Establishing a core domain set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: an online Delphi study

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

doi:10.1136/bmjopen-2023-079769

Establishing a core domain set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: an online Delphi study

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

^*Corresponding author for this work

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Abstract

Tinnitus is the awareness of 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.

OBJECTIVE: This study sought to address this issue by establishing a core domain set: a common standard of what specific tinnitus-related complaints are critically important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus. DESIGN: A two-round Delphi survey was conducted, followed by a stakeholder consensus meeting to identify a core domain set. Setting All data collection took place online

PARTICIPANTS: Participants represented one of two stakeholder groups: patients with lived experience of tinnitus and professionals with relevant clinical, commercial or research experience.

RESULTS: Stakeholders achieved consensus on the inclusion of ability to ignore, concentration, treatment satisfaction, helplessness (lack of control) and tinnitus intrusiveness in the core domain set, in addition to adverse effects.

CONCLUSION: This study established a core domain set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. This 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.

Original language	English
Article number	e079769
Journal	BMJ Open
Volume	15
Issue number	3
Early online date	4 Mar 2025
DOIs	https://doi.org/10.1136/bmjopen-2023-079769
Publication status	Published - Mar 2025

Keywords

Electric Stimulation Therapy
Internet
Otolaryngology
Patient Reported Outcome Measures

ASJC Scopus subject areas

General Medicine

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title = "Establishing a core domain set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: an online Delphi study",

abstract = "Tinnitus is the awareness of 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. OBJECTIVE: This study sought to address this issue by establishing a core domain set: a common standard of what specific tinnitus-related complaints are critically important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus. DESIGN: A two-round Delphi survey was conducted, followed by a stakeholder consensus meeting to identify a core domain set. Setting All data collection took place online PARTICIPANTS: Participants represented one of two stakeholder groups: patients with lived experience of tinnitus and professionals with relevant clinical, commercial or research experience. RESULTS: Stakeholders achieved consensus on the inclusion of ability to ignore, concentration, treatment satisfaction, helplessness (lack of control) and tinnitus intrusiveness in the core domain set, in addition to adverse effects. CONCLUSION: This study established a core domain set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. This 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.",

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Establishing a core domain set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: an online Delphi study

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