TY - JOUR
T1 - Effect of electrical stimulation with a cochlear implant on tinnitus impact
T2 - protocol of an individual patient data meta-analysis
AU - Assouly, Kelly
AU - Smit, Adriana L.
AU - Stegeman, Inge
N1 - Funding Information: KA received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant (agreement number 764604). KA is employed at Cochlear Technology Centre Belgium, Mechelen, Belgium. The content of the study belongs to the authors alone and do not reflect Cochlear Technology Centre Belgium policy. No further conflict of interest is reported by the authors. Funding Information: Contributors KA, ALS and IS conceptualised, designed the study and developed the protocol. All authors (KA, ALS and IS) critically revised the draft of the protocol. IS provided statistical expertise in clinical trial design. KA drafted the manuscript. All other authors revised the manuscript. All authors read and approved the final version. Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. Competing interests KA received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant (agreement number 764604). KA is employed at Cochlear Technology Centre Belgium, Mechelen, Belgium. The content of the study belongs to the authors alone and do not reflect Cochlear Technology Centre Belgium policy. No further conflict of interest is reported by the authors. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/6/17
Y1 - 2022/6/17
N2 - 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.
AB - 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.
KW - adult otolaryngology
KW - epidemiology
KW - otolaryngology
UR - http://www.scopus.com/inward/record.url?scp=85132294920&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-063432
DO - https://doi.org/10.1136/bmjopen-2022-063432
M3 - Article
C2 - 35715189
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e063432
ER -