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Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study

Labree, Bas; Hoare, Derek J.; Fackrell, Kathryn; Hall, Deborah A.; Gascoyne, Lauren E.; Sereda, Magdalena

Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study Thumbnail


Authors

Bas Labree

DEREK HOARE derek.hoare@nottingham.ac.uk
Associate Professor in Hearing Sciences

Deborah A. Hall



Abstract

Background: Tinnitus is the awareness of a sound in the ear or head in the absence of an external source. It affects around 10–15% of people and current treatment options are limited. Experimental treatments include various forms of electrical stimulation of the brain. Currently, there is no consensus on the outcomes that should be measured when investigating the efficacy of this type of intervention for tinnitus. This study seeks to address this by establishing a Core Domain Set: a common standard of what specific tinnitus-related complaints are critical and important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus. Methods: A two-round online survey will be conducted, followed by a stakeholder consensus meeting to identify a Core Domain Set. Participants will belong to one of two stakeholder groups: healthcare users with lived experience of tinnitus, and professionals with relevant clinical, commercial, or research experience. Discussion: This study will establish a Core Domain Set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. The resulting Core Domain Set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.

Citation

Labree, B., Hoare, D. J., Fackrell, K., Hall, D. A., Gascoyne, L. E., & Sereda, M. (2022). Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study. Trials, 23(1), Article 1039. https://doi.org/10.1186/s13063-022-07020-2

Journal Article Type Article
Acceptance Date Dec 15, 2022
Online Publication Date Dec 21, 2022
Publication Date 2022
Deposit Date Mar 1, 2023
Publicly Available Date Mar 2, 2023
Journal Trials
Electronic ISSN 1745-6215
Peer Reviewed Peer Reviewed
Volume 23
Issue 1
Article Number 1039
DOI https://doi.org/10.1186/s13063-022-07020-2
Keywords Study Protocol, Tinnitus, Neuromodulation, Core Domain Set
Public URL https://nottingham-repository.worktribe.com/output/15432345
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-07020-2

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