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Womens preference for HPV self-sampling devices: a programme-embedded, large-scale paired comparative study within the cervical cancer screening programme in the Capital Region of Denmark

Por: Andreasen · E. K. · Arum · A. · Pedersen · H. · Dahl Nielsen · T. · Frandsen · P. · Pedersen · B. T. · Serizawa · R. · Bonde · J.
Objective

To demonstrate women’s preferences for three human papillomavirus (HPV) self-sampling devices.

Design

Cross-sectional, programme-embedded paired comparative study with randomised sampling order within device pairs.

Setting

Organised cervical cancer screening programme in the Capital Region of Denmark.

Participants

1760 women eligible for cervical cancer screening (April 2024 to May 2025), assigned to one of three groups: (1) Evalyn versus FLOQSwab (n=518), (2) Evalyn versus SensiGrip (n=657) and (3) FLOQSwab versus SensiGrip (n=585).

Outcome measures

Primary: device preference. Secondary: sampling-experience (self-reported). Data were assessed with ² tests for preference, logistic regression for predictor analysis and Wilcoxon signed-rank equivalence test with two one-sided test procedures to assess sampling experience.

Results

Overall, 95.7% rated HPV self-sampling a positive experience and 87.3% preferred HPV self-sampling in future screening. SensiGrip was preferred significantly over FLOQSwab (p0.05) although Evalyn scored higher in sampling certainty. Sampling order influenced preference in Evalyn comparisons. Prior experience with self-sampling, screening history and subcohort membership did not significantly influence device preference.

Conclusions

Overall, participants rated self-sampling a positive experience. SensiGrip was preferred over FLOQSwab, while Evalyn demonstrated comparable overall acceptability to both alternative devices in the primary implementation-focused analysis. These findings suggest that device replacement would be acceptable from a screening participation perspective, particularly a shift from FLOQSwab to SensiGrip.

S-ketamine versus placebo for cortical spreading depolarisation in severe acute brain injury (KETA-BID): protocol for a pilot, randomised, blinded clinical trial

Por: Andreasen · T. H. · Olsen · M. H. · Gluud · C. · Lindschou · J. · Fabricius · M. · Hauerberg · J. · Moller · K.
Introduction

Cortical spreading depolarisation (SD) is a pathological wave of depolarisation in the cortex. SDs occur frequently after severe acute brain injury, and SDs in clusters can contribute to secondary brain damage in patients with severe acute brain injury through hypoperfusion and upregulation of cerebral metabolism in vulnerable brain tissue. Ketamine appears to inhibit SDs both in vitro and in patient series of severe acute brain injury. The KETA-BID trial aims to examine the efficacy and safety of S-ketamine for SDs in severe acute brain injury, as well as the feasibility of the trial design.

Methods and analysis

This randomised, blinded feasibility and pilot trial includes adults (≥ 18 years) undergoing a supratentorial craniotomy or craniectomy for severe acute brain injury (ie, traumatic brain injury, aneurysmal subarachnoid haemorrhage or spontaneous intracerebral haemorrhage). During surgery, an electrocorticography (ECoG) strip is placed adjacent to injured brain tissue. Patients are continuously monitored throughout their stay at the neurointensive care unit and the neurosurgical step-down unit. In the case of an SD, physiological optimisation of intracranial pressure, brain tissue oxygen tension (PbtO2), core temperature and blood glucose is initiated. Participants developing SD clusters are randomised for continuous infusion with S-ketamine or matching placebo in a 1:1 allocation with full blinding of the treatment allocation. Infusion rates (ie, dose) and duration of trial medication are adjusted following a dosing algorithm according to SD occurrence. Surviving participants are followed until 6 months after the injury with recording of functional outcome. The primary outcome is occurrence of SDs per hour of monitoring after randomisation.

Ethics and dissemination

The Scientific Ethics Committee of the Capital Region of Denmark (H-21056972), the Danish Medicines Agency (EudraCT 2021-003716-12), as well as the Clinical Trials Information System (CTIS 2024-515315-22-00) approved this trial. This trial will provide insight into both SD and the clinical effects of ketamine following severe acute brain injury, presenting a potential new treatment for these patients. The findings will be submitted for publication in peer-reviewed publications.

Trial registration number

NCT05095857.

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