Client and stakeholder perceptions of a novel, nurse practitioner-led alcohol and other drug ambulatory withdrawal service.

INTRODUCTION: Despite recommendations for ambulatory withdrawal programs appearing in many contemporary alcohol and other drug treatment guidelines, to date there have been few studies exploring such programs from client and service stakeholder perspectives. The aim of this study was to explore both individual and service stakeholder perceptions of a nurse practitioner-led ambulatory withdrawal service on the Gold Coast, Queensland, Australia. METHODS: Data were obtained from three groups: clinicians with knowledge of the service (n = 6); relatives of clients who had used the service (n = 2); and clients who had used the service (n = 10) using a Qualitative Descriptive design. Saldaña's (Saldaña, The coding manual for qualitative researchers. 2013) structural coding framework was used to analyse and code data into themes, with the study reported in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist (Tong et al. Int J Qual Health Care 2017;19:349-57). RESULTS: Participants noted advantages of the nurse practitioner-led ambulatory withdrawal service, including rapid availability of admission to the service and a person-centred approach. Compared with other ambulatory withdrawal options, clients valued the ability to remain in their own environment, however participants suggested greater follow-up after withdrawal, with the potential of a home visiting service for greater client engagement and treatment retention. DISCUSSION AND CONCLUSIONS: Findings provide evidence to suggest that nurse practitioner-led ambulatory withdrawal services are an acceptable option for a proportion of clients who need rapid access to services when they wish to make changes to their alcohol and/or other drug use. Furthermore, they can provide person-centred care for comorbid physical and mental ill health occurring in addition to psychosocial issues associated with alcohol and/or other drug use.

Development and testing of a patient-reported experience measure for cancer: A cross-sectional survey.

AIM: To develop and psychometrically test the Patient-reported Experience Measure-Cancer (PREM-C), reflecting patients' perceptions of cancer care experiences according to the Institute of Medicine domains. DESIGN: A three-phase cross-sectional survey was conducted. METHODS: Development, reliability and validity testing of the PREM-C measure was undertaken. Data collection included three phases: firstly (development) between October and November, 2015; secondly (psychometric testing), May 2016-June, 2017, and finally, (revision and psychometric testing) May 2019-March 2020. RESULTS: The final PREM-C structure, created using the Institute of Medicine domains, was psychometrically sound with five factors identified in the Exploratory Factor Analysis, demonstrating internal reliability ranging from 0.8 to 0.9. Confirmatory Factor Analysis indicated the hypothesized model fitted well (Root mean square error of approximation = 0.076). External convergent and divergent validity was established with the PREM-C found to be moderately correlated with the Picker Patient Experience Questionnaire but weakly correlated with the WHOQoL-BREF. CONCLUSION: The development and testing of the PREM-C demonstrated good fit as a clinically relevant measure of ambulatory cancer patients' experiences of care. To make meaningful changes to nursing practice and health services, patient experience measures such as the PREM-C might support staff to identify areas for service improvement. IMPACT: Few reliable measures and less validated measures collect patients' perceptions of the quality of their healthcare provision. Rigorous psychometric testing of the newly developed PREM-C demonstrated good internal consistency, test-retest reliability, and external convergent and divergent validity. The PREM-C is a potentially relevant measure of cancer patients' experiences of care. It might be used to assess patient-centred care and guide safety and quality improvements in clinical settings. PREM-C use might inform service providers of experiences of care in their institution and inform policy and practice development. This measure is sufficiently generic, allowing potential use in other chronic disease populations. PATIENT OR PUBLIC CONTRIBUTION: This conduct of this study was supported by the participating patients of the hospital Cancer Outpatients Service.

Oral health promotion for rural adolescents: A process evaluation of a co-designed pilot program.

INTRODUCTION: Adolescents living in rural areas are more likely to have poorer oral health compared with their metropolitan counterparts. Co-design is emerging as an effective method for developing health promotion programs that meets the needs of stakeholders; however, little evidence exists to inform successful co-designed oral health promotion programs for rural adolescents. OBJECTIVE: The aim of this study is to understand the value of a co-designed oral health promotion program undertaken with rural adolescents in northeast Victoria with objectives to: Co-design an oral health promotion program with rural adolescents. Evaluate the program for appropriateness, acceptability, and feasibility. Make recommendations for program refinement and scalability. DESIGN: Study participants included year 11 and 12 students in a rural secondary school in Northern Victoria (n=2), who collaboratively along with schoolteachers, and the local health service staff led by an oral health therapist, co-designed, and delivered an oral gealth promotion program in their schools. This qualitative study used semi-structured group interviews (n = 8) to evaluate the co-design process and impact. Audio-recorded interviews were transcribed and thematically analysed using a co-design evaluation toolkit as a framework for analysis. FINDINGS: Qualitative inductive analysis revealed three main thematic categories around participant benefits (intended and unintended learning outcomes; interpersonal skills), the quality of the process (value of co-design, qualities of facilitators, and engagement); and scalability and replicability. CONCLUSION: The study indicates that co-design was both acceptable and appropriate for designing an oral health promotion program for rural adolescents delivering unexpected benefits. Building the capacity of schoolteachers could offer sustainable and cost-effective solutions for scalability.

Delandistrogene Moxeparvovec Gene Therapy in Ambulatory Patients (Aged ≥4 to <8 Years) with Duchenne Muscular Dystrophy: 1-Year Interim Results from Study SRP-9001-103 (ENDEAVOR).

OBJECTIVE: Delandistrogene moxeparvovec is approved in the USA for the treatment of ambulatory patients (4-5 years) with Duchenne muscular dystrophy. ENDEAVOR (SRP-9001-103; NCT04626674) is a single-arm, open-label study to evaluate delandistrogene moxeparvovec micro-dystrophin expression, safety, and functional outcomes following administration of commercial process delandistrogene moxeparvovec. METHODS: In cohort 1 of ENDEAVOR (N = 20), eligible ambulatory males, aged ≥4 to <8 years, received a single intravenous infusion of delandistrogene moxeparvovec (1.33 × 1014 vg/kg). The primary endpoint was change from baseline (CFBL) to week 12 in delandistrogene moxeparvovec micro-dystrophin by western blot. Additional endpoints evaluated included: safety; vector genome copies; CFBL to week 12 in muscle fiber-localized micro-dystrophin by immunofluorescence; and functional assessments, including North Star Ambulatory Assessment, with comparison with a propensity score-weighted external natural history control. RESULTS: The 1-year safety profile of commercial process delandistrogene moxeparvovec in ENDEAVOR was consistent with safety data reported in other delandistrogene moxeparvovec trials (NCT03375164 and NCT03769116). Delandistrogene moxeparvovec micro-dystrophin expression was robust, with sarcolemmal localization at week 12; mean (SD) CFBL in western blot, 54.2% (42.6); p < 0.0001. At 1 year, patients demonstrated stabilized or improved North Star Ambulatory Assessment total scores; mean (SD) CFBL, +4.0 (3.5). Treatment versus a propensity score-weighted external natural history control demonstrated a statistically significant difference in least squares mean (standard error) CFBL in North Star Ambulatory Assessment, +3.2 (0.6) points; p < 0.0001. INTERPRETATION: Results confirm efficient transduction of muscle by delandistrogene moxeparvovec. One-year post-treatment, delandistrogene moxeparvovec was well tolerated, and demonstrated stabilized or improved motor function, suggesting a clinical benefit for patients with Duchenne muscular dystrophy. ANN NEUROL 2023;94:955-968.

Supporting the needs of pre- and primary school children in rural Victoria: Multidisciplinary views and experiences.

PROBLEM: Predicted effects on children from the COVID-19 pandemic include poorer mental health and increased behavioural and developmental concerns. Rural children are at higher risk due to socio-economic factors, isolation and reduced access to services. Investigation by health services into the physical, social and emotional needs of children in rural areas is critical to inform local health promotion planning, service delivery priorities and workforce capacity building. SETTING: Located in a Modified Monash Model category 5, our northern Victorian health service undertook a child-focused needs assessment in order to be strategically responsive to community issues. KEY MEASURES: The project utilised a quantitative community profiling approach and qualitative interviews with a purposive sample (n = 17) of multidisciplinary professionals. STRATEGIES FOR CHANGE: Three main themes emerged: (1) Perpetual navigation of rural access limitations highlighted professionals' exhaustion in working in environments with ongoing unmet needs. (2) Cycles of disadvantage and early intervention gaps identified flow-on negative effects, with concerning trends in poorer child outcomes. (3) Solutions through collaboration grouped ideas to improve support for children. EFFECTS OF CHANGE: Community-level enablement strategies could increase contact with allied health professionals for rural children and reduce reliance on individualised treatment approaches. LESSONS LEARNT: One collaborative action is to pilot and evaluate allied health student placement models to deliver group programs for rural children.

Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment.

BACKGROUND: Acceptable, effective and feasible support strategies (interventions) for parents experiencing complex post-traumatic stress disorder (CPTSD) symptoms or with a history of childhood maltreatment may offer an opportunity to support parental recovery, reduce the risk of intergenerational transmission of trauma and improve life-course trajectories for children and future generations. However, evidence relating to the effect of interventions has not been synthesised to provide a comprehensive review of available support strategies. This evidence synthesis is critical to inform further research, practice and policy approaches in this emerging area. OBJECTIVES: To assess the effects of interventions provided to support parents who were experiencing CPTSD symptoms or who had experienced childhood maltreatment (or both), on parenting capacity and parental psychological or socio-emotional wellbeing. SEARCH METHODS: In October 2021 we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, together with checking references and contacting experts to identify additional studies. SELECTION CRITERIA: All variants of randomised controlled trials (RCTs) comparing any intervention delivered in the perinatal period designed to support parents experiencing CPTSD symptoms or with a history of childhood maltreatment (or both), to any active or inactive control. Primary outcomes were parental psychological or socio-emotional wellbeing and parenting capacity between pregnancy and up to two years postpartum. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of trials for inclusion, extracted data using a pre-designed data extraction form, and assessed risk of bias and certainty of evidence. We contacted study authors for additional information as required. We analysed continuous data using mean difference (MD) for outcomes using a single measure, and standardised mean difference (SMD) for outcomes using multiple measures, and risk ratios (RR) for dichotomous data. All data are presented with 95% confidence intervals (CIs). We undertook meta-analyses using random-effects models. MAIN RESULTS: We included evidence from 1925 participants in 15 RCTs that investigated the effect of 17 interventions. All included studies were published after 2005. Interventions included seven parenting interventions, eight psychological interventions and two service system approaches. The studies were funded by major research councils, government departments and philanthropic/charitable organisations. All evidence was of low or very low certainty. Parenting interventions Evidence was very uncertain from a study (33 participants) assessing the effects of a parenting intervention compared to attention control on trauma-related symptoms, and psychological wellbeing symptoms (postpartum depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Evidence suggested that parenting interventions may improve parent-child relationships slightly compared to usual service provision (SMD 0.45, 95% CI -0.06 to 0.96; I2 = 60%; 2 studies, 153 participants; low-certainty evidence). There may be little or no difference between parenting interventions and usual perinatal service in parenting skills including nurturance, supportive presence and reciprocity (SMD 0.25, 95% CI -0.07 to 0.58; I2 = 0%; 4 studies, 149 participants; low-certainty evidence). No studies assessed the effects of parenting interventions on parents' substance use, relationship quality or self-harm. Psychological interventions Psychological interventions may result in little or no difference in trauma-related symptoms compared to usual care (SMD -0.05, 95% CI -0.40 to 0.31; I2 = 39%; 4 studies, 247 participants; low-certainty evidence). Psychological interventions may make little or no difference compared to usual care to depression symptom severity (8 studies, 507 participants, low-certainty evidence, SMD -0.34, 95% CI -0.66 to -0.03; I2 = 63%). An interpersonally focused cognitive behavioural analysis system of psychotherapy may slightly increase the number of pregnant women who quit smoking compared to usual smoking cessation therapy and prenatal care (189 participants, low-certainty evidence). A psychological intervention may slightly improve parents' relationship quality compared to usual care (1 study, 67 participants, low-certainty evidence). Benefits for parent-child relationships were very uncertain (26 participants, very low-certainty evidence), while there may be a slight improvement in parenting skills compared to usual care (66 participants, low-certainty evidence). No studies assessed the effects of psychological interventions on parents' self-harm. Service system approaches One service system approach assessed the effect of a financial empowerment education programme, with and without trauma-informed peer support, compared to usual care for parents with low incomes. The interventions increased depression slightly (52 participants, low-certainty evidence). No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills. AUTHORS' CONCLUSIONS: There is currently a lack of high-quality evidence regarding the effectiveness of interventions to improve parenting capacity or parental psychological or socio-emotional wellbeing in parents experiencing CPTSD symptoms or who have experienced childhood maltreatment (or both). This lack of methodological rigour and high risk of bias made it difficult to interpret the findings of this review. Overall, results suggest that parenting interventions may slightly improve parent-child relationships but have a small, unimportant effect on parenting skills. Psychological interventions may help some women stop smoking in pregnancy, and may have small benefits on parents' relationships and parenting skills. A financial empowerment programme may slightly worsen depression symptoms. While potential beneficial effects were small, the importance of a positive effect in a small number of parents must be considered when making treatment and care decisions. There is a need for further high-quality research into effective strategies for this population.

The effect of childhood maltreatment on adult survivors' parental reflective function, and attachment of their children: A systematic review.

BACKGROUND: Parental reflective function (PRF) is a candidate mechanism in the transmission of intergenerational trauma. This systematic review examined (1) the association between parental history of childhood maltreatment and PRF, (2) how PRF relates to attachment in children of parent survivors, and (3) whether PRF moderates the association between parental maltreatment history and child attachment. METHODS: Ten databases were searched (from inception to 10th November 2021). Inclusion criteria were primary study, quantitative, parent participants, measures of childhood maltreatment, and postnatal PRF. Exclusion criteria were qualitative, intervention follow-up, gray literature, or a review study. Risk of bias was assessed using recommended tools. Data were narratively synthesized. RESULTS: One-thousand-and-two articles were retrieved, of which eleven met inclusion criteria (N = 974 participants). Four studies found a significant association between parental childhood maltreatment and disrupted PRF, six did not, one found mixed results. One study reported the association between childhood maltreatment and attachment (nonsignificant results). DISCUSSION: There is no clear evidence PRF is routinely disrupted in parent survivors, though there is high heterogeneity in studies. Future research should standardize design to better understand whether PRF is a candidate mechanism in intergenerational trauma. OTHER: PROSPERO CRD42020223594.

The implementation of interprofessional education: a scoping review.

INTRODUCTION: Implementation of interprofessional education (IPE) is recognised as challenging, and well-designed programs can have differing levels of success depending on implementation quality. The aim of this review was to summarise the evidence for implementation of IPE, and identify challenges and key lessons to guide faculty in IPE implementation. METHODS: Five stage scoping review of methodological characteristics, implementation components, challenges and key lessons in primary studies in IPE. Thematic analysis using a framework of micro (teaching), meso (institutional), and macro (systemic) level education factors was used to synthesise challenges and key lessons. RESULTS: Twenty-seven primary studies were included in this review. Studies were predominantly descriptive in design and implementation components inconsistently reported. IPE was mostly integrated into curricula, optional, involved group learning, and used combinations of interactive and didactic approaches. Micro level implementation factors (socialisation issues, learning context, and faculty development), meso level implementation factors (leadership and resources, administrative processes), and macro level implementation factors (education system, government policies, social and cultural values) were extrapolated. Sustainability was identified as an additional factor in IPE implementation. CONCLUSION: Lack of complete detailed reporting limits evidence of IPE implementation, however, this review highlighted challenges and yielded key lessons to guide faculty in the implementation of IPE.

Rural primary care workforce views on trauma-informed care for parents experiencing complex trauma: A descriptive study.

BACKGROUND: An important service system for rural parents experiencing complex trauma is primary health care. AIM: To investigate workforce knowledge, attitudes and practices, and barriers and enablers to trauma-informed care in rural primary health care. MATERIAL & METHODS: This study used a descriptive, cross-sectional design. It involved an on-line survey conducted in 2021 in rural Victoria, Australia. Participants were the primary health care workforce. The main outcome measures were study-developed and included, a 21-item Knowledge, Attitudes and Practices tool, a 16-item Barriers and Enablers to Trauma-Informed Care Implementation tool, and three open-ended questions. RESULTS: The 63 respondents were from community health (n = 40, 63%) and child and family services (n = 23, 37%). Many (n = 43, 78%) reported undertaking trauma-informed care training at some point in their career; with 32% (n = 20) during higher education. Respondents self-rated their knowledge, attitudes and practices positively. Perceived enablers were mainly positioned within the service (e.g. workforce motivation and organisational supports) and perceived barriers were largely external structural factors (e.g. availability of universal referral pathways, therapeutic-specific services). Open-ended comments were grouped into four themes: (1) Recognition and understanding; (2) Access factors; (3) Multidisciplinary and collaborative approaches; and (4) Strengths-based and outcome-focused approaches. DISCUSSION & CONCLUSION: Primary health care is an important driver of population health and well-being and critical in rural contexts. Our findings suggest this sector needs a rural trauma-informed care implementation strategy to address structural barriers. This also requires policy and system development. Long-term investment in the rural workforce and primary care service settings is essential to integrate trauma-informed care.

Using participatory action research to co-design perinatal support strategies for Aboriginal and Torres Strait Islander parents experiencing complex trauma.

PROBLEM & BACKGROUND: Support is important for all parents but critical for those experiencing complex trauma. The The Healing the Past by Nurturing the Future project uses participatory action research to co-design effective perinatal support for Aboriginal and Torres Strait Islander parents. AIM: This research aims to identify and refine culturally appropriate support strategies for Aboriginal and Torres Strait Islander parents experiencing complex trauma. DESIGN: We presented our synthesised eight parent support goals and 60 strategies, collated from Elder and parent focus groups, previous participatory workshops, and evidence reviews, for discussion at a stakeholder workshop. Stakeholder perspectives were captured using a three-point agreement activity and, self- and scribe-recorded comments. Aboriginal and non-Aboriginal researchers analysised the qualitative data, to identify core factors which might facilitate or help enact the parenting related goals. FINDINGS: Overall, stakeholders (n = 37) strongly endorsed all eight goals. Workshop attendees (57% Aboriginal) represented multiple stakeholder roles including Elder, parent and service provider. Four core factors were identified as crucial for supporting parents to heal from complex trauma: Culture (cultural traditions, practices and strengths), Relationality (family, individual, community and services), Safety (frameworks, choice and control) and Timing (the right time socio-emotionally and stage of parenting). DISCUSSION: Context-specific support tailored to the Culture, Relationality, Safety, and Timing needs of parents is essential. These four factors are important elements to help enact or facilitate parenting support strategies. CONCLUSION: Further work is now required to develop practical resources for parents, and to implement and evaluate these strategies in perinatal care to address cumulative and compounding cycles of intergenerational trauma.

Exploring barriers to and enablers of antimicrobial stewardship in rural health services.

BACKGROUND: World-wide antimicrobial resistance is increasing, and antimicrobial stewardship (AMS) interventions aimed at increasing compliance with optimal antimicrobial prescribing are essential in tackling this issue. Local level research about antimicrobial use is important to tailor interventions in a place-based approach to solve local level problems. METHODS: As part of a broader mixed methods study, Medical Practitioners and Senior Nurses at three rural health services were invited by email to participate in interviews to explore opinions and practices of antimicrobial prescribing. RESULTS: Seven Medical Practitioners and thirteen Senior Nurses from three small rural health services participated in the study. The major findings were that nurses were perceived as the 'gatekeepers' to antimicrobial initiatives by all participants. Senior Nurses perceived AMS activities as being a link in a world-wide program to eradicate antimicrobial resistance, while Medical Practitioners perceived it as a local level program, aimed at educating individual prescribers. There was consensus that an intervention aimed at improved documentation at the point of prescribing and increased accessibility to antimicrobial prescribing guidelines had a high potential for increased compliance with optimal prescribing of antimicrobials. CONCLUSION: The research enabled identification of interventions aimed at increasing optimal compliance with antimicrobial prescribing that are acceptable to and appropriate for Medical Practitioners and nursing staff at three rural health services.

Long-term follow-up of patients with type 2 and non-ambulant type 3 spinal muscular atrophy (SMA) treated with olesoxime in the OLEOS trial.

In a previous Phase 2 study, olesoxime had a favorable safety profile. Although the primary endpoint was not met, analyses suggested that olesoxime might help in the maintenance of motor function in patients with Types 2/3 SMA. This open-label extension study (OLEOS) further characterizes the safety, tolerability and efficacy of olesoxime over longer therapy durations. In OLEOS, no new safety risks were identified. Compared to matched natural history data, patients treated with olesoxime demonstrated small, non-significant changes in motor function over 52 weeks. Motor function scores were stable for 52 weeks but declined over the remainder of the study. The greatest decline in motor function was seen in patients ≤15 years old, and those with Type 2 SMA had faster motor function decline versus those with Type 3 SMA. Previous treatment with olesoxime in the Phase 2 study was not protective of motor function in OLEOS. Respiratory outcomes were stable in patients with Type 3 SMA >15 years old but declined in patients with Type 2 SMA and in patients with Type 3 SMA ≤15 years old. Overall, with no stabilization of functional measures observed over 130 weeks, OLEOS did not support significant benefit of olesoxime in patients with SMA.

High-Fidelity Simulation and Clinical Judgment of Nursing Students in a Maternal-Newborn Course.

Clinical judgment, one's ability to think like a nurse, is an essential skill for safe nursing practice. With the rise of simulation to replace clinical experiences, there is limited evidence regarding the effectiveness of simulation on the development of clinical judgment. This study explored differences in clinical judgment in maternal-newborn courses between undergraduate nursing students participating exclusively in simulation and those participating in hospital-based clinical experiences. Following completion of the clinical rotation, students participated in an evaluative maternal-newborn high-fidelity simulation experience that was recorded and evaluated using the Lasater's Clinical Judgment Rubric (2007). Lasater's Clinical Judgment Rubric scores between the simulation and clinical practice groups were compared using an independent sample t-test. There was no statistical difference in clinical judgment scores between the simulation and hospital-based clinical groups (t = -1.056, P = .295). Our findings suggest that simulation may be a comparable alternative to clinical experience in nursing education.

Nurse practitioner interventions for smokers with chronic hepatitis C.

BACKGROUND: Smoking is a grossly overlooked risk factor for people with chronic hepatitis C with regard to disease progression. It is unclear whether current smoking cessation interventions are effective for this population. PURPOSE: The purpose was to evaluate the effectiveness of a telephone counseling and nicotine replacement therapy (NRT) intervention for smokers with chronic hepatitis C to quit or reduce rates of smoking. METHODS: A randomized controlled trial was conducted with participants randomized and stratified according to heaviness of smoking. Ninety-two eligible adults who smoked cigarettes and attended hepatology outpatient clinics were recruited. The intervention included NRT and telephone counseling compared with telephone counseling alone. Data collection occurred from December 2010 to November 2011. Data were collected at baseline, 6, and 12 weeks to assess smoking cessation. Change scores were analyzed using analysis of variance to examine the differences between smoking interventions. RESULTS: At 6 weeks, both control and intervention groups had quit or reduced the number of cigarettes smoked daily. However, over 12 weeks, the intervention group showed sustained quitting or reduced smoking, with 5.8 (confidence interval [CI]: 2.4, 9.3) fewer cigarettes smoked per day from baseline. The control group maintained an average reduction of 1.6 (CI: -1.9, 5.2) fewer cigarettes per day. IMPLICATIONS FOR PRACTICE: Nicotine replacement therapy and individualized telephone counseling interventions increase the prospects of smoking cessation. Interventions such as these, introduced at routine clinic appointments in the outpatients' setting, by a nurse practitioner (hepatology) showed clinically important results for smoking cessation in this population.

Doctors in secondary schools program: the first year of program implementation in a rural Victorian school.

INTRODUCTION: Lifelong health behaviour habits are often consolidated in adolescence, with primary health care an important element of current and future health and wellbeing. Barriers to adolescent primary healthcare access are complex and include social, behavioural and geographical issues as well as organisational and systemic barriers. METHOD: This article describes the first year of implementation of a Doctors in Secondary School program in a rural setting in Victoria, Australia. RESULTS: The program provided 332 primary healthcare appointments over 10 months, equating to 102.33 hours of general practitioner contact with students. The program offered scheduled and unscheduled (drop-in) appointments with above-average consultation times. Cancellations and 'no-shows' were low, at 9% overall. Health promotion resources, material and information, were sourced and provided by the clinic practice nurse. CONCLUSION: The role of the practice nurse has been instrumental in providing a needs-based service for students, connecting to local and regional health and community services. Adolescents in rural areas require holistic primary care including provision of resources, basic wellbeing needs and advocacy. Programs to support rural adolescents should be integrated across the strengths and opportunities that exist in each unique context.

Implementation of an older person's nurse practitioner in rural aged care in Victoria, Australia: a qualitative study.

BACKGROUND: There are staff shortages nation-wide in residential aged care, which is only predicted to grow as the population ages in Australia. The aged care staff shortage is compounded in rural and remote areas where the health service workforce overall experiences difficulties in recruitment and retention. There is evidence that nurse practitioners fill important service gaps in aged care and rural health care but also evidence that barriers exist in introducing this extended practice role. METHODS: In 2018, 58 medical and direct care staff participated in interviews and focus groups about the implementation of an older person's nurse practitioner (OPNP) in aged care. All 58 interviewees had previously or currently worked in an aged care setting where the OPNP delivered services. The interviews were analysed using May's implementation theory framework to better understand staff perceptions of barriers and enablers when an OPNP was introduced to the workplace. RESULTS: The major perceived barrier to capacity of implementing the OPNP was a lack of material resources, namely funding of the role given the OPNP's limited ability to self-fund through access to the Medicare Benefits Schedule (MBS). Staff perceived that benefits included timely access to care for residents, hospital avoidance and improved resident health outcomes. CONCLUSION: Despite staff perceptions of more timely access to care for residents and improved outcomes, widespread implementation of the OPNP role may be hampered by a poor understanding of the role of an OPNP and the legislative requirement for a collaborative arrangement with a medical practitioner as well as limited access to the MBS. This study was not a registered trial.

Safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 spinal muscular atrophy: a randomised, double-blind, placebo-controlled phase 2 trial.

BACKGROUND: Spinal muscular atrophy (SMA) is a progressive motor neuron disease causing loss of motor function and reduced life expectancy, for which limited treatment is available. We investigated the safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 SMA. METHODS: This randomised, double-blind, placebo-controlled, phase 2 study was done in 22 neuromuscular care centres in Belgium, France, Germany, Italy, Netherlands, Poland, and the UK. Safety and efficacy of olesoxime were assessed in patients aged 3-25 years with genetically confirmed type 2 or non-ambulatory type 3 SMA. A centralised, computerised randomisation process allocated patients (2:1 with stratification by SMA type and centre) to receive olesoxime (10 mg/kg per day) in an oral liquid suspension or placebo for 24 months. Patients, investigators assessing outcomes, and sponsor study personnel were masked to treatment assignment. The primary outcome measure was change from baseline compared with 24 months between the two treatment groups in functional domains 1 and 2 of the Motor Function Measure (MFM D1 + D2) assessed in the full analysis population. A shorter, 20-item version of the MFM, which was specifically adapted for young children, was used to assess patients younger than 6 years. Safety was assessed in all patients who received one or more doses of the study drug. The trial is registered with ClinicalTrials.gov, number NCT01302600. FINDINGS: The trial was done between Nov 18, 2010, and Oct 9, 2013. Of 198 patients screened, 165 were randomly assigned to olesoxime (n=108) or placebo (n=57). Five patients in the olesoxime group were not included in the primary outcome analysis because of an absence of post-baseline assessments. The change from baseline to month 24 on the primary outcome measure was 0·18 for olesoxime and -1·82 for placebo (treatment difference 2·00 points, 96% CI -0·25 to 4·25, p=0·0676). Olesoxime seemed to be safe and generally well tolerated, with an adverse event profile similar to placebo. The most frequent adverse events in the olesoxime group were pyrexia (n=34), cough (n=32), nasopharyngitis (n=25), and vomiting (n=25). There were two patient deaths (one in each group), but these were not deemed to be related to the study treatment. INTERPRETATION: Olesoxime was safe at the doses studied, for the duration of the trial. Although the primary endpoint was not met, secondary endpoints and sensitivity analyses suggest that olesoxime might maintain motor function in patients with type 2 or type 3 SMA over a period of 24 months. Based on these results, olesoxime might provide meaningful clinical benefits for patients with SMA and, given its mode of action, might be used in combination with other drugs targeting other mechanisms of disease, although additional evidence is needed. FUNDING: AFM Téléthon and Trophos SA.

Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies.

BACKGROUND: There is currently no standard of care for treatment of negative symptoms of schizophrenia, although some previous results with glutamatergic agonists have been promising. METHODS: Three (SunLyte [WN25308], DayLyte [WN25309], and FlashLyte [NN25310]) phase III, multicenter, randomized, 24-week, double-blind, parallel-group, placebo-controlled studies evaluated the efficacy and safety of adjunctive bitopertin in stable patients with persistent predominant negative symptoms of schizophrenia treated with antipsychotics. SunLyte met the prespecified criteria for lack of efficacy and was declared futile. Key inclusion criteria were age ≥18 years, DSM-IV-TR diagnosis of schizophrenia, score ≥40 on the sum of the 14 Positive and Negative Syndrome Scale negative symptoms and disorganized thought factors, unaltered antipsychotic treatment, and clinical stability. Following a 4-week prospective stabilization period, patients were randomly assigned 1:1:1 to bitopertin (5 mg and 10 mg [DayLyte] and 10 mg and 20 mg [FlashLyte]) or placebo once daily for 24 weeks. The primary efficacy end point was mean change from baseline in Positive and Negative Syndrome Scale negative symptom factor score at week 24. RESULTS: The intent-to-treat population in DayLyte and FlashLyte included 605 and 594 patients, respectively. At week 24, mean change from baseline showed improvement in all treatment arms but no statistically significant separation from placebo in Positive and Negative Syndrome Scale negative symptom factor score and all other end points. Bitopertin was well tolerated. CONCLUSIONS: These studies provide no evidence for superior efficacy of adjunctive bitopertin in any of the doses tested over placebo in patients with persistent predominant negative symptoms of schizophrenia.

Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme.

BACKGROUND: Many patients with schizophrenia require high doses of medication for their ongoing psychotic symptoms. Glutamate theories and findings from studies showing efficacy of sarcosine, an endogenous, non-selective glycine-reuptake inhibitor mediated by GlyT1, offer an alternative approach. We undertook the SearchLyte trial programme to examine the efficacy of bitopertin, a selective GlyT1-mediated glycine-reuptake inhibitor, as an adjunctive treatment to ongoing antipsychotic treatment. METHODS: SearchLyte consisted of three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies done in outpatient clinics in Asia, Europe, and North and South America (TwiLyte done at 109 sites, NightLyte at 84, and MoonLyte at 87). Participants were male and female outpatients, aged at least 18 years, meeting DSM-IV criteria for schizophrenia with suboptimally controlled positive symptoms despite treatment with antipsychotics. Inclusion criteria included a Positive and Negative Syndrome Scale (PANSS) total score of at least 70 and antipsychotic treatment stability for the past 12 weeks before randomisation. Key exclusion criteria included meeting criteria for symptomatic remission or previous treatment with a GlyT1 inhibitor or any other investigational drug. After a screening or 4-week prospective stabilisation period, we randomly assigned participants (1:1:1) to a 12-week, double-blind treatment of either placebo or one of two fixed doses of oral, once-daily bitopertin (10 or 20 mg in TwiLyte and NightLyte; 5 or 10 mg in MoonLyte) added to their current antipsychotic medicine. After completion of 12 weeks' treatment, the study design allowed for additional double-blind treatment for 40 weeks to assess maintenance of the effect, followed by a randomised 4-week washout period to assess withdrawal effects. Subsequently, all patients were offered the opportunity to receive bitopertin treatment in a 3-year follow-up. The primary efficacy endpoint was the mean change from baseline in the PANSS Positive Symptom Factor Score (PSFS) at week 12, analysed in the modified intention-to-treat population. The trials were registered at ClinicalTrials.gov (numbers NCT01235520 [TwiLyte], NCT01235585 [MoonLyte], and NCT01235559 [NightLyte]). FINDINGS: Between Nov 19, 2010, and Dec 12, 2014, we randomly assigned 1794 patients to treatment, of whom 1772 were treated and analysed. MoonLyte was discontinued in September, 2014, on the basis of results from futility analyses. Across studies and treatment arms, most patients completed 12 weeks of treatment (505 in TwiLyte, 517 in NightLyte, and 506 in MoonLyte). Only one study, NightLyte, met the primary endpoint where the PANSS PSFS significantly differed from placebo at week 12, and only in the 10-mg arm: mean difference in score -1·37, 95% CI -2·27 to -0·47; p=0·0028. Improvements from baseline for the bitopertin 20-mg arm in Nightlyte were not significant compared with placebo: -3·77, 95% CI -4·40 to -3·14; p=0·3142. Results from the other two studies also did not differ from placebo (TwiLyte 0·58, 95% CI -0·34 to 1·50, p=0·22 for 10 mg and 0·43, -0·49 to 1·36, p=0·36 for 20 mg; MoonLyte 0·06, 95% CI -0·79 to 0·92, p=0·88 for 5 mg and 0·44, -0·41 to 1·28, p=0·31 for 10 mg). Placebo responses varied across studies and might have contributed to the differences in efficacy between studies. Four deaths occurred during the 12-week treatment period, three in NightLyte (upper gastrointestinal haemorrhage, alcohol poisoning and related head injury, and a completed suicide) and one in MoonLyte (myocardial infarction in a patient with pre-existing risk factors). Only the death by suicide was deemed related to the study drug. The incidence of serious adverse events was low across treatment groups in all three studies; psychiatric disorders were the most frequently reported serious adverse events and the most frequent cause of adverse events leading to discontinuation. INTERPRETATION: Only one of six active treatment arms across the three studies offered an advantage of adjunctive bitopertin over placebo for the treatment of suboptimally controlled symptoms of schizophrenia. The small improvement associated with bitopertin together with the varying placebo response suggests that adjunctive bitopertin treatment might offer only modest benefit to suboptimal responders to antipsychotics, if any. FUNDING: F Hoffmann-La Roche.

Using Simulation to Teach About Poverty in Nursing Education: A Review of Available Tools.

Poverty is one of the most significant social determinants of health, and as such, it is imperative that nurses have an understanding of the impact that living in poverty has upon one's life and health. A lack of such understanding will impede nurses from providing care that is patient centered, treats all patients fairly, and advocates for social justice. It is essential that nursing educators assure that poverty-related content and effective teaching strategies are used in nursing curricula in order to help students develop this understanding. Several poverty-simulation tools are available and may be able to assist with development of accurate knowledge, skills, and attitudes. Unfortunately, little evidence exists to evaluate most poverty simulation tools. This article will provide an introduction to several poverty-related simulation tools, discuss any related research that evaluates their effectiveness, and make recommendations for integration of such simulation tools into nursing curricula.