Intravenous ferric carboxymaltose versus oral ferrous sulphate for the treatment of moderate to severe postpartum anaemia in Nigerian women (IVON-PP): protocol for an open-label randomised controlled type 1 hybrid effectiveness-implementation trial.

INTRODUCTION: Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50-80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted. OBJECTIVE: To determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria. METHODS AND ANALYSIS: This study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration <100 g/L) will be randomised to intravenous ferric carboxymaltose; a single dose at 20 mg/kg to a maximum of 1000 mg infusion administered at enrolment (intervention) or oral ferrous sulphate; 200 mg (65 mg elemental iron) two times per day from enrolment until 6 weeks postpartum (control). The primary outcome, proportion of participants who are anaemic (Hb <110 g/L) at 6 weeks postpartum will be analysed by intention-to-treat. Haemoglobin concentration, full blood count, serum iron, serum ferritin, transferrin saturation and total iron binding capacity will be measured at specific intervals. Implementation outcomes such as acceptability and feasibility of using ferric carboxymaltose for postpartum anaemia treatment in Nigeria will be assessed. ETHICS AND DISSEMINATION: This study is approved by the ethics committee of the teaching hospitals, Ministry of Health of the four states as required, National Health Research Ethics Committee and the drug regulatory agency, National Agency for Food and Drug Administration and Control (NAFDAC). Findings of this research will be presented at conferences and will be published in international peer-reviewed journals and shared with stakeholders within and outside Nigeria. TRIAL REGISTRATION NUMBER: International standard randomised controlled trial number: ISRCTN51426226.

Emollient application from birth to prevent eczema in high-risk children: the BEEP RCT.

Background: Atopic eczema is a common childhood skin problem linked with asthma, food allergy and allergic rhinitis that impairs quality of life. Objectives: To determine whether advising parents to apply daily emollients in the first year can prevent eczema and/or other atopic diseases in high-risk children. Design: A United Kingdom, multicentre, pragmatic, two-arm, parallel-group randomised controlled prevention trial with follow-up to 5 years. Setting: Twelve secondary and four primary care centres. Participants: Healthy infants (at least 37 weeks' gestation) at high risk of developing eczema, screened and consented during the third trimester or post delivery. Interventions: Infants were randomised (1 : 1) within 21 days of birth to apply emollient (Doublebase Gel®; Dermal Laboratories Ltd, Hitchin, UK or Diprobase Cream®) daily to the whole body (excluding scalp) for the first year, plus standard skin-care advice (emollient group) or standard skin-care advice only (control group). Families were not blinded to allocation. Main outcome measures: Primary outcome was eczema diagnosis in the last year at age 2 years, as defined by the UK Working Party refinement of the Hanifin and Rajka diagnostic criteria, assessed by research nurses blinded to allocation. Secondary outcomes up to age 2 years included other eczema definitions, time to onset and severity of eczema, allergic rhinitis, wheezing, allergic sensitisation, food allergy, safety (skin infections and slippages) and cost-effectiveness. Results: One thousand three hundred and ninety-four newborns were randomised between November 2014 and November 2016; 693 emollient and 701 control. Adherence in the emollient group was 88% (466/532), 82% (427/519) and 74% (375/506) at 3, 6 and 12 months. At 2 years, eczema was present in 139/598 (23%) in the emollient group and 150/612 (25%) in controls (adjusted relative risk 0.95, 95% confidence interval 0.78 to 1.16; p = 0.61 and adjusted risk difference -1.2%, 95% confidence interval -5.9% to 3.6%). Other eczema definitions supported the primary analysis. Food allergy (milk, egg, peanut) was present in 41/547 (7.5%) in the emollient group versus 29/568 (5.1%) in controls (adjusted relative risk 1.47, 95% confidence interval 0.93 to 2.33). Mean number of skin infections per child in the first year was 0.23 (standard deviation 0.68) in the emollient group versus 0.15 (standard deviation 0.46) in controls; adjusted incidence rate ratio 1.55, 95% confidence interval 1.15 to 2.09. The adjusted incremental cost per percentage decrease in risk of eczema at 2 years was £5337 (£7281 unadjusted). No difference between the groups in eczema or other atopic diseases was observed during follow-up to age 5 years via parental questionnaires. Limitations: Two emollient types were used which could have had different effects. The median time for starting emollients was 11 days after birth. Some contamination occurred in the control group (< 20%). Participating families were unblinded and reported on some outcomes. Conclusions: We found no evidence that daily emollient during the first year of life prevents eczema in high-risk children. Emollient use was associated with a higher risk of skin infections and a possible increase in food allergy. Emollient use is unlikely to be considered cost-effective in this context. Future research: To pool similar studies in an individual patient data meta-analysis. Trial registration: This trial is registered as ISRCTN21528841. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/67/12) and is published in full in Health Technology Assessment; Vol. 28, No. 29. See the NIHR Funding and Awards website for further award information.

Eczema is a troublesome itchy skin condition affecting 1 in 5 children and 1 in 10 UK adults. There is no cure and affected children are more likely to develop food allergies. We wanted to see if we could prevent eczema by protecting the skin of babies at higher risk of developing eczema (with an immediate relative with eczema, asthma or hay fever) with moisturisers used to treat dry skin. Previous research suggested that protecting the skin barrier might also prevent food allergy. One thousand three hundred and ninety-four families took part in a study; half of them were asked to apply moisturiser every day to their newborn baby for the first year and half to look after their baby's skin in the normal way. At the age of 2 years, we did not see any difference in how common eczema was between the two groups: 23% had eczema in the moisturiser group and 25% in the normal care group. It did not matter how we defined eczema ­ whether examined by a researcher or parent report. We did not find any differences in related conditions like asthma or hay fever either. We found that children using moisturisers had seen their doctor slightly more often for mild skin infections. There was a hint that food allergy might have been increased in the moisturiser group, but there was not enough data to be sure. We followed up the children to age 5 years, but we still did not find any benefits from using moisturisers in early life. Since this study, other similar research has been done using newer types of moisturisers, but their results are the same. This study shows that using daily moisturisers on healthy babies with a high risk of eczema does not prevent eczema. It is one less thing for busy families to worry about.

The acceptability of group B streptococcal bacteria (GBS) testing to women, including self-swabbing procedures: A qualitative study.

BACKGROUND: Group B streptococcus (GBS) is a bacterium carried by 20-25 % of pregnant women in the UK, which can be transmitted from pregnant women to their babies at the time of birth. Women can be tested for GBS in pregnancy using a vaginal-rectal swab, however, this testing is currently not routinely offered in the UK. A large clinical trial is underway to determine the clinical and cost-effectiveness of routine testing (ISRCTN reference number ISRCTN49639731). A crucial part of understanding whether this type of test should be implemented is women's views on the acceptability of being offered GBS tests, their preferences towards testing procedures and their willingness to receive these tests. AIM: To explore women's views on the acceptability of different methods of Group B streptococcal bacteria (GBS) testing in pregnancy, including self-swabbing procedures. METHODS: A convenience sample of 19 women (5 pregnant and 14 postpartum) were interviewed using a semi-structured interview guide. Interviews were transcribed and analysed using systematic thematic analysis. RESULTS: Findings show that many of the women interviewed were not concerned about being offered a GBS test, were willing to provide a sample and felt positive towards samples being taken to detect GBS. Women varied in their preferences on the best time for sampling. Some thought being approached during pregnancy gave them time to understand the purpose of testing, prepare for what may happen next and ask questions about potential treatment if needed. Others thought labour was a good time to provide accurate results on GBS carriage at birth and reduce unnecessary worry during pregnancy. However, women were concerned that they may be unable to make an informed decision in labour due to time, pain and the prospect of birthing quickly. Women perceived clinician swabbing as more accurate than self-sampling; however, many thought clinician swabbing might be embarrassing so self-swabs should be available to increase uptake for some women. CONCLUSIONS: Overall, women thought both pregnancy and labour were acceptable times to test for GBS. The majority found both clinician and self-swabbing procedures acceptable; however, many had a preferred swabbing option and thought women should be given the choice of the swabbing procedure most acceptable to them. It is important that women are given information about GBS testing and its procedures in pregnancy regardless of when the GBS swabbing is performed.

A mixed-methods study to investigate feasibility and acceptability of an early warning score for preterm infants in neonatal units in Kenya: results of the NEWS-K study : Neonatal early warning scores in Kenya.

Preterm birth (< 37 weeks gestation) complications are the leading cause of neonatal mortality. Early-warning scores (EWS) are charts where vital signs (e.g., temperature, heart rate, respiratory rate) are recorded, triggering action. To evaluate whether a neonatal EWS improves clinical outcomes in low-middle income countries, a randomised trial is needed. Determining whether the use of a neonatal EWS is feasible and acceptable in newborn units, is a prerequisite to conducting a trial. We implemented a neonatal EWS in three newborn units in Kenya. Staff were asked to record infants' vital signs on the EWS during the study, triggering additional interventions as per existing local guidelines. No other aspects of care were altered. Feasibility criteria were pre-specified. We also interviewed health professionals (n = 28) and parents/family members (n = 42) to hear their opinions of the EWS. Data were collected on 465 preterm and/or low birthweight (< 2.5 kg) infants. In addition to qualitative study participants, 45 health professionals in participating hospitals also completed an online survey to share their views on the EWS. 94% of infants had the EWS completed at least once during their newborn unit admission. EWS completion was highest on the day of admission (93%). Completion rates were similar across shifts. 15% of vital signs triggered escalation to a more senior member of staff. Health professionals reported liking the EWS, though recognised the biggest barrier to implementation was poor staffing. Newborn unit infant to staff ratios varied between 10 and 53 staff per 1 infant, depending upon time of shift and staff type. A randomised trial of neonatal EWS in Kenya is possible and acceptable, though adaptations are required to the form before implementation.

Mental health integrated care models in primary care and factors that contribute to their effective implementation: a scoping review.

BACKGROUND: In the state of Victoria, Australia, the 111-day lockdown due to the COVID-19 pandemic exacerbated the population's prevailing state of poor mental health. Of the 87% of Australians who visit their GP annually, 71% of health problems they discussed related to psychological issues. This review had two objectives: (1) To describe models of mental health integrated care within primary care settings that demonstrated improved mental health outcomes that were transferable to Australian settings, and (2) To outline the factors that contributed to the effective implementation of these models into routine practice. METHODS: A scoping review was undertaken to synthesise the evidence in order to inform practice, policymaking, and research. Data were obtained from PubMed, CINAHL and APA PsycINFO. RESULTS: Key elements of effective mental health integrated care models in primary care are: Co-location of mental health and substance abuse services in the primary care setting, presence of licensed mental health clinicians, a case management approach to patient care, ongoing depression monitoring for up to 24 months and other miscellaneous elements. Key factors that contributed to the effective implementation of mental health integrated care in routine practice are the willingness to accept and promote system change, integrated physical and mental clinical records, the presence of a care manager, adequate staff training, a healthy organisational culture, regular supervision and support, a standardised workflow plan and care pathways that included clear role boundaries and the use of outcome measures. The need to develop sustainable funding mechanisms has also been emphasized. CONCLUSION: Integrated mental health care models typically have a co-located mental health clinician who works closely with the GP and the rest of the primary care team. Implementing mental health integrated care models in Australia requires a 'whole of system' change. Lessons learned from the Mental Health Nurse Incentive Program could form the foundation on which this model is implemented in Australia.

Factors influencing nursing and allied health recent graduates' rural versus urban preferred principal place of practice: A cross-sectional data linkage study.

INTRODUCTION: Disparities between metropolitan and non-metropolitan health workforce must be addressed to reduce inequities in health care access. Understanding factors affecting early career practitioners' choice of practice location can inform workforce planning. OBJECTIVE: To investigate influences on rural practice location preferences of recent graduates. DESIGN: Cross-sectional analysis linked university enrolment, Graduate Outcomes Survey (GOS) and Australian Health Professional Regulation Agency (Ahpra) principal place of practice (PPP) for 2018 and 2019 nursing and allied health graduates from two Australian universities. Chi-squared tests and logistic regression compared rural versus urban PPP and locational preference. FINDINGS: Of 2979 graduates, 1295 (43.5%) completed the GOS, with 63.7% (n = 825) working in their profession and 84.0% of those (n = 693) in their preferred location. Ahpra PPP data were extracted for 669 (81.1%) of those working in their profession. Most reported influences were 'proximity to family/friends' (48.5%), 'lifestyle of the area' (41.7%) and 'opportunity for career advancement' (40.7%). Factors most influential for rural PPP were 'cost of accommodation/housing' (OR = 2.26, 95% CI = 1.23-4.17) and 'being approached by an employer' (OR = 2.10, 95% CI = 1.12-3.92). Having an urban PPP was most influenced by 'spouse/partners employment/career' (OR = 0.53, 95% CI = 0.30-0.93) and 'proximity to family/friends' (OR = 0.41, 95% CI = 0.24-0.72). DISCUSSION: While the findings add strength to the understanding that graduates who originated from a rural area are most likely to take up rural practice in their preferred location, varied social and professional factors are influential on decision-making. CONCLUSIONS: It is imperative to recruit students from non-metropolitan regions into health professional degrees, as well as addressing other influences on choice of practice location.

Emollients for preventing atopic eczema: Cost-effectiveness analysis of the BEEP trial.

BACKGROUND: Recent discoveries have led to the suggestion that enhancing skin barrier from birth might prevent eczema and food allergy. OBJECTIVE: To determine the cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children at 2 years from a health service perspective. We also considered a 5-year time horizon as a sensitivity analysis. METHODS: A within-trial economic evaluation using data on health resource use and quality of life captured as part of the BEEP trial alongside the trial data. Parents/carers of 1394 infants born to families at high risk of atopic disease were randomised 1:1 to the emollient group, which were advised to apply emollient (Doublebase Gel or Diprobase Cream) to their child at least once daily to the whole body during the first year of life or usual care. Both groups received advice on general skin care. The main economic outcomes were incremental cost-effectiveness ratio (ICER), defined as incremental cost per percentage decrease in risk of eczema in the primary cost-effectiveness analysis. Secondary analysis, undertaken as a cost-utility analysis, reports incremental cost per Quality-Adjusted Life Year (QALY) where child utility was elicited using the proxy CHU-9D at 2 years. RESULTS: At 2 years, the adjusted incremental cost was £87.45 (95% CI -54.31, 229.27) per participant, whilst the adjusted proportion without eczema was 0.0164 (95% CI -0.0329, 0.0656). The ICER was £5337 per percentage decrease in risk of eczema. Adjusted incremental QALYs were very slightly improved in the emollient group, 0.0010 (95% CI -0.0069, 0.0089). At 5 years, adjusted incremental costs were lower for the emollient group, -£106.89 (95% CI -354.66, 140.88) and the proportion without eczema was -0.0329 (95% CI -0.0659, 0.0002). The 5-year ICER was £3201 per percentage decrease in risk of eczema. However, when inpatient costs due to wheezing were excluded, incremental costs were lower and incremental effects greater in the usual care group. CONCLUSIONS: In line with effectiveness endpoints, advice given in the BEEP trial to apply daily emollient during infancy for eczema prevention in high-risk children does not appear cost-effective.

The barriers and enablers of older person health assessments in Australian primary care: clinician and patient perspectives.

BACKGROUND: Health assessments (HAs) were introduced for at-risk patients, including older people, to have their health comprehensively monitored by their GP, to assess specific areas of health, such as risk factors for chronic disease and psychosocial problems, which may be overlooked in shorter consultations. Two forms of older person HAs are available for GPs to perform annually, HAs for non-Indigenous older Australians aged >75 (75+ HA) and for Aboriginal and Torres Strait Islander Australians aged >55 years (55+ ATSIHA). AIM: The present study aimed to explore the perspectives of older Australians undertaking HA (both 75+HA and 55+ ATSIHA) and clinician perspectives (GPs and practice nurses [PNs]) to enhance the items covered within the HA and develop targeted education resources to improve uptake of HAs. STUDY & DESIGN: A qualitative study design incorporating semi-structured interviews and narrative inquiry was performed, inviting patients who have undergone HAs (75+HA and 55+ ATSIHAs) across two metropolitan general practice clinics. Clinicians who completed the HAs were also invited to participate in this study. METHOD: A total of 15 clinicians (11 GPs and 4 PNs) and 15 patients participated in this study. Thematic analysis was used to identify barriers and enablers of HAs. RESULTS: Common barriers to both patients and clinicians include time, language, lack of relevance, and fear of the unknown. Identification of risk factors and the opportunity to discuss topics not covered in shorter consults were common enablers for both patients and clinicians. CONCLUSION: Four major patient barriers identified in this study include communication, accessibility, lack of engagement, and lack of patient preparation. The comprehensive nature of HAs was a major enabler for both clinicians and patients.

Natural disasters and perinatal mental health: what are the impacts on perinatal women and the service system?

Aim: The perinatal period is characterised by radical change across multiple domains. When it coincides with natural disasters, women and families need targeted support to mitigate the impacts on their birthing and early parenting experiences. Disaster planning in Australia has paid scant attention to the needs of this group. This study aimed to explore rural maternal and child health nurses' perceptions of how women receiving postnatal care during times of disaster manage mental health and wellbeing issues. Subject and methods: Eight female maternal and child health nurses (MCHNs) were recruited through purposive sampling across two rural regions of Victoria, Australia. A qualitative design using an online survey followed by in-depth interviews, was underpinned by intersectional feminist theory. Thematic analysis was applied to qualitative data. Results: Three overarching themes: context of practice, impact of disasters on mothers, and impact of disasters on services were identified. Isolation for mothers was highlighted, necessitating increased provision of emotional support, at a time when service providers themselves were under strain. Conclusion: Natural disasters exacerbate stressors on perinatal rural women and can impede their access to formal and informal supports, jeopardizing mental health outcomes. Targeted investment in rural perinatal services to enable proactive planning and implementation of disaster strategies is urgently needed to reduce the impact of natural disasters on rural perinatal women and their families. Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-023-01855-y.

Clinicians' and Users' Views and Experiences of a Tele-Mental Health Service Implemented Alongside the Public Mental Health System during the COVID-19 Pandemic.

A tele-mental health model called Head to Health was implemented in the state of Victoria, Australia to address the crisis caused by the COVID-19 pandemic. It was a free centralized intake service that adopted a targeted approach with several novel elements, such as stepped care and telehealth. This study examines the views and experiences of clinicians and service users of the tele-mental health service in the Gippsland region of Victoria during the COVID-19 pandemic. Data from clinicians were obtained via an online 10-item open-ended survey instrument and from service users through semi-structured interviews. Data were obtained from 66 participants, including 47 clinician surveys and 19 service user interviews. Six categories emerged from the data. They were: 'Conditions where use of tele-mental health is appropriate', 'Conditions where tele-mental health may not be useful', 'Advantages of tele-mental health', 'Challenges in using tele-mental health', 'Client outcomes with tele-mental health', and 'Recommendations for future use'. This is one of a few studies where clinicians' and service users' views and experiences have been explored together to provide a nuanced understanding of perspectives on the efficacy of tele-mental health when it was implemented alongside public mental health services.

Evaluating the effect of weekly patient-reported symptom monitoring on trial outcomes: results of the Eczema Monitoring Online randomized controlled trial.

BACKGROUND: Patient-reported outcome measures (PROMs) are commonly used in eczema clinical trials. Several trials have used PROMs weekly for symptom monitoring. However, the increased frequency of patient-reported symptom monitoring may prompt participants to enhance the self-management of eczema and increase standard topical treatment use that can lead to improvements in outcomes over time. This is concerning as weekly symptom monitoring may constitute an unplanned intervention, which may mask small treatment effects and make it difficult to identify changes in the eczema resulting from the treatment under investigation. OBJECTIVES: To evaluate the effect of weekly patient-reported symptom monitoring on participants' outcomes and to inform the design of future eczema trials. METHODS: This was an online parallel-group nonblinded randomized controlled trial. Parents/carers of children with eczema and young people and adults with eczema were recruited online, excluding people scoring < 3 points on the Patient Oriented Eczema Measure (POEM), to avoid floor effects. Electronic PROMs were used for data collection. Participants were allocated using online randomization (1 : 1) to weekly POEM for 7 weeks (intervention) or no POEM during this period (control). The primary outcome was change in eczema severity based on POEM scores, assessed at baseline and week 8. Secondary outcomes included change in standard topical treatment use and data completeness at follow-up. Analyses were conducted according to randomized groups in those with complete data at week 8. RESULTS: A total of 296 participants were randomized from 14 September 2021 to 16 January 2022 (71% female, 77% white, mean age 26.7 years). The follow-up completion rate was 81.7% [n = 242; intervention group, n = 118/147 (80.3%); control group n = 124/149 (83.2%)]. After adjusting for baseline disease severity and age, eczema severity improved in the intervention group (mean difference in POEM score -1.64, 95% confidence interval -2.91 to -0.38; P = 0.01). No between-group differences were noted in the use of standard topical treatments and data completeness at follow-up. CONCLUSIONS: Weekly patient-reported symptom monitoring led to a small perceived improvement in eczema severity.

Women's knowledge of and attitudes towards group B streptococcus (GBS) testing in pregnancy: a qualitative study.

BACKGROUND: 20-25% pregnant women in the UK carry group B streptococcus (GBS) which, if left undetected, is transmitted from pregnant mothers to their babies during birth in 36% of cases. This transmission leads to early onset GBS infection (EOGBS) in 1% of babies which is a significant cause of mortality and morbidity in newborns. The literature available suggests women's knowledge of GBS is low, with many women unaware of the GBS bacterium. In addition, attitudes towards GBS testing have not been widely examined, with research mostly focusing on attitudes towards potential GBS vaccination. AIM: To examine women's knowledge of GBS in pregnancy and their attitudes towards GBS testing. METHODS: Semi-structured interviews with 19 women (5 pregnant and 14 postpartum). Interviews were transcribed and analysed using systematic thematic analysis. RESULTS: Four main theme categories were identified. Participants had varying levels of awareness of GBS, with the information provided by health professionals not being clearly explained or the importance of GBS being downplayed. Participants wanted more information and to feel informed. Overall, the majority had positive attitudes towards being offered and taking up GBS testing, and this study identified some of the key factors influencing their decision. These included: seeing GBS testing as just another routine procedure during pregnancy; that it would lower the risk of their baby becoming unwell; provide reassurance; and allow them to prepare; and provide informed choices. Participants also expressed a few common concerns about GBS testing: questioning the invasiveness of the procedure; risks to themselves and the baby; and the risk of receiving antibiotics. CONCLUSIONS: Women need clear, detailed information about GBS and GBS testing, and women's concerns are important to address if routine GBS testing is implemented. The efficacy of implementing routine universal testing in the UK is currently being investigated in a large multi-centre clinical trial; the GBS3trial, further qualitative research is needed to look at the acceptability of different methods of GBS testing, as well as the acceptability of GBS testing to women in specific groups, such as those planning a home birth or those from different ethnic backgrounds.

Parents and healthcare professionals' attitudes to Kangaroo Care for preterm infants in the United Kingdom.

AIM: To explore the attitudes of parents and healthcare professionals (HCPs), and facilitators and barrier to implementation of Kangaroo Care (KC) in the United Kingdom. METHODS: Online cross-sectional survey; distributed via the British Association of Perinatal Medicine, Bliss (UK-based charity), social media. RESULTS: Sixty HCPs responded. 37 (62%) were nurses/nurse practitioners. 57 (95%) regularly implement KC. The most important factor that supported KC implementation was the team's belief in benefits of KC. Increased workload, staff shortage and fear about safely of KC in unwell infants were recognised as the challenges preventing implementation. Five hundred eighteen parents responded. 421 (81%) had a preterm baby within 3 years. 338 (80%) were familiar with KC. The main facilitator was the belief that their baby enjoyed it. Excess noise and crowding on the unit were the most frequently reported barriers. Lack of opportunity and limited staff support were the main reasons why they had been unable to practice KC. CONCLUSION: We found that most HCPs and parents believe that KC is beneficial and would like to practice it. Lack of resources to enable effective implementation is the main barrier. Service development and implementation research is required to ensure that KC is delivered in all UK neonatal units.

Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study.

Background: Second-stage caesarean sections, of which there are around 34,000 per year in the UK, have greater maternal and perinatal morbidity than those in the first stage. The fetal head is often deeply impacted in the maternal pelvis, and extraction can be difficult. Numerous techniques are reported, but the superiority of one over another is contentious and there is no national guidance. Objective: To determine the feasibility of a randomised trial of different techniques for managing an impacted fetal head during emergency caesarean. Design: A scoping study with five work packages: (1) national surveys to determine current practice and acceptability of research in this area, and a qualitative study to determine acceptability to women who have experienced a second-stage caesarean; (2) a national prospective observational study to determine incidence and rate of complications; (3) a Delphi survey and consensus meeting on choice of techniques and outcomes for a trial; (4) the design of a trial; and (5) a national survey and qualitative study to determine acceptability of the proposed trial. Setting: Secondary care. Participants: Health-care professionals, pregnant women, women who have had a second-stage caesarean, and parents. Results: Most (244/279, 87%) health-care professionals believe that a trial in this area would help guide their practice, and 90% (252/279) would be willing to participate in such a trial. Thirty-eight per cent (98/259) of parents reported that they would take part. Women varied in which technique they thought was most acceptable. Our observational study found that impacted head is common (occurring in 16% of second-stage caesareans) and leads to both maternal (41%) and neonatal (3.5%) complications. It is most often treated by an assistant pushing the head up vaginally. We designed a randomised clinical trial comparing the fetal pillow with the vaginal push technique. The vast majority of health-care professionals, 83% of midwives and 88% of obstetricians, would be willing to participate in the trial proposed, and 37% of parents reported that they would take part. Our qualitative study found that most participants thought the trial would be feasible and acceptable. Limitations: Our survey is subject to the limitation that, although responses refer to contemporaneous real cases, they are self-reported by the surgeon and collected after the event. Willingness to participate in a hypothetical trial may not translate into recruitment to a real trial. Conclusions: We proposed a trial to compare a new device, the fetal pillow, with a long-established procedure, the vaginal push technique. Such a trial would be widely supported by health-care professionals. We recommend that it be powered to test an effect on important short term maternal and baby outcomes which would require 754 participants per group. Despite the well-known difference between intent and action, this would be feasible within the UK. Future work: We recommend a randomised controlled trial of two techniques for managing an impacted fetal head with an in-built internal pilot phase and alongside economic and qualitative substudies. Study registration: This study is registered as Research Registry 4942. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 6. See the NIHR Journals Library website for further project information.

Text: One-quarter of UK pregnant women have a caesarean section. Most of these procedures are straightforward, but in a small number of cases unexpected complications can make the birth difficult. One complication, an impacted fetal head, may happen when caesarean sections are done in the second 'pushing' stage of labour. If the baby's head is low and wedged in the woman's pelvis, lifting it can be difficult, which can result in damage to the mother's womb and vagina, and to her baby. Occasionally, babies die. There are different techniques doctors and midwives can use to make these births easier, but there is uncertainty around which is best. To plan a trial to test these techniques, we needed to know how often impacted head happens, what techniques are used to manage it and whether or not research is acceptable to parents and health-care professionals. We surveyed doctors and midwives to find out which techniques they use and what training they need. We surveyed parents and pregnant women and interviewed women who had experienced a second-stage caesarean. We collected information from UK hospitals to find out how common this is and the impact on women and babies. We found out the following. List: • Around 7% of caesareans take place in second stage, and impacted fetal head occurs in 16% of these births. List: • One-third of women would consent to take part in a trial, if the complication happened to them. List: • Nearly all midwives and doctors thought that this research was important and would be willing to take part. Text: Using all of the information we collected, we designed a clinical trial. We wanted to compare two techniques for managing an impacted fetal head. The first is the vaginal push technique, where the doctor or midwife puts their hand into the mother's vagina to push her baby's head up, and the second is the fetal pillow, a device inserted into the mother's vagina before the operation starts to dislodge the baby's head upwards.

The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study.

BACKGROUND: Caesarean sections (CS) account for 26% of all births in the UK, of which at least 5% are done at full dilatation, in the second stage of labour. Second stage CS may be complicated by the fetal head being deeply impacted in the maternal pelvis, requiring specialist skills to achieve a safe birth. Numerous techniques are used to manage impacted fetal head, however, there are no national clinical guidelines in the UK. AIM: To explore health professionals' and women's views on the acceptability and feasibility of a randomised controlled trial (RCT) designed to explore approaches to managing an impacted fetal head during emergency CS. METHODS: Semi-structured interviews with 10 obstetricians and 16 women (6 pregnant and 10 who experienced an emergency second stage CS). Interviews were transcribed and analysed using systematic thematic analysis. RESULTS: The findings considered the time at which you obtain consent, how and when information about the RCT is presented, and barriers and facilitators to recruiting health professionals and women into the RCT. Obstetricians emphasised the importance of training in the techniques, as well as the potential conflict between the RCT protocol and current site or individual practices. Women said they would trust health professionals' to use the most appropriate technique and abandon the RCT protocol if necessary. Similarly, obstetricians raised the tension between the RCT protocol versus safety in reverting to what they knew under emergency situations. Both groups reflected on how this might affect the authenticity of the results. A range of important maternal, infant and clinical outcomes were raised by women and obstetricians. However, there were varying views on which of the two RCT designs presented to participants would be preferred. Most participants thought the RCT would be feasible and acceptable. CONCLUSIONS: This study suggests an RCT designed to evaluate different techniques for managing an impacted fetal head would be feasible and acceptable. However, it also identified a number of challenges that need to be considered when designing such an RCT. Results can be used to inform the design of RCTs in this area.

Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial.

BACKGROUND: The effectiveness of emollients for preventing atopic dermatitis/eczema is controversial. The Barrier Enhancement for Eczema Prevention trial evaluated the effects of daily emollients during the first year of life on atopic dermatitis and atopic conditions to age 5 years. METHODS: 1394 term infants with a family history of atopic disease were randomized (1:1) to daily emollient plus standard skin-care advice (693 emollient group) or standard skin-care advice alone (701 controls). Long-term follow-up at ages 3, 4 and 5 years was via parental questionnaires. Main outcomes were parental report of a clinical diagnosis of atopic dermatitis and food allergy. RESULTS: Parents reported more frequent moisturizer application in the emollient group through to 5 years. A clinical diagnosis of atopic dermatitis between 12 and 60 months was reported for 188/608 (31%) in the emollient group and 178/631 (28%) in the control group (adjusted relative risk 1.10, 95% confidence interval 0.93 to 1.30). Although more parents in the emollient group reported food reactions in the previous year at 3 and 4 years, cumulative incidence of doctor-diagnosed food allergy by 5 years was similar between groups (92/609 [15%] emollients and 87/632 [14%] controls, adjusted relative risk 1.11, 95% confidence interval 0.84 to 1.45). Findings were similar for cumulative incidence of asthma and hay fever. CONCLUSIONS: Daily emollient application during the first year of life does not prevent atopic dermatitis, food allergy, asthma or hay fever.

Implementing two-stage consent pathway in neonatal trials.

Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.

Alcohol and Parkinson's Disease: A Systematic Review and Meta-Analysis.

BACKGROUND: A substantial body of research has examined the relationship between alcohol consumption and risk of Parkinson's disease (PD). OBJECTIVE: To provide an updated systematic review and meta-analysis of observational studies examining the relationship between alcohol consumption and risk of PD. METHODS: Eligible studies comparing PD risk in ever vs. never alcohol drinkers were sourced from six databases. Outcomes were pooled using standard meta-analysis techniques. Separate female and male estimates were generated from studies reporting sex-specific data. Additionally, cohort studies stratifying participants by quantity of alcohol intake were integrated in a dose-response analysis. RESULTS: 52 studies were included, totaling 63,707 PD patients and 9,817,924 controls. Our meta-analysis supported a statistically significant overrepresentation of never drinkers among PD subjects; odds ratio (OR) for ever drinking alcohol 0.84 (95% confidence interval (CI) 0.76 - 0.92). A subgroup analysis revealed similar effect estimates in females and males. A further synthesis of seven cohort studies suggested a negative, dose-dependent association between alcohol and risk of PD. CONCLUSION: In the absence of a known neuroprotective pathway, there may be reason to doubt a true biological effect. The role of survivor bias, selection and recall bias, misclassification, and residual confounding requires consideration. Alternatively, observations might be attributable to reverse causation if those predestined for PD alter their alcohol habits during the preclinical phase. Major limitations of our study include high between-study heterogeneity (I2 = 93.2%) and lack of adjustment for key confounders, namely smoking status.

A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial.

BACKGROUND: Participant recruitment into clinical trials remains challenging. The global increase in the number of social media users has accelerated the use of social media as a modality of recruitment, particularly during the COVID-19 pandemic when traditional recruitment methods were reduced. However, there is limited evidence on the performance of social media recruitment strategies into eczema clinical trials. METHODS: From September 2021 to January 2022, we recruited participants with eczema into an online randomised controlled trial using free advertising on Twitter, Facebook, Instagram and Reddit (unpaid methods), followed by paid Facebook advertisements (paid method). Unpaid methods were used periodically for 63 days, whilst the paid method for 16 days. Interested individuals who clicked on the advertisement link were directed to the study website, where they could sign up to participate. Consenting, randomisation and data collection occurred exclusively online, using a database management web platform. Evaluation of the social media recruitment methods was performed, including the number of expression of interests, enrolment yield, cost, baseline characteristics and retention. RESULTS: Our multi-platform based social media recruitment strategy resulted in 400 expressions of interests, leading to 296 participants. Unpaid methods accounted for 136 (45.9%) of participants, incurring no financial cost. Paid Facebook adverts reached 154,370 individuals, resulting in 123 (41.6%) trial participants for a total cost of £259.93 (£2.11 per participant) and other recruitment methods resulted in 37 (12.5%) enrolments. Paid advertisements predominantly attracted younger participants below the age of 20, whereas unpaid methods mainly drew in participants between 20-29 years of age. The social media platforms recruited an ethnically diverse participant population. Completion rate of follow-up was slightly higher for the paid method (n = 103, 83.7%) compared with the unpaid methods (n = 111, 81.6%). CONCLUSIONS: Unpaid social media posts recruited the most participants; however, it was time consuming for the researcher. Paid Facebook adverts rapidly recruited a large number of participants for a low cost and provided flexibility to target specific audiences. Our findings indicate that social media is an efficient tool that can potentially support recruitment to clinical trials. TRIAL REGISTRATION: ISRCTN45167024. Registered on 29 June 2021.

The Apis mellifera alpha 5 nicotinic acetylcholine receptor subunit expresses as a homomeric receptor that is sensitive to serotonin.

Insect nicotinic acetylcholine receptors (nAChRs) are molecular targets of highly effective insecticides such as neonicotinoids. Functional expression of these receptors provides useful insights into their functional and pharmacological properties. Here, we report that the α5 nAChR subunit of the honey bee, Apis mellifera, functionally expresses in Xenopus laevis oocytes, which is the first time a homomeric insect nAChR has been robustly expressed in a heterologous system without the need for chaperone proteins. Using two-electrode voltage-clamp electrophysiology we show that the α5 receptor has low sensitivity to acetylcholine with an EC50 of 2.37 mM. However, serotonin acts as an agonist with a considerably lower EC50 at 119 µM that is also more efficacious than acetylcholine in activating the receptor. Molecular modelling indicates that residues in the complementary binding site may be involved in the selectivity towards serotonin. This is the first report of a ligand-gated ion channel activated by serotonin from an insect and phylogenetic analysis shows that the α5 subunit of A. mellifera and other non-Dipteran insects, including pest species, belong to a distinct subgroup of subunits, which may represent targets for the development of novel classes of insecticides.