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

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

doi:10.1186/s13063-022-07020-2

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

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	1039
Journal	Trials
Volume	23
DOIs	https://doi.org/10.1186/s13063-022-07020-2
Publication status	Published - 21 Dec 2022

Keywords

Tinnitus
Neuromodulation
Core Domain Set

ASJC Scopus subject areas

Pharmacology (medical)
Medicine (miscellaneous)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

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

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.",

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author = "Bas Labree and Hoare, {Derek J.} and Kathryn Fackrell and Deborah Hall and Gascoyne, {Lauren E.} and Magdalena Sereda",

note = "Funding Information: We thank Prof Paula Williamson for reviewing the protocol and ensuring compatibility with the DelphiManager software, and Dr Adele Horobin for organising PPI input. The study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice and the UK Department of Health Policy Framework for Health and Social Care, 2017. All personal and research data will be held in compliance with the ICH/GCP guidelines, regulations and in accordance with the University of Nottingham Code of Research Conduct and Research Ethics. The study documents held by the Chief Investigator (MS) on behalf of the Sponsor shall be finally archived at secure archive facilities at the University of Nottingham. This archive shall include all anonymised audio recordings, study databases and associated meta-data encryption codes. A full data management plan is available upon request. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

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AU - Fackrell, Kathryn

AU - Hall, Deborah

AU - Gascoyne, Lauren E.

AU - Sereda, Magdalena

N1 - Funding Information: We thank Prof Paula Williamson for reviewing the protocol and ensuring compatibility with the DelphiManager software, and Dr Adele Horobin for organising PPI input. The study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice and the UK Department of Health Policy Framework for Health and Social Care, 2017. All personal and research data will be held in compliance with the ICH/GCP guidelines, regulations and in accordance with the University of Nottingham Code of Research Conduct and Research Ethics. The study documents held by the Chief Investigator (MS) on behalf of the Sponsor shall be finally archived at secure archive facilities at the University of Nottingham. This archive shall include all anonymised audio recordings, study databases and associated meta-data encryption codes. A full data management plan is available upon request. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12/21

Y1 - 2022/12/21

N2 - 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.

AB - 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.

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ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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