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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.
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Distrofia Muscular de Duchenne , Masculino , Humanos , Distrofia Muscular de Duchenne/genética , Distrofia Muscular de Duchenne/terapia , Distrofina/genética , Terapia Genética/métodos , Infusões Intravenosas , Fibras Musculares EsqueléticasRESUMO
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.
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Neoplasias , Satisfação do Paciente , Humanos , Estudos Transversais , Reprodutibilidade dos Testes , Inquéritos e Questionários , Psicometria , Medidas de Resultados Relatados pelo PacienteRESUMO
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.
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Transtornos de Estresse Pós-Traumáticos , Feminino , Gravidez , Humanos , Transtornos de Estresse Pós-Traumáticos/terapia , Pais/educação , Psicoterapia/métodos , Mães/educação , GestantesRESUMO
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.
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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.
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Currículo , Educação Interprofissional , Humanos , Escolaridade , Docentes , LiderançaRESUMO
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.
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Serviços de Saúde Rural , Humanos , Criança , Pandemias , Pessoal Técnico de Saúde/psicologia , Recursos Humanos , Instituições AcadêmicasRESUMO
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.
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Promoção da Saúde , Saúde Bucal , Humanos , Adolescente , Projetos Piloto , Instituições Acadêmicas , Pesquisa Qualitativa , Avaliação de Programas e Projetos de SaúdeRESUMO
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.
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Serviços de Saúde Rural , Criança , Humanos , Estudos Transversais , Recursos Humanos , Vitória , Atenção Primária à SaúdeRESUMO
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.
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Enfermagem Geriátrica/métodos , Profissionais de Enfermagem/estatística & dados numéricos , Papel do Profissional de Enfermagem , Serviços de Saúde Rural/normas , Idoso , Estudos de Avaliação como Assunto , Humanos , Entrevistas como Assunto , VitóriaRESUMO
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.
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Promoção da Saúde/métodos , Promoção da Saúde/estatística & dados numéricos , Médicos/estatística & dados numéricos , População Rural/estatística & dados numéricos , Serviços de Saúde Escolar/organização & administração , Serviços de Saúde Escolar/estatística & dados numéricos , Instituições Acadêmicas/estatística & dados numéricos , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudantes/estatística & dados numéricos , VitóriaRESUMO
The purpose of the study was to undertake rigorous psychometric testing of the Caring Efficacy Scale in a sample of Registered Nurses. A cross-sectional survey of 2000 registered nurses was undertaken. The Caring Efficacy Scale was utilized to inform the psychometric properties of the selected items of the Caring Efficacy Scale. Cronbach's Alpha identified reliability of the data. Exploratory Factor Analysis and Confirmatory Factor Analysis were undertaken to validate the factors. Confirmatory factor analysis confirmed the development of two factors; Confidence to Care and Doubts and Concerns. The Caring Efficacy Scale has undergone rigorous psychometric testing, affording evidence of internal consistency and goodness-of-fit indices within satisfactory ranges. The Caring Efficacy Scale is valid for use in an Australian population of registered nurses. The scale can be used as a subscale or total score reflective of self-efficacy in nursing. This scale may assist nursing educators to predict levels of caring efficacy.
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Empatia , Autoeficácia , Adulto , Austrália , Estudos Transversais , Feminino , Humanos , Masculino , Recursos Humanos de Enfermagem , Psicometria , Reprodutibilidade dos TestesRESUMO
A cross-sectional survey was conducted, and the construct validity and reliability of the Brisbane Practice Environment Measure in an Australian sample of registered nurses were examined. Nurses were randomly selected from the database of an Australian nursing organization. The original 33 items of the Brisbane Practice Environment Measure were utilized to inform the psychometric properties using confirmatory factor analysis. The Cronbach's alpha was 0.938 for the total scale and ranged 0.657-0.887 for the subscales. A five-factor structure of the measure was confirmed, χ(2) = 944.622, (P < 0.01), χ(2) /d.f. ratio = 2.845, Tucker Lewis Index 0.929, Root Mean Square Error = 0.061 and Comparative Fit Index = 0.906. The selected 28 items of the measure proved reliable and valid in measuring effects of the practice environment upon Australian nurses. The implications are that regular measurement of the practice environment using these 28 items might assist in the development of strategies which might improve job satisfaction and retention of registered nurses in Australia.
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Recursos Humanos de Enfermagem Hospitalar , Inquéritos e Questionários , Local de Trabalho/organização & administração , Adulto , Idoso , Austrália , Estudos Transversais , Análise Fatorial , Feminino , Humanos , Satisfação no Emprego , Masculino , Pessoa de Meia-Idade , Análise de Componente Principal , Psicometria , Reprodutibilidade dos Testes , Adulto JovemRESUMO
Adolescent violence in the home (AVITH) is increasing. In Victoria alone, police call-out data indicates a consistent 9% rise per annum from 2006. Community services are struggling to provide a cohesive response to this issue. This study examined the prevalence, risk factors and service system capacity regarding AVITH in Mitchell Shire, a geographical location in central Victoria. The results of the study revealed that specific funding was perceived by organisations to be the single highest need in regards to this phenomenon. Recommendations for the service system in Mitchell Shire included a collaborative approach to establish assessment guidelines, referral pathways and protocols for responding to the disclosure of AVITH. To effectively support workers in Mitchell Shire, a quality service system response would involve the development of common standards of practices across these processes. The methodology used with the AVITH Service System Capacity Assessment Survey, specifically developed for this study, may provide a useful tool for other locations investigating service gaps and needs in relation to adolescent family violence.
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Violência Doméstica/prevenção & controle , Violência Doméstica/estatística & dados numéricos , Adolescente , Feminino , Humanos , Masculino , Avaliação das Necessidades , Prevalência , Alocação de Recursos , População Rural , Inquéritos e Questionários , Vitória/epidemiologiaRESUMO
AIM: To develop and psychometrically test the Barriers to Nurses' use of Physical Assessment Scale. BACKGROUND: There is growing evidence of failure to recognize hospitalized patients at risk of clinical deterioration, in part due to inadequate physical assessment by nurses. Yet, little is known about the barriers to nurses' use of physical assessment in the acute hospital setting and no validated scales have been published. DESIGN: Instrument development study. METHOD: Scale development was based on a comprehensive literature review, focus groups, expert review and psychometric evaluation. The scale was administered to 434 acute care Registered Nurses working at a large Australian teaching hospital between June and July 2013. Psychometric analysis included factor analysis, model fit statistics and reliability testing. RESULTS: The final scale was reduced to 38 items representing seven factors, together accounting for 57·7% of the variance: (1) reliance on others and technology; (2) lack of time and interruptions; (3) ward culture; (4) lack of confidence; (5) lack of nursing role models; (6) lack of influence on patient care; and (7) specialty area. Internal reliability ranged from 0·70-0·86. CONCLUSION: Findings provide initial evidence for the validity and reliability of the Barriers to Nurses' use of Physical Assessment Scale and point to the importance of understanding the organizational determinants of nurses' assessment practices. The new scale has potential clinical and research applications to support nursing assessment in acute care settings.
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Avaliação em Enfermagem , Processo de Enfermagem , Humanos , Psicometria , QueenslandRESUMO
'Success' in drug development is bringing to patients a new medicine that has an acceptable benefit-risk profile and that is also cost-effective. Cost-effectiveness means that the incremental clinical benefit is deemed worth paying for by a healthcare system, and it has an important role in enabling manufacturers to obtain new medicines to patients as soon as possible following regulatory approval. Subgroup analyses are increasingly being utilised by decision-makers in the determination of the cost-effectiveness of new medicines when making recommendations. This paper highlights the statistical considerations when using subgroup analyses to support cost-effectiveness for a health technology assessment. The key principles recommended for subgroup analyses supporting clinical effectiveness published by Paget et al. are evaluated with respect to subgroup analyses supporting cost-effectiveness. A health technology assessment case study is included to highlight the importance of subgroup analyses when incorporated into cost-effectiveness analyses. In summary, we recommend planning subgroup analyses for cost-effectiveness analyses early in the drug development process and adhering to good statistical principles when using subgroup analyses in this context. In particular, we consider it important to provide transparency in how subgroups are defined, be able to demonstrate the robustness of the subgroup results and be able to quantify the uncertainty in the subgroup analyses of cost-effectiveness.
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Análise Custo-Benefício/métodos , Avaliação da Tecnologia Biomédica , Humanos , Avaliação da Tecnologia Biomédica/economia , IncertezaRESUMO
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.
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BACKGROUND: The results of the few studies found investigating relationships between sociodemographic variables and job satisfaction in nurses are mixed. Nevertheless some evidence exists which indicates that some socio-demographic variables are related to nurses' job satisfaction. Moreover reports indicate that job satisfaction is Linked to the retention of nurses. Relationships between socio-demographics and job satisfaction of Australian nurses are examined in the current study. AIM: To examine relationships between socio-demographic factors and job satisfaction and identify if these factors predicted job satisfaction Levels in Australian nurses. METHODS: A cross sectional survey was conducted of 2000 Australian registered nurses who were at the time members of an industrial and professional organisation. The nurses were randomised and stratified according to gender and were asked to answer questions on a socio-demographic questionnaire developed by the researcher. RESULTS: The majority of respondents showed positive job satisfaction scores. Pearson's correlation coefficients (r) found the covariates age, years of experience and years in current job were all moderately to highly positively correlated with each other (all r > 0.40, p < 0.001), however there were no significant interactions between these covariates and Job Satisfaction. Multivariable analysis found significant positive relationships existed between job satisfaction, specialty area and health sector. CONCLUSIONS: Specialty area and health sector showed significant associations with job satisfaction in nurses. These variables should be considered by governments, nursing, organisational leaders and policy makers when developing future policies and strategies aimed at retention. These variables should be investigated further in relation to nursing job satisfaction.
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Satisfação no Emprego , Enfermeiras e Enfermeiros/provisão & distribuição , Enfermagem , Reorganização de Recursos Humanos , Adulto , Austrália , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Fatores Socioeconômicos , Especialidades de Enfermagem , Recursos HumanosRESUMO
OBJECTIVE: To examine the effect of sildenafil in patients with Raynaud's phenomenon (RP) secondary to limited cutaneous systemic sclerosis (lcSSc). METHODS: In this double-blind, placebo-controlled study, 57 patients with RP secondary to lcSSc were randomized to receive modified-release sildenafil 100 mg once daily for 3 days followed by modified-release sildenafil 200 mg once daily for 25 days or placebo. The primary assessment was the percentage change in the number of RP attacks per week in the per-protocol population. Secondary end points included Raynaud's Condition Score, duration of attacks, RP pain score, endothelial dysfunction assessed by a peripheral arterial tonometric (PAT) device, and serum biomarker levels. RESULTS: The mean percentage reduction from baseline to day 28 in attacks per week was greater for modified-release sildenafil than for placebo (-44.0% versus -18.1%, P = 0.034); the mean number of attacks per week improved from 25.0 at baseline to 19.3 after placebo treatment and from 30.5 to 18.7 after modified-release sildenafil treatment (P = 0.244). Decreases from baseline in Raynaud's Condition Score, duration of attacks, and RP pain score were not significantly different between groups. Mean values and changes from baseline in PAT responses and serum biomarker levels were similar between groups. The most frequent adverse events were headache and dyspepsia; the majority of adverse events were mild or moderate. CONCLUSION: Our findings indicate that modified-release sildenafil reduced attack frequency in patients with RP secondary to lcSSc and was well tolerated. Modified-release sildenafil may be a treatment option in this patient population.
Assuntos
Piperazinas/administração & dosagem , Doença de Raynaud/tratamento farmacológico , Doença de Raynaud/etiologia , Esclerodermia Limitada/complicações , Sulfonas/administração & dosagem , Vasodilatadores/administração & dosagem , Adulto , Idoso , Biomarcadores/sangue , Preparações de Ação Retardada/administração & dosagem , Preparações de Ação Retardada/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Piperazinas/efeitos adversos , Purinas/administração & dosagem , Purinas/efeitos adversos , Prevenção Secundária , Citrato de Sildenafila , Sulfonas/efeitos adversos , Resultado do Tratamento , Vasodilatadores/efeitos adversosRESUMO
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.
Assuntos
Serviços de Saúde do Indígena , Havaiano Nativo ou Outro Ilhéu do Pacífico , Idoso , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , Povos Indígenas , Poder Familiar , Pais/psicologia , GravidezRESUMO
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: Prescribing errors are common and are caused by multiple factors. Standard medication charts have been recommended by British and Australian Health services. A study of a standard medication chart in five hospitals in one state of Australia significantly reduced prescribing errors. WHAT THIS STUDY ADDS: A standard medication chart developed in one area can be adopted through a collaborative process and successfully implemented across a diverse country resulting in similar reductions in prescribing errors. Three of the four stages of the prescribing process (information gathering, decision making and communication of instructions) can be improved by the use of an improved standard medication chart. The introduction of a standard medication chart has enabled development of standard prescribing education programmes. AIMS: To establish whether a standard national inpatient medication chart (NIMC) could be implemented across a range of sites in Australia and reduce frequency of prescribing errors and improve the completion of adverse drug reaction (ADR) and warfarin documentation. METHODS: A medication chart, which had previously been implemented in one state, was piloted in 22 public hospitals across Australia. Prospective before and after observational audits of prescribing errors were undertaken by trained nurse and pharmacist teams. The introduction of the chart was accompanied by local education of prescribers and presentation of baseline audit findings. RESULTS After the introduction of the NIMC, prescribing errors decreased by almost one-third, from 6383 errors in 15,557 orders, a median (range) of 3 (0-48) per patient to 4293 in 15,416 orders, 2 (0-45) per patient (Wilcoxon Rank Sum test, P < 0.001). The documentation of drugs causing previous ADRs increased significantly from 81.9% to 88.9% of drugs (χ(2) test, P < 0.001). The documentation of the indication for warfarin increased from 12.1 to 34.3% (χ(2) test, P= 0.001) and the documentation of target INR increased from 10.8 to 70.0% (χ(2) test, P < 0.001) after implementation of the chart. CONCLUSIONS: National implementation of a standard medication chart is possible. Similar reduction in the rate of prescribing errors can be achieved in multiple sites across one country. The consequent benefits for patient care and training of staff could be significant.