Magnetic Resonance-Guided Focused Ultrasound without Anesthesiologist Support.

INTRODUCTION: Magnetic resonance-guided focused ultrasound (MRgFUS) is an effective treatment option for essential tremor (ET) and tremor dominant Parkinson's disease (TDPD), which is often performed with sedation or in the presence of an anesthesiologist in an effort to minimize adverse events and maximize patient comfort. This study explores the safety, feasibility, and tolerability of performing MRgFUS without an anesthesiologist. METHODS: This is a single academic center, retrospective review of 180 ET and TDPD patients who underwent MRgFUS treatment without anesthesiologist support. Patient demographics, intra-procedural treatment parameters, peri-procedural adverse events, and 3-month Clinical Rating Scale for Tremor Part B (CRST-B) scores were compared to MRgFUS studies that utilized varying degrees of anesthesia. RESULTS: There were no anesthesia related adverse events or unsuccessful treatments. There were no early treatment terminations due to patient discomfort, regardless of skull density ratio. 94.6% of patients would repeat the procedure again. The most common side effects during treatment were facial/tongue paresthesia (26.3%), followed by nausea (22.3%), dysarthria (8.6%), and scalp pain (8.0%). No anxiolytic, pain, or antihypertensive medications were administered. The most common early adverse event after MRgFUS procedure was gait imbalance (58.3%). There was a significant reduction of 83.1% (83.4% ET and 80.5% TDPD) of the mean CRST-B scores of the treated hand when comparing 3-month and baseline scores (1.8 vs. 10.9, n = 109, p < 0.0001). CONCLUSION: MRgFUS without intra-procedural anesthesiologist support is a safe, feasible, and well-tolerated option, without an increase in peri-procedural adverse events.

COVID-19 Nursing Staff Sizing Technology.

This study shows the development of a software for calculating the number of nursing team members required for providing care during the coronavirus disease 2019 pandemic. Study about the development of a technology based on the literature about data and indicators. The indicators were systematized in the following dimensions: institutional, professional, and occupational structure, all with a focus on coronavirus disease 2019. The software was created to be used on the Web, client-server, in browsers such as Internet Chrome, Explorer, and/or Mozilla Firefox, accessing via an Internet address and also allowing access by Windows, Android, and Linux operating systems, with MySQL database used for data storage. The data and indicators related to the institutional structure for coronavirus disease 2019 were systematized with 10 dimensions and indicators, and the professional and occupational structure, with 14 dimensions and indicators. The construction of computer requirements followed the precepts of software engineering, with theoretical support from the area. In the evaluation of the software, data simulation revealed points that had to be adjusted to ensure security, data confidentiality, and easy handling. The software provides to calculate the size and quality of the team, nursing sizing required due to the needs generated by the coronavirus disease 2019 pandemic.

Down syndrome: Parental experiences of a postnatal diagnosis.

Globally it is estimated that Down syndrome occurs in 1 in 800 live births (Bull 2020). It has also been estimated that the incidence of Down syndrome occurs in 1/444 live births in the Republic of Ireland. Given the prevalence of Down syndrome births in Ireland and the fact that care is provided by the majority of parents at home, this qualitative study aimed to explore the experiences of Irish parents receiving a postnatal diagnosis of Down syndrome. A qualitative research approach was used through semi structured interviews. Eight parents of a baby diagnosed postnatally with Down syndrome participated in this study sharing their stories of their postnatal diagnosis experiences. Five overarching themes emerged using a descriptive thematic analysis; 1. prenatal screening, pregnancy and delivery; 2. how the diagnosis was delivered; 3. setting and emotional experiences; 4. moving on with the postnatal diagnosis and 5. Future recommendations from parents' perspectives. This study highlighted the importance of the need for clinicians to ensure that partners are present at the time of the disclosure, that ample time is allocated and that verbal and written communications are provided to parents using less medical jargon when delivering the postnatal diagnosis of Down syndrome. These reasonable adjustments could alleviate parental anxiety at this critical juncture in their lives. Online resources and support forums were also identified as an integral support for families on discharge from the maternity centres and in the early months and years.

Cortisol levels versus self-report stress measures during pregnancy as predictors of adverse infant outcomes: a systematic review.

Systematically review existing evidence to (1) identify the association between self-report stress and cortisol levels measured during pregnancy; and, (2) assess their association with adverse infant outcomes to determine which is the better predictor. A systematic review was conducted in accordance with PRISMA guidelines. Search terms focused on pregnancy, psychological stress and cortisol. Nine electronic databases were searched, in addition to reference lists of relevant papers. Eligibility criteria consisted of studies that included measurement of self-reported psychological stress, cortisol and assessed their associations with any infant-related outcome. Further limits included studies published in English or Spanish with human female participants. A meta-regression was not feasible due to differences in study samples, measurement tools employed, types of cortisol assessed and outcomes reported. A narrative synthesis was provided. 28 studies were eligible for inclusion. Convergent validity between self-report measures and cortisol was reported by three studies (range r = 0.12-0.41). Higher levels of self-report stress were significantly associated with intrauterine growth restriction (fetal biparietal diameter, low fetal head circumference, abdominal circumference), low gestational age at birth, low anthropometric measures (birth length, head circumference, length of the neonate), poor infant neurodevelopment (cognitive development) and potentially pathogenic gut microbiota (Clostridiaceae Clostridium, Haemophilus) in six studies. Higher cortisol levels were significantly associated with intrauterine growth restriction (fetal biparietal diameter, low fetal head circumference, abdominal circumference), low gestational age at birth, low infant birth weight, poor infant neurodevelopment (attention scores on the Network Neurobehavioral Scale) and low levels of potentially protective gut microbiota (Lactobacillus, Slackia and Actinobaculum) in 13 studies. Of the studies that assessed which type of measure was a better predictor of infant outcomes (n = 6), there was agreement that cortisol levels were statistically better at predicting adverse outcomes than self-reported stress. Self-report stress measures appear to be modest predictors of adverse infant outcomes in comparison to cortisol. A number of methodological limitations need to be addressed in future studies to help understand the relationship between cortisol and self-reported stress and how they are related to adverse infant outcomes.

Support for healthy breastfeeding mothers with healthy term babies.

BACKGROUND: There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended that infants be breastfed exclusively until six months of age, with breastfeeding continuing as an important part of the infant's diet until at least two years of age. However, current breastfeeding rates in many countries do not reflect this recommendation. OBJECTIVES: 1. To describe types of breastfeeding support for healthy breastfeeding mothers with healthy term babies. 2. To examine the effectiveness of different types of breastfeeding support interventions in terms of whether they offered only breastfeeding support or breastfeeding support in combination with a wider maternal and child health intervention ('breastfeeding plus' support).  3. To examine the effectiveness of the following intervention characteristics on breastfeeding support:      a. type of support (e.g. face-to-face, telephone, digital technologies, group or individual support, proactive or reactive);      b. intensity of support (i.e. number of postnatal contacts);      c. person delivering the intervention (e.g. healthcare professional, lay person);     d. to examine whether the impact of support varied between high- and low-and middle-income countries. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (which includes results of searches of CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP)) (11 May 2021) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care. Support could be provided face-to-face, over the phone or via digital technologies. All studies had to meet the trustworthiness criteria.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed risk of bias and study trustworthiness.  The certainty of the evidence was assessed using the GRADE approach. MAIN RESULTS: This updated review includes 116 trials of which 103 contribute data to the analyses. In total more than 98,816 mother-infant pairs were included.  Moderate-certainty evidence indicated that 'breastfeeding only' support probably reduced the number of women stopping breastfeeding for all primary outcomes: stopping any breastfeeding at six months (Risk Ratio (RR) 0.93, 95% Confidence Interval (CI) 0.89 to 0.97); stopping exclusive breastfeeding at six months (RR 0.90, 95% CI 0.88 to 0.93); stopping any breastfeeding at 4-6 weeks (RR 0.88, 95% CI 0.79 to 0.97); and stopping exclusive breastfeeding at 4-6 (RR 0.83 95% CI 0.76 to 0.90). Similar findings were reported for the secondary breastfeeding outcomes except for any breastfeeding at two months and 12 months when the evidence was uncertain if 'breastfeeding only' support helped reduce the number of women stopping breastfeeding.  The evidence for 'breastfeeding plus' was less consistent. For primary outcomes there was some evidence that 'breastfeeding plus' support probably reduced the number of women stopping any breastfeeding (RR 0.94, 95% CI 0.91 to 0.97, moderate-certainty evidence) or exclusive breastfeeding at six months (RR 0.79, 95% CI 0.70 to 0.90).  'Breastfeeding plus' interventions may have a beneficial effect on reducing the number of women stopping exclusive breastfeeding at 4-6 weeks, but the evidence is very uncertain (RR 0.73, 95% CI 0.57 to 0.95). The evidence suggests that 'breastfeeding plus' support probably results in little to no difference in the number of women stopping any breastfeeding at 4-6 weeks (RR 0.94, 95% CI 0.82 to 1.08, moderate-certainty evidence). For the secondary outcomes, it was uncertain if 'breastfeeding plus' support helped reduce the number of women stopping any or exclusive breastfeeding at any time points.  There were no consistent findings emerging from the narrative synthesis of the non-breastfeeding outcomes (maternal satisfaction with care, maternal satisfaction with feeding method, infant morbidity, and maternal mental health), except for a possible reduction of diarrhoea in intervention infants.  We considered the overall risk of bias of trials included in the review was mixed. Blinding of participants and personnel is not feasible in such interventions and as studies utilised self-report breastfeeding data, there is also a risk of bias in outcome assessment.   We conducted meta-regression to explore substantial heterogeneity for the primary outcomes using the following categories: person providing care; mode of delivery; intensity of support; and income status of country.  It is possible that moderate levels (defined as 4-8 visits) of 'breastfeeding only' support may be associated with a more beneficial effect on exclusive breastfeeding at 4-6 weeks and six months. 'Breastfeeding only' support may also be more effective in reducing women in low- and middle-income countries (LMICs) stopping exclusive breastfeeding at six months compared to women in high-income countries (HICs). However, no other differential effects were found and thus heterogeneity remains largely unexplained. The meta-regression suggested that there were no differential effects regarding person providing support or mode of delivery, however, power was limited.  AUTHORS' CONCLUSIONS: When 'breastfeeding only' support is offered to women, the duration and in particular, the exclusivity of breastfeeding is likely to be increased. Support may also be more effective in reducing the number of women stopping breastfeeding at three to four months compared to later time points.  For 'breastfeeding plus' interventions the evidence is less certain. Support may be offered either by professional or lay/peer supporters, or a combination of both. Support can also be offered face-to-face, via telephone or digital technologies, or a combination and may be more effective when delivered on a schedule of four to eight visits. Further work is needed to identify components of the effective interventions and to deliver interventions on a larger scale.

Identifying postnatal anxiety: comparison of self-identified and self-reported anxiety using the Edinburgh Postnatal Depression Scale.

BACKGROUND: Identifying women with perinatal anxiety is important in order to provide timely support and prevent adverse outcomes. Self-report instruments are commonly used in maternity settings. An alternative is to ask women directly whether they self-identify as having anxiety. We examine the agreement between self-reported and self-identified anxiety at 3 months postpartum and compare the characteristics of women with self-reported and self-identified anxiety. METHODS: A secondary analysis of national maternity surveys conducted in 2014 in England and Northern Ireland was conducted. Self-reported anxiety was assessed using the Edinburgh Postnatal Depression Scale anxiety subscale (EPDS-3A). Agreement between self-reported and self-identified anxiety was measured using Cohen's kappa. Logistic regression was used to identify characteristics of women in each group. RESULTS: In our sample of 6752 women, 14.2% had self-reported anxiety, 5.9% had self-identified anxiety and 3.5% were positive on both measures. Among those with self-identified anxiety, 58.1% also had self-reported anxiety. Of those with self-reported anxiety, 24.4% also had self-identified anxiety. Statistical agreement between the two measures was minimal with Cohen's kappa 0.283 at an EPDS-3A threshold of ≥6. Among both self-identified and self-reported anxiety groups, psychological factors were the strongest associated factors. Women with self-reported anxiety had higher odds of being from Northern Ireland (OR 1.81); having a mixed or unhappy reaction to the pregnancy (OR 1.65); living without a partner (aOR 1.37); and antenatal depression (aOR 1.32). Women with self-identified anxiety had higher odds of physical problems (OR 1.84); and being of Black or minority ethnicity (OR 0.39). CONCLUSIONS: Asking postnatal women directly whether they self-identify as having anxiety identifies a different group of women from those who score highly on self-report measures. Women with self-identified anxiety may benefit from further follow-up and support.

Age is but a number when considering epilepsy surgery in older adults.

BACKGROUND: A quarter of patients with newly diagnosed epilepsy are older, yet they are less likely to be offered resective surgery potentially because of clinical bias that they incur increased surgical risks. There are few peer-reviewed case series that address this cohort and their outcomes. OBJECTIVE: In the context of current literature, the objective of this study was to report on all epilepsy surgeries in patients aged 50 years or older from a tertiary care center over 15 years with an average follow-up period of 6 years. METHODS: Patients with epilepsy who underwent surgery between 2001 and 2016 were reviewed retrospectively. Inclusion criteria were age > 50 at surgery, availability of presurgical evaluation data, and minimum one year of follow-up data. We identified 34 patients. Seizure outcome was evaluated using the Engel classification system. RESULTS: Thirty-four patients aged 50 years and older out of 276 underwent epilepsy surgery. Average age at time of surgery was 55 years, and average duration of epilepsy was 30 years. Average length of follow-up was 6 years (1-15 years). Twenty-two out of 34 patients (64%) were seizure-free (Engel class I) at their last follow-up visit. Patients with lesional pathology on neuroimaging were more likely to achieve seizure freedom (p < 0.02). Parameters associated with poorer outcome included extratemporal epileptogenic focus (p = 0.07) and bitemporal interictal epileptiform activity (p = 0.003). CONCLUSION: Our study cohort is one of the largest and most representative outcome studies of this age group, following the cohort for 6 years. Our findings demonstrated that when considering epilepsy surgery in an older adult, their age should not play a determining role in the decision-a finding that is more common in modern literature.

Exploring parents' reasons for attending the emergency department for children with minor illnesses: a mixed methods systematic review.

BACKGROUND: The number of EDs visit is on the increase, and the pressure on EDs is of significant concern worldwide. The usage of EDs by parents of children with minor illness is an important and still unresolved problem causing a burden to healthcare services. The aim of this study was to review the literature to summarise parental reasons for visiting ED for children with minor illness. METHOD: Seven electronic databases (Medline, Embase, PsycINFO, CINAHL, PubMed, Web of Science and Scopus) were comprehensively searched during a 2-week period in August 2016 and updated between 11 and 20 June 2018. The study selection process was undertaken independently by two authors. Qualitative and quantitative studies that focused on the reasons for parents of children with minor illness to attend an ED were included. Studies were assessed for quality and data were analysed by means of narrative synthesis. RESULTS: Twenty-four studies were included. Eleven studies employed quantitative methods, eleven studies used qualitative methods and two studies used mixed methods. Parental reasons for using ED included perceived urgency, ED advantages (eg, faster service, superior ED resources and efficiency), difficulties with getting a general practitioner appointment, lack of facilities in primary healthcare services, lack of health insurance, reassurance, convenience and access. CONCLUSION: This review identified some of the reasons why parents bring their children to the ED for minor illnesses highlighting the multifaceted nature of this problem. Understanding parental reasons behind their choice to use the ED may help us better design targeted interventions to reduce unnecessary ED visits and alleviate the burden on overstretched healthcare services. This review may help inform emergency care policy makers, researchers and healthcare staff to understand parents' reasons for visiting the ED, to better meet their healthcare needs.

Psychometric validation of the Prenatal Distress Questionnaire (PDQ) in pregnant women in Spain.

The Prenatal Distress Questionnaire (PDQ) was developed among English-speaking women in the United States to assess specific worries and concerns during pregnancy. Our aim was to analyze the factor structure of the PDQ, using confirmatory factor analysis, and assess its convergent validity in Spanish women. A sample of 233 pregnant women with ages ranging from 19 to 42 years in the south of Spain (Europe) (January 2015 - March 2016) completed the translated PDQ, the Perceived Stress Scale (PSS) and the Symptom Checklist-90-revised (SCL-90-R). Confirmatory factor analysis revealed a three-factor structure supporting the original PDQ factor structure (χ2 (31) = 55.43, p = 0.004; CFI = 0.96; RMSEA = 0.058; WRMR = 0.702). The Spanish PDQ significantly correlated with the PSS and SCL-90-R (r's 0.18-0.49, p's < 0.05), providing evidence of convergent validity. These results illustrate that the stress dimensions investigated by the PDQ adequately represent pregnant women's distress across a different cultural context and corroborate the psychometric properties of this instrument previously demonstrated in English-speaking women. The Spanish version of the PDQ can be used by clinical practitioners to evaluate specific worries and concerns women experience during pregnancy.

The "Petechiae in children" (PiC) study: evaluating potential clinical decision rules for the management of feverish children with non-blanching rashes, including the role of point of care testing for Procalcitonin & Neisseria meningitidis DNA - a study protocol.

BACKGROUND: Children commonly present to Emergency Departments (ED) with a non-blanching rash in the context of a feverish illness. While most have a self-limiting viral illness, this combination of features potentially represents invasive serious bacterial infection, including meningococcal septicaemia. A paucity of definitive diagnostic testing creates diagnostic uncertainty for clinicians; a safe approach mandates children without invasive disease are often admitted and treated with broad-spectrum antibiotics. Conversely, a cohort of children still experience significant mortality and morbidity due to late diagnosis. Current management is based on evidence which predates (i) the introduction of meningococcal B and C vaccines and (ii) availability of point of care testing (POCT) for procalcitonin (PCT) and Neisseria meningitidis DNA. METHODS: This PiC study is a prospective diagnostic accuracy study evaluating (i) rapid POCT for PCT and N. meningitidis DNA and (ii) performance of existing clinical practice guidelines (CPG) for feverish children with non-blanching rash. All children presenting to the ED with a history of fever and non-blanching rash are eligible. Children are managed as normal, with detailed prospective collection of data pertinent to CPGs, and a throat swab and blood used for rapid POCT. The study is running over 2 years and aims to recruit 300 children. PRIMARY OBJECTIVE: Report on the diagnostic accuracy of POCT for (i) N. meningitidis DNA and (ii) PCT in the diagnosis of early MD Report on the diagnostic accuracy of POCT for PCT in the diagnosis of Invasive bacterial infection Secondary objectives: Evaluate the performance accuracy of existing CPGs Evaluate cost-effectiveness of available diagnostic testing strategies Explore views of (i) families and (ii) clinicians on research without prior consent using qualitative methodology Report on the aetiology of NBRs in children with a feverish illness DISCUSSION: The PiC study will provide important information for policy makers regarding the value of POCT and on the utility and cost of emerging diagnostic strategies. The study will also identify which elements of existing CPGs may merit inclusion in any future study to derive clinical decision rules for this population. TRIAL REGISTRATION: NCT03378258 . Retrospectively registered on December 19, 2017.

Music therapy for children and adolescents with behavioural and emotional problems: a randomised controlled trial.

BACKGROUND: Although music therapy (MT) is considered an effective intervention for young people with mental health needs, its efficacy in clinical settings is unclear. We therefore examined the efficacy of MT in clinical practice. METHODS: Two hundred and fifty-one child (8-16 years, with social, emotional, behavioural and developmental difficulties) and parent dyads from six Child and Adolescent Mental Health Service community care facilities in Northern Ireland were randomised to 12 weekly sessions of MT plus usual care [n = 123; 76 in final analyses] or usual care alone [n = 128; 105 in final analyses]. Follow-up occurred at 13 weeks and 26 weeks postrandomisation. Primary outcome was improvement in communication (Social Skills Improvement System Rating Scales) (SSIS) at 13 weeks. Secondary outcomes included social functioning, self-esteem, depression and family functioning. RESULTS: There was no significant difference for the child SSIS at week 13 (adjusted difference in mean 2.4; 95% CI -1.2 to 6.1; p = .19) or for the guardian SSIS (0.5; 95% CI -2.9 to 3.8; p = .78). However, for participants aged 13 and over in the intervention group, the child SSIS communication was significantly improved (6.1, 95% CI 1.6 to 10.5; p = .007) but not the guardian SSIS (1.1; 95% CI -2.9 to 5.2; p = .59). Overall, self-esteem was significantly improved and depression scores were significantly lower at week 13. There was no significant difference in family or social functioning at week 13. CONCLUSIONS: While the findings provide some evidence for the integration of music therapy into clinical practice, differences relating to subgroups and secondary outcomes indicate the need for further study. ISRCTN Register; ISRCTN96352204.

Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis.

BACKGROUND: Stress and anxiety are common in pregnancy and shown to have adverse effects on maternal and infant health outcomes. The aim of this review and meta-analysis was to assess the effectiveness of music-based interventions in reducing levels of stress or anxiety among pregnant women. METHODS: Six databases were searched using key terms relating to pregnancy, psychological stress, anxiety and music. Inclusion criteria were randomised controlled or quasi-experimental trials that assessed the effect of music during pregnancy and measured levels of psychological stress or anxiety as a primary or secondary outcome. Two authors independently assessed and extracted data. Quality assessment was performed using The Cochrane Collaboration risk of bias criteria. Meta-analyses were conducted to assess stress and anxiety reduction following a music-based intervention compared to a control group that received routine antenatal care. RESULTS: Five studies with 1261 women were included. Music interventions significantly reduced levels of maternal anxiety (Standardised Mean Difference (SMD): -0.21; 95% Confidence Interval (CI) -0.39, -0.03; p = 0.02). There was no significant effect on general stress (SMD: -0.08; 95% CI -0.25, 0.09; p = 0.35) or pregnancy-specific stress (SMD: -0.02; 95% CI -0.19, 0.15; p = 0.80). The methodological quality of included studies was moderate to weak, all studies having a high or unclear risk of bias in allocation concealment, blinding and selective outcome reporting. CONCLUSIONS: There is evidence that music-based interventions may reduce anxiety in pregnancy; however, the methodological quality of the studies was moderate to weak. Additional research is warranted focusing on rigour of assessment, intensity of interventions delivered and methodological limitations.

Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models.

BACKGROUND: Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models. METHODS: A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions. RESULTS: Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or complications); Restricted 'lower-risk'-based provision model (midwifery-led or reduced/flexible visit approach for healthy women); Augmented provision model (antenatal care as in Universal provision above but augmented by clinical, educational or behavioural intervention); Targeted 'higher-risk'-based provision model (for woman with defined clinical or socio-demographic risk factors). The first category was most commonly tested in low-income countries (i.e. resource-poor settings), particularly in Asia. The other categories were tested around the world. The trials included a range of care providers, including midwives, nurses, doctors, and lay workers. CONCLUSIONS: Interventions can be defined and described in many ways. The intended antenatal care population group proved the simplest and most clinically relevant way of distinguishing trials which might otherwise be categorised together. Since our review excluded non-trial interventions, the taxonomy does not represent antenatal care provision worldwide. It offers a stable and reproducible approach to describing the purpose and content of models of antenatal care which have been tested in a trial. It highlights a lack of reported detail of trial interventions and usual care processes. It provides a baseline for future work to examine and test the salient characteristics of the most effective models, and could also help decision-makers and service planners in planning implementation.

Midwifery-led antenatal care models: mapping a systematic review to an evidence-based quality framework to identify key components and characteristics of care.

BACKGROUND: Implementing effective antenatal care models is a key global policy goal. However, the mechanisms of action of these multi-faceted models that would allow widespread implementation are seldom examined and poorly understood. In existing care model analyses there is little distinction between what is done, how it is done, and who does it. A new evidence-informed quality maternal and newborn care (QMNC) framework identifies key characteristics of quality care. This offers the opportunity to identify systematically the characteristics of care delivery that may be generalizable across contexts, thereby enhancing implementation. Our objective was to map the characteristics of antenatal care models tested in Randomised Controlled Trials (RCTs) to a new evidence-based framework for quality maternal and newborn care; thus facilitating the identification of characteristics of effective care. METHODS: A systematic review of RCTs of midwifery-led antenatal care models. Mapping and evaluation of these models' characteristics to the QMNC framework using data extraction and scoring forms derived from the five framework components. Paired team members independently extracted data and conducted quality assessment using the QMNC framework and standard RCT criteria. RESULTS: From 13,050 citations initially retrieved we identified 17 RCTs of midwifery-led antenatal care models from Australia (7), the UK (4), China (2), and Sweden, Ireland, Mexico and Canada (1 each). QMNC framework scores ranged from 9 to 25 (possible range 0-32), with most models reporting fewer than half the characteristics associated with quality maternity care. Description of care model characteristics was lacking in many studies, but was better reported for the intervention arms. Organisation of care was the best-described component. Underlying values and philosophy of care were poorly reported. CONCLUSIONS: The QMNC framework facilitates assessment of the characteristics of antenatal care models. It is vital to understand all the characteristics of multi-faceted interventions such as care models; not only what is done but why it is done, by whom, and how this differed from the standard care package. By applying the QMNC framework we have established a foundation for future reports of intervention studies so that the characteristics of individual models can be evaluated, and the impact of any differences appraised.

Evaluating the objective structured long examination record for nurse education.

An objective structured long examination record (OSLER) is a modification of the long-case clinical examination and is mainly used in medical education. This study aims to obtain nursing students' views of the OSLER compared with the objective structured clinical examination (OSCE), which is used to assess discrete clinical skills. A sample of third-year undergraduate nursing students (n=21) volunteered to participate from a cohort of 230 students. Participants undertook the OSLER under examination conditions. Pre-and post-test questionnaires gathered the students' views on the assessments and these were analysed from a mainly qualitative perspective. Teachers' and simulated patient views were also used for data triangulation. The findings indicate that the OSLER ensures more holistic assessment of a student's clinical skills and particularly essential skills such as communication, and that the OSLER, together with the OSCE, should be used to supplement the assessment of clinical competence in nursing education.

Preferences for a third-trimester ultrasound scan in a low-risk obstetric population: a discrete choice experiment.

OBJECTIVE: Establish maternal preferences for a third-trimester ultrasound scan in a healthy, low-risk pregnant population. DESIGN: Cross-sectional study incorporating a discrete choice experiment. SETTING: A large, urban maternity hospital in Northern Ireland. PARTICIPANTS: One hundred and forty-six women in their second trimester of pregnancy. METHODS: A discrete choice experiment was designed to elicit preferences for four attributes of a third-trimester ultrasound scan: health-care professional conducting the scan, detection rate for abnormal foetal growth, provision of non-medical information, cost. Additional data collected included age, marital status, socio-economic status, obstetric history, pregnancy-specific stress levels, perceived health and whether pregnancy was planned. Analysis was undertaken using a mixed logit model with interaction effects. MAIN OUTCOME MEASURES: Women's preferences for, and trade-offs between, the attributes of a hypothetical scan and indirect willingness-to-pay estimates. RESULTS: Women had significant positive preference for higher rate of detection, lower cost and provision of non-medical information, with no significant value placed on scan operator. Interaction effects revealed subgroups that valued the scan most: women experiencing their first pregnancy, women reporting higher levels of stress, an adverse obstetric history and older women. CONCLUSIONS: Women were able to trade on aspects of care and place relative importance on clinical, non-clinical outcomes and processes of service delivery, thus highlighting the potential of using health utilities in the development of services from a clinical, economic and social perspective. Specifically, maternal preferences exhibited provide valuable information for designing a randomized trial of effectiveness and insight for clinical and policy decision makers to inform woman-centred care.

Recruiting participants for randomized controlled trials of music therapy: a practical illustration.

BACKGROUND: Failure to recruit sufficient numbers of participants to randomized controlled trials is a common and serious problem. This problem may be additionally acute in music therapy research. OBJECTIVE: To use the experience of conducting a large randomized controlled trial of music therapy for young people with emotional and behavioral difficulties to illustrate the strategies that can be used to optimize recruitment; to report on the success or otherwise of those strategies; and to draw general conclusions about the most effective approaches. METHODS: Review of the methodological literature, and a narrative account and realist analysis of the recruitment process. RESULTS: The strategies adopted led to the achievement of the recruitment target of 250 subjects, but only with an extension to the recruitment period. In the pre-protocol stage of the research, these strategies included the engagement of non-music therapy clinical investigators, and extensive consultation with clinical stakeholders. In the protocol development and initial recruitment stages, they involved a search of systematic reviews of factors leading to under-recruitment and of interventions to promote recruitment, and the incorporation of their insights into the research protocol and practices. In the latter stages of recruitment, various stakeholders including clinicians, senior managers and participant representatives were consulted in an attempt to uncover the reasons for the low recruitment levels that the research was experiencing. CONCLUSIONS: The primary mechanisms to promote recruitment are education, facilitation, audit and feedback, and time allowed. The primary contextual factors affecting the effectiveness of these mechanisms are professional culture and organizational support.

Integrated palliative care in oncology: a protocol for a realist synthesis.

INTRODUCTION: Emerging evidence suggests improved quality of life, reduced symptom burden and lower health services costs when integrated palliative care and cancer care are implemented. Integrated palliative care aims to achieve care continuity by integrating organisational, administrative and clinical services involved in patient care networks. However, integrated palliative care for cancer is not common practice. This project, therefore, aims to understand how integrated palliative care and cancer care works in different healthcare settings (inpatient/outpatient), and for which groups of people (at what stage of the cancer journey), so we can develop guidance for optimal delivery. METHODS AND ANALYSIS: We will conduct a realist synthesis to develop a programme theory of how integrated palliative care in cancer works, for whom and in what contexts to achieve improved symptom management and quality of life for patients and their families.This realist synthesis will follow the five stages outlined by Pawson: (1) locating existing theories, (2) searching for evidence, (3) article selection, (4) extracting and organising data and (5) synthesising the evidence and drawing conclusions. We will work closely with our expert stakeholder group, which includes health and social care professionals providing palliative care and oncology; management and policy groups and members of the public and patients. We will adhere to RAMESES quality standards for undertaking a realist synthesis. ETHICS AND DISSEMINATION: Ethics approval for this project is not required.The realist synthesis will develop a programme theory that provides clarity on the optimal delivery of palliative care for adults with cancer. We will use the programme theory to coproduce guidance and user-friendly outputs, working with stakeholders to inform delivery of best practice. Findings will inform further research in integrated palliative care and cancer. Stakeholder engagement will assist in the dissemination of our findings. PROSPERO REGISTRATION NUMBER: CRD42023389791.

Lessons for the UK on implementation and evaluation of breastfeeding support: evidence syntheses and stakeholder engagement.

Background: Breastfeeding impacts positively on multiple health outcomes, but < 50% of UK women breastfeed at 8 weeks. Women with long-term conditions face additional challenges in breastfeeding. Objectives: To synthesise global and UK evidence to co-create an implementation and evaluation toolkit for cost-effective breastfeeding support in the NHS. Design: Evidence syntheses with stakeholder engagement. Review methods: Systematic reviews examined effectiveness of breastfeeding support for (1) healthy women and (2) women with long-term conditions using Cochrane Pregnancy and Childbirth Group methods. Mixed-methods systematic reviews synthesised process evaluations of effective breastfeeding support interventions for healthy women and experiences of receiving/providing support for breastfeeding women with long-term conditions. Cross-study synthesis integrated qualitative and quantitative findings. Systematic reviews synthesised evidence on the incremental costs and cost-effectiveness of breastfeeding support following National Institute for Health and Care Excellence guidance. All searches were conducted from May 2021 to October 2022. Stakeholder engagement and toolkit development comprised online discussions, a modified Delphi study, focus groups and four workshops. Participants were 23 stakeholders, 16 parents in the parents' panels, 15 women in the focus groups and 87 stakeholders who attended the workshops. Results: We found considerably more interventions designed for healthy women (review 1) than aimed at women with long-term conditions (reviews 1 and 4); approximately half of the studies were targeted at groups at higher risk of poor breastfeeding outcomes, and the impact of support may be different in these populations. Despite this, studies from review 2 found that women perceived the provision of support as positive, important and needed. Studies from review 5 echoed a range of suggestions from participants regarding potential strategies to improve breastfeeding support, with the most widely reported being the need to acknowledge the role and influence of other sources of support (e.g. partners, family, friends, peers, external professionals, web-based resources) and involving these sources in the provision of breastfeeding support for women with long-term conditions. In reviews 3 and 6, there was uncertainty about the cost-effectiveness of breastfeeding support interventions due to the limited number of studies and lack of good-quality evidence. Limitations: There was a lack of evidence for the effectiveness and cost-effectiveness of breastfeeding interventions in the UK. There was often insufficient information reported about intervention characteristics. Conclusions: 'Breastfeeding only' support probably reduces the number of women stopping any or exclusive breastfeeding. The evidence for 'breastfeeding plus' interventions is less consistent, but these may reduce the number of women stopping exclusive breastfeeding at 4-6 weeks and at 6 months. We found no evidence of differential intervention effects regarding mode of provision or provider. Cost-effectiveness is uncertain due to the lack of good-quality evidence. Key enablers of successful implementation were responsiveness and tailoring of interventions to both women's and supporters' needs. Breastfeeding support as delivered in the included studies probably has little to no effect on breastfeeding outcomes for women with long-term conditions. The mixed-methods synthesis and stakeholder work identified that existing interventions may not address the complex needs of these women. The main study output is a co-produced toolkit to guide implementation and evaluation of breastfeeding support services in the UK. Future work: Evaluation of breastfeeding support for all women, particularly those at risk of poor breastfeeding outcomes (e.g. long-term conditions, deprivation). This could involve tailoring the toolkit to local contexts via implementation and effectiveness studies or using quality improvement studies. Study registration: This study is registered as PROSPERO CRD42022337239, CRD42021229769 and CRD42022374509. The reviews of economic evidence were not registered; however, the review protocol can be accessed via the repository held by Queen's University Belfast Research Portal (https://pure.qub.ac.uk/). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR130995) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 20. See the NIHR Funding and Awards website for further award information.

We know that breastfeeding is good for the health of mothers and babies, yet many mothers experience difficulties and stop breastfeeding before they want to. This is noticeable among women living in disadvantaged areas where there are low rates of breastfeeding. Good support may help women overcome difficulties so that they can continue to breastfeed. Women with chronic illnesses such as diabetes and depression face additional challenges in breastfeeding. We wanted to understand how to improve breastfeeding support for UK women. We brought together previous scientific studies to learn about what works. We also spoke with parents and service providers. We combined all our findings into a toolkit to help the NHS improve breastfeeding support for women. We found that, for healthy women, some forms of breastfeeding support can probably help reduce the number of women stopping breastfeeding and help them breastfeed exclusively. For women with chronic illnesses, we found that the types of support used in the studies probably did not help women to breastfeed. Most of the evidence did not come from the UK. We identified barriers to providing breastfeeding support for all women, especially those who are disadvantaged. We identified strategies that could help the NHS overcome these barriers. There was a lack of evidence on how cost-effective these interventions are compared with usual care, but parents and providers saw the value of paying for breastfeeding support. Giving women targeted breastfeeding support will help them to breastfeed; however, we need to test if this support works in the NHS. We also need to develop additional services for women with chronic illnesses. The NHS could use our findings to improve support for all breastfeeding women by identifying specific barriers and using evidence-based strategies to overcome them.

Applying clinical decision aids for the assessment and management of febrile infants presenting to emergency care in the UK and Ireland: Febrile Infant Diagnostic Assessment and Outcome (FIDO) Study protocol.

INTRODUCTION: Febrile infants 90 days and younger are at risk of invasive bacterial infections (bacteraemia and meningitis) and urinary tract infections. Together this is previously termed serious bacterial infection with an incidence of approximately 10-20%. The National Institute for Health and Care Excellence guidance advocates a cautious approach with most infants requiring septic screening, parenteral broad-spectrum antibiotics and hospital admission. Internationally, variations exist in the approach to febrile infants, with European and North American guidance advocating a tailored approach based on clinical features and biomarker testing. None of the available international clinical decision aids (CDAs) has been validated in the UK and Irish cohorts. The aim of the Febrile Infant Diagnostic Assessment and Outcome (FIDO) Study is to prospectively validate a range of CDAs in a UK and Irish population including CDAs that use procalcitonin testing. METHODS AND ANALYSIS: The FIDO Study is a prospective multicentre mixed-methods cohort study conducted in UK and Irish hospitals. All infants aged 90 days and younger presenting with fever or history of fever (≥38°C) are eligible for inclusion. Infants will receive standard emergency clinical care without delay. Clinical data and blood samples will be collected, and consent will be obtained at the earliest appropriate opportunity using research without prior consent methodology. The performance and cost-effectiveness of CDAs will be assessed. An embedded qualitative study will explore clinician and caregiver views on different approaches to care and perceptions of risk. ETHICS AND DISSEMINATION: This study was reviewed and approved by the Office for Research Ethics Committees Northern Ireland-Health and Social Care Research Ethics Committee B, Public Benefit and Privacy Panel for Health and Social Care Scotland, and Children's Health Ireland Research and Ethics Committee Ireland. The results of this study will be presented at academic conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05259683.