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Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care. ispartof: OTOLOGY & NEUROTOLOGY vol:43 issue:5 pages:513-529 ispartof: location:United States status: published

Objective Evidence for the management of acute otitis externa (AOE) is limited, with unclear diagnostic criteria and variably reported outcome measures that may not reflect key stakeholder priorities. We aimed to develop 1) a definition, 2) diagnostic criteria and 3) a core outcome set (COS) for AOE. Study design COS development according to Core Outcome Measures in Effectiveness Trials (COMET) methodology and parallel consensus selection of diagnostic criteria/definition. Setting Stakeholders from the United Kingdom. Subjects and methods Comprehensive literature review identified candidate items for the COS, definition and diagnostic criteria. Nine individuals with past AOE generated further patient-centred candidate items. Candidate items were rated for importance by patient and professional (ENT doctors, general practitioners, microbiologists, nurses, audiologists) stakeholders in a three-round online Delphi exercise. Consensus items were grouped to form the COS, diagnostic criteria, and definition. Results Candidate COS items from patients (n = 28) and literature (n = 25) were deduplicated and amalgamated to a final candidate list (n = 46). Patients emphasised quality-of-life and the impact on daily activities/work. Via the Delphi process, stakeholders agreed on 31 candidate items. The final COS covered six outcomes: pain; disease severity; impact on quality-of-life and daily activities; patient satisfaction; treatment-related outcome; and microbiology. 14 candidate diagnostic criteria were identified, 8 reaching inclusion consensus. The final definition for AOE was ‘diffuse inflammation of the ear canal skin of less than 6 weeks duration’. Conclusion The development and adoption of a consensus definition, diagnostic criteria and a COS will help to standardise future research in AOE, facilitating meta-analysis. Consulting former patients throughout development highlighted deficiencies in the outcomes adopted previously, in particular concerning the impact of AOE on daily life.

Introduction The SeaSHeL Study is an ongoing national, multi-centre, cohort study investigating Sudden Sensorineural Hearing Loss (SSNHL). The study is supported by the INTEGRATE ENT Trainee Research Network and the Audiology NIHR Champions, as well as being adopted onto the NIHR Clinical Research Network. It aims to map the pathway of patients with SSNHL, develop a prognostic model to predict recovery of patients with idiopathic SSNHL and establish the impact on patients’ quality of life. Here we summarise the impact of the Covid-19 pandemic on the study and highlight methods employed to improve data collection. Methods Data collection commenced in October 2019 and as of August 2020, 227 patients have been recruited from 66 registered sites across England. This interim data was analysed. The primary outcome was the change in monthly patient recruitment and site registration. The secondary outcome was the completeness of the dataset. Results Initially, monthly site registration increased to a peak of 31 in December 2019 and monthly patient recruitment increased to a peak of 34 in February 2020. Both levels decreased during the first wave of Covid-19 with 11 patients recruited and 0 sites registered in April 2020. Both levels have been increasing since, with 21 patients recruited and 5 sites registered in August 2020. The dataset of 227 patients has 113 (49.7%) completed records. Conclusions This study represents the largest national cohort study into SSNHL. Despite the Covid-19 pandemic, data collection continued during the first wave and rates are now recovering to pre-Covid-19 levels. Key factors in this recovery are a collaborative research approach involving motivated trainees, an ethics amendment for follow-up data to be collected by telephone and continued engagement of collaborators through regular email correspondence and fortnightly newsletters.

Objective The regulation of surgical implants is vital to patient safety, and there is an international drive to establish registries for all implants. Hearing loss is an area of unmet need, and industry is targeting this field with a growing range of surgically implanted hearing devices. Currently, there is no comprehensive UK registry capturing data on these devices; in its absence, it is difficult to monitor safety, practices and effectiveness. A solution is developing a national registry of all auditory implants. However, developing and maintaining a registry faces considerable challenges. In this systematic review, we aimed to identify the essential features of a successful surgical registry. Methods A systematic literature review was performed adhering to Preferred Reporting Items for Systematic Review and Meta-Analysis recommendations. A comprehensive search of the Medline and Embase databases was conducted in November 2016 using the Ovid Portal. Inclusion criteria were: publications describing the design, development, critical analysis or current status of a national surgical registry. All registry names identified in the screening process were noted and searched in the grey literature. Available national registry reports were reviewed from registry websites. Data were extracted using a data extraction table developed by thematic analysis. Extracted data were synthesised into a structured narrative. Results Sixty-nine publications were included. The fundamentals to successful registry development include: steering committee to lead and oversee the registry; clear registry objectives; planning for initial and long-term funding; strategic national collaborations among key stakeholders; dedicated registry management team; consensus meetings to agree registry dataset; established data processing systems; anticipating challenges; and implementing strategies to increase data completion. Patient involvement and awareness of legal factors should occur throughout the development process. Conclusions This systematic review provides robust knowledge that can be used to inform the successful development of any UK surgical registry. It also provides a methodological framework for international surgical registry development.

Objectives : To identify United Kingdom (UK)-specific research priorities in the field of bone conduction hearing devices (BCHDs). Method : Narrative summary of the discussions and outcomes of a UK BCHD research workshop. The workshop was organized on 8 September 2016 under the auspices of the National Institute for Health Research (NIHR) Clinical Research Network (CRN) ENT Specialty group and Royal College of Surgeons (RCS) Clinical Research Initiative. Representatives from a wide range of patient and professional groups from the UK and abroad were invited to attend. Main outcome measures were research priorities and approaches in the field of BCHDs. Results : Key research questions in the field of BCHDs are as follows: (1) What are the existing national BCHD practices? (2) What are the patient information and support needs on BCHDs? (3) Which outcomes should be measured across clinical studies in the field of BCHDs? The workshop suggested the following approaches to address these priorities: (1) a service evaluation of current UK BCHD practice; development of a national registry of BCHDs; (2) qualitative research to understand patient information and support needs; development of patient decision support tools; (3) development of core outcome sets for BCHDs. Discussion : Building upon the framework of the recent UK Research Agenda for ENT, Hearing and Balance, patients and professionals defined key UK-specific research priorities and approaches in the field of BCHDs. This approach promotes engagement, buy-in, national collaboration and thereby value of future BCHD research.

Managing pain in sleep surgery patients Objectives:Sleep surgery patients typically experience significant post-operative pain, with subsequent impact on quality of life. There is uncertainty around optimal peri-operative analgesia strategies for these patients, with resultant variation in practices. This paper presents a literature review and our novel practice on analgesia strategies for patients undergoing sleep surgery. tMethod:A literature search was performed using the Medline and Embase databases. An article was included if it discussed analgesia strategies for patients undergoing sleep surgery. We compared pain outcomes between two patient groups. 1) Patients using our previous pain management protocol. 2) Patients using our novel pain management protocol. Results:A total of 256 abstracts were reviewed and 23 full text articles were included. Four peri-operative analgesia strategies were identified. Our novel pain management protocol resulted in significant reduction in pain scores. Conclusions: This paper provides an evidence-based overview of strategies to manage post-operative pain following sleep surgery.