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Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol

Por: Kanaan · R. · Duncan · R. · Mihalopoulos · C. · Braat · S. · OBrien · T. J. · Velakoulis · D. · Kwan · P. · Mulder · R. T. · Cook · M. · Mullen · S. · Mayne · D. · Oliver · G. · Eleftheriadis · D. · Ameen · O. · Chatterton · M. L. · DSouza · W. · Nicolo · J.-P. · Perucca · P. · Winton-Brow
Introduction

Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.

Methods and analysis

A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.

Ethics and dissemination

The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.

Nurse and Other Healthcare Managers' Experiences and Recommendations for Patient Incident Reporting Processes and Real‐Time Software Development: A Qualitative Study

ABSTRACT

Aims

To (1) analyse managers' experiences with handling patient safety incident reports in an incident reporting software, identifying key challenges; (2) analyse the incident report processes from the managers' perspective; (3) examine managers' perceptions of ways to support and improve health professionals' experiences of report-handling processes; and (4) investigate how, from their point of view, incident reporting software should be developed in the future.

Design

A descriptive qualitative study.

Methods

Interviews and focus group discussions on Microsoft Teams from 11/2024 to 3/2025, including 16 participants, analysis with deductive and inductive content analysis.

Results

Of 16 participants, 15 were managers and one was a patient safety expert. Most were nurse managers (n = 9). Four discussion themes were divided into 30 categories. Participants highlighted the need to improve the reporting software's terminology, classification and analysis tools. The use of artificial intelligence was desired but not currently integrated into the software. Participants were unsure of their skills to use all the software features. Clear and transparent handling processes, feedback, managers' behaviour and communication methods were seen as key to improving staff's experience with report processes. A real-time warning system was considered beneficial for various incident types. Specific questions must be answered before further developing such systems.

Conclusion

This study deepened the understanding of reporting software's challenges regarding its handling features. The handling processes of incident reports had multiple shortcomings, which may negatively affect health professionals' experiences in report handling. Real-time warning systems could assist healthcare managers in processing reports.

Implications for the Profession and/or Patient Care

Organisational-level guidance for incident report processing is needed. Improvements to report processing and reporting software can improve shared learning and understanding of the status of patient safety.

Patient or Public Contribution

No patient or public contribution.

Reporting Method

COnsolidated criteria for REporting Qualitative research Checklist.

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