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Effect of electrical stimulation with a cochlear implant on tinnitus impact: protocol of an individual patient data
Kelly Assouly1,2,3, Adriana L Smit4,2, Inge Stegeman4,2
1Department of Otorhinolaryngology and Head & Neck Surgery, UMC Utrecht, Utrecht, The Netherlands k.k.s.assouly@umcutrecht.nl.
Introduction:
Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing, buzzing sound. While several studies have shown a reduction in tinnitus distress following cochlear implantation, others showed an increase or no change after implantation. At this stage, clinicians have little certainty when counselling their patients prior to implantation regarding tinnitus post-implantation. To help clinicians to counsel cochlear implant (CI) candidates on the risk of developing or improving tinnitus after implantation, we aim to assess the effect of electrical stimulation with a CI on tinnitus impact for individual adult patients with tinnitus. We will also apply prediction models to individual patient data (IPD) of clinical trials to find predictive factors of the effect of electrical stimulation on tinnitus impact.
Method And Analysis:
The IPD meta-analysis is a follow-up project of the systematic review on cochlear implantation in patients with tinnitus as a primary complaint. First, the systematic searches will be updated to date. Methodological quality of eligible studies will be assessed using the Risk of Bias In Non-randomised Studies of Intervention tool (ROBINS-I). Based on a data-sharing agreement, authors of the eligible studies will be invited to share their deidentified and complete IPD. The primary outcome is the effect of electrical stimulation with a CI on tinnitus impact 1 month or more post-implantation. IPD meta-analysis will be used to assess the primary outcome, while differentiating the tinnitus impact questionnaires. Second, linear regression analyses will be used to model the effect of electrical stimulation on tinnitus impact based on relevant predictors.
Ethics And Dissemination:
The Medical Research Involving Human Subject Act does not apply, and ethical approval is not required. The study results will be made accessible to the public in a peer-review open access journal.
Prospero Registration Number:
CRD42022319367, review ongoing.
