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Trans Tasman Radiation Oncology Group 20.01 CHEST-RT (Chemotherapy and Immunotherapy in Extensive Stage Small cell with Thoracic Radiotherapy) is a single-arm, open-label, prospective, multicentre phase II trial study that aims to establish the safety, feasibility and describe the efficacy of incorporating thoracic radiotherapy (TRT) (concurrent or sequential) to chemotherapy and immunotherapy in patients with extensive-stage small-cell lung cancer.
A single arm of up to 30 evaluable participants given TRT concurrent or sequentially with chemoimmunotherapy will be enrolled. Participants should commence radiotherapy with cycle 3 or cycle 4 of chemotherapy. Those not suitable for concurrent radiotherapy due to large tumour volumes may receive sequential radiotherapy. Accounting for a 15% non-evaluable rate, up to 35 participants will be enrolled. An independent data and safety monitoring committee will review the data and assess safety and feasibility. Progression to a phase III trial would be considered feasible if ≤20% of participants experienced ≥grade 3 oesophageal toxicity and ≤10% experienced ≥grade 3 pneumonitis. This approach would be considered feasible if there is ≤20% treatment discontinuation of systemic therapy secondary to radiation toxicities and ≥75% of participants have tumour volumes that can be safely treated to a dose of 30 Gy in 10 fractions. The primary outcome of the trial is safety and feasibility, and survival and responses will be assessed as secondary endpoints. A predefined subgroup analysis of toxicity will be performed on group 1 (concurrent TRT) versus group 2 participants (consolidation TRT).
This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/73189/PMCC-2021). The protocol, technical and clinical data will be disseminated by conference presentations and publications. Any modifications to the protocol will be formally documented by administrative letters and will be submitted to the approving HREC for review and approval.
Australian New Zealand Clinical Trials Registry (ACTRN12621000586819) and ClinicalTrials.gov identifier (NCT05796089).
by Leigh Huggard, Finiki Nearchou, Cliódhna O’Connor
Existing measures of lay causal attributions for mental illness do not discriminate between the diverse array of social factors known to influence mental health. Moreover, while ample research has emphasised the negative stigma consequences of biological attributions, limited research investigates how different social attributions might relate to stigma attitudes. The study developed and validated a novel scale to measure lay social attributions for various categories of mental illness. Scale items were generated via data triangulation from an online qualitative survey, a rapid umbrella literature review, and a media analysis. An online survey was disseminated to 500 participants, who rated items’ importance in causing four mental illness categories: anorexia nervosa, depression, schizophrenia, and post-traumatic stress disorder. Exploratory and confirmatory factor analysis identified and validated the factor structure of the Social Attributions for Mental Illness scale (SAMI) for each mental illness. Factors identified were life circumstances, violence/abuse, relational challenges, and sociopolitical turmoil. Tests of validity demonstrated good construct validity. This scale enables investigation of how social attributions may differ across populations and mental illness categories, and the consequences of such differences for attitudes and behaviour.To validate the psychometric properties of the Paediatric-Friendly Care Assessment Scale in the Emergency Department (PFCAS-ED) among clinical nurses.
A cross-sectional study.
A total of 463 emergency nurses participated in the study between May and September 2023. The participants were randomly divided into two groups to assess the psychometric properties of the PFCAS-ED, including its reliability, construct validity, convergent validity, discriminant validity, and criterion-related validity.
Exploratory factor analysis on data from the first group revealed six components of the PFCAS-ED: paediatric/adolescent timely care and resources, child protection mechanisms and safety, paediatric emergency care competency training and practice, paediatric emergency consultation information and space, paediatric crisis management and response, and a harmless environment and actions for toddlers. These factors explained 69.408% of the total variance and exhibited strong internal consistency. This six-factor structure and its 28 items were further validated using confirmatory factor analysis on data from the second group, yielding satisfactory fit indices and convergent and discriminant validity. Additionally, the scale exhibited excellent 2-week test–retest reliability and criterion-related validity.
The PFCAS-ED had excellent psychometric properties when used with clinical nurses and was proven to be a reliable instrument for evaluating emergency nurses' perceptions of the importance of providing paediatric-friendly care to children and their families.
This standardised scale enables nurses to assess their perceptions of the importance of paediatric-friendly care and design targeted interventions on the basis of available resources. Additionally, hospital administrators can use the PFCAS-ED to identify priorities, strengths, and areas requiring improvement in paediatric emergency care, thereby informing the development of effective strategies and comprehensive policies.
This study adhered to the STROBE guidelines.
No patient or public involvement.
Childhood obesity is an escalating crisis in the United States. Health policy may impact this epidemic which disproportionally affects underserved populations.
The aim was to use the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to assess health policy impact on preventing or treating school-aged children (5 > 18 years) with obesity in underserved populations.
A scoping review of 842 articles was conducted. Twenty-four articles met the inclusion criteria and underwent data extraction.
Twelve studies included subgroup analysis, with four suggesting an impact of policy on at-risk groups. None of the 24 studies fully applied the RE-AIM framework. Policies positively impacted childhood obesity in 12 studies across the sample.
Our review revealed inconsistent evidence for the effectiveness of policy on childhood obesity, perhaps due to the lack of focus on the social determinants of health. In addition, many studies did not evaluate the outcomes for underserved populations. Therefore, we propose more attention to social determinants in future legislation and evaluation of policy effectiveness on underserved populations. Findings identify an urgent need for the design, implementation, and evaluation of policies specifically directed to address the inequities of racism, social injustices, and social determinants of health that impact childhood obesity in the United States. Future work needs to identify who was reached by the policy, who benefitted from the policy, and how policies were implemented to address obesity-related health disparities. Nurses should advocate for the evaluation of childhood obesity policies, particularly in underserved populations, to determine effectiveness. Nurses, particularly those trained in population and community health and research, should advocate for policy research that considers inequities rather than controls for these variables. Multi-layered interventions can then be tailored to sub-populations and evaluated more effectively.
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