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.
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.
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.
Observational studies play a pivotal role in understanding population health trends and informing public health policy. However, many such studies inadequately address dimensions of health inequality, potentially perpetuating existing disparities. There is currently no comprehensive overview of frameworks specifically designed to integrate health-inequality constructs into observational public health research. This protocol outlines the methodology of the scoping review, which aims to identify, describe and critically evaluate existing frameworks that explicitly incorporate health inequalities within observational studies.
We will conduct this scoping review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Six electronic databases (PubMed, Embase, Scopus, Web of Science, Global Health and CINAHL) and eligible grey literature sources will be searched using a combination of keywords and subject headings related to health inequalities, observational study design and frameworks. Two independent reviewers will perform title/abstract screening and full-text eligibility assessment using Rayyan, while discrepancies will be resolved by consultation with a third reviewer. Findings will be synthesised narratively.
As this study involves analysis of publicly available literature, formal ethical approval is not required. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and communication with key stakeholders in public health and equity research. The results will also be shared directly with charities and local organisations which focus on addressing health inequalities. By providing a comprehensive map of existing frameworks, this review will inform researchers on best practices for embedding health-inequality considerations in observational studies and support the development of more equitable research methodologies.