Conectar
Progressive supranuclear palsy (PSP) is a devastating neurodegenerative disease characterised by cognitive, behavioural and motor problems. Motor symptoms are highly disabling, while cognitive and behavioural changes have a major impact on carer burden, quality of life and prognosis. Apathy and impulsivity are very common, often coexistent in PSP, and negatively predict survival. In preclinical models and other diseases, apathy and impulsivity are associated with noradrenergic deficits, which can be severe in PSP.
Noradrenaline for Progressive Supranuclear Palsy Syndromes trial is a randomised, double-blind, placebo-controlled, crossover design, Phase IIb clinical trial to evaluate the efficacy and safety of oral atomoxetine for the treatment of cognitive and behavioural changes in PSP. Participants receive atomoxetine 40 mg (10 mg/mL oral solution) once daily or a matched placebo solution, in random order, each for 8 weeks. An ‘informant’, who knows the patient with PSP well, is co-recruited to complete some of the trial outcome measures. Participants remain in the trial for 22 weeks after randomisation. The primary objectives are to assess (1) safety and tolerability and (2) efficacy versus placebo on challenging behaviours as reported in a subscale of the Cambridge Behavioural Inventory. Secondary and exploratory measures relate to cognition, the PSP Rating Scale, mood and potential baseline predictors of individual response to atomoxetine computed from imaging, genetic and cognitive measures at baseline.
The trial was approved by the South Central-Oxford B Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (REC reference: 20/SC/0416). Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences and engagement with patients, the public, policymakers and practitioners.
ISRCTN99462035; DOI:
Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility.
This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes.
The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the National Medicines Regulatory Authority (Sri Lanka). The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.
Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).
High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs (‘triple pill’) compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.
Guided by the UK Medical Research Council’s framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.
Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of ‘better than usual’ care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill’s large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.
Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.
ACTRN12612001120864, SLCTR/2015/020.
The purpose of this study was to determine how strongly mean systolic blood pressure (mSBP, mm Hg) was related to hypertension control and if an mSBP
mSBP and per cent control to
SPRINT randomised participants with hypertension to two SBP targets:
SPRINT participants with year 2 data. Patients in MAP (had hypertension, were aged≥18 years, had ≥2 healthcare visits from November 2019 through October 2021 and received care from clinicians (n=544) with ≥24 patients.
mSBP and control to
In SPRINT-S (n=4303) and SPRINT-I (n=4323), mSBP values at the last visit were 136.7 and 121.7 with BP
mSBP is strongly related to hypertension control. Moreover, mSBP
To understand, from a nursing perspective, factors affecting the use of prophylactic dressings to prevent pressure injuries in acute hospitalised adults.
Pressure injury causes harm to patients and incurs significant costs to health services. Significant emphasis is placed on their prevention. Relatively recently, prophylactic dressings have been promoted to reduce pressure injury development. However, in the acute care setting, information about the clinical use of these dressing is lacking.
Qualitative, descriptive.
Nineteen medical and surgical nurses participated. Semi-structured interviews were conducted and transcribed verbatim. Thematic analysis was performed using an inductive approach using NVivo software.
Three themes were identified, reflecting factors that influenced and perpetuated indiscriminate use of prophylactic dressings: False sense of security; Convenience and task prioritisation; and Navigating challenges in evidence-based pressure injury prevention.
The findings indicate inconsistent prevention practices, with prophylactic dressings often applied without justification or referral to research-based evidence to guide clinical decision-making. There was a prevailing attitude of ‘job done’ when a prophylactic dressing was applied.
This study has identified several factors that perpetuate the inappropriate use of prophylactic dressings for pressure injury prevention that may be amenable to organisational change. The findings indicate that nurses often rely on these dressings as a shortcut due to time constraints, which led to missed skin assessments and low-value care. The research can be used to inform the development of clear guidelines on dressings within hospital settings which encourage assessment-based selection for their use, and process-based guidance for their application, skin surveillance, dressing inspection and removal.
The Consolidated Criteria for Reporting Qualitative Research (COREQ) reporting guideline was followed.
Neither patients nor the public were directly involved in this study.
FreshRSS 