Looking after bubba for all our mob: Aboriginal and Torres Strait Islander community experiences and perceptions of stillbirth.

The stillbirth rate among Aboriginal and Torres Strait Islander women and communities in Australia is around double that of non-Indigenous women. While the development of effective prevention strategies during pregnancy and improving care following stillbirth for women and families in communities has become a national priority, there has been limited progress in stillbirth disparities. With community permission, this study aimed to gain a better understanding of community experiences, perceptions, and priorities around stillbirth. We undertook an Indigenous researcher-led, qualitative study, with community consultations guided by a cultural protection protocol and within an unstructured research framework. A total of 18 communities were consulted face-to-face through yarning interviews, focus groups and workshops. This included 54 community member and 159 health professional participants across remote, regional, and urban areas of Queensland, Western Australia, Victoria, South Australia, and Northern Territory. Thematic analysis of consultation data identified common themes across five focus/priority areas to address stillbirth: Stillbirth or Sorry Business Baby care needs to be family-centered; using Indigenous "ways of knowing, being, and doing" to ensure cultural safety; application of Birthing on Country principles to maternal and perinatal care; and yarning approaches to improve communication and learning or education. The results underscore the critical need to co-design evidence-based, culturally appropriate, and community-acceptable resources to help reduce existing disparities in stillbirth rates.

Development of Web-Based Education Modules to Improve Carer Engagement in Cancer Care: Design and User Experience Evaluation of the e-Triadic Oncology (eTRIO) Modules for Clinicians, Patients, and Carers.

BACKGROUND: Carers often assume key roles in cancer care. However, many carers report feeling disempowered and ill-equipped to support patients. Our group published evidence-based guidelines (the Triadic Oncology [TRIO] Guidelines) to improve oncology clinician engagement with carers and the management of challenging situations involving carers. OBJECTIVE: To facilitate implementation of the TRIO Guidelines in clinical practice, we aimed to develop, iteratively refine, and conduct user testing of a suite of evidence-based and interactive web-based education modules for oncology clinicians (e-Triadic Oncology [eTRIO]), patients with cancer, and carers (eTRIO for Patients and Carers [eTRIO-pc]). These were designed to improve carer involvement, communication, and shared decision-making in the cancer management setting. METHODS: The eTRIO education modules were based on extensive research, including systematic reviews, qualitative interviews, and consultation analyses. Guided by the person-based approach, module content and design were reviewed by an expert advisory group comprising academic and clinical experts (n=13) and consumers (n=5); content and design were continuously and iteratively refined. User experience testing (including "think-aloud" interviews and administration of the System Usability Scale [SUS]) of the modules was completed by additional clinicians (n=5), patients (n=3), and carers (n=3). RESULTS: The final clinician module comprises 14 sections, requires approximately 1.5 to 2 hours to complete, and covers topics such as carer-inclusive communication and practices; supporting carer needs; and managing carer dominance, anger, and conflicting patient-carer wishes. The usability of the module was rated by 5 clinicians, with a mean SUS score of 75 (SD 5.3), which is interpreted as good. Clinicians often desired information in a concise format, divided into small "snackable" sections that could be easily recommenced if they were interrupted. The carer module features 11 sections; requires approximately 1.5 hours to complete; and includes topics such as the importance of carers, carer roles during consultations, and advocating for the patient. The patient module is an adaptation of the relevant carer module sections, comprising 7 sections and requiring 1 hour to complete. The average SUS score as rated by 6 patients and carers was 78 (SD 16.2), which is interpreted as good. Interactive activities, clinical vignette videos, and reflective learning exercises are incorporated into all modules. Patient and carer consumer advisers advocated for empathetic content and tone throughout their modules, with an easy-to-read and navigable module interface. CONCLUSIONS: The eTRIO suite of modules were rigorously developed using a person-based design methodology to meet the unique information needs and learning requirements of clinicians, patients, and carers, with the goal of improving effective and supportive carer involvement in cancer consultations and cancer care.

An online intervention to improve oncology health professional self-efficacy in communicating with carers: Hybrid effectiveness-implementation evaluation of the eTRIO program.

OBJECTIVES: Many oncology health professionals (HPs) report communicating with carers as complex; and receive limited carer-relevant training. We developed an online HP education program for supporting and managing carer involvement (eTRIO). We aimed to assess whether HPs' self-efficacy in carer communication, knowledge, and decision-making preferences improve following eTRIO. Satisfaction and implementation potential were assessed. METHODS: This type 1 hybrid effectiveness-implementation study used a pre-post single arm intervention design. HPs completed baseline measures, the eTRIO online module, and measures at 1- and 12-weeks post-intervention. Measures included: self-efficacy in carer communication (13-items), applied knowledge (7-items), preference for carer involvement in decisions (1-item). Fifteen of participants completed feedback interviews which underwent thematic analysis. User analytics were collected and analysed. RESULTS: Fifty-six HPs completed baseline measures, 42 completed post- and follow-up measures. At baseline mean self-efficacy score was 88. HPs showed a statistically significant increase in self-efficacy post-intervention (mean = 105.8, CI [12.99, 20.47]), maintained at 12-weeks (mean = 101.1, CI [8.00, 15.72]). There were no changes in knowledge or decision-making preferences. Program engagement and satisfaction were high, 86.7% participants rated eTRIO as very/extremely helpful. CONCLUSIONS AND PRACTICE IMPLICATIONS: eTRIO provided HPs with confidence to effectively engage with carers and manage complex situations such as family dominance. These gains are noteworthy, as conflict with families/carers contributes to HP burnout.

Assessing Knowledge, Competence, and Performance Following Web-Based Education on Early Breast Cancer Management: Health Care Professional Questionnaire Study and Anonymized Patient Records Analysis.

BACKGROUND: Web-based learning activities are key components of continuing medical education (CME) for health care professionals (HCPs). However, the published outcomes of web-based educational interventions for early breast cancer (EBC) are limited. OBJECTIVE: This study aims to objectively assess knowledge, competence, and performance among HCPs following participation in 2 EBC-focused CME activities and to identify the remaining educational gaps. METHODS: We developed 2 CME-accredited web-based educational activities addressing high-risk EBC, including integration of shared decision-making to optimize patient care (touchMDT) and stratification for early identification of high-risk patients and novel treatment strategies (touchPANEL DISCUSSION). Knowledge, competence, and performance were assessed before and after the activities against an expanded outcomes framework (levels 1-5) using self-reported questionnaires and an analysis of anonymized data extracted from patient records. RESULTS: Six months after the launch of the activity, 7047 and 8989 HCP participants engaged with touchMDT and touchPANEL DISCUSSION, respectively. The overall satisfaction was 82% (a total score of 20.6 out of 25) for the touchMDT and 88% (a total score of 21.9 out of 25) for the touchPANEL DISCUSSION. For the evaluation of knowledge and competence (50 respondents before the activity and 50 learners after the activity), there was a significant increase in the mean number of correctly answered questions from pre- to postactivity (touchMDT: median 4.0, IQR 3.0-5.0 to median 5.5, IQR 4.0-7.0; mean 4.00, SD 1.39 to mean 5.30, SD 1.56 and touchPANEL DISCUSSION: median 4.0, IQR 4.0-5.0 to median 6.0, IQR 5.0-7.0; mean 4.32, SD 1.30 to mean 5.88, SD 1.49; both P<.001). A significant improvement in self-reported performance (50 respondents before the activity and 50 learners after the activity) was observed in a combined analysis of both activities (median 3.0, IQR 2.0-3.0 to median 4.0, IQR 3.0-5.0; mean 2.82, SD 1.08 to mean 4.16, SD 1.45; P<.001). Patient record analysis (50 respondents before the activity and 50 learners after the activity) showed that the HCPs used a range of measures to determine EBC recurrence risk and revealed no significant differences in adjuvant therapies used before and after the activity (P=.97 and P>.99 for Ki-67 <20% and Ki-67 ≥20% tumors, respectively). The remaining educational gaps included strategies for implementing shared decision-making in clinical practice and the use of genetic and biomarker testing to guide treatment selection. CONCLUSIONS: Brief, web-based CME activities on EBC were associated with an improvement in HCP knowledge, competence, and self-reported performance and can help identify unmet needs to inform the design of future CME activities.

Professionally led support groups for people living with advanced or metastatic cancer: a systematic scoping review of effectiveness and factors critical to implementation success within real-world healthcare and community settings.

PURPOSE: To examine the effectiveness of professionally led support groups for people with advanced or metastatic cancer, and identify factors critical to implementation success within real-world settings. METHODS: Databases (MEDLINE; PsychINFO; CINAHL) and grey literature were searched for empirical publications and evaluations. Articles were screened for eligibility and data systematically extracted, charted and summarised using a modified scoping review methodology. Implementation factors were mapped using Proctor's implementation framework and the Consolidated Framework for Implementation Research 2.0. RESULTS: A total of 1691 publications were identified; 19 were eligible for inclusion (8 randomised controlled trials, 7 qualitative studies, 2 cohort studies, 2 mixed methods studies). Most (n=18) studies focused on tumour-specific support groups. Evidence supported professionally led support groups in reducing mood disturbances (n=5), distress (i.e. traumatic stress, depression) (n=4) and pain (n=2). Other benefits included social connectedness (n=6), addressing existential distress (n=5), information and knowledge (n=6), empowerment and sense of control (n=2), relationships with families (n=2) and communication with health professionals (n=2). Thirteen studies identified factors predicting successful adoption, implementation or sustainment, including acceptability (n=12; 63%), feasibility (n=6; 32%) and appropriateness (n=1; 5%). Key determinants of successful implementation included group leaders' skills/experience, mode of operation, travelling distance, group composition and membership and resourcing. CONCLUSIONS: Professionally led tumour-specific support groups demonstrate effectiveness in reducing mood disturbances, distress and pain among patients. Successful implementation hinges on factors such as leadership expertise, operational methods and resource allocation. IMPLICATIONS FOR CANCER SURVIVORS: Professionally led support groups may fill an important gap in supportive care for people with advanced or metastatic cancer.

Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Two years of adjuvant abemaciclib combined with endocrine therapy (ET) resulted in a significant improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) that persisted beyond the 2-year treatment period in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer (EBC). Here, we report 5-year efficacy results from a prespecified overall survival (OS) interim analysis. In the intent-to-treat population, with a median follow-up of 54 months, the benefit of abemaciclib was sustained with hazard ratios of 0.680 (95% CI, 0.599 to 0.772) for IDFS and 0.675 (95% CI, 0.588 to 0.774) for DRFS. This persistence of abemaciclib benefit translated to continuous separation of the curves with a deepening in 5-year absolute improvement in IDFS and DRFS rates of 7.6% and 6.7%, respectively, compared with rates of 6% and 5.3% at 4 years and 4.8% and 4.1% at 3 years. With fewer deaths in the abemaciclib plus ET arm compared with the ET-alone arm (208 v 234), statistical significance was not reached for OS. No new safety signals were observed. In conclusion, abemaciclib plus ET continued to reduce the risk of developing invasive and distant disease recurrence beyond the completion of treatment. The increasing absolute improvement at 5 years is consistent with a carryover effect and further supports the use of abemaciclib in patients with high-risk EBC.

Parents' descriptions of labouring with an antepartum fetal death: Findings from the Birthing in Grief study.

BACKGROUND: Evidence to guide intrapartum care when an unborn baby has died is limited. AIMS: To explore parents' experiences of care during labour of an antepartum stillbirth. MATERIALS AND METHODS: Semi-structured interviews with 18 bereaved parents from across Australia. Content analysis was conducted. FINDINGS: Two broad themes were identified: 'explaining every step' and 'helping us feel like parents.' Sub-themes under the first broad theme, 'explaining every step', were 'how and when information was given' and 'what happens next.' 'Like any other parent', 'feeling the pain' and 'everything is clouded' were sub-themes of the second broad theme. These findings mapped to current Australian clinical practice guidelines for bereavement care around stillbirth and neonatal death, ie good communication, recognition of parenthood, shared decision making and effective support. CONCLUSIONS: This study on parents' experiences of labour with a fetal death in utero brings an important perspective to intrapartum care for this group. As far as we are aware, this study is the first to focus solely on this aspect of care. Our findings could be readily mapped to the four perinatal bereavement care goals. Parents wanted care providers to facilitate their choices, their sense of control, their autonomy and their agency. They wanted to feel that they had received the 'best' care available.

The incurable self: Negotiating social bonds and dis/connection with metastatic breast cancer.

As the culture of silence that once surrounded cancer has gradually given way to greater public awareness, normative visions of what cancer survivorship should entail have proliferated. These visions emphasise positivity and perseverance in pursuit of cure. While these visions provide comfort to many, for people with metastatic cancer, the emphasis on cure can undermine their sense of belonging to the broader collective of people living with cancer. Drawing on semi-structured interviews with 38 Australian women living with metastatic breast cancer, we explore how incurable cancer inflects understandings of self and transforms interpersonal relationships. Extending ideas around biosociality and belonging, we explore the tenuousness of social bonds, revealing how (in)visibility, (in)authenticity and (in)validation circulate within the daily lives of women with metastatic breast cancer. We conceptualise accounts according to four social bonds: (1) threatened bonds where a relationship is strained by misunderstanding, (2) severed bonds where a relationship is ruptured due to misunderstanding, (3) attuned bonds whereby a relationship is based on shared identification and (4) flexible social bonds when a relationship is based on mutual understanding. More broadly, we illustrate the persistence of normative visions of cancer survivorship and their enduring effects on those whom such visions exclude.

Telehealth follow-up consultations for melanoma patients during the COVID-19 pandemic: Patient and clinician satisfaction.

INTRODUCTION: The COVID-19 pandemic caused rapid implementation of telehealth for melanoma follow-up care in Australia. This study explores Australian melanoma patients and clinicians' level of satisfaction with telehealth. METHODS: A cross-sectional study was conducted across three specialist melanoma centres in Sydney, Australia. Melanoma patients (all stages) and clinicians completed mixed methods surveys seeking socio-demographic and clinical information and questionnaires to assess satisfaction with telehealth. Additionally, patients completed measures of quality of life, fear of cancer recurrence and trust in their oncologist. Patients and clinicians provided open-ended responses to qualitative questions about their perceptions of telehealth. RESULTS: One hundred and fifteen patients and 13 clinicians responded to surveys. Telephone was used by 109 (95%) patients and 11 (85%) clinicians. Fifty-seven (50%) patients and nine (69%) clinicians preferred face-to-face consultations, 38 (33%) patients and 3 (23%) clinicians preferred a combination of face-to-face and telehealth consultations. Five (4%) patients and nil clinicians preferred telehealth consultations. Patients diagnosed with early-stage melanoma, using telehealth for the first time, who have lower trust in their oncologist, and having higher care delivery, communication and supportive care concerns were likely to report lower satisfaction with telehealth. Open-ended responses were consistent between patients and clinicians, who reported safety, convenience and improved access to care as major benefits, while identifying personal, interpersonal, clinical and system-related disadvantages. DISCUSSION: While telehealth has been widely implemented during COVID-19, the benefits identified by patients and clinicians may extend past the pandemic. Telehealth may be considered for use in conjunction with face-to-face consultations to provide melanoma follow-up care.

Improving Access to Cancer Clinical Trials for Patients From Culturally and Linguistically Diverse Backgrounds in Australia: A Survey of Clinical and Research Professionals.

PURPOSE: Patients with cancer from racial and ethnic minorities, referred to as culturally and linguistically diverse (CALD) in Australia, are significantly under-represented in cancer clinical trials. We performed a national survey of the Australian cancer clinical trials workforce to determine barriers and preferred solutions to address this inequity. METHODS: A 15-item online survey containing both closed- and open-ended purpose-designed questions was created using REDCap. The survey was emailed to members of the Clinical Oncology Society of Australia, Medical Oncology Group of Australia, and Australian cancer cooperative trial groups, and promoted via Twitter. Descriptive analyses summarized quantitative data, and free-text entries underwent thematic analysis with NVivo Version 12. RESULTS: Ninety one respondents completed the survey-with representation across Australia. Eighty-seven percent were directly involved in clinical trial recruitment. Sixty-eight percent were clinicians. Seventy-four percent of respondents did not collect routine data on CALD patient enrollment to cancer clinical trials. Communication (eg, lack of translated materials) and opportunity-related barriers (eg, exclusionary trial protocols) were the most frequently perceived barriers to recruitment. Additionally, qualitative analysis indicated that insufficient consultation time and difficulties accessing interpreters for patients with non-English language preference were significant barriers. Trial navigators and a generic cancer trial pamphlet available in multiple languages were judged the most likely solutions to improve recruitment. CONCLUSION: This study articulates the Australian clinical trials workforce's perspective on current barriers and potential solutions to the under-representation of patients from CALD backgrounds on cancer clinical trials. The insights and solutions from this survey provide steps toward achieving equity in Australian cancer clinical trials.

Adverse childhood experiences, the risk of pregnancy complications and adverse pregnancy outcomes: a systematic review and meta-analysis.

BACKGROUND: Adverse childhood experiences (ACEs) have a profound negative impact on health. However, the strength of the association between ACEs and pregnancy complications and adverse pregnancy outcomes is not well quantified or understood. OBJECTIVE: To conduct a systematic review and meta-analysis of the association between ACEs and risk of pregnancy complications and adverse pregnancy outcomes. SEARCH STRATEGY: A comprehensive search was conducted using PubMed, Embase, CINAHL, PsycINFO, ClinicalTrials.gov and Google scholar up to July 2022. DATA COLLECTION AND ANALYSIS: Two reviewers independently conducted the screening and quality appraisal using a validated tool. Meta-analysis using the quality-effects model on the reported odds ratio (OR) was conducted. Heterogeneity and inconsistency were examined using the I2 statistics. RESULTS: 32 studies from 1508 met a priori inclusion criteria for systematic review, with 21 included in the meta-analysis. Pooled analyses showed that exposure to ACEs increased the risk of pregnancy complications (OR 1.37, 95% CI 1.20 to 1.57) and adverse pregnancy outcomes (OR 1.31, 95% CI 1.17 to 1.47). In sub-group analysis, maternal ACEs were associated with gestational diabetes mellitus (OR 1.39, 95% CI 1.11 to 1.74), antenatal depression (OR 1.59, 95% CI 1.15 to 2.20), low offspring birth weight (OR 1.27, 95% CI 1.02 to 1.47), and preterm delivery (OR 1.41, 95% CI 1.16 to 1.71). CONCLUSION: The results suggest that exposure to ACEs increases the risk of pregnancy complications and adverse pregnancy outcomes. Preventive strategies, screening and trauma-informed care need to be examined to improve maternal and child health.

Patient-reported health-related quality of life outcomes following mastectomy for breast cancer, with immediate, delayed or no breast reconstruction: Four-year follow-up from a prospective cohort study.

BACKGROUND: Breast reconstruction (BR) improves women's health-related quality of life (HRQOL) following mastectomy for breast cancer, yet factors contributing to improved HRQOL remain unclear. This study aimed to explore the overall impact of mastectomy with or without BR on participants' perceptions of HRQOL over time in a cohort of women with high-risk breast cancer; to examine differences in mean HRQOL scores between immediate BR, delayed BR and no BR groups; to assess the influence of patient characteristics potentially associated with HRQOL scores; and to determine the feasibility of long-term collection of patient-reported outcome measures in clinical settings. METHODS: A prospective, longitudinal study of 100 women with high-risk breast cancer who underwent mastectomy with or without breast reconstruction and were likely to require post-mastectomy radiotherapy. Four validated patient-reported questionnaires, comprising 21 outcome measures relating to HRQOL, administered at baseline and up to 4 years post-mastectomy. Demographic, clinical and surgical data extracted from patient medical records. RESULTS: Consistently significant declines in perceptions of future health and arm symptoms, consistently significant improvements in treatment side effects, breast symptoms and fatigue, as well as significant improvements, compared to baseline, in social functioning and financial difficulties at 48 months. No significant differences in mean HRQOL scores between women given a choice of reconstructive options. CONCLUSION: Similar trajectories of HRQOL scores were found in women with high-risk breast cancer who were offered a choice of BR. Informed choice may be an independent contributing factor in long-term maintenance of most HRQOL indicators at their pre-mastectomy levels.

Supportive care needs in Australian melanoma patients and caregivers: results from a quantitative cross-sectional survey.

PURPOSE: This study aimed to investigate the supportive care needs of Australian melanoma patients and their caregivers to form the basis for improving services. METHODS: General and melanoma-related supportive care needs in melanoma patients were measured using the SCNS-SF34 and SCNS-M12 respectively, whereas caregivers completed the SCNS-P&C. Patients also completed the MCQ-28 and FCRI-9, with all participants completing the QLQ-C30, DASS-21, and questions measuring utilisation and preference for supportive health services. Multivariable stepwise logistic regression was used to identify variables associated with unmet needs in melanoma patients. RESULTS: A total of 56 early-stage patients, 100 advanced-stage patients, and 37 caregivers participated. At least three-quarters ([Formula: see text] 75%) of each participant group reported at least one unmet need. Of the ten most reported unmet needs in each participant group, at least six ([Formula: see text] 60%) were related to psychological and emotional well-being, with access to a psychologist the most desired service (> 25%). Fear of cancer recurrence was equally prevalent in both patient groups at a level indicative of need for intervention. Advanced-stage patients reported significantly (p < 0.05) more unmet psychological, physical and daily living, and sexuality needs, and significantly (p < 0.05) worse functioning than early-stage patients. CONCLUSION: Australian melanoma patients and caregivers report substantial unmet supportive care needs, particularly regarding their psychological and emotional well-being. Psychological and emotional well-being services, such as access to a clinical psychologist or implementation of patient-reported outcome measures, should be incorporated into routine melanoma care to address unmet patient and caregiver needs and improve well-being.

Validation of a tool for determining the clinical utility of stillbirth investigations.

BACKGROUND: Up to 20% of all stillbirths and 45% of term stillbirths are currently classified as unexplained. Many of these stillbirths do not undergo currently recommended investigations. This may leave questions unanswered and not identify stillbirths with a recurrence risk in subsequent pregnancies. AIMS: To validate a new tool (Stillbirth Investigation Utility Tool) to identify the clinical utility of investigations in stillbirth and the inter-rater agreement on cause of stillbirth using the Perinatal Society of Australia and New Zealand-Perinatal Death Classification (PSANZ-PDC). MATERIALS AND METHODS: Thirty-four stillbirths were randomly selected for inclusion, each assessed independently by five blinded assessors. The investigations were grouped into three categories: clinical and laboratory; placental pathology; and autopsy examination. The cause of death was assigned at the end of each group. Outcome measures were clinical utility of investigations measured by assessor rated usefulness and inter-rater agreement on the assigned cause of death. RESULTS: Comprehensive maternal history, maternal full blood count, maternal blood group and screen and placenta histopathology were useful in all cases. Clinical photographs were not performed and should have been performed in 50% of cases. The inter-rater agreement on cause of death assigned after all investigation results was 0.93 (95% CI 0.87-1.0). CONCLUSIONS: The new Stillbirth Investigation Utility Tool showed very good agreement in assigning the cause of death using PSANZ-PDC. Four investigations were useful in all cases. Minor refinements will be made based on feedback to enhance usability for wider implementation in research studies to assess the yield of investigations in stillbirths.

A Standardized, 3-Tiered, Seizure Burden-Based Protocol for the Treatment of Neonatal Seizures.

OBJECTIVE: To evaluate use of a standardized, 3-tiered, seizure burden-based protocol for treatment of all electroencephalography (EEG)-confirmed seizures in a level IV neonatal intensive care unit (NICU). STUDY DESIGN: All infants admitted to the NICU with EEG-confirmed seizures over a 25-month period were enrolled in the study. We compared short-term outcomes before and after implementation of a standardized, 3-tiered protocol. RESULTS: A total of 107 infants were enrolled in the study. Use of midazolam infusions was reduced by 53.7% (p = 0.02). Midazolam infusion duration increased from 4 to 7.5 days (p = 0.003); however, when excluding 3 outliers, there was no significant difference between groups (-p = 0.67). Duration of EEG monitoring decreased from 5 to 3 days (p = 0.005). Hospital length of stay was unchanged. CONCLUSION: Implementation of a standardized, 3-tiered protocol for treatment of neonatal seizures improved short-term outcomes. Although not measured directly, reductions in EEG duration and midazolam use are promising indicators of overall seizure burden. More research is needed to evaluate impact on long-term neurodevelopmental outcomes.

Tolerability and Safety of Lacosamide in Neonatal Population.

Lacosamide is a newer antiepileptic medication used in refractory neonatal seizures with limited safety and efficacy data. This case series spans 4 years and includes 38 neonates cared for in the neonatal, pediatric, and cardiovascular intensive care units, who received lacosamide for refractory seizures. Because lacosamide affects atrioventricular node function in adults, among other metrics, electrocardiogram (ECG) changes were monitored closely in these neonates. Within this cohort, 2 neonates were found to have atrial bigeminy on ECG and telemetry. Otherwise, lacosamide was generally well tolerated with sleepiness being the most common symptom noted. This case series reports data on the tolerability of lacosamide and emphasizes the importance of monitoring key cardiac intervals with ECG before and after the use of lacosamide in this population.

Treatment patterns and out-of-hospital healthcare resource utilisation by patients with advanced cancer living with pain: An analysis from the Stop Cancer PAIN trial.

BACKGROUND: About 70% of patients with advanced cancer experience pain. Few studies have investigated the use of healthcare in this population and the relationship between pain intensity and costs. METHODS: Adults with advanced cancer and scored worst pain ≥ 2/10 on a numeric rating scale (NRS) were recruited from 6 Australian oncology/palliative care outpatient services to the Stop Cancer PAIN trial (08/15-06/19). Out-of-hospital, publicly funded services, prescriptions and costs were estimated for the three months before pain screening. Descriptive statistics summarize the clinico-demographic variables, health services and costs, treatments and pain scores. Relationships with costs were explored using Spearman correlations, Mann-Whitney U and Kruskal-Wallis tests, and a gamma log-link generalized linear model. RESULTS: Overall, 212 participants had median worst pain scores of five (inter-quartile range 4). The most frequently prescribed medications were opioids (60.1%) and peptic ulcer/gastro-oesophageal reflux disease (GORD) drugs (51.6%). The total average healthcare cost in the three months before the census date was A$6,742 (95% CI $5,637, $7,847), approximately $27,000 annually. Men had higher mean healthcare costs than women, adjusting for age, cancer type and pain levels (men $7,872, women $4,493, p<0.01) and higher expenditure on prescriptions (men $5,559, women $2,034, p<0.01). CONCLUSIONS: In this population with pain and cancer, there was no clear relationship between healthcare costs and pain severity. These treatment patterns requiring further exploration including the prevalence of peptic ulcer/GORD drugs, and lipid lowering agents and the higher healthcare costs for men. TRIAL REGISTRATION: ACTRN12615000064505. World Health Organisation unique trial number U1111-1164-4649. Registered 23 January 2015.

Neonatal Electroencephalogram Electrode-Related Pressure Injury Prevention Quality Improvement Study.

OBJECTIVE: To lengthen the days between electroencephalogram electrode-related pressure injury (EERPI) to 100 EERPI-free days in 6 months of study implementation with a goal to maintain 200 EERPI-free days thereafter (≤1 EERPI event/year). METHODS: This quality improvement study took place in a level IV neonatal ICU over three epochs spanning 2 years: epoch 1 or baseline (January-June 2019), epoch 2 or implementation of intervention (July-December 2019), and epoch 3 or sustainment (January-December 2020). A daily electroencephalogram (EEG) skin assessment tool, introduction in practice of a flexible hydrogel EEG electrode, and successive rapid-cycle staff-education sessions were key interventions of the study. RESULTS: Seventy-six infants were monitored for 214 continuous EEG (cEEG) days, of which six (13.2%) developed EERPI in epoch 1. Eighty infants were monitored for 193 cEEG days, of which two (2.5%) developed EERPI in epoch 2. One hundred thirty-nine infants were monitored for 338 cEEG days, and none developed EERPI in epoch 3. There was no statistical difference with respect to the median cEEG days among study epochs. A G-chart of EERPI-free days showed an increase in EERPI-free days from an average of 34 days in epoch 1 to 182 days in epoch 2 and 365 days (or zero harm) in epoch 3. Skin erythema from EEG electrodes was noted during the study. CONCLUSIONS: The structured study interventions eliminated EERPI events in infants monitored with cEEG. Preventive intervention at the cEEG-electrode level coupled with skin assessment successfully reduced EERPIs in neonates.

Metastatic primary breast neuroendocrine neoplasms: a case series.

BACKGROUND: Breast neuroendocrine neoplasms represent a rare subtype of breast cancer which have not been well studied or characterised, particularly in the metastatic setting. AIM: To present clinicopathological characteristics, treatment and outcomes of a series of patients with metastatic neuroendocrine carcinoma of the breast and review the current literature. METHODS: We performed a retrospective review to identify and describe patients with metastatic neuroendocrine carcinoma of the breast at our centre between 2011 and 2021. Medical records, pathology and imaging results were examined to evaluate the clinical and histopathological features as well as the treatment pathways and prognosis of these patients. RESULTS: We present a series of seven female patients with metastatic neuroendocrine carcinoma of the breast, as defined by the World Health Organization classification, over a period of 10 years (2011-2021) from a single centre. Median age at diagnosis was 48 years (range 39-63). Six of seven tissue samples expressed synaptophysin and chromogranin and were also oestrogen and progesterone receptor positive; median Ki-67 index was 50% (range 20-90%). All seven patients had demonstrated avidity on 18 F-FDG PET imaging, and the six who underwent 68 Ga-DOTATATE PET all had significant avidity. Treatment modalities and sequencing varied, but all patients received chemotherapy during their disease course. Six patients received three or more lines of treatment. Median overall survival was 31.8 months (range 3.7-108.6). Median progression-free survival (PFS) with first-line therapy for metastatic disease was 5.8 months (range 1.8-37.8). CONCLUSIONS: This series shows the use of multiple modalities in treating this disease, with different sequencing in different patients. Despite multiple modalities used in the first-line setting, first-line PFS remains short. Larger series and further molecular characterisation are required to aid clinicians in managing this condition and to guide optimal treatment sequencing to improve outcomes in this rare patient group.

Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1.

The monarchE Cohort 1 patient population was enrolled based on high-risk clinicopathological features that can easily be identified as part of routine clinical breast cancer evaluation. Efficacy data from Cohort 1 demonstrate substantial evidence of benefit for adjuvant abemaciclib+ET in patients with HR+, HER2- early breast cancer at high risk of recurrence (ClinicalTrials.gov: NCT03155997 [monarchE]).