Does introducing a dedicated early labour area improve birth outcomes? A pre-post intervention study.

PROBLEM: Women increasingly present to hospital in early labour, but admission before active labour contributes to overuse of interventions, poorer clinical and psychological outcomes, and higher healthcare costs. BACKGROUND: Innovative models of early labour care have so far not improved birth outcomes. AIM: To examine if reconfiguring the early labour service in a large Australian maternity service improved (1) the birth outcomes of women who presented in early labour and (2) alleviated bed blockages by decreasing length of stay in the Pregnancy Assessment and Observation Unit. METHODS: Pre-post intervention design, using routinely collected clinical data before and after the implementation of the reconfigured early labour service. FINDINGS: There were 527 women in pre-intervention cohort and 747 in the post-intervention cohort. The two groups were similar in age, body mass index, marital status, education level and gestation at birth. Post intervention, epidural use did not change significantly, but rates of amniotomy (35.7% vs. 49.9%, p = <0.001), meconium-stained liquor (20.1% vs 26.1%, p = 0.04), and neonatal nursery admission (2.7% vs. 5.8% p = 0.01) increased. The proportion of women staying in the Assessment unit more than two hours decreased, but not significantly. CONCLUSION: Changing the location and model of early labour care did not influence epidural use, nor improve women's birth outcomes. For women in early labour, admission to any location within the hospital may be as problematic as admission to birth suite specifically.

The influence of hospital location and 'level of care' on continuing professional development.

Healthcare workers core skills are reinforced and knowledge of latest developments ensured by undertaking systematic continuing professional development. The current study explored the impact of health facility location and level of care provided on the continuing professional development offered to maternity services healthcare workers in Victoria, Australia. An online survey of middle to senior management staff of 71 public and private health services as well as 7 professional bodies was conducted, yielding 114 participants. Analysis was by location (metropolitan or regional/rural) and level of care provided. The findings revealed Australian Health Practitioner Regulation Agency registration is the predominant requirement to provide continuing professional development to staff. Dedicated education departments or educators are significantly underrepresented in Level 1&2 facilities, while Level 5&6 facilities are more likely to provide breastfeeding continuing professional development. Metropolitan locations provided more wide-ranging programmes compared with rural/regional locations. Key enablers are the capacity to share resources, have access to external courses and simulation equipment/centres, and the provision of relevant and timely continuing professional development programmes, indicating that 'Educational hubs' with credentialed staff working from better resourced regional facilities could deliver a complete array of CPD programmes to lower level facilities.

Competencies and skill development in maternity care services in Victoria - A qualitative study.

In healthcare, continuing professional development is provided to ensure professional standards are maintained and for clinicians to remain fit to practice. The purpose of the study was to identify potential gaps or issues with continuing professional development in maternity services through consultations with key stakeholders and, in addition, to generate possible solutions or recommendations towards the development of a state wide continuing professional development program. The data was collected through semi-structured interviews of a purposive sample between June and August 2018. A thematic analysis was undertaken. Participants included a practicing midwife, allied health practitioner (physiotherapist), manager, healthcare educator, and an outlier service worker (maternal and child health nurse). Following the thematic analysis, four main themes (education, practitioner standards, programme monitoring and resources) were identified along with nine sub-themes. The results suggest organisations need to offer explicit support for staff to access to continuing professional development. In addition, the qualifications of facilitators of continuing professional development and/or consumer education are recommended to go beyond education levels required for registration. In this respect, some organisations credentialed their educators locally in a 'train the trainer' manner however, most participants supported professional preparation for the role of educator.

Informing the development midwifery standards for practice: A literature review for policy development.

AIM: To critically appraise and synthesise the literature regarding the role and scope of midwifery practice, specifically to inform the evidence based development of standards for practice for all midwives in Australia. DESIGN: A structured scoping review of the literature DATA SOURCES: CINAHL Complete, MEDLINE Complete and Cochrane Libraries databases, online and grey literature databases REVIEW METHODS: Comprehensive searches of databases used key words and controlled vocabulary for each database to search for publications 2006-2016. Studies were not restricted by research method. FINDINGS: There is no substantive body of literature on midwifery competency standards or standards for practice. From 1648 papers screened, twenty-eight papers were identified to inform this review. Eight studies including systematic reviews were annotated with three research papers further assessed as having direct application to this review. To inform the development of Midwife standards for practice, the comprehensive role of the midwife across multiple settings was seen to include: woman centred and primary health care; safe supportive and collaborative practice; clinical knowledge and skills with interpersonal and cultural competence. KEY CONCLUSIONS: Midwifery practice is not restricted to the provision of direct clinical care and extends to any role where the midwife uses midwifery skills and knowledge. This practice includes working in clinical and non-clinical relationships with the woman and other clients as well as working in management, administration, education, research, advisory, regulatory, and policy development roles. IMPLICATIONS FOR PRACTICE: This review articulates the definition, role and scope of midwifery practice to inform the development of contemporary standards for practice for the Australian midwife.

Transforming community prevention systems for sustained impact: embedding active implementation and scaling functions.

Traditional efforts to translate evidence-based prevention strategies to communities, at scale, have not often produced socially significant outcomes or the local capacity needed to sustain them. A key gap in many efforts is the transformation of community prevention systems to support and sustain local infrastructure for the active implementation, scaling, and continuous improvement of effective prevention strategies. In this paper, we discuss (1) the emergence of applied implementation science as an important type 3-5 translational extension of traditional type 2 translational prevention science, (2) active implementation and scaling functions to support the full and effective use of evidence-based prevention strategies in practice, (3) the organization and alignment of local infrastructure to embed active implementation and scaling functions within community prevention systems, and (4) policy and practice implications for greater social impact and sustainable use of effective prevention strategies.

Evaluating a standardised clinical assessment tool for pre-registration midwifery students: A cross-sectional survey of midwifery students and midwives in Australia.

BACKGROUND: Assessment of clinical competence is a core component of midwifery education. Clinical assessment tools have been developed to help increase consistency and overcome subjectivity of assessment. AIM: The study had two main aims. The first was to explore midwifery students and educators/clinical midwives' views and experiences of a common clinical assessment tool used for all preregistration midwifery programmes in Victoria and the University of South Australia. The second was to assess the need for changes to the tool to align with developments in clinical practice and evidence-based care. METHODS: A cross-sectional, web-based survey including Likert-type scales and open-ended questions was utilised. SETTING: Students enrolled in all four entry pathways to midwifery at seven Victorian and one South Australian university and educators/clinical midwives across both states. FINDINGS: One hundred and ninety-one midwifery students' and 86 educators/clinical midwives responded. Overall, students and educators/clinical midwives were positive about the Clinical Assessment Tool with over 90% reporting that it covered the necessary midwifery skills. Students and educators/clinical midwives reported high levels of satisfaction with the content of the learning tools. Only 4% of educators/clinical midwives and 6% of students rated the Clinical Assessment Tool as poor overall. Changes to some learning tools were necessary in order to reflect recent practice and evidence. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: A common clinical assessment tool for evaluating midwifery students' clinical practice may facilitate the provision of consistent, reliable and objective assessment of student skills and competency.

The BLEED pilot study: determining the usability of a medical device before the clinical trial.

AIM: To discuss the methods of a study which will aim to determine the usability of a medical device not yet approved for use in a clinical trial. BACKGROUND: The Blood Loss Estimation and Evaluation of Drape (BLEED) pilot aims to determine the usability of a drape which measures blood loss during third stage labour. Third stage blood loss is usually estimated visually. This method has been found to be inaccurate. The drape has been tested in developing countries overseas and has been found to more accurately measure third stage blood loss when compared with visual methods. The usability of the drape has not yet been evaluated. REVIEW METHODS: Before starting the BLEED pilot study, the risks to the participants were evaluated and the drape was determined to pose minimal risk of harm for participants. The pilot study will involve recruitment of women and health professionals who will use the drape to measure third stage blood loss and then complete a survey about their opinion of the drape's usability. The data will be used to determine the suitability of using the drape in a clinical trial. DISCUSSION: The benefits of pursing this programme of research outweigh the challenges. The drape has been validated as more accurate than visual estimation for evaluating blood loss during third stage labour, yet the usability has not been established and a clinical trial is needed. This programme of research will determine if routine use of this drape in research and practice is justified. CONCLUSION: This work will assist health professionals who are considering ways to improve clinical outcomes and will particularly inform researchers who are interested in piloting new devices in maternity care. While adherence to monitoring requirements and governance of clinical trials is essential, the system has become complicated for investigator-initiated research using devices. Despite these challenges, the authors of this paper believe that this research programme is justified. IMPLICATIONS FOR PRACTICE: The complexity of navigating documentation and governance required for clinical trials may deter some healthcare professionals who plan to initiate research that involves the use of a medical device. While adherence to monitoring requirements and governance of clinical research is essential, research involving the evaluation of emerging medical technologies can be complicated, particularly for an investigator-initiated (clinician) researcher who does not have the support of a biotech company. These issues may deter clinician researchers from initiating trials and impede their ability to implement clinical research. Despite the challenges, the effectiveness and safety of technologies must be evaluated for their effectiveness in improving clinical outcomes for patients.

Exploring the 'follow-through experience': a statewide survey of midwifery students and academics conducted in Victoria, Australia.

OBJECTIVE: Follow-through experiences (which enable midwifery students to experience continuity of care with individual women through pregnancy, labour and birth and the postnatal period) are a component of midwifery education programmes in Australia and the United Kingdom. Current accreditation standards in Australia require midwifery students to have a total of 20 continuity of care experiences with an average of 20 hours per woman over the duration of their course. There has been limited research regarding students' and academics' experiences of follow-through experiences; and there has been debate regarding the appropriate number of follow-through experiences in midwifery curricula. This study aimed to explore the follow-through experience from the perspective of midwifery students and academics in Victoria, Australia. DESIGN: cross-sectional design using a web-based survey. SETTING: Victoria, Australia. PARTICIPANTS: Students (n=401) and academics (n=35) from all seven universities in Victoria that offer accredited midwifery programmes including the Bachelor of Midwifery, Bachelor of Nursing/Bachelor of Midwifery double degree, Postgraduate Diploma of Midwifery and Masters of Midwifery (entry to practice). FINDINGS: Students and academics were in agreement that continuity of care is important to women. They considered the follow-through experience to be a unique and valuable learning opportunity and agreed that follow-through experiences should be included in midwifery education programmes. However, students and academics raised major concerns about the impact of follow-through experiences on students' capacity to meet university course requirements (such as missing lectures/tutorials and clinical placements), and spending extensive periods of time on-call both within and outside the university semester. Students and academics also reported concerns about the impact of follow-through experiences on students' personal lives, including paid employment and family responsibilities (such as childcare or caring for family members). KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: In settings where continuity of care options for women are relatively limited, prescriptive requirements regarding the number and hours of follow-through experiences can present significant challenges for midwifery students. Midwifery regulatory bodies should consider these findings when developing or revising standards for midwifery education.

Redesigning postnatal care: exploring the views and experiences of midwives.

OBJECTIVE: women have consistently rated postnatal care less favourably than other episodes of maternity care. Midwives have also reported concerns with postnatal care, with challenges related to workloads, busy environments and lack of staff. Given these concerns, a regional hospital in Victoria, Australia redesigned its postnatal care provision. The changes included cessation of routine postnatal observations and the use of clinical pathways for women who gave birth vaginally; promotion of rest through minimal disturbances before 9 am; discouraging the use of the call bell system except in emergency situations; introduction of 'one-to-one' time with women; and promotion of normalcy and independence. This paper examines midwives' views of the changes and their impressions of the effects of the changes on women and their infants. DESIGN: cross-sectional surveys of midwives were conducted six months after the changes to postnatal care were introduced then again, two years later. Midwives' views and experiences of the changes; the impact of the changes on confidence and autonomy of practice; views regarding the effect on women's satisfaction with care; and the perceived safety of the changes were explored. SETTING: a regional hospital in Victoria, Australia where approximately 2,000 births occur each year. PARTICIPANTS: permanent part-time and full-time midwives. FINDINGS: response rates were 64% (50/78) at baseline and 60% (50/84) two years later. Overall, midwives were supportive of, and complied with, the changes to postnatal care. They agreed that change was needed and believed that the new way of providing care would be better for women and increase individualised care. Midwives also agreed that the changes would facilitate rest for women, believed that removal of routine observations for women after a vaginal birth was safe and that it would allow more time with women. Over time, midwives were more likely to feel autonomous when providing postnatal care. However, some concerns were raised, mostly in relation to the challenges around postnatal documentation, care provision without the guidance of a care/clinical pathway, and about limiting the use of the call bell to only emergency situations. Midwives were not confident that the changes would necessarily translate to a measurable increase in women's satisfaction with care, and were not confident that the changes translated into more time to spend listening and providing support to women. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: overall, midwives were supportive of the changes and agreed that change to postnatal care was needed. Challenges remain around the most effective method of communication and documentation of postnatal care. It is important that when major changes to care provision are implemented that care providers' views and experiences are explored given their crucial role in the introduction and maintenance of changes and the potential impact on them as care providers.

Preclinical evaluation of the immunogenicity and safety of plasmid DNA-based prophylactic vaccines for human cytomegalovirus.

Human cytomegalovirus (CMV) establishes a lifelong persistent infection characterized by periods of latency and sporadic viral replication and is a major infectious cause of birth defects following congenital infection. Currently, no licensed vaccine is available that would prevent CMV infection. In an effort to develop a prophylactic CMV vaccine, the effects of different formulations, immunization routes and delivery devices on the immunogenicity of plasmid DNA (pDNA)-based vaccines were evaluated in rabbits and mice. Compared with PBS- and poloxamer-based formulations, significantly higher antibody responses were obtained with pDNA formulated with Vaxfectin (®) , a cationic lipid-based adjuvant. With low vaccine doses, the intradermal (ID) route resulted in higher antibody responses than obtained when the same dose was administered intramuscularly (IM). Since the IM route allowed injection of larger volumes and higher doses than could be administered at a single ID site, better antibody responses were obtained using the IM route. The needle-free injection system Biojector (®) 2000 and electroporation devices enhanced antibody responses only marginally compared with responses obtained with Vaxfectin (®) -formulated pDNA injected IM with a needle. A single-vial Vaxfectin (®) formulation was developed in a dosage form ready for use after thawing at room temperature. Finally, in a GLP-compliant repeat-dose toxicology study conducted in rabbits, single-vial Vaxfectin (®) -formulated vaccines, containing pDNA and Vaxfectin (®) up to 4.5 mg and 2 mg/injection, respectively, showed a favorable safety profile and were judged as well-tolerated. The results support further development of a Vaxfectin (®) -formulated pDNA vaccine to target congenital CMV infection.

Managing projected midwifery workforce deficits through collaborative partnerships.

To address workforce shortages, the Australian Government funded additional nursing and midwifery places in 2009 pre-registration courses. An existing deficit in midwifery clinical placements, combined with the need to secure additional clinical placements, contributed to a serious shortfall. In response, a unique collaboration between Midwifery Academics of Victoria (MIDAC), rural and metropolitan maternity managers (RMM and MMM) groups and Department of Health (DOH) Victoria was generated, in order to overcome difficulties experienced by maternity services in meeting the increased need. This group identified the large number of different clinical assessment tools required to be being completed by midwives supervising students as problematic. It was agreed that the development of a Common Assessment Tool (CAT) for use in clinical assessment across all pre-registration midwifery courses in Victoria had the potential to reduce workload associated with student assessments and, in doing so, release additional placements within each service. The CAT was developed in 2009 and implemented in 2010. The unique collaboration involved in the development of the CAT is a blueprint for future projects. The collaboration on this project provided a range of benefits and challenges, as well as unique opportunities for further collaborations involving industry, government, regulators and the tertiary sector.

Nonclinical biodistribution, integration, and toxicology evaluations of an H5N1 pandemic influenza plasmid DNA vaccine formulated with Vaxfectin®.

Vaxfectin(®) is a lipid-based adjuvant initially developed for use with plasmid DNA (pDNA) vaccines. Here we present detailed nonclinical assessments performed prior to Vaxfectin(®)'s first-in-man use, as an adjuvant in the H5N1 influenza vaccine VCL-IPT1. Following IM delivery to rabbits, VCL-IPT1 pDNA localized primarily to injection sites, where levels steadily declined over the 2 months examined. Risk of pDNA integration into genomic DNA was negligible. Toxicology studies in rabbits revealed mild inflammatory/immune responses at injection sites characteristic of IM vaccine delivery; Vaxfectin(®) directly contributed to these responses. These data support clinical development of H5N1 pDNA vaccines, and also present an encouraging profile for further development of Vaxfectin(®) as an adjuvant for vaccines in general.

Plasmid DNA-based vaccines protect mice and ferrets against lethal challenge with A/Vietnam/1203/04 (H5N1) influenza virus.

Plasmid DNA (pDNA) vaccines represent an alternative to conventional inactivated influenza vaccines that are likely to experience supply constraints during a pandemic. Several Vaxfectin-formulated pDNA vaccines were tested in mice and ferrets for efficacy against a lethal challenge with the highly pathogenic A/Vietnam/1203/04 (H5N1) influenza virus strain; the vaccines encoded influenza A virus hemagglutinin (HA), and/or nucleoprotein (NP), and M2 protein. Complete protection from death and disease was achieved in mice and ferrets with 2 doses of a Vaxfectin-formulated vaccine containing H5 HA, NP, and M2 plasmids and in ferrets with only 1 dose. A Vaxfectin-formulated vaccine containing NP and M2 pDNA provided significant protection against death in mice and provided some benefit in ferrets (i.e., 17% survival, delayed time to illness and death, and significant reduction in viral load compared with that in negative control animals). These experiments support the clinical testing of pDNA vaccine candidates that may ultimately increase global vaccine supply options during pandemics.

Comparison of rabbit and mouse models for persistence analysis of plasmid-based vaccines.

Experiments were conducted with a cationic lipid-formulated pDNA vaccine (VCL-AB01) to evaluate the models used to determine biodistribution, persistence and the potential for integration (into genomic DNA) of plasmid DNA-based vaccines. Mice were injected with a high-dose volume of 50 microL unilaterally containing approximately 1.33 x 10(13) plasmid copy numbers (PCN) or a low-dose volume of 20 microL bilaterally ( approximately 5.3 x 10(12) PCN). Rabbits were injected bilaterally with a 0.5 mL ( approximately 1.33 x 10(14) PCN) volume. Injection site muscle tissue was harvested two days, one month, and two months postinjection for the low-dose murine and rabbit models and two days and two months postinjection for the high-dose murine model. Total DNA was extracted and analyzed by real-time quantitative PCR for sequences specific to the injected pDNA. The geometric mean PCN/microg of total DNA from the high and low dose models were compared to determine if injection volume impacts clearance and/or persistence. Results from these studies showed that PCN clearance over two months was similar in mice injected with 20 microL and rabbits injected with 0.5 mL, but PCN clearance was slower in mice injected with similar PCN in 50 microL (1.33 x 10(13) PCN) compared to 20 microL (5.3 x 10(12) PCN). Persistence at two months in the rabbit and low-dose murine models was comparable, with geometric mean of 5.22 x 10(3) PCN/microg of total DNA for the low-dose volume murine model and 2.81 x 10(3)/microg DNA for the rabbit model. Interanimal variability in persistence was not impacted by dose volume.