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Glaucoma is one of the leading causes of irreversible blindness and is characterised by progressive loss of retinal ganglion cells. While therapies to lower intraocular pressure slow the progression of the disease in most patients, a significant subset still shows progression despite treatment. Transcorneal electrical stimulation (TES) may potentially activate neuroprotective pathways and slow the progression of visual field defects. The OkuStim 2 System is a medical device for TES which was originally developed for the treatment of retinitis pigmentosa and similar retinal dystrophies and shall now be tested for the treatment of glaucoma. Stimulation of the diseased retina with weak currents can activate signalling pathways and the release of substances that have a protective effect on the retinal cells. This neuroprotective effect might preserve physiological functions of the retina for longer and slow down its gradual degeneration. Long-term use is required to maintain this effect. The TES-GPS study is investigating the safety and efficacy of TES in open-angle glaucoma.
TES-GPS (short title for glaucoma pilot study) is a prospective, randomised, double-blind, sham-controlled, single-centre pilot study at the University Medical Center Mainz. 50 patients with progressive visual field loss due to open-angle glaucoma will be randomised 1:1 to receive either TES with the OkuStim 2 System or sham stimulation. The primary endpoint is the change in visual field sensitivity (Humphrey mean deviation) after 18 months. Secondary endpoints include changes in visual acuity, intraocular pressure, optical coherence tomography (OCT) parameters and quality of life (National Eye Institute Visual Function Questionnaire 25, NEI-VFQ 25). The intervention consists of weekly 30 min TES sessions, which are conducted in the patient’s home after initial training in the clinic. The study comprises up to 13 scheduled visits over 18 months.
The study is conducted in accordance with ISO14155, Medical Device Regulation (EU) 2017/745, International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the Ethics Committee of the Landesaerztekammer Rheinland-Pfalz in Mainz and from Bundesinstitut fuer Arzneimittel und Medizinprodukte. Results will be published in peer-reviewed journals and presented at scientific conferences.
Physical activity is crucial for young children’s health and development. Many young children do not meet the recommended 3 hours of daily physical activity, including 60 min of energetic play. Early childhood education and care (ECEC/childcare) is a key setting to intervene to improve children’s physical activity. The Play Active programme is a scalable evidence-informed ECEC-specific physical activity policy intervention with implementation support strategies to improve educators’ physical activity-related practices.
This hybrid type III effectiveness-implementation trial will use a quasi-experimental repeated measures design to assess the real-world effectiveness of Play Active’s scalable implementation support strategies in helping ECEC services adopt the practices included in the Play Active policy. Secondary aims will examine changes in educator-reported and device-measured children’s physical activity; assess the sustainability of the programme; identify effective dissemination strategies; assess cost-effectiveness; and involve comprehensive process evaluation. All ECEC services in Western Australia (n=776), Queensland (n=1744) and South Australia (n=445) will be invited to participate. Data will be collected at baseline, 6, 12, 18, 24 and 30 months.
Ethics approval has been provided by The University of Western Australia Human Research Ethics Committee (HREC) (2023/ET000187), the University of Queensland HREC (2024/HE000076) and the University of South Australia HREC (206023). This real-world trial of Play Active is vital for understanding its implementation in practice and to generate evidence for further scale-up and roll-out nationally. Key findings will be disseminated to stakeholders, collaborators, policy-makers as well as families and practitioners in the ECEC sector.
ACTRN12624000406505.
To explore barriers and facilitators for reducing low-value home-based nursing care.
Qualitative exploratory study.
Seven focus group interviews and two individual interviews were conducted with homecare professionals, managers and quality improvement staff members within seven homecare organizations. Data were deductively analysed using the Tailored Implementation for Chronic Diseases checklist.
Barriers perceived by homecare professionals included lack of knowledge and skills, such as using care aids, interactions between healthcare professionals and general practitioners creating expectations among clients. Facilitators perceived included reflecting on provided care together with colleagues, clearly communicating agreements and expectations towards clients. Additionally, clients' and relatives' behaviour could potentially hinder reduction. In contrast, clients' motivation to be independent and involving relatives can promote reduction. Lastly, non-reimbursement and additional costs of care aids were perceived as barriers. Support from organization and management for the reduction of care was considered as facilitator.
Understanding barriers and facilitators experienced by homecare professionals in reducing low-value home-based nursing care is crucial. Enhancing knowledge and skills, fostering cross-professional collaboration, involving relatives and motivating clients' self-care can facilitate reduction of low-value home-based nursing care.
Implications for profession and patient care: De-implementing low-value home-based nursing care offers opportunities for more appropriate care and inclusion of clients on waitlists.
Addressing barriers with tailored strategies can successfully de-implement low-value home-based nursing care.
The Consolidated Criteria for Reporting Qualitative Research checklist was used.
No patient or public contribution.
Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advances in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. This approach can downstage the tumour and may possibly reduce toxicity and improve cosmetic outcomes compared with postoperative radiotherapy. This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery (BCS) for patients with an ipsilateral recurrent breast event (IRBE) after previous BCT.
The REPEAT trial is a multicentre, prospective, single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE. Eligible patients are ≥50 years, have a unifocal non-lobular invasive breast cancer ≤2 cm, Bloom-Richardson grade 1 or 2, oestrogen receptor-positive, human epidermal growth factor receptor 2-negative and clinically negative axillary lymph nodes. The study plans to enrol 25 patients. Radiotherapy planning will involve the use of CT and MRI in the treatment position. Single-dose PBI of 20 Gy to the tumour and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator. Tumour response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity. BCS will be performed 3 (±one) weeks post PBI. The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days. Secondary endpoints include the evaluation of acute (grade 1) and late toxicity, radiologic and pathologic response, mastectomy rate, patient-reported outcomes, cosmetic outcome, local, regional and distant recurrence rates, survival outcome and biomarkers in liquid biopsies and tumour tissue. Patients will be followed up to 5 years after PBI.
Ethical approval from the Medical Research Ethics Committee of the Amsterdam UMC has been obtained (NL85983.018.24). The results will be disseminated via peer-reviewed academic journal and presentation at conferences. In addition, summaries will be shared with the participating patients.
The trial was registered prospectively on October 11th 2024 at clinicaltrials.gov (NCT06640881).
FreshRSS 