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

Autor: Labree B; NIHR Nottingham Biomedical Research Centre, Nottingham, UK. bas.labree@nottingham.ac.uk.; Hearing Sciences, Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, UK. bas.labree@nottingham.ac.uk., Hoare DJ; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.; Hearing Sciences, Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, UK., Fackrell K; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.; Hearing Sciences, Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, UK.; Wessex Institute, University of Southampton, Southampton, UK., Hall DA; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.; Department of Psychology, School of Social Sciences, Heriot-Watt University, Putrajaya, Malaysia., Gascoyne LE; Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, UK., Sereda M; NIHR Nottingham Biomedical Research Centre, Nottingham, UK.; Hearing Sciences, Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2022 Dec 21; Vol. 23 (1), pp. 1039. Date of Electronic Publication: 2022 Dec 21.
DOI: 10.1186/s13063-022-07020-2
Abstrakt: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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