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Development and internal validation of a multivariable prediction model for tinnitus recovery following unilateral cochlear implantation: a cross-sectional retrospective study.

ABSTRACT: OBJECTIVE:To develop and internally validate a prediction model for tinnitus recovery following unilateral cochlear implantation. DESIGN:A cross-sectional retrospective study. SETTING:A questionnaire concerning tinnitus was sent to patients with bilateral severe to profound hearing loss, who underwent unilateral cochlear implantation at the University Medical Center Utrecht, the Netherlands, between 1 January 2006 and 31 December 2015. PARTICIPANTS:Of 137 included patients, 87 patients experienced tinnitus preoperatively. Data of these 87 patients were used to develop the prediction model. PRIMARY AND SECONDARY OUTCOME MEASURES:The outcome of the prediction model was tinnitus recovery. Investigated predictors were: age, gender, duration of deafness, preoperative hearing performance, tinnitus duration, severity and localisation, follow-up duration, localisation of cochlear implant (CI) compared with tinnitus side, surgical approach, insertion depth of the electrode, CI brand and difference in hearing threshold following cochlear implantation. Multivariable backward logistic regression was performed. Missing data were handled using multiple imputation. The performance of the model was assessed by the calibrative and discriminative ability of the model. The prediction model was internally validated using bootstrapping techniques. RESULTS:The tinnitus recovery rate was 40%. A lower preoperative Consonant-Vowel-Consonant (CVC) score, unilateral localisation of tinnitus and larger deterioration of residual hearing at 250?Hz revealed to be relevant predictors for tinnitus recovery. The area under the receiver operating characteristics curve (AUC) of the initial model was 0.722 (IQR: 0.703-0.729). After internal validation of this prediction model, the AUC decreased to 0.696 (IQR: 0.667-0.700). CONCLUSION AND RELEVANCE:Lower preoperative CVC score, unilateral localisation of tinnitus and larger deterioration of residual hearing at 250?Hz were significant predictors for tinnitus recovery following unilateral cochlear implantation. The performance of the model developed in this retrospective study is promising. However, before clinical use of the model, the conduction of a larger prospective study is recommended.

SUBMITTER: Ramakers GGJ

PROVIDER: S-EPMC6009556 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Development and internal validation of a multivariable prediction model for tinnitus recovery following unilateral cochlear implantation: a cross-sectional retrospective study.

Ramakers Geerte G J GGJ van Zanten Gijsbert A GA Thomeer Hans G X M HGXM Stokroos Robert J RJ Heymans Martijn W MW Stegeman Inge I

BMJ open 20180611 6

<h4>Objective</h4>To develop and internally validate a prediction model for tinnitus recovery following unilateral cochlear implantation.<h4>Design</h4>A cross-sectional retrospective study.<h4>Setting</h4>A questionnaire concerning tinnitus was sent to patients with bilateral severe to profound hearing loss, who underwent unilateral cochlear implantation at the University Medical Center Utrecht, the Netherlands, between 1 January 2006 and 31 December 2015.<h4>Participants</h4>Of 137 included pa ...[more]

PMID: 29895652

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Project description:The use of neonatal hearing screening has enabled the identification of congenital unilateral sensorineural hearing loss (USNHL) immediately after birth, and today there are several intervention options available to minimize potential adverse effects of this disease, including cochlear implantation. This study aims to analyze the characteristics of the inner ear of a homogeneous group of congenital non-syndromic USNHL to highlight the features of the inner ear, which can help in clinical, surgical, and rehabilitative decision-making. A retrospective chart review was carried out at a tertiary referral center. Systematic diagnostic work-up and rigorous inclusion-exclusion criteria were applied to 126 children with unilateral hearing impairment, leading to a selection of 39 strictly congenital and non-syndromic USNHL cases, undergoing computed tomography (CT) and magnetic resonance (MR) imaging studies. The frequency and type of malformations of the inner ear in USNHL and unaffected contralateral ears were assessed, with an in-depth analysis of the deficiency of the cochlear nerve (CND), the internal auditory canal (IAC) and the cochlear aperture (CA). Inner ear anomalies were found in 18 out of 39 (46%) of the USNHL patients. In 1 subject, the anomalies were bilateral, and the CND resulted in the predominant identified defect (78% of our abnormal case series), frequently associated with CA stenosis. Only 3 out of 14 children with CND presented stenosis of the IAC. CND and CA stenosis (and to a much lesser extent IAC stenosis) are a frequent association within congenital and non-syndromic USNHL that could represent a distinct pathological entity affecting otherwise healthy infants. In the context of a diagnostic work-up, the evaluation with CT and MRI measurements should take place in a shared decision-making setting with thorough counseling. Both imaging techniques have proven useful in differentiating the cases that will most likely benefit from the cochlear implant, from those with potentially poor implant performance.

Project description:Cochlear implantation is a surgical alternative to traditional amplification (hearing aids) that can facilitate spoken language development in young children with severe to profound sensorineural hearing loss (SNHL).To prospectively assess spoken language acquisition following cochlear implantation in young children.Prospective, longitudinal, and multidimensional assessment of spoken language development over a 3-year period in children who underwent cochlear implantation before 5 years of age (n = 188) from 6 US centers and hearing children of similar ages (n = 97) from 2 preschools recruited between November 2002 and December 2004. Follow-up completed between November 2005 and May 2008.Performance on measures of spoken language comprehension and expression (Reynell Developmental Language Scales).Children undergoing cochlear implantation showed greater improvement in spoken language performance (10.4; 95% confidence interval [CI], 9.6-11.2 points per year in comprehension; 8.4; 95% CI, 7.8-9.0 in expression) than would be predicted by their preimplantation baseline scores (5.4; 95% CI, 4.1-6.7, comprehension; 5.8; 95% CI, 4.6-7.0, expression), although mean scores were not restored to age-appropriate levels after 3 years. Younger age at cochlear implantation was associated with significantly steeper rate increases in comprehension (1.1; 95% CI, 0.5-1.7 points per year younger) and expression (1.0; 95% CI, 0.6-1.5 points per year younger). Similarly, each 1-year shorter history of hearing deficit was associated with steeper rate increases in comprehension (0.8; 95% CI, 0.2-1.2 points per year shorter) and expression (0.6; 95% CI, 0.2-1.0 points per year shorter). In multivariable analyses, greater residual hearing prior to cochlear implantation, higher ratings of parent-child interactions, and higher socioeconomic status were associated with greater rates of improvement in comprehension and expression.The use of cochlear implants in young children was associated with better spoken language learning than would be predicted from their preimplantation scores.

Project description:IntroductionTinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.Method and analysisIn this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck's Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.Ethics and disseminationThis research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.Trial registration numberTrial registration number NL8693; Pre-results.

Project description:Understanding speech is essential for adequate social interaction, and its functioning affects health, wellbeing, and quality of life (QoL). Untreated hearing loss (HL) is associated with reduced social activity, depression and cognitive decline. Severe and profound HL is routinely rehabilitated with cochlear implantation. The success of treatment is mostly assessed by performance-based outcome measures such as speech perception. The ultimate goal of cochlear implantation, however, is to improve the patient's QoL. Therefore, patient-reported outcomes measures (PROMs) would be clinically valuable as they assess subjective benefits and overall effectiveness of treatment. The aim of this study was to assess the patient-reported benefits of unilateral cochlear implantation in an unselected Finnish patient cohort of patients with bilateral HL. The study design was a prospective evaluation of 118 patients. The patient cohort was longitudinally followed up with repeated within-subject measurements preoperatively and at 6 and 12 months postoperatively. The main outcome measures were one performance-based speech-in-noise (SiN) test (Finnish Matrix Sentence Test), and two PROMs [Finnish versions of the Speech, Spatial, Qualities of Hearing questionnaire (SSQ) and the Nijmegen Cochlear Implant Questionnaire (NCIQ)]. The results showed significant average improvements in SiN scores, from +0.8 dB signal-to-noise ratio (SNR) preoperatively to -3.7 and -3.8 dB SNR at 6 and12 month follow-up, respectively. Significant improvements were also found for SSQ and NCIQ scores in all subdomains from the preoperative state to 6 and 12 months after first fitting. No clinically significant improvements were observed in any of the outcome measures between 6 and 12 months. Preoperatively, poor SiN scores were associated with low scoring in several subdomains of the SSQ and NCIQ. Poor preoperative SiN scores and low PROMs scoring were significantly associated with larger postoperative improvements. No significant association was found between SiN scores and PROMs postoperatively. This study demonstrates significant benefits of cochlear implantation in the performance-based and patient-reported outcomes in an unselected patient sample. The lack of association between performance and PROMs scores postoperatively suggests that both capture unique aspects of benefit, highlighting the need to clinically implement PROMs in addition to performance-based measures for a more holistic assessment of treatment benefit.

Project description:Conservation of a patient's residual hearing and prevention of fibrous tissue/new bone formation around an electrode array are some of the major challenges in cochlear implant (CI) surgery. Although it is well-known that fibrotic tissue formation around the electrode array can interfere with hearing performance in implanted patients, and that associated intracochlear inflammation can initiate loss of residual hearing, little is known about the molecular and cellular mechanisms that promote this response in the cochlea. In vitro studies in neonatal rats and in vivo studies in adult mice were performed to gain insight into the pro-inflammatory, proliferative, and remodeling phases of pathological wound healing that occur in the cochlea following an electrode analog insertion. Resident Schwann cells (SC), macrophages, and fibroblasts had a prominent role in the inflammatory process in the cochlea. Leukocytes were recruited to the cochlea following insertion of a nylon filament in adult mice, where contributed to the inflammatory response. The reparative stages in wound healing are characterized by persistent neuro-inflammation of spiral ganglion neurons (SGN) and expression of regenerative monocytes/macrophages in the cochlea. Accordingly, genes involved in extracellular matrix (ECM) deposition and remodeling were up-regulated in implanted cochleae. Maturation of scar tissue occurs in the remodeling phase of wound healing in the cochlea. Similar to other damaged peripheral nerves, M2 macrophages and de-differentiated SC were observed in damaged cochleae and may play a role in cell survival and axonal regeneration. In conclusion, the insertion of an electrode analog into the cochlea is associated with robust early and chronic inflammatory responses characterized by recruitment of leukocytes and expression of pro-inflammatory cytokines that promote intracochlear fibrosis and loss of the auditory hair cells (HC) and SGN important for hearing after CI surgery.

Dataset Information

Development and internal validation of a multivariable prediction model for tinnitus recovery following unilateral cochlear implantation: a cross-sectional retrospective study.

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Development and internal validation of a multivariable prediction model for tinnitus recovery following unilateral cochlear implantation: a cross-sectional retrospective study.

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