Dataset Information

Prognostic factors for outcomes of idiopathic sudden sensorineural hearing loss: protocol for the SeaSHeL national prospective cohort study.

ABSTRACT: INTRODUCTION:The mainstay of treatment for idiopathic sudden sensorineural hearing loss (SSNHL) includes oral steroids, intratympanic steroid injections or a combination of both. The National Institute for Health and Care Excellence, in their recent hearing loss guidelines, highlighted the paucity of evidence assessing the comparative effectiveness of these treatments; and the National Institute for Health Research (NIHR) Health Technology Assessment Programme has since released a commissioned call for a trial to identify the most effective route of administration of steroids as a first-line treatment for idiopathic SSNHL. For such trials to be run effectively, reliable information is needed on patients with SSNHL: where they present, numbers, demographics, treatment pathways, as well as outcomes. This study will collect these data in a nationwide cohort study of patients presenting with SSNHL across 97 National Health Service (NHS) trusts. The study will be delivered through ear, nose and throat (ENT) trainee networks, the NIHR Clinical Research Network (CRN) Audiology Champions and the NIHR CRN. Importantly, this study will also provide a dataset to develop a prognostic model to predict recovery for patients with idiopathic SSNHL. The study objectives are to: (1) map the patient pathway and identify the characteristics of adult patients presenting to NHS ENT and hearing services with SSNHL, (2) develop a prognostic model to predict recovery for patients with idiopathic SSNHL and (3) establish the impact of idiopathic SSNHL on patients' quality of life (QoL). METHODS AND ANALYSIS:Study design: national multicentre prospective cohort study across 97 NHS trusts. INCLUSION CRITERIA:adult patients presenting to NHS ENT and hearing services with SSNHL. OUTCOMES:change in auditory function; change in QoL score. ANALYSIS:multivariable prognostic model, using prespecified candidate predictors. Mean change in QoL scores will be calculated from initial presentation to follow-up. ETHICS AND DISSEMINATION:Health Research Authority and NHS Research Ethics Committee approved the study. Publication will be on behalf of study sites and collaborators. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry (NCT04108598).

SUBMITTER: Mandavia R

PROVIDER: S-EPMC7523222 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Prognostic factors for outcomes of idiopathic sudden sensorineural hearing loss: protocol for the SeaSHeL national prospective cohort study.

Mandavia Rishi R Hannink Gerjon G Ahmed Muhammad Nayeem MN Premakumar Yaami Y Chu Timothy Shun Man TSM Blackshaw Helen H Ferdous Tanjinah T Mehta Nishchay N Manjaly Joseph J Khan Maha M Schilder Anne Gm AG

BMJ open 20200928 9

<h4>Introduction</h4>The mainstay of treatment for idiopathic sudden sensorineural hearing loss (SSNHL) includes oral steroids, intratympanic steroid injections or a combination of both. The National Institute for Health and Care Excellence, in their recent hearing loss guidelines, highlighted the paucity of evidence assessing the comparative effectiveness of these treatments; and the National Institute for Health Research (NIHR) Health Technology Assessment Programme has since released a commis ...[more]

PMID: 32988948

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Project description:IntroductionTo compare inpatient treated patients with idiopathic (ISSNHL) and non-idiopathic sudden sensorineural hearing loss (NISSNHL) regarding frequency, hearing loss, treatment and outcome.MethodsAll 574 inpatient patients (51% male, median age: 60 years) with ISSNHL and NISSNHL, who were treated in federal state Thuringia in 2011 and 2012, were included retrospectively. Univariate and multivariate statistical analyses were performed.ResultsISSNHL was diagnosed in 490 patients (85%), NISSNHL in 84 patients (15%). 49% of these cases had hearing loss due to acute otitis media, 37% through varicella-zoster infection or Lyme disease, 10% through Menière disease and 7% due to other reasons. Patients with ISSNHL and NISSNHL showed no difference between age, gender, side of hearing loss, presence of tinnitus or vertigo and their comorbidities. 45% of patients with ISSNHL and 62% with NISSNHL had an outpatient treatment prior to inpatient treatment (p < 0.001). The mean interval between onset of hearing loss to inpatient treatment was shorter in ISSNHL (7.7 days) than in NISSNHL (8.9 days; p = 0.02). The initial hearing loss of the three most affected frequencies in pure-tone average (3PTAmax) scaled 72.9 dBHL ± 31.3 dBHL in ISSNHL and 67.4 dBHL ± 30.5 dBHL in NISSNHL. In the case of acute otitis media, 3PTAmax (59.7 dBHL ± 24.6 dBHL) was lower than in the case of varicella-zoster infection or Lyme disease (80.11 dBHL ± 34.19 dBHL; p = 0.015). Mean absolute hearing gain (Δ3PTAmaxabs) was 8.1 dB ± 18.8 dB in patients with ISSNHL, and not different in NISSNHL patients with 10.2 dB ± 17.6 dB. A Δ3PTAmaxabs ≥ 10 dB was reached in 34.3% of the patients with ISSNHL and to a significantly higher rate of 48.8% in NISSNHL patients (p = 0.011).ConclusionsISSNHL and NISSNHL show no relevant baseline differences. ISSNHL tends to have a higher initial hearing loss. NISSHNL shows a better outcome than ISSNHL.

Project description:ImportancePatients with idiopathic sudden sensorineural hearing loss (ISSNHL) often experience permanent hearing impairment, which could result in psychological perturbations. However, the relationship between ISSNHL and affective disorders, including depression, anxiety, and bipolar disorder, has not been fully evaluated.ObjectiveTo investigate the potential relationship between ISSNHL and affective disorders using nationwide representative cohort sample data.Design, setting, and participantsThis study used a nationwide propensity score-matched cohort sample from the Korean National Health Insurance Service database from 2002 through 2013, which comprises data from approximately 1 million patients. The study included 1425 patients with ISSNHL and 7125 individuals without ISSNHL who were matched using propensity score matching, according to sociodemographic factors and enrollment year.Main outcomes and measuresSurvival analysis, the log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio (HR) of developing affective disorders (anxiety, depression, and bipolar disorder) for each group.ResultsOf the total study population of 8550 (51.5% female), 961 developed affective disorders during the 11-year follow-up: 225 in the ISSNHL group (15.8%) and 736 in the comparison group (10.3%). We examined a total of 96 885.5 person-years (81 177.4 person-years in the comparison group and 15 708.1 person-years in the ISSNHL group). The incidence of affective disorders was 14.3 per 1000 person-years in the ISSNHL group and 9.1 per 1000 person-years in the comparison group. After adjustment for other factors, individuals with ISSNHL developed affective disorders more frequently than those in the comparison group (HR, 1.50; 95% CI, 1.30-1.75). Among the affective disorders, the HR of developing depression (HR, 1.66; 95% CI, 1.44-1.91) and anxiety disorder (HR, 1.79; 95% CI, 1.56-2.05) but not bipolar disorder (HR, 0.95; 95% CI, 0.54-1.70), was significantly greater in patients with ISSNHL.Conclusions and relevanceThis cohort study suggests that ISSNHL is associated with an increased incidence of affective disorders, specifically depression and anxiety. Therefore, these findings suggest that clinicians should monitor patients with ISSNHL carefully, and take specific precautions to reduce their risk of depression and anxiety disorder.

Dataset Information

Prognostic factors for outcomes of idiopathic sudden sensorineural hearing loss: protocol for the SeaSHeL national prospective cohort study.

Publications

Prognostic factors for outcomes of idiopathic sudden sensorineural hearing loss: protocol for the SeaSHeL national prospective cohort study.

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