Accepted for/Published in: Journal of Participatory Medicine
Date Submitted: Sep 24, 2025
Date Accepted: Jan 29, 2026
Patient and Public Involvement in a Real-Time Cardiac Biofeedback Intervention: PPI for a Randomised Controlled Trial
ABSTRACT
Background:
Patient and Public Involvement (PPI) is crucial for enhancing research quality, relevance, and addressing health inequalities. PPI ensures that studies tackle relevant and meaningful questions, as there is a recognised need by the research community to document and share PPI studies to advance the field and encourage the adoption of such activities.
Objective:
The aim of this paper is to provide a detailed report on the PPI activities undertaken to develop and implement a randomised controlled trial of a novel therapeutic tool designed to increase interoception and metacognition (i.e., the InMe trial).
Methods:
The InMe trial integrated insights from experts by experience, as well as from clinical and academic experts. This collaborative approach resulted in the development of comprehensive trial across four main stages, that include the design, delivery, result interpretation, and future planning.
Results:
Here, we highlight the unique insights and the added value in incorporating PPI activities into our trial development and implementation, while reporting challenges and shortcomings that were identified throughout this process.
Conclusions:
PPI activities within the InMe trial led to meaningful changes, while collaborations expressed satisfaction and increased interest in interoception research. Further improvements on how to best support experts by experience when sharing their experiences were also identified. Clinical Trial: ISRCTN16762367
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.