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

Twenty-five years since the Shearman Report: How far have we come? Are we there yet?

© 2015 Published by Elsevier Australia. Background: In 1989, the first major state-wide report into maternity services, known as the Shearman Report after its author, was released in New South Wales, the most populous state in Australia. Aim: This paper reflects upon the report and tracks the progress of five of its key recommendations. The recommendations are still some of the major issues facing maternity services across the country. These are: community-based maternity care, rural maternity services, hospital visiting rights for privately practising midwives, obstetric intervention, and midwifery continuity of maternity care. Findings: In some ways, much has changed in 25 years including the terminology used in the report, the importance of midwifery continuity of care and the woman-centred nature of many services. However, in other ways, there is still a long way to go to address these major issues. Despite more than a quarter of a century, many recommendations have not been fulfilled, especially access to care in rural areas, rates of obstetric intervention, and the issue of visiting rights for privately practising midwives which has gone backwards. Conclusion: A continued and renewed effort is needed to ensure that the forward thinking recommendations of the Shearman Report are ultimately realised for all women and their families

Birthplace as the midwife's work place: How does place of birth impact on midwives?

© 2016 Australian College of Midwives Background In, many high and middle-income countries, childbearing women have a variety of birthplaces available to them including home, birth centres and traditional labour wards. There is good evidence indicating that birthplace impacts on outcomes for women but less is known about the impact on midwives. Aim To explore the way that birthplace impacts on midwives in Australia and the United Kingdom. Method A qualitative descriptive study was undertaken. Data were gathered through focus groups conducted with midwives in Australia and in the United Kingdom who worked in publicly-funded maternity services and who provided labour and birth care in at least two different settings. Findings Five themes surfaced relating to midwifery and place including: 1. practising with the same principles; 2. creating ambience: controlling the environment; 3. workplace culture: being watched 4. Workplace culture: “busy work” versus “being with” and 5. midwives’ response to place. Discussion While midwives demonstrate a capacity to be versatile in relation to the physicality of birthplaces, workplace culture presents a challenge to their capacity to “be with” women. Conclusion Given the excellent outcomes of midwifery led care, we should focus on how we can facilitate the work of midwives in all settings. This study suggests that the culture of the birthplace rather than the physicality is the highest priority

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

Lessons learned from measuring safety culture: An Australian case study

Background: adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. Aim: this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. Setting: the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. Design: a descriptive case study using three approaches: • Safety Attitudes Questionnaire and Safety Climate Scale surveys administered to maternity health professionals (59/210, 28% response rate) measured six safety culture domains: Safety climate, Teamwork climate, Job satisfaction, Perceptions of management, Stress recognition and Working conditions. • Semi-structured interviews (15) with key maternity, clinical governance and policy stakeholders augmented the survey data and explored the complex issues associated with safety culture. • A policy audit and chronological mapping of the key policies influencing safety culture identified through the surveys and interviews within the maternity service. Findings: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. Conclusion: the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture. Undertaking research in this way requires local engagement, commitment and capacity from the study site. The absence of these factors is likely to limit the practicality of this approach in the clinical setting. Significance: the use of safety culture surveys as the only method of assessing safety culture is of limited value in identifying strategies to potentially improve the safety culture. © 2010 Elsevier Ltd

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

Birth after caesarean section: Changes over a nine-year period in one Australian state

Objectives: to describe the outcomes related to birth after a caesarean section (CS) in one Australian state, New South Wales (NSW), over a nine-year period. The objectives were to determine whether changes had occurred in the rates of attempted and successful vaginal birth after caesarean section (VBAC), induction of labour, place of birth, admission to special care or neonatal intensive care nursery and perinatal mortality. Design and setting: cross-sectional analytic study of hospital births in New South Wales using population-based data from 1998-2006. Participants: women experiencing the next birth after a CS where: the total number of previous CS was 1; the presentation at birth was vertex; it was a singleton pregnancy; and, the estimated gestational age was greater than or equal to 37 weeks. A total of 53,455 women met these criteria. Measurements: data were obtained from NSW Health Department's Midwives Data Collection (MDC). The MDC includes all live births and stillbirths of at least 20 weeks gestation or 400. g birth weight in the state. Findings: over the nine-year period, the rate of vaginal birth after caesarean section declined significantly (31-19%). The proportion of women who 'attempted a vaginal birth' also declined (49-35%). Of those women who laboured, the vaginal birth rate declined from 64% to 53%. Babies whose mothers 'attempted' a VBAC were significantly less likely to require admission to a special care nursery (SCN) or neonatal intensive care (NICU). The perinatal mortality rate in babies whose mothers 'attempted' a VBAC was higher than those babies born after an elective caesarean section although the absolute numbers are very small. Key conclusions: rates of VBAC have declined over this nine-year period. Rates of neonatal mortality and proxy measures of morbidity (admission to a nursery) are generally in the low range for similar settings. Implications for practice: decisions around the next birth after CS are complex. Efforts to keep the first birth normal and support women who have had a CS to have a normal birth need to be made. More research to predict which women are likely to achieve a successful VBAC and the most effective ways to facilitate a VBAC is essential. Midwives have a critical role to play in these endeavours. © 2009 Elsevier Ltd