The post-operative tonsillectomy (POPT) study: A multi-centre prospective paediatric cohort study.

OBJECTIVES: Tonsillectomy is the most common operation performed by otolaryngologists in the UK, despite this we have a poor understanding of the post-operative recovery. We aimed to investigate post-operative bleeding and pain following paediatric tonsillectomy using a patient diary. DESIGN: Prospective observational cohort study. SETTING: Multi-centre study involving 12 secondary and tertiary otolaryngology units across the North of England. Patients were recruited from 1st March 2020 to 30th June 2022. Multilevel ordered logistic regression model statistics were performed. PARTICIPANTS: Children (≥4 years, ≤16 years) undergoing tonsillectomy (with or without adenoidectomy) for benign pathology. MAIN OUTCOME MEASURES: Frequency and severity of post-operative bleeding. Intensity and pattern of post-operative pain. RESULTS: In total 297 children were recruited, with 91 (30.6%) diaries eligible for analysis. Post-operative bleeding occurred in 44% of children. Most frequently blood in the saliva was reported (82.9%). Increasing age significantly increased bleeding odds by 17% per year (p = .001). Bleeding frequency decreased with higher surgeon grade (p = .003) and when performing intracapsular coblation tonsillectomy (p = .02) compared with other techniques. Lower age and intracapsular coblation tonsillectomy, against other techniques, significantly reduced rates of pain post-operatively (p < .0001 and p = .0008). CONCLUSION: A high level of low-level post-operative bleeding was observed. Pain scores remained high for 5 days post-operatively then gradually reduce to normal by day 13. Intracapsular coblation tonsillectomy appears to be superior to all other techniques in terms of reducing post-operative bleeding and pain. These findings should be used to guide patients in the consent process to inform them of the expected nature of post-surgical recovery.

Acute paediatric mastoiditis in the UK before and during the COVID-19 pandemic: A national observational study.

OBJECTIVES: To explore the impact of COVID-19 on the management and outcomes of acute paediatric mastoiditis across the UK. DESIGN: National retrospective and prospective audit. SETTING: 48 UK secondary care ENT departments. PARTICIPANTS: Consecutive children aged 18 years or under, referred to ENT with a clinical diagnosis of mastoiditis. MAIN OUTCOME MEASURES: Cases were divided into Period 1 (01/11/19-15/03/20), before the UK population were instructed to reduce social contact, and Period 2 (16/03/20-30/04/21), following this. Periods 1 and 2 were compared for population variables, management and outcomes. Secondary analyses compared outcomes by primary treatment (medical/needle aspiration/surgical). RESULTS: 286 cases met criteria (median 4 per site, range 0-24). 9.4 cases were recorded per week in period 1 versus 2.0 in period 2, with no winter increase in cases in December 2020-Febraury 2021. Patient age differed between periods 1 and 2 (3.2 vs 4.7 years respectively, p < 0.001). 85% of children in period 2 were tested for COVID-19 with a single positive test. In period, 2 cases associated with P. aeruginosa significantly increased. 48.6% of children were scanned in period 1 vs 41.1% in period 2. Surgical management was used more frequently in period 1 (43.0% vs 24.3%, p = 0.001). Treatment success was high, with failure of initial management in 6.3%, and 30-day re-admission for recurrence in 2.1%. The adverse event rate (15.7% overall) did not vary by treatment modality or between periods 1& 2. CONCLUSION: The COVID-19 pandemic led to a significant change in the presentation and case mix of acute paediatric mastoiditis in the UK.

The Evidence Base for the Benefits of Functional Septorhinoplasty and its Future Post COVID-19.

Ever since the introduction of the concept of Procedures of Limited Clinical Value (PoLCV), procedures such as functional septorhinoplasty have been subject to additional funding restrictions within the British National Health Service. Recent publications have suggested that 10% of Clinical Commissioning Groups in the United Kingdom no longer fund septorhinoplasty surgery irrespective of the indications, including congenital malformations or post-trauma, and despite the strong evidence available in the literature in treating a range of health conditions. Thus, inequity exists across the country. At present functional septorhinoplasty surgery is frequently but incorrectly grouped together with aesthetic rhinoplasty, both of which are deemed to be cosmetic interventions. Moreover, as we exit the peak of the current coronavirus disease 2019 (COVID-19) pandemic, procedures deemed to be of lower clinical priority will potentially be at risk throughout Europe. The purpose of this review is twofold; the first is to put forward the evidence to commissioners in favor of functional septorhinoplasty surgery on patient well-being and mental health; the second is to demonstrate why functional septorhinoplasty surgery is a distinct procedure from aesthetic rhinoplasty and why it ought not to be classified as a procedure of limited clinical value.

Descending cervical mediastinitis: the multidisciplinary surgical approach.

PURPOSE: Descending cervical mediastinitis (DCM) is defined as spread of oropharyngeal or odontogenic infection into the mediastinum. It occurs uncommonly and has a high mortality rate. METHODS: Six patients underwent surgery at our centre for DCM between November 2013 and October 2016. Five of six patients underwent drainage of neck collections via a cervical approach, and all six patients subsequently underwent thoracic surgery for drainage of pleural and mediastinal collections. RESULTS: Four patients required further surgical intervention, of which two subsequently required a third thoracic operation. The average length of stay was 73 days (range 4-193). There were no in-hospital deaths and all patients were discharged from our hospital. CONCLUSIONS: Following diagnosis, prompt surgical intervention from ENT and cardiothoracic surgeons is essential. Our experience demonstrates that favourable outcomes can be achieved in patients with DCM when they are managed aggressively and promptly in specialist centres with appropriate multidisciplinary team involvement.

Is OperaVOX a clinically useful tool for the assessment of voice in a general ENT clinic?

BACKGROUND: Objective acoustic analysis is a key component of multidimensional voice assessment. OperaVOX is an iOS app which has been shown to be comparable to Multi Dimensional Voice Program for most principal measures of vocal function. As a relatively cheap, portable and easily accessible form of acoustic analysis, OperaVOX may be more clinically useful than laboratory-based software in many situations. This study aims to determine whether correlation exists between acoustic measurements obtained using OperaVOX, and perceptual evaluation of voice. METHODS: Forty-four voices from the multidisciplinary voice clinic were examined. Each voice was assessed blindly by a single experienced voice therapist using the GRBAS scale, and analysed using OperaVOX. The Spearman rank correlation co-efficient was calculated between each element of the GRBAS scale and acoustic measurements obtained by OperaVOX. RESULTS: Significant correlations were identified between GRBAS scores and OperaVOX parameters. Grade correlated significantly with jitter (ρ = 0.495, p < 0.05), shimmer (ρ = 0.385, p < 0.05), noise-to-harmonic ratio (NHR; ρ = 0.526, p < 0.05) and maximum phonation time (MPT; ρ = -0.415, p < 0.05). Roughness did not correlate with any of the measured variables. Breathiness correlated significantly with jitter (ρ = 0.342, p < 0.05), NHR (ρ = 0.344, p < 0.05) and MPT (ρ = -0.336, p < 0.05). Aesthenia correlated with NHR (ρ = 0.413, p < 0.05) and MPT (ρ = -0.399, p < 0.05). Strain correlated with Jitter (ρ = 0.560, p < 0.05), NHR (ρ = 0.600, p < 0.05) and MPT (ρ = -0.356, p < 0.05). CONCLUSIONS: OperaVOX provides objective acoustic analysis which has shown statistically significant correlation to perceptual evaluation using the GRBAS scale. The accessibility of the software package makes it possible for a wide range of health practitioners, e.g. general ENT surgeons, vascular surgeons, thyroid surgeons and cardiothoracic surgeons to objectively monitor outcomes and complications of surgical procedures that may affect vocal function. Given the increasing requirement for surgeons to monitor their outcomes as part of the move towards 'surgeon reported outcomes' this may become an invaluable tool towards that goal.

Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT.

Background: The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking. Objective: The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum. Design: This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation. Setting: The trial was set in 17 NHS secondary care hospitals in the UK. Participants: A total of 378 eligible participants aged > 18 years were recruited. Interventions: Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery (n = 188) or (2) medical management with intranasal steroid spray and saline spray (n = 190). Main outcome measures: The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes - Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements - peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms. Results: At the 6-month time point, 307 participants provided primary outcome data (septoplasty, n = 152; medical management, n = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were -20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was 39.5 (95% confidence interval -23.6 to -16.4; p < 0.0001)]. This was confirmed by sensitivity analyses and through the analysis of secondary outcomes. Outcomes were statistically significantly related to baseline severity, but not to gender or turbinate reduction. In the surgical and medical management arms, 132 and 95 adverse events occurred, respectively; 14 serious adverse events occurred in the surgical arm and nine in the medical management arm. On average, septoplasty was more costly and more effective in improving Sino-nasal Outcome Test-22 items scores and quality-adjusted life-years than medical management, but incurred a larger number of adverse events. Septoplasty had a 15% probability of being considered cost-effective at 12 months at a £20,000 willingness-to-pay threshold for an additional quality-adjusted life-year. This probability increased to 99% and 100% at 24 and 36 months, respectively. Limitations: COVID-19 had an impact on participant-facing data collection from March 2020. Conclusions: Septoplasty, with or without turbinate reduction, is more effective than medical management with a nasal steroid and saline spray. Baseline severity predicts the degree of improvement in symptoms. Septoplasty has a low probability of cost-effectiveness at 12 months, but may be considered cost-effective at 24 months. Future work should focus on developing a septoplasty patient decision aid. Trial registration: This trial is registered as ISRCTN16168569 and EudraCT 2017-000893-12. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/226/07) and is published in full in Health Technology Assessment; Vol. 28, No. 10. See the NIHR Funding and Awards website for further award information.

Septoplasty is an operation to straighten the septum, which is the partition wall between the nostrils inside the nose. Septoplasty can be used as a treatment for people who have a bent septum and symptoms of a blocked nose, such as difficulty sleeping and exercising. Medical management (a saltwater spray to clear the nose followed by a nose steroid spray) is an alternative treatment to septoplasty. The Nasal AIRway Obstruction Study (NAIROS) aimed to find out whether septoplasty or medical management is a better treatment for people with a bent septum and symptoms of a blocked nose. We recruited 378 patients with at least moderately severe nose symptoms from 17 hospitals in England, Scotland and Wales to take part in the NAIROS. Participants were randomly put into one of two groups: septoplasty or medical management. Participants' nose symptoms were measured both when they joined the study and after 6 months, using a questionnaire called the Sino-nasal Outcome Test-22 items. This questionnaire was chosen because patients reported that it included symptoms that were important to them. Other studies have shown that a 9-point change in the Sino-nasal Outcome Test-22 items score is significant. After 6 months, on average, people in the septoplasty group improved by 25 points, whereas people in the medical management group improved by 5 points. We saw improvement after septoplasty among patients with moderate symptoms, and among those with severe symptoms. Most patients who we spoke to after a septoplasty were happy with their treatment, but some would have liked more information about what to expect after their nose surgery. In the short term, septoplasty is more costly than medical management. However, over the longer term, taking into account all the costs and benefits of treatment, suggests that septoplasty would be considered good value for money for the NHS.

Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial.

OBJECTIVE: To assess the clinical effectiveness of septoplasty. DESIGN: Multicentre, randomised controlled trial. SETTING: 17 otolaryngology clinics in the UK's National Health Service. PARTICIPANTS: 378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale). INTERVENTIONS: Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex. MAIN OUTCOME MEASURES: The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures. RESULTS: Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence interval 16.4 to 23.6, P<0.001, adjusted for baseline continuous SNOT-22 score and the stratification variables sex and baseline NOSE severity categories). Greater improvement in SNOT-22 scores was predicted by higher baseline symptom severity scores. Quality of life outcomes and nasal airflow measures (including peak nasal inspiratory flow and absolute inhalational nasal partitioning ratio) improved more in participants in the septoplasty group. Readmission to hospital with bleeding after septoplasty occurred in seven participants (4% of 174 who had septoplasty), and a further 20 participants (12%) required antibiotics for infections. CONCLUSIONS: Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16168569.

Multidisciplinary management of laryngeal pathology identified in patients with COVID-19 following trans-laryngeal intubation and tracheostomy.

Background: COVID-19 disease often requires invasive ventilatory support. Trans-laryngeal intubation of the trachea may cause laryngeal injury, possibly compounded by coronavirus infection. Fibreoptic Endoscopic Evaluation of Swallowing (FEES) provides anatomical and functional assessment of the larynx, guiding multidisciplinary management. Our aims were to observe the nature of laryngeal abnormalities in patients with COVID-19 following prolonged trans-laryngeal intubation and tracheostomy, and to describe their impact on functional laryngeal outcomes, such as tracheostomy weaning. Methods: A retrospective observational cohort analysis was undertaken between March and December 2020, at a UK tertiary hospital. The Speech and Language Therapy team assessed patients recovering from COVID-19 with voice/swallowing problems identified following trans-laryngeal intubation or tracheostomy using FEES. Laryngeal pathology, treatments, and outcomes relating to tracheostomy and oral feeding were noted. Results: Twenty-five FEES performed on 16 patients identified a median of 3 (IQR 2-4) laryngeal abnormalities, with 63% considered clinically significant. Most common pathologies were: oedema (n = 12, 75%); abnormal movement (n = 12, 75%); atypical lesions (n = 11, 69%); and erythema (n = 6, 38%). FEES influenced management: identifying silent aspiration (88% of patients who aspirated (n = 8)), airway patency issues impacting tracheostomy weaning (n = 8, 50%), targeted dysphagia therapy (n = 7, 44%); ENT referral (n = 6, 38%) and reflux management (n = 5, 31%). Conclusions: FEES is beneficial in identifying occult pathologies and guiding management for laryngeal recovery. In our cohort, the incidence of laryngeal pathology was higher than a non-COVID-19 cohort with similar characteristics. We recommend multidisciplinary investigation and management of patients recovering from COVID-19 who required prolonged trans-laryngeal intubation and/or tracheostomy to optimise laryngeal recovery.

A 10-Year Review of the Complications Caused by Ingested and Aspirated Dentures.

INTRODUCTION: Dentures are worn by 20% of the United Kingdom population for both physical and psychological symptoms associated with tooth loss. However, significant morbidity and mortality can result if dentures are swallowed or aspirated. This 10-year review investigated the development of complications following denture aspiration or ingestion, and identified key learning points. METHODS: The Medline database was searched for cases of denture ingestion or aspiration from October 1, 2009, to October 31, 2019. Search terms included "dental prosthesis, denture, dental plate, bridge and false teeth" and "swallow, ingest, eat, aspirate and inhale." Potential factors influencing the development of complications were assessed (hollow viscus perforation, fistula formation, abscess, bowel obstruction, necrosis, hemorrhage, and airway obstruction). Statistical analysis was performed using χ2 and Pearson correlation tests in R Studio. No ethical approval was required. RESULTS: Eighty-five patients were identified from 77 case reports. Fourteen articles were excluded due to insufficient information. Complications were documented in 37.6% (n = 32) of patients with 2 cases resulting in death. Duration of symptoms over 1 day (P = .005) and delayed removal beyond 4 days post-ingestion (P = .017) was significantly associated with increased rates of complications. There was no significant association between complication rate and patient age, denture type, level of impaction, or radiolucency. CONCLUSION: Denture aspiration or ingestion can have serious consequences. Factors impacting complication rate revolve around early recognition and treatment. Clinician awareness of the potential risks of dentures is paramount to early diagnosis. We recommend early intervention to reduce the morbidity associated with this unassuming device.

Higher Speciality Training Boot Camp in Otolaryngology: A Quantitative and Qualitative Analysis of the Northern National Formative Specialty Training 3 Induction Course.

Background Opportunities for new otolaryngology trainees to develop their skills as they embark on specialty training can be limited. Our facility hosted a national simulation-based boot camp for new otolaryngology trainees in the UK. This study aimed to assess the effectiveness of the boot camp in improving trainee confidence as they transitioned from core surgical training (CST) to higher specialty training (HST) in otolaryngology. Methodology We conducted a prospective study on the effectiveness of the boot camp on trainee induction. The boot camp included hands-on simulation, small group teaching and didactic lectures addressing technical skills in the fields of otology, laryngology, rhinology, facial plastics, and paediatrics, as well as non-technical skills involving human factors, simulated ward round, and cognitive simulation. The boot camp curriculum reflected the competencies expected by the Joint Committee of Surgical Training (JCST) at this level of training. Participants completed a pre- and post-course questionnaire addressing their self-confidence for the technical and non-technical skills they developed during the boot camp. All participants were invited to participate in an interview 12 months after the boot camp. Results A total of 27 new otolaryngology trainees (approximately half of all new otolaryngology trainees in the UK) participated in the boot camp. A significant increase in median confidence was observed for all technical and non-technical stations (p < 0.0001). The increase in confidence observed was similar for participants regardless of prior experience in otolaryngology. Five candidates were interviewed a year after the boot camp. Analysis of the transcripts generated distinct comments that were grouped into five key themes. Conclusions A simulation-based boot camp mapped to the JCST curriculum can increase the confidence of new otolaryngology Specialty Training 3 trainees during their transition from CST to HST. It can provide valuable and durable technical and non-technical skills to aid trainees in the clinic, theatre environment, and when on-call during their inaugural year of training.

Lansoprazole for persistent throat symptoms in secondary care: the TOPPITS RCT.

BACKGROUND: Persistent throat symptoms are commonly attributed to 'laryngopharyngeal reflux'. Despite a limited evidence base, these symptoms are increasingly being treated in primary care with proton pump inhibitors. OBJECTIVE: To assess the value of proton pump inhibitor therapy in patients with persistent throat symptoms. DESIGN: This was a double-blind, placebo-controlled, randomised Phase III trial. SETTING: This was a multicentre UK trial in eight UK ear, nose and throat departments. PARTICIPANTS: A total of 346 participants aged ≥ 18 years with persistent throat symptoms and a Reflux Symptom Index score of ≥ 10, exclusive of the dyspepsia item, were recruited. INTERVENTION: Random allocation (1 : 1 ratio) to either 30 mg of lansoprazole twice daily or matched placebo for 16 weeks. MAIN OUTCOME MEASURE: Symptomatic response (i.e. total Reflux Symptom Index score after 16 weeks of therapy). RESULTS: A total of 1427 patients were screened and 346 were randomised. The mean age was 52 years (standard deviation 13.7 years, range 20-84 years); 150 (43%) participants were male and 196 (57%) were female; 184 (53%) participants had a mild Reflux Symptom Index minus the heartburn/dyspepsia item and 162 (47%) had a severe Reflux Symptom Index minus the heartburn/dyspepsia item. A total of 172 patients were randomised to lansoprazole and 174 were randomised to placebo. MAIN OUTCOMES: A total of 267 participants completed the primary end-point visit (lansoprazole, n = 127; placebo, n = 140), of whom 220 did so between 14 and 20 weeks post randomisation ('compliant' group); 102 received lansoprazole and 118 received placebo. The mean Reflux Symptom Index scores at baseline were similar [lansoprazole 22.0 (standard deviation 8.0), placebo 21.7 (standard deviation 7.1), overall 21.9 (standard deviation 7.5)]. The mean Reflux Symptom Index scores at 16 weeks reduced from baseline in both groups [overall 17.4 (standard deviation 9.9), lansoprazole 17.4 (standard deviation 9.9), placebo 15.6 (standard deviation 9.8)]. Lansoprazole participants had estimated Reflux Symptom Index scores at 16 weeks that were 1.9 points higher (worse) than those of placebo participants (95% confidence interval -0.3 to 4.2; padj = 0.096), adjusted for site and baseline severity. SECONDARY OUTCOMES: Ninety-five (43%) participants achieved a Reflux Symptom Index score in the normal range (< 12) at 16 weeks: 42 (41%) in the lansoprazole group and 53 (45%) in the placebo group. A total of 226 participants completed the end-of-trial follow-up visit (lansoprazole, n = 109; placebo, n = 117), of whom 181 were 'compliant'. The mean Reflux Symptom Index scores at 12 months reduced from baseline in both groups [lansoprazole 16.0 (standard deviation 10.8), placebo 13.6 (standard deviation 9.6), overall 14.7 (standard deviation 10.2)]. A total of 87 (48%) participants achieved a Reflux Symptom Index score in the normal range at 12 months: 33 (40%) in the lansoprazole group and 54 (55%) in the placebo group. Likewise, the Comprehensive Reflux Symptom Score and Laryngopharyngeal Reflux - Health Related Quality of Life total scores and subscales all showed very similar changes in the lansoprazole and placebo cohorts at both 16 weeks and 12 months. LIMITATIONS: Drop-out rate and compliance are issues in pragmatic clinical trials. The Trial Of Proton Pump Inhibitors in Throat Symptoms (TOPPITS) aimed to detect clinically relevant difference with 90% power. The 346 randomised participants reduced to 283 at the primary end point; 267 completed the primary outcome measure, 220 within the protocol time scale. Despite this, the powers to detect the clinically relevant difference in Reflux Symptom Index score at 16 weeks were 82% (compliant comparison) and 89% (pragmatic comparison). The lack of difference between lansoprazole and placebo is generalisable across NHS clinics. CONCLUSIONS: Participants on lansoprazole did not report significantly better outcomes than participants on placebo on any of the three patient-reported outcome tools (Reflux Symptom Index, Comprehensive Reflux Symptom Score and Laryngopharyngeal Reflux - Health Related Quality of Life). This multicentre, pragmatic, powered, definitive Phase III trial found no evidence of benefit for patients by treating persistent throat symptoms with lansoprazole. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38578686 and EudraCT number 2013-004249-17. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 3. See the NIHR Journals Library website for further project information.

BACKGROUND: One of the commonest reasons for patients attending hospital throat or voice clinics is persistent throat symptoms, which include a feeling of a lump in the throat, a cough or a hoarse voice. Over time, more of these patients are being treated with proton pump inhibitors to suppress stomach acid in the belief that stomach acid entering the throat causes the symptoms, but there is little evidence that these medications work. STUDY AIM: The aim of this study is to explore whether or not having a 16-week course of proton pump inhibitors has any impact on throat symptoms. We also tested the usefulness of three different questionnaires in measuring throat symptoms, explored side effects and whether or not patients adhere to treatment, and measured patients' quality of life. METHODS: Patients with persistent (lasting for more than 6 weeks) throat symptoms who agreed to participate were randomised to receive either the proton pump inhibitor lansoprazole or a placebo. Participants took lansoprazole or placebo for 16 weeks. Symptoms and quality of life were measured before patients were randomised and at 4 and 12 months after randomisation. RESULTS: The total number of participants was 346. The mean Reflux Symptom Index outcome score (higher scores meaning worse symptoms) was 22 before the 4-month course of capsules, 16 after 4 months and 15 after 12 months. Participant-reported throat symptoms and quality of life in all participants improved over the 12 months of the study. There was no difference in the symptom improvement experienced by proton pump inhibitor and placebo participants. CONCLUSIONS: This study shows that proton pump inhibitors do not benefit patients with persistent throat symptoms. Future research should focus on other available therapies.

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.

ENT Quality Improvement Program as a tool to improve the collection of morbidity and mortality data: a multisite audit carried out over 6 months.

OBJECTIVE: This project aims to assess the role of a standardised process of data collection to improve morbidity and mortality data across the region. DESIGN: Six hospitals within the North West (UK) were recruited and adopted the ENT Quality Improvement Program (QIP) into their daily practice. Monthly anonymous data were sent back to the reviewer for trend analysis. OUTCOME MEASURES: Four outcome measures were defined: (1) number of cases recorded within the region each month; (2) assessment of the severity of cases and trends; (3) assessment of action plans reviewing any changes in practice made as a result of using this tool; (4) long-term use of the tool and qualitative feedback from units. RESULTS: 162 patients over the 6 months were included with 180 case discussions. 170 of these were morbidities and 10 were mortalities. Mortality was more frequent in patients with a diagnosis of head and neck cancer. Of the 162 patients, 133 encountered postoperative complications. Post-tonsillectomy (62/133 47%) and post-thyroid surgery (19/133 14%) complications were the most frequently encountered. 66% of the complications were low grade with 18% requiring management under general anaesthetic. Actions plans included four policy reviews with the introduction of three new policies. All sites found the tool user-friendly and are continuing to use it beyond the data collection period. CONCLUSIONS: The ENT QIP has been found to be a simple, user-friendly tool which has improved the quality of data over the six sites and resulted in improvements in practice. Implementation of the tool allows clinicians to critically appraise their practice and to reflect as well as to demonstrate how complications have resulted in change.

Laryngeal Trauma Following an Inhalation Injury: A Review and Case Report.

The primary concern when managing a patient with inhalation injury is security of the airway. Airflow may be impeded by both edema of the upper airway and reduction of oxygen delivery to the lower respiratory tract. Although there has been much discussion regarding management of the latter, the focus of this article is the management of the former. This review aimed to determine the optimum management in burn victims with upper airway inhalation injury as an attempt to prevent laryngeal trauma leading to long-term voice disorders and upper airway dyspnea. We describe the case of a 57-year-old woman with significant inhalation injury and discuss the natural progression of her injuries and the laryngeal controversies surrounding her care. We conclude with advice on the optimal management of this condition based on our experience, combined with current best evidence.

Evaluating the quality improvement impact of the Global Tracheostomy Collaborative in four diverse NHS hospitals.

Tracheostomies are predominantly used in Head & Neck Surgery and the critically ill. The needs of these complex patients frequently cross traditional speciality working boundaries and locations and any resulting airway problems can rapidly lead to significant harm. The Global Tracheostomy Collaborative (GTC) was formed in 2012 with the aim of bringing together international expertise in tracheostomy care in order to bring about rapid adoption of best practices and to improve the quality and safety of care to this vulnerable group. The primary aim of this project was to improve the safety and quality of care delivered to adult patients with new or existing tracheostomies. We implemented changes guided by the GTC using multiple PDSA cycles over a 12-month period. Interventions were across three themes: educational, patient-centred (earlier vocalisation and enteral intake) and organisational. We hypothesised that systematic healthcare improvements would reduce the severity of harm resulting from tracheostomy-related safety incidents and improve surrogate markers of the quality of patient-centred care. Furthermore, we hypothesised that raising the quality and safety of healthcare services would lead to more efficient care, measured by earlier tracheostomy decannulation times and reduced hospital lengths of stay. This Quality Improvement project implemented the GTC into four diverse NHS Trusts in Greater Manchester. Key drivers implemented included multidisciplinary tracheostomy steering groups, ward rounds and bedside teams, standardisation of tracheostomy protocols, staff education and meaningful involvement of patient and family. Surrogates for the quality and safety of care were captured for all patients using a bespoke database. Implementing the GTC into four NHS Trusts rapidly and positively impacted on patient safety metrics and surrogates for the quality of care delivered. It is likely that the comprehensive resources of the GTC will be of benefit to other NHS hospitals and indeed other healthcare systems around the world.

Immediate lamina papyracea reconstruction during endoscopic sinus surgery for surgically managed subperiosteal abscess in children.

The sinonasal area of a child's face is the keystone of facial architecture, and any trauma to this area may result in facial dysplasia. Animal studies have proven facial skeletal growth retardation following functional endoscopic sinus surgery. The effect of sinus surgery on facial skeletal growth in humans still needs to be established. Therefore, very conservative surgical resection during functional endoscopic sinus surgery in children is advocated. We present a surgical technique of immediate lamina papyracea reconstruction during endoscopic sinus surgery in children. We have used this technique in endoscopic surgical decompression of subperiosteal abscess secondary to sinusitis in children. We present two cases in which this technique was used in children aged 33 months and 8 years old. The postoperative computed tomography scans showed an intact lamina papyracea.

An unusual case of dysphasia and seizures.

Defects in the tegmen tympani can have serious consequences such as intracranial infection and seizures, however, they can be difficult to diagnose due to their subtlety on cross-sectional imaging and the non-specific way in which they can present. Repair of such defects can be undertaken via a middle fossa or transmastoid approach; both, however, usually necessitate a general anaesthetic and, furthermore, middle cranial fossa surgery carries the risk of epilepsy while transmastoid repair can result in the loss of hearing. We present a novel method of repair in a patient who would otherwise have been managed conservatively.

Cochlear implantation in patients deafened by ototoxic drugs.

OBJECTIVE: To investigate the outcome of cochlear implantation (CI) in patients deafened by ototoxic drugs and to compare this, with the outcome of CI in sudden sensorineural hearing loss (SSNHL) with a similar duration of deafness. METHODS: The Manchester Auditory Implant Centre database was reviewed to identify patients who were implanted to rehabilitate profound sensorineural hearing loss resulting from treatment with ototoxic agents and patients with SSNHL group. A retrospective case note review of selected patients was carried out. Primary outcome measure was post-implantation Bamford-Kowal-Bench (BKB) score in quiet in both the groups. Secondary outcome measure was any significant complications following implantation. RESULTS: We identified 14 patients in the ototoxic group, which were matched with 13 patients in the SSNHL group. The post-operative BKB score in the ototoxic group ranged from 33 to 100% (median score 91%). One patient had bilateral CI. One patient required explantation following an infection. The post-operative BKB score in the SSNHL group ranged from 16 to 100% (median score 88%). One patient in this group could not be tested using this method as they did not have open set speech discrimination. Two patients in this group had bilateral CI. The data were analysed using Mann-Whitney U test. There was no statistically significant difference in the BKB scores in the two groups of patients (P value -0.983). CONCLUSION: Patients with profound hearing loss secondary to ototoxic agents can be rehabilitated successfully with CI. The outcomes may be variable and may be dependent on the underlying pathology for which the ototoxic agents were prescribed.