Adult-onset hearing loss and incident cognitive impairment and dementia - A systematic review and meta-analysis of cohort studies.

BACKGROUND: We comprehensively summarized the cohort evidence to date on adult-onset hearing loss as risk factor for incident cognitive impairment and dementia, and examined the evidence for dose-response, risk for various dementia subtypes, and other moderators. Previous meta-analyses were less comprehensive. METHODS: We included cohort studies with participants without dementia and with hearing assessments at baseline, minimum 2 years follow-up and incident cognitive outcomes. We used random-effect models and subgroup and meta-regression on moderator analyses. RESULTS: We identified fifty studies (N=1,548,754). Hearing loss (yes/no) was associated with incident dementia risk (HR=1.35 [95% CI = 1.26 - 1.45), mild cognitive impairment (MCI HR=1.29 [95% CI = 1.11 - 1.50]), cognitive decline not specified as MCI or dementia (HR=1.29 [95% CI = 1.17 - 1.42]), and Alzheimer's disease dementia (ADD, HR=1.56 [95% CI = 1.30 - 1.87]), but not with vascular dementia (HR, 1.30 [95% CI = 0.83 - 2.05]). Each 10-decibel worsening of hearing was associated with a 16% increase in dementia risk (95% CI = 1.07 - 1.27). The effect of hearing loss did not vary across potential moderators. CONCLUSIONS: Cohort studies consistently support that adult-onset hearing loss increases the risk of incident cognitive decline, dementia, MCI, and ADD.

Treatment of periorbital veins with vascular laser: A systematic review and retrospective case series.

INTRODUCTION: Vascular lasers may represent a promising treatment option for periorbital veins. This article aims to: (1) systematically review the literature on the safety and effectiveness of vascular laser treatment for periorbital veins and (2) assess safety and effectiveness through a retrospective case series. METHODS: Systematic review: Articles that assessed the safety and effectiveness of vascular laser treatment for periorbital veins were included and quality assessed using the Downs and Black checklist. CASE SERIES: Patient records were retrospectively reviewed from January 2020 to November 2023 to identify all patients who underwent laser treatment for periorbital veins. Outcomes assessment included percentage improvement, patient overall satisfaction and adverse effects. RESULTS: Systematic review: Three articles were included, discussing treatment of blue, periorbital veins using a 1064 nm Nd:YAG laser. Patient Fitzpatrick skin Types I-IV were treated with high patient satisfaction rates and complete clearance of treated veins. Adverse effects included pain, erythema, mild oedema, urticaria and blister formation. Quality of included studies ranged from 7 to 14 out of 21 points. CASE SERIES: Thirty-four patients with skin Types I-V were included. Blue and red periorbital veins were treated using 1064 and 532 nm wavelengths respectively. Mean percentage improvement was 4.8 (complete resolution) and patients' overall satisfaction was ranked 3 (completely satisfied). Adverse effects included erythema, oedema, and bruising. CONCLUSION: Treatment of red and blue periorbital veins using 532 and 1064 nm vascular lasers appears a safe treatment option. The procedure has a short recovery time, with patients able to resume normal activities within 1 day of treatment.

An Evidence-based Pathway for Body Dysmorphic Disorder in Facial Aesthetics.

Aesthetic procedures should be avoided in patients with body dysmorphic disorder (BDD) since they can negatively impact mental health and lead to further aesthetic dissatisfaction. There are no evidence-based patient pathways for BDD in facial aesthetics which can result in the failure to identify patients with BDD, leading to unsuitable treatments and suboptimal patient care. We aim to construct the first evidence-based patient pathway for BDD in surgical and nonsurgical facial aesthetics. A systematic review was performed and articles that discussed screening or patient pathways for BDD in field of facial aesthetics were included. We extracted relevant information from each article on screening tools and pathways for BDD. Data were synthesized by summarizing the data under column headings into a structured narrative and into new tables. Based on this synthesis, a practical pathway for BDD was constructed. Forty articles fulfilled the criteria for inclusion. Twenty-eight BDD screening tools were discussed in the included articles, and we provide an overview of these tools. Thirty-one articles discussed patient pathways for BDD, and we synthesized this information into a structured narrative. Combining these findings, we present an evidence-based patient pathway for BDD for patients presenting for facial aesthetic treatments. This systematic review has resulted in the first, evidence-based, patient pathway for BDD in surgical and nonsurgical facial aesthetics. This practical pathway can be used by aesthetic clinicians to identify patients with potential BDD and provide clear guidance for managing cases where BDD is suspected. It will help reduce the number of facial aesthetic procedures performed on patients with BDD, safeguard patient mental well-being, and prevent further aesthetic dissatisfaction.

Cataloging Existing Hearing Loss Cohort Data to Guide the Development of Precision Medicine for Sensorineural Hearing Loss: A Systematic Review of Hearing Repositories.

Recent breakthroughs in our understanding of sensorineural hearing loss etiology have encouraged the identification of novel hearing therapeutics, paving the way for precision hearing medicine. Critical to this field is the curation of health resources on hearing data. A systematic review of the literature was conducted to map existing (inter)national and regional datasets that include hearing data to inform the development of future hearing repositories. Systematic literature review was performed adhering to Preferred Reporting Items for Systematic Review and MetaAnalysis recommendations. Databases, including those from gray literature, were searched to identify publications reporting on phenotypic and/ or genotypic hearing data in May 2019. The databases reviewed were Medline, PubMed, Embase databases, and Google Scholar. Publications on local datasets were excluded. All hearing datasets identified in the screening process were noted. For each dataset, geography, context, objective, period of time run, numbers and demographics of participants, genomic data, hearing measures and instruments used were extracted and cataloged. One hundred and eighty-eight datasets were identified, containing hearing data on populations ranging from 100 to 1.39 million individuals, and all extracted data have been cataloged. This searchable resource has been made accessible online. This unique catalog provides an overview of existing datasets that contain valuable information on hearing. This can be used to inform the development of national and international patient data repositories for hearing loss and guide strategic collaboration between key stakeholder groups, pivotal to the delivery and development of sensorineural hearing loss precision diagnostics and treatments.

Combination radiofrequency microneedling and carbon dioxide laser for acne scarring: A systematic review and retrospective case series across two centers.

INTRODUCTION: Combination radiofrequency (RF) microneedling with fractional ablative carbon dioxide (CO2 ) laser is a new approach for acne scar treatment. AIMS: (1) to systematically review the literature on the safety and effectiveness of this treatment for acne scarring; (2) to assess safety and effectiveness in a 2-center case series. METHODS: Systematic review: Articles that assessed the safety and effectiveness of combination RF microneedling and fractional CO2 laser for acne scarring were included and quality assessed using the Downs and Black checklist. CASE SERIES: Patient records were reviewed from 2 clinics, one in London, UK, and the other in Washington D.C., United States, to identify patients who underwent a single treatment with RF microneedling and fractional CO2 laser for acne scarring. Outcome assessment was via the Scar Global Assessment (SGA) scale. RESULTS: Systematic review: Three articles were included and reported improvements in acne scar severity. Adverse effects included erythema, edema, pain, vesicle formation, erosion, petechiae, desquamation, post-inflammatory hyperpigmentation (PIH), and acne flare. Quality scores ranged from 14 to 15 (maximum of 21). CASE SERIES: Twenty-six patients were included. Mean SGA Score was 3.0 at baseline and 1.3 at follow-up. All patients had an improved SGA score. Adverse effects included erythema, pain, edema, skin crusting, PIH, and acne flare. All patients resumed normal activities within 7 days of treatment. CONCLUSION: Combination RF microneedling and fractional CO2 laser appears a safe and effective treatment for patients with acne scarring. A single treatment can result in noticeable improvements in acne scar severity with a short recovery time.

Early Health Economic Modeling of Novel Therapeutics in Age-Related Hearing Loss.

Background: Health systems face challenges to accelerate access to innovations that add value and avoid those unlikely to do so. This is very timely to the field of age-related sensorineural hearing loss (ARHL), where a significant unmet market need has been identified and sizeable investments made to promote the development of novel hearing therapeutics (NT). This study aims to apply health economic modeling to inform the development of cost-effective NT. Methods: We developed a decision-analytic model to assess the potential costs and effects of using regenerative NT in patients ≥50 with ARHL. This was compared to the current standard of care including hearing aids and cochlear implants. Input data was collected from systematic literature searches and expert opinion. A UK NHS healthcare perspective was adopted. Three different but related analyses were performed using probabilistic modeling: (1) headroom analysis, (2) scenario analyses, and (3) threshold analyses. Results: The headroom analysis shows an incremental net monetary benefit (iNMB) of £20,017[£11,299-£28,737] compared to the standard of care due to quality-adjusted life-years (QALY) gains and cost savings. Higher therapeutic efficacy and access for patients with all degrees of hearing loss yields higher iNMBs. Threshold analyses shows that the ceiling price of the therapeutic increases with more severe degrees of hearing loss. Conclusion: NT for ARHL are potentially cost-effective under current willingness-to-pay (WTP) thresholds with considerable room for improvement in the current standard of care pathway. Our model can be used to help decision makers decide which therapeutics represent value for money and are worth commissioning, thereby paving the way for urgently needed NT.

Acute otitis externa: Consensus definition, diagnostic criteria and core outcome set development.

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.

What health policy makers need to know about mismatches between public perceptions of disease risk, prevalence and severity: a national survey.

OBJECTIVES: The aim of this study was to assess people's perceptions of their personal risk, population prevalence and perceived severity in relation to three key health conditions (cancer, heart disease and hearing loss), gauge the size of any misperceptions, and identify correlates of such misperceptions. DESIGN: This study was a cross-sectional survey. STUDY SAMPLE: A total of 10,401 adults representative of the UK population were participated in the study. RESULTS: Clear majorities of people incorrectly believe that they are at greater personal risk of cancer (>75%), that cancer is more prevalent in the population (>50%) and that cancer is more disabling (>65%), than either heart disease or hearing loss. In turn, people consistently regard their personal risk of hearing loss, the population prevalence of hearing loss and the severity of hearing loss as lower than either cancer or heart disease. Multiple regression analyses showed inconsistent patterns of relationships between people's beliefs, sociodemographic characteristics and their health behaviours. CONCLUSIONS: Accuracy in beliefs about cancer, heart disease and hearing loss is low, and the relationships between these beliefs, their potential antecedents and consequences are complex. Policy makers should ensure close adherence to evidence or risk-making decisions that are costly both in financial terms and in terms of suboptimal population subjective well-being.

The Potential Added Value of Novel Hearing Therapeutics: An Early Health Economic Model for Hearing Loss.

OBJECTIVE: To construct an early health economic model to assess the potential added value of novel hearing therapeutics, compared with the current standard of care. We use idiopathic sudden sensorineural hearing loss (ISSNHL) as a case example, because it is a lead indication for several emerging hearing therapeutics. METHODS: A decision analytic model was developed to assess the costs and effects of using novel hearing therapeutics for patients with ISSNHL. This was compared to the current standard of care. Input data were derived from literature searches and expert opinion. The study adopted a healthcare perspective of the UK National Health Service. Four analyses were conducted: 1) headroom, 2) scenario, 3) threshold, 4) sensitivity. RESULTS: The decision analytic model showed that novel therapeutics for ISSNHL have potential value both in terms of improved patient outcomes, as well as incremental net monetary benefit (iNMB). The base case analysis revealed an iNMB of £39,032 for novel therapeutics compared with the current standard of care. Results of the threshold and scenario analysis revealed that age of treatment and severity of ISSNHL are major determinants of iNMB for novel therapeutics. CONCLUSION: This article describes the first health economic model for novel therapeutics for hearing loss; and shows that novel hearing therapeutics can be cost-effective under NICE's cost-effectiveness threshold, with considerable room for improvement in the current standard of care. Our model can be used to inform the development of cost-effective hearing therapeutics; and help decision makers decide which therapeutics represent value for money.

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

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).

Introducing a new classification for drug-induced sleep endoscopy (DISE): the PTLTbE system.

PURPOSE: A new classification system is proposed to help the interpretation of drug-induced sleep endoscopy (DISE). The purpose is to create a classification system that improves upon existing systems designed to assess suitability of lateral wall surgery such as expansion pharyngoplasty whilst improving the reliability of the classification. METHODS: A qualitative study into the difficulties trainees had with existing systems was used to identify key issues that needed to be addressed. A visual description of the palate, tonsils, lateral pharyngeal wall, tongue base, epiglottis (PTLTbE) classification was developed. Preliminary data on the inter-rater reliability of PTLTbE were collected. Twenty junior doctors were asked to interpret 5 DISE videos using the PTLTbE classification, and the kappa and percentage agreement were calculated. RESULTS: The Krippendorff alpha ranged between 0.56 and 0.86 for individual DISE videos which compared favourably with the results from those who also completed the VOTE classification (range 0.31 to 0.66). The overall percentage agreement for PTLTbE was 90.1%. CONCLUSIONS: There are a number of advantages of the PTLTbE system over other existing DISE classifications. (1) Tonsillar obstruction is separated from lateral pharyngeal wall collapse. (2) Interobserver reliability is improved, critical to improve communication, patient outcomes and future research. (3) The learning curve to use this system is short. Most doctors did not need to refer to the classification images as an aide-memoire after a few uses of the PTLTbE system. A fuller examination of the reliability of the PTLTbE system is underway along with examination of its use in clinical settings.

Total endoscopic stapes surgery: Systematic review and pooled analysis of audiological outcomes.

OBJECTIVE: This study evaluates the current evidence base for total endoscopic stapes surgery, specifically to establish current efficacy and safety of the technique within clinical practice. DATA SOURCES: A systematic review of the literature on endoscopic stapes surgery was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis checklist. A comprehensive search of PubMed, Embase, and the Cochrane Central Register of Controlled Trials database for relevant publications for all available dates with appropriate Medical Subject Headings search criteria in January 2018. STUDY SELECTION: Out of the 160 articles identified in the search, 14 met the inclusion criteria for further analysis. Four of these were level III and 10 level IV evidence. DATA EXTRACTION: A pooled patient population of 314 individuals was analyzed. DATA SYNTHESIS: Documented postoperative air bone gap closure to within 20 dB was found in 95.3% of individuals (285 patients). Facial nerve palsy (temporary) occurred in three patients (0.6%), with all recovering. No total sensorineural hearing losses were recorded, but two moderate sensorineural hearing losses occurred (0.6%). Perilymph fistula was noted on four occasions (1.3%). Chorda tympani trauma was documented in 3.5% of cases, with taste disturbance documented in 13 patients (5%). CONCLUSIONS: Our pooled analysis uses the current published evidence to establish the complication rate and audiological outcome for the endoscopic approach to stapes surgery. These outcomes are comparable to those documented in traditional use of the microscope for stapedectomy. Laryngoscope, 130:1282-1286, 2020.

Guidelines on the surgical management of sleep disorders: A systematic review.

OBJECTIVE: To facilitate the development of U.K. guidelines for sleep surgery and to guide sleep surgeons to existing guidelines relevant to their practice, we provide a systematic review and quality assessment of all existing guidelines on the surgical management of sleep disorders. METHODS: Systematic review using preferred reporting items for systematic reviews and meta-analyses (PRISMA) recommendations. Medline and Embase databases were searched from inception to April 2018. Publications were included if they described a guideline for the surgical management of sleep disorders. Three assessors used the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument to evaluate included guidelines. RESULTS: The systematic search revealed 1,161 publications. Twenty-two guidelines from eight countries were included. Fourteen focused on adults, five on children, and three on both. The guidelines discussed nasal, tonsillar, palatal, tongue, hyoid, maxillomandibular, tracheal, bariatric, and multilevel surgeries. The mean overall AGREE II quality score of included guidelines was 3.5 (range = 2 to 5.3; maximum possible score = 7). CONCLUSION: This article provides a summary and quality assessment of all published guidelines on the surgical management of sleep disorders. No U.K. guidelines were identified, and existing guidelines have several shortcomings. This highlights the need for robust U.K. national guidelines on sleep surgery to promote clinical and cost-effective care in this field. Our findings can be used by stakeholders as a foundation for the development of new guidelines and can be used by sleep surgeons to direct them to existing guidelines relevant to their practice, promoting evidence-based clinical care. Laryngoscope, 130:1070-1084, 2020.

Patient-reported outcome measure for obstructive sleep apnea: Symptoms, Tiredness, Alertness, Mood and Psychosocial questionnaire: Preliminary results.

Obstructive sleep apnea (OSA) is a common chronic condition that has a significant impact on the biopsychosocial aspects of the patient's life. There is currently no psychometrically validated patient-reported outcome measure to assess the impact of this condition on the health-related quality of life. We designed a novel instrument based on common patient statements, prioritized by patient preference. Sixty-three patients with OSA and 33 participants with no symptoms of sleep-disordered breathing were asked to complete a 20-item initial questionnaire. The acceptability, reliability and validity of the instrument were assessed using known psychometric techniques. The instrument had strong acceptability and was completed within 180 s with no missing data. Five items were removed as they had a high ceiling factor. A further three items were removed as they did not represent the central construct uniquely. The final 12-item instrument had high internal consistency (Cronbach's alpha 0.91), strong test-retest reliability (p = .83) and high discriminant validity when comparing mean total scores of controls (6.88; 95% confidence interval [CI], 4.67-9.08) and those with OSA (31.39; 95% CI, 27.94-34.84) (p < .001). Further studies are planned to help validate this instrument for clinical use.

Early phase trials of novel hearing therapeutics: Avenues and opportunities.

Novel hearing therapeutics are rapidly progressing along the innovation pathway and into the clinical trial domain. Because these trials are new to the hearing community, they come with challenges in terms of trial design, regulation and delivery. In this paper, we address the key scientific and operational issues and outline the opportunities for interdisciplinary and international collaboration these trials offer. Vital to the future successful implementation of these therapeutics is to evaluate their potential for adoption into healthcare systems, including consideration of their health economic value. This requires early engagement with all stakeholder groups along the hearing innovation pathway.

What are the requirements for developing a successful national registry of auditory implants? A qualitative study.

OBJECTIVES: 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 clinical and cost-effectiveness and develop national policy. Recognising that developing such a registry faces considerable challenges, it is important to gather opinions from stakeholders and patients. This paper builds on our systematic review on surgical registry development and aims to identify the specific requirements for developing a successful national registry of auditory implants. DESIGN: Qualitative study. PARTICIPANTS: Data were collected in two ways: (1) semistructured interviews with UK professional stakeholders; and (2) focus groups with patients with hearing loss. The interview and focus group schedules were informed by our systematic review on registry development. Data were analysed using directed content analysis. Judges mapped the themes obtained against a conceptual framework developed from our systematic review on registry development. The conceptual framework consisted of five categories for successful registry development: (1) planning, (2) registry governance, (3) registry dataset, (4) anticipating challenges, (5) implementing solutions. RESULTS: Twenty-seven themes emerged from 40 semistructured interviews with professional stakeholders and 18 themes emerged from three patient focus groups. The most important factor for registry success was high rates of data completion. Benefits of developing a successful registry of auditory implants include: strengthening the evidence base and regulation of auditory implants, driving quality and safety improvements, increased transparency, facilitating patient decision-making and informing policy and guidelines development. CONCLUSIONS: This study identifies the requirements for developing a successful national registry of auditory implants, benefiting from the involvement of numerous professional stakeholder groups and patients with hearing loss. Our approach may be used internationally to inform successful registry development.

Effectiveness of UK provider financial incentives on quality of care: a systematic review.

BACKGROUND: Provider financial incentives are being increasingly adopted to help improve standards of care while promoting efficiency. AIM: To review the UK evidence on whether provider financial incentives are an effective way of improving the quality of health care. DESIGN AND SETTING: Systematic review of UK evidence, undertaken in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. METHOD: MEDLINE and Embase databases were searched in August 2016. Original articles that assessed the relationship between UK provider financial incentives and a quantitative measure of quality of health care were included. Studies showing improvement for all measures of quality of care were defined as 'positive', those that were 'intermediate' showed improvement in some measures, and those classified as 'negative' showed a worsening of measures. Studies showing no effect were documented as such. Quality was assessed using the Downs and Black quality checklist. RESULTS: Of the 232 published articles identified by the systematic search, 28 were included. Of these, nine reported positive effects of incentives on quality of care, 16 reported intermediate effects, two reported no effect, and one reported a negative effect. Quality assessment scores for included articles ranged from 15 to 19, out of a maximum of 22 points. CONCLUSION: The effects of UK provider financial incentives on healthcare quality are unclear. Owing to this uncertainty and their significant costs, use of them may be counterproductive to their goal of improving healthcare quality and efficiency. UK policymakers should be cautious when implementing these incentives - if used, they should be subject to careful long-term monitoring and evaluation. Further research is needed to assess whether provider financial incentives represent a cost-effective intervention to improve the quality of care delivered in the UK.

What are the essential features of a successful surgical registry? a systematic review.

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.