Most older adults living in residential aged care facilities (RACFs) have at least one marker of potentially suboptimal prescribing. Pharmacists play a crucial role in medication management, with their effectiveness enhanced by using computerised decision support tools. The Pharmacists Review to Optimise Medicines in Residential Aged Care (PROMPT-RC) study aims to optimise medicine use by providing pharmacists in RACFs with an electronic medicine management app with integrated decision support (AusTAPER App/Pathway) to use as part of medication reviews they undertake.
The PROMPT-RC study is a parallel cluster randomised controlled trial design involving Australian RACFs. It will assess if pharmacists’ use of the AusTAPER App/Pathway for medication reviews improves medication regimens for RACF residents compared with usual care. Pharmacists in RACFs randomised to the intervention arm will be trained to use the AusTAPER App/Pathway, which flags potentially inappropriate medicines (PIMs) across a person’s entire medicine regimen. Pharmacists in RACFs randomised to the control arm will not have access to the AusTAPER App/Pathway—they will continue to provide usual care. The primary outcome is the difference in the number of regular medicines between treatment arms at 12 months. Secondary outcomes will measure the number of regular and pro re nata medicines, PIMs, medicine administration times, medicine regimen complexity, use of antipsychotics, antidepressants, and benzodiazepines, quality of life, mortality, instances of physical restraint, and the number of falls, hospitalisations and general practitioner/health professional visits. The cost-effectiveness of the AusTAPER App/Pathway compared with usual care will be calculated. Data collection will occur at baseline, 3, 6, 9 and 12 months postrandomisation and 3 and 6 months prebaseline. We aim to recruit 668 participants to adjust for an estimated 10% loss to follow-up, giving 334 participants in each arm. Data analysis will follow an intention-to-treat approach using a linear mixed model.
Ethical approval was obtained from The University of Western Australia Human Research Ethics Committee (Reference: 2024/ET000525; approved 14 August 2024). Reciprocal approval was also obtained in other states. This study is registered on the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au). Trial findings will be disseminated through national and international peer-reviewed publications and conferences.
ACTRN12624001409561.
Patients with node-positive breast cancer having primary surgery currently undergo axillary node clearance (ANC) to reduce the risk of breast cancer recurrence. Evidence that this highly morbid procedure improves survival is lacking, but approximately 30% of patients will develop lifelong complications which significantly impact their quality of life.
Targeted axillary dissection (TAD) may be a safe, less morbid alternative to ANC and will be evaluated in the upcoming Targeted Axillary Dissection versus axillary node clearance in patients with POsitive axillary Lymph nodes in Early breast cancer (TADPOLE) randomised controlled trial.
TAD is not currently routine practice in patients having primary surgery, so it is vital that the procedure is performed in an agreed upon, standardised way within the trial and procedure fidelity monitored to ensure the results are generalisable and will be accepted by the surgical community. Robust surgical quality assurance (SQA) is essential. Here we describe the first phase of the TADPOLE SQA, a consensus process with the breast surgical community to agree upon how (1) surgery should be performed and standardised; (2) procedure fidelity will be monitored and (3) requirements for surgeon credentialling within the trial.
The consensus process will have three phases:
Generation of a long list of possible components of TAD from a scoping review and expert opinion. Identified items will be categorised and formatted into Delphi consensus questionnaire items. At least two rounds of an online Delphi survey in which at least 100 breast cancer surgeons will rate the importance of mandating/prohibiting, standardising and/or monitoring each component. A consensus meeting with surgeons to discuss, agree upon and ratify the approach to SQA within TADPOLE.
Ethical approval has been obtained from the University of Bristol Faculty of Health Sciences Ethics Committee. Educational materials including videos and webinars will be developed and shared with surgeons participating in TADPOLE. Results will be presented at national/international meetings and published in peer-reviewed journals.
Mammographic screening identifies many women with small breast cancers with favourable biological features, which have an excellent prognosis. Some of these may never have become clinically apparent without screening and are commonly described as ‘overdiagnosed’ cancers. Despite this, all patients with screen-detected cancers are currently treated with surgical excision and sentinel lymph node biopsy, although this may represent overtreatment. There is, therefore, a need for less invasive approaches to reduce treatment burden for patients while maintaining current excellent oncological outcomes. Vacuum-assisted excision (VAE) may represent such an alternative treatment approach, and the SMALL (Open Surgery versus Minimally invasive-vacuum Assisted excision for smaLL screen-detected breast cancer) trial aims to investigate the use of VAE for the safe de-escalation of surgical treatment for such excellent prognosis invasive breast cancers.
SMALL is a prospective, multicentre, randomised phase III trial of VAE versus surgery in patients with small, biologically favourable screen-detected invasive breast cancer. SMALL has an innovative hybrid design with coprimary endpoints. These include a randomised non-inferiority comparison of surgical re-excision rates following initial treatment, and a single-arm analysis of local recurrence at 5 years following VAE. Secondary outcomes include complication rates, overall survival, quality of life and a health economic analysis. The trial includes a QuinteT Recruitment Intervention to support recruitment.
Ethical approval was obtained from the Office for Research Ethics (Northern Ireland) for all UK sites. Results will be submitted for publication in a peer-reviewed journal, presented, shared with patient partners and with relevant professional organisations to inform future guideline development for the management of screen-detected breast cancer.
There are known risk factors for patient violence, but it is not known whether nurses are aware of them. Nurses' expectations regarding exposure to patient violence and risk tolerance have not been investigated.
To examine hospital-based nurses' frequency of and expectations regarding exposure to patient violence, risk factors perceived to be associated with violence and self-reported risk tolerance.
Cross-sectional, descriptive design following STROBE checklist.
The sample consisted of 499 hospital-based nurses. Exposure to any patient violence was high; exposure to physical violence was less common and occurred less frequently. Most nurses did not think it was possible to eliminate patient violence in hospitals and expected to be exposed to it. Some of the personal patient risk factors identified (race, veteran status) have not been noted in the literature. Most nurses were identified as having high work-related risk tolerance.
Patient violence is a serious occupational risk for hospital-based nurses. Some of the rhetoric related to violence towards nurses presents this risk as something that is not part of nursing work, discounting widespread exposure. It is also presented as something that ought not to be tolerated when it does occur. Both positions seem misaligned with the reality that exposure to violence is high, as is nurses' risk tolerance. When conceptualised as a serious occupational risk, opportunities for prevention, mitigation and recovery efforts can emerge. If risk tolerance is recognised as a strength, for example, it could be bolstered in the context of interventions such as robust prevention and mitigation training.
Objetivo principal: Conocer la percepción de los profesionales de enfermería sobre la prevención y tratamiento de lesiones en pacientes hospitalizados con enfermedades potencialmente mortales. Metodología: Estudio con enfoque cualitativo y cuantitativo, descriptivo y exploratorio, realizado en unidades clínicas, quirúrgicas, unidad de cuidados intensivos y unidad de urgencias de un hospital del sur de Brasil. Datos recogidos en 2014 mediante entrevistas semiestructuradas con 118 profesionales de enfermería. Resultados principales: Se identificaron tres categorías temáticas: La percepción de la atención; Prevención y tratamiento de lesiones; y Dificultades y estrategias para implementar la atención. Conclusión principal: El escenario de investigación no cuenta con unidad de cuidados paliativos. Realidad de la mayoría de los servicios, aumentando la posibilidad de desconocimiento del tema. Sin embargo, se cree que los resultados de este estudio pueden contribuir a reforzar la necesidad de esta línea de atención.