RESUMEN
Importance: The prognosis of idiopathic sudden onset sensorineural hearing loss (iSSNHL) is uncertain, which creates challenges in clinical decision-making for ear, nose, and throat (ENT) physicians and adds to the burden of the condition experienced by patients. Objective: To develop and internally validate a prognostic model for hearing recovery among patients with iSSNHL to support ENT surgeons in making informed and individualized treatment decisions. Design, Settings, and Participants: This prognostic study and model used cohort data from the Sudden Onset Sensorineural Hearing Loss study, which included 812 patients (age ≥16 years) diagnosed with iSSNHL at 76 National Health Service ENT departments in the UK from December 2019 to May 2022. Nine variables previously reported as independent prognostic factors for complete recovery of patients with iSSNHL were selected for inclusion. The final model was internally validated using bootstrapping with 500 repetitions, then coefficients were adjusted for the degree of optimism in the model. The model intercept was reassessed after adjustment of model coefficients. Impact of individual predictors was evaluated by estimating odds ratios with corresponding 95% CIs. Model performance was re-evaluated after internal validation and expressed by discrimination, calibration, and clinical utility. Data analyses were performed from March 2022 to April 2024. Intervention: Routine treatment (per National Health Service standards), including oral steroids and intratympanic steroid injections. Main Outcome and Measures: Complete hearing recovery defined as a return to within 10 dB of the patient's before iSSNHL hearing levels at all frequencies in the affected ear at 6 to 16 weeks after iSSNHL symptom onset. Results: The study sample included 498 patients (mean [SD] age, 58.7 [16.0] years; 215 [46.9%] females and 243 [53.1%] males) who met the criteria for inclusion in the model. Of those, 210 (46%) were classified as having experienced complete hearing recovery. Five variables were found to be independent predictors for complete hearing recovery: steroid treatment within 7 days from symptom onset (OR, 5.23 vs no treatment ), lower severity of hearing loss at presentation (OR, 0.19 if loss is mild), absence of vertigo (OR, 0.56 vs no vertigo), younger patient age (OR, 0.64 per year), and a history of cardiovascular disease (OR, 1.84 vs no cardiovascular disease). The model showed good performance after internal validation with a c-index of 0.77 (95% CI, 0.7-0.81). Predictions for complete recovery aligned well with observed complete recovery rates, and greater clinical utility than treat all or treat none strategies was shown. Conclusion and Relevance: This prognostic model evaluated in this study may be able to assist ENT surgeons in making informed treatment decisions for individual patients with iSSNHL. It is available online at no cost.
RESUMEN
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).