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PLoS One2025;20(8):e0324927.January 1, 2025Journal Article

Decentralised trials for hearing and tinnitus therapies: Lessons from the Digital thErapy For Improved tiNnitus carE (DEFINE) randomised controlled trial.

Joseph Salem1,2, Dhiraj Sharma3,2, Amy Moore4, Olivia Dantonio4, Luke Twelves4, Emma Ogburn4, Michael Young4, Jan Multmeier4,5, Jameel Muzaffar2,6, Matthew E Smith7,8
1Univeristy College London Hospitals NHS Foundation Trust, London, United Kingdom.
2Oto Health, London, United Kingdom.
3Imperial College Healthcare NHS Foundation Trust, London, United Kingdom.
4Lindus Health, London, United Kingdom.
5TotalEffects, Berlin, Germany.
6University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
7University of Cambridge, Cambridge, United Kingdom.
8Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
PubMed PMC DOI PDF

Abstract

Randomised Controlled Trials (RCTs) are the gold standard for evaluating the efficacy of interventions; yet, traditional methods involving multiple recruitment sites often involve significant logistical and financial challenges. The DEFINE trial demonstrates the feasibility of a decentralised approach to RCTs by comparing smartphone-delivered self-guided tinnitus therapy against one-to-one therapi…

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