way from their degree and were supported by midwives they worked alongside. The participants reported having more confidence to practice when they have a relationship with the woman, as occurs in these models

Narrowing the Gap? Describing women's outcomes in Midwifery Group Practice in remote Australia

© 2016 Australian College of Midwives Background In Australia, Aboriginal women and babies experience higher maternal and perinatal morbidity and mortality rates than their non-Aboriginal counterparts. Whilst midwifery led continuity of care has been shown to be safe for women and their babies, with benefits including reducing the preterm birth rate, access to this model of care in remote areas remains limited. A Midwifery Group Practice was established in 2009 in a remote city of the Northern Territory, Australia, with the aim of improving outcomes and access to midwifery continuity of care. Aim The aim of this paper is to describe the maternal and newborn outcomes for women accessing midwifery continuity of care in a remote context in Australia. Methods A retrospective descriptive design using data from two existing electronic databases was undertaken and analysed descriptively. Findings In total, 763 women (40% of whom were Aboriginal) gave birth to 769 babies over a four year period. There were no maternal deaths and the rate of perinatal mortality was lower than that across the Northern Territory. Lower rates of preterm birth (6%) and low birth weight babies (5%) were found in comparison to population based data. Conclusion Continuity of Midwifery Care can be effectively provided to remote dwelling Aboriginal women and appears to improve outcomes for women and their infants