Conectar
Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.
A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.
Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.
REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).
The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.
The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.
Cutaneous vascular anomalies and scars can cause significant physical and psychosocial difficulties for children, but can be ameliorated with pulsed dye laser (PDL) and neodymium-doped yttrium aluminium garnet (Nd:YAG) laser treatment. Given that multiple rounds of treatment are often required, and that the procedures are painful, achieving adequate analgesia is imperative in this setting. Paediatric procedural pain management guidelines suggest that multimodal non-pharmacological and pharmacological analgesia should be used for such procedures; however, the place of topical anaesthetic (TA) within this paradigm has not been adequately studied.
This feasibility and pilot trial will investigate the feasibility of performing a randomised, placebo-controlled trial assessing pain intensity in children receiving TA in conjunction with other multimodal analgesic methods for laser procedures. The primary objective of the trial will be to assess feasibility, and secondary objectives will be to assess pain intensity, acceptability of trial procedures to participating families and their clinical team, to assess the laser treatment response, and obtain data necessary for full-scale trial sample size calculations.
The trial will include 50 children aged 0–18 years old who are undergoing awake PDL and/or Nd:YAG laser treatment for scars or vascular anomalies. Patients will be randomised in a 1:1 ratio to receive either TA cream (lidocaine 2.5%/prilocaine 2.5% (Numit 5% cream, Ego Pharmaceuticals, Braeside, VIC, Australia)) or a placebo, along with our unit’s standard multimodal analgesic agents for laser treatment (including paracetamol, ibuprofen or oxycodone and intraprocedural sucrose solution or intranasal fentanyl). Investigators, participants and their caregivers, and clinicians will be blinded to participant allocation.
The primary outcome of the trial will be trial feasibility based on pre-specified criteria. The secondary outcome of pain intensity will be assessed by observer, caregiver and self-reported measures, and the secondary outcome of trial method acceptability with a Theoretical Framework of Acceptability questionnaire. The assessment of laser treatment response will be assessed with lesion-specific evaluation tools. Feasibility and acceptability data will be summarised using descriptive statistics. The association between treatment groups and pain scores, treatment groups and laser treatment response will be investigated using a univariable linear regression model, with the effect estimate reported as mean difference and 95% CI.
This trial has undergone ethical review and has been granted approval by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (ref HREC/23/QCHQ/91002) and the Griffith University Human Research Ethics Committee (ref 2023/308). The protocol has been prospectively registered in the Australian and New Zealand Clinical Trials Registry (ACTRN12623000494639). Results of this trial may be presented at scientific meetings and will be published in a peer-reviewed journal. Participating families that have indicated an interest in trial results will receive a plain-language summary of the trial results by email.
ACTRN12623000494639.
To evaluate the clinical effectiveness of a Nurse Practitioner led procedural support service for children with procedural anxiety, and identify facilitators and barriers to its sustained implementation and optimisation.
An effectiveness–implementation hybrid type 3 study used a prospective mixed methods evaluation approach.
From December 2022 to May 2023, data were collected from children, parents and clinicians using a nurse practitioner-led service at a quaternary paediatric hospital in Brisbane, Australia. A prospective audit assessed clinical outcomes, while qualitative interviews explored implementation barriers and facilitators.
The clinical audit (n = 40) confirmed the service was effective and safe, ensuring procedural completion with minimal distress. Descriptive statistics indicated low pain and anxiety scores. There was a moderate negative relationship between pain scores and the use of distraction techniques. Interviews with thirty-three participants showed the service improved access to procedural care, reduced the need for physical restraint and general anaesthesia, and enhanced clinical workflow through preadmission assessments.
Utilising a Nurse Practitioner support service represents a safe and effective strategy to enhance access for paediatric patients with procedural anxiety.
This study underscores the significance of specialised nursing roles in managing paediatric procedural anxiety, offering a replicable model to enhance procedural outcomes and mitigate medical trauma across healthcare settings.
Minimising pain and distress is important in all clinical encounters with children to reduce the risk of medical-related trauma and the future avoidance of healthcare.
The report of study outcomes was guided by the Standards for Reporting Implementation Studies (StaRI) initiative.
Patients or the public were not included in the design, conduct or reporting of the study.
To explore the barriers and facilitators influencing emergency department clinicians' adherence to the Australian Peripheral Intravenous Catheter (PIVC) Clinical Care Standard, using the Behaviour Change Wheel (BCW).
Suboptimal PIVC practices are frequently linked to a range of patient-important adverse outcomes. The first Australian Peripheral Intravenous Catheter Clinical Care Standard was introduced in 2021, aiming to standardize practice. However, a recent national survey revealed a lack of adherence to the Standard among emergency department clinicians.
A qualitative descriptive study.
The study was conducted across two Australian emergency departments in 2023. Utilizing purposive sampling, semi-structured interviews were conducted. The analysis incorporated both deductive and inductive approaches, mapping the findings to the BCW.
Interviews with 25 nurses and doctors revealed nine key subthemes. The main barriers were the stressful environment, insufficient education and training, and the absence of a feedback mechanism. The main facilitators were recognition of suboptimal practice, belief in the importance of patient engagement, and the desire to improve practice.
Multiple complex factors have an impact on clinicians' adherence to the Standard. The identified interventions will serve as a guide for future implementation of the Standard.
The findings inform healthcare organizations of the significance of implementing strategies to enhance clinicians' acceptance of the Standard. Clinicians should consider incorporating the multifaceted interventions developed in accordance with the BCW for future implementation projects.
Promoting adherence to standards opens avenues to challenge suboptimal practice and has the potential to instigate a culture shift in the fundamental skills of frontline clinicians.
The study is designed and reported according to the Consolidated Criteria for Reporting Qualitative Research checklist.
No patient or public contribution.
This qualitative study aimed to identify nurses' and allied health professionals' perceptions and experiences of providing hospital-acquired pressure injury (HAPI) prevention in a paediatric tertiary hospital in Australia, as well as understand the perceived barriers and facilitators to preventing HAPI.
A qualitative, exploratory study of hospital professionals was undertaken using semi-structured interviews between February 2022 and January 2023.
Two frameworks, the Capability, Opportunity and Motivation Model of Behaviour (COM-B) and the Theoretical Domains Framework (TDF), were used to give both theoretical and pragmatic guidance. Participants included 19 nursing and allied health professionals and data analysis was informed by the framework approach.
Analysis revealed nine core themes regarding professionals' beliefs about the barriers and facilitators to HAPI prevention practices across seven TDF domains. Themes included HAPI prevention skills and education, family-centred care, automated feedback and prompts, allocation and access to equipment, everybody's responsibility, prioritizing patients and clinical demands, organizational expectations and support, integrating theory and reality in practice and emotional influence.
These findings provide valuable insights into the barriers and facilitators that impact paediatric HAPI prevention and can help identify and implement strategies to enhance evidence-based prevention care and prevent HAPI in paediatric settings.
Overcoming barriers through evidence-based interventions is essential to reduce HAPI cases, improve patient outcomes, and cut healthcare costs. The findings have practical implications, informing policy and practice for improved preventive measures, education, and staffing in paediatric care, ultimately benefiting patient well-being and reducing HAPIs.
No patient or public contribution. The focus of the study is on healthcare professionals and their perspectives and experiences in preventing HAPIs in paediatric patients. Therefore, the involvement of patients or the public was not deemed necessary for achieving the specific research objectives.
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