Eating and drinking experience in patients with idiopathic pulmonary fibrosis: a qualitative study.

OBJECTIVE: To explore eating and drinking experiences of patients with idiopathic pulmonary fibrosis (IPF), the impact of any changes associated with their diagnosis and any coping mechanisms developed by patients. SETTING: Pulmonary fibrosis support groups around the UK and the regional Interstitial Lung Diseases Clinic, Newcastle upon Tyne. PARTICIPANTS: 15 patients with IPF (9 men, 6 women), median age 71 years, range (54-92) years, were interviewed. Inclusion criteria included competent adults (over the age of 18 years) with a secure diagnosis of IPF as defined by international consensus guidelines. Patients were required to have sufficient English language competence to consent and participate in an interview. Exclusion criteria were a history of other lung diseases, a history of pre-existing swallowing problem of other causes that may be associated with dysphagia and individuals with significant communication or other memory difficulties that render them unable to participate in an interview. DESIGN: A qualitative study based on semistructured interviews used purpose sampling conducted between February 2021 and November 2021. Interviews were conducted via video videoconferencing call platform or telephone call, transcribed and data coded and analysed using a reflexive thematic analysis. RESULTS: Three main themes were identified, along with several subthemes, which were: (1) Eating, as such, is no longer a pleasure. This theme mainly focused on the physical and sensory changes associated with eating and drinking and their effects and the subsequent emotional and social impact of these changes; (2) It is something that happens naturally and just try and get on with it. This theme centred on the self-determined strategies employed to manage changes to eating and drinking; and (3) What is normal. This theme focused on patients seeking information to better understand the changes in their eating and drinking and the patients' beliefs about what has changed their eating and drinking. CONCLUSIONS: To our knowledge, this is the first study to report on IPF patients' lived experience of eating and drinking changes associated with their diagnosis. Findings demonstrate that some patients have substantial struggles and challenges with eating and drinking, affecting them physically, emotionally and socially. There is a need to provide better patient information for this area and further study.

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.

Psychosocial impacts of being nil-by-mouth as an adult: A scoping review.

AIM: To map existing evidence and identify gaps in the literature concerning psychosocial impacts of being nil by mouth (NBM) as an adult. DESIGN: A scoping review of the literature was undertaken using JBI guidance. A protocol was registered on the Open Science Framework (osf.io/43g9y). Reporting was guided by Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR). METHODS: A comprehensive search of six databases (CINAHL, Embase, MEDLINE, PsycINFO, SCOPUS and Web of Science) was performed for studies published up to February 2023, with no restriction to study type. A scope of the grey literature was also undertaken. Two authors independently assessed eligibility and extracted data. Descriptive statistical analysis and narrative synthesis were used, and patient and public involvement included in funding discussions. RESULTS: A total of 23 papers were included in the review, consisting of 14 primary studies (7 qualitative and 7 quantitative) and 9 grey literature. Both global psychological distress and distress specific to being NBM (thirst, missing food and drink) were reported. Caregivers also experience distress from their family member being NBM. Furthermore, social impacts were reported for both patient and caregiver, primarily social isolation and subsequent low mood. CONCLUSION: Furthermore, research is needed to understand the prevalence of this population, how best to measure psychosocial impacts and to explore whether (and how) psychosocial impacts change over time. Advancement in this area would enable better service development to optimize care for this patient group. WHAT IS KNOWN ABOUT THIS TOPIC?: Eating and drinking provides more than nutrition and hydration. A wide range of conditions can lead to recommendations for no longer eating and drinking (nil by mouth). Being nil by mouth (NBM) for short periods such as pre-operative fasting causes distress; however, little is understood about impact on longer-term abstinence from eating and drinking. WHAT THIS PAPER ADDS?: Psychosocial consequences of being nil by mouth (NBM)have been investigated by both quantitative and qualitative studies. Being NBM impacts both patients and caregivers in various psychosocial aspects, including distress and social isolation. Several gaps remain, however, regarding ways to measure psychosocial impact of being NBM.

Can we use machine learning to improve the interpretation and application of urodynamic data?: ICI-RS 2023.

INTRODUCTION: A "Think Tank" at the International Consultation on Incontinence-Research Society meeting held in Bristol, United Kingdom in June 2023 considered the progress and promise of machine learning (ML) applied to urodynamic data. METHODS: Examples of the use of ML applied to data from uroflowmetry, pressure flow studies and imaging were presented. The advantages and limitations of ML were considered. Recommendations made during the subsequent debate for research studies were recorded. RESULTS: ML analysis holds great promise for the kind of data generated in urodynamic studies. To date, ML techniques have not yet achieved sufficient accuracy for routine diagnostic application. Potential approaches that can improve the use of ML were agreed and research questions were proposed. CONCLUSIONS: ML is well suited to the analysis of urodynamic data, but results to date have not achieved clinical utility. It is considered likely that further research can improve the analysis of the large, multifactorial data sets generated by urodynamic clinics, and improve to some extent data pattern recognition that is currently subject to observer error and artefactual noise.

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.

Screening for silent aspiration in hyperacute stroke: A feasibility study of clinical swallowing examination and cough reflex testing.

BACKGROUND: Silent aspiration (SA) is common post-stroke and associated with increased risk of pneumonia, length of stay and healthcare costs. Clinical swallow examinations (CSEs) are unreliable measures of SA. There is no consensus on the clinical components that best detect SA. Cough reflex testing (CRT) is an alternative/adjunct whose SA detection accuracy also lacks consensus. AIMS: To investigate the feasibility of CSE versus CRT against gold standard flexible endoscopic evaluation of swallowing (FEES) for SA identification and to estimate its prevalence in a hyperacute stroke setting. METHODS & PROCEDURES: A single-arm preliminary, prospective, feasibility study of patients less than 72 h post-stroke, over a 31-day period on a hyperacute stroke unit: the Royal Victoria Infirmary, Newcastle-upon-Tyne, UK. Ethical approval for the study was obtained. The study tested the feasibility and acceptability of introducing CRT and developing a standardized CSE. Consent/assent was obtained for all participants. Patients unfit for study were excluded. OUTCOMES & RESULTS: A total of 62% of patients less than 72 h post-stroke (n = 61) were eligible. A total of 75% of those approached (n = 30) consented. A total of 23 patients completed all tests. The principal barrier was anxiety regarding FEES. Mean test time for CRT = 6 min; CSE = 8 min; FEES = 17 min. Patients rated CRT and FEES on average as moderately uncomfortable. A total of 30% (n = 7) of participants who received FEES presented with SA. CONCLUSIONS & IMPLICATIONS: CRT, CSE and FEES are feasible in 58% of hyperacute stroke patients in this setting. FEES anxiety is the main recruitment barrier and is not always well tolerated. Results support further work to establish optimum methods and differential sensitivity/specificity of CRT and CSE in hyperacute stroke for SA identification. WHAT THIS PAPER ADDS: What is already known on this subject SA significantly increases the risk of pneumonia in the early days post-stroke. CSEs are unreliable for identification of SA risk in this population. CRT is gaining popularity as a potential tool to identify stroke patients at risk of SA, though there are questions regarding the efficacy of the clinical protocol currently being used in the UK. What this study adds to existing knowledge This study demonstrates that it is practical and feasible to carry out a larger scale study in this setting to compare CSE and CRT including a consideration of an approach combining both methods for clinical identification of SA versus FEES. Preliminary findings suggest that CSE may have higher levels of sensitivity than CRT for SA identification. What are the potential or actual clinical implications of this work? The results of this study suggest that further work is needed to establish the optimum methods and differential sensitivity/specificity of clinical tools for SA detection in hyperacute stroke.

The utility of a symptom model to predict the risk of oesophageal cancer.

OBJECTIVE: To assess whether extra-oesophageal symptoms are predictive of oesophageal malignancy. METHODS: A prospective, single-centre cross-sectional questionnaire study at a tertiary referral unit for oesophageal cancer using the Comprehensive Reflux Symptoms Scale (CReSS) questionnaire tool. Respondents with oesophageal malignancy were compared with historical cohorts undergoing airway examination or upper gastrointestinal endoscopy and found to have benign diagnoses. We developed a model for predicting oesophageal cancer using linear discriminant analysis and logistic regression, assessed by Monte Carlo cross validation. RESULTS: Respondents with oesophageal malignancy (n = 146; mean age 70.5; male: female, 71:29) were compared with those undergoing airway examination (n = 177) and upper gastrointestinal endoscopy (n = 351), found to have benign diagnoses. No single questionnaire item, or group of co-varying items (factors), reliably discriminated oesophageal cancer from other diagnoses. Individual items which suggested higher risk of oesophageal malignancy included dysphagia (area under the curve (AUC) 0.68), low appetite (AUC 0.66), and early satiety (AUC 0.58). Conversely, throat pain (AUC 0.38), bloating (AUC 0.38) and heartburn (AUC 0.37) were inversely related to cancer risk. A forward stepwise regression analysis including a subset of 12 CReSS questionnaire items together with age and sex derived a model predictive of oesophageal malignancy in this cohort (AUC 0.89). CONCLUSION: We demonstrate a model comprised of 12 questionnaire items and 2 demographic parameters as a potential predictive tool for oesophageal malignancy diagnosis in this study population. Translating this model for predicting oesophageal malignancy in the general population is a valuable topic for future research.

Oropharyngeal swallowing physiology and safety in patients with Idiopathic Pulmonary Fibrosis: a consecutive descriptive case series.

INTRODUCTION: Dysphagia occurs in multiple respiratory pathophysiologies, increasing the risk of pulmonary complications secondary to aspiration. Reflux associated aspiration and a dysregulated lung microbiome is implicated in Idiopathic Pulmonary Fibrosis (IPF), but swallowing dysfunction has not been described. We aimed to explore oropharyngeal swallowing in IPF patients, without known swallowing dysfunction. METHODS: Fourteen consecutive outpatients with a secure diagnosis of IPF were recruited and the 10-item Eating Assessment Tool (Eat 10) used to assess patient perception of swallowing difficulty. Oropharyngeal swallowing was assessed in ten patients using Videofluoroscopy Swallow Studies (VFSS). The studies were rated using validated scales: Penetration-Aspiration Scale (PAS); standardised Modified Barium Swallow Impairment Profile (MBSImP). RESULTS: EAT-10 scores indicated frank swallowing difficulty in 4/14 patients. Videofluoroscopy Studies showed that 3/10 patients had airway penetration, and one aspirated liquid without a cough response. Median MBSImp for oral impairment was 5, range [3-7] and pharyngeal impairment 4, range [1-14] indicating, overall mild alteration to swallowing physiology. CONCLUSION: We conclude that people with IPF can show a range of swallowing dysfunction, including aspiration into an unprotected airway. To our knowledge, this is the first report on swallowing physiology and safety in IPF. We believe a proportion of this group may be at risk of aspiration. Further work is indicated to fully explore swallowing in this vulnerable group.

Shrinkage of the non-malignant prostate gland volume after receiving incidental radiotherapy for rectal cancer.

Background: The purpose of this study was to assess the impact of coincidental radiotherapy on the volume of the non-malignant prostate gland in rectal cancer patients treated with neo-adjuvant radiotherapy. Materials and methods: In this retrospective analysis, thirty male patients with rectal cancer who had neoadjuvant radiotherapy met the inclusion criteria. These patients had pre-treatment magnetic resonance imaging (MRI) and at least one post-treatment MRI of the pelvis and the whole of their prostate volume received the full prescribed radiotherapy dose; 45 Gy in 25 fractions (n = 22), 45 Gy in 20 fractions (n = 4) and 25 Gy in 5 fractions (n = 4). Results: The median age of this patient cohort was 66 years (range: 30-87). With a median interval between pre-treatment MRI and first MRI post-treatment of 2 months (range: 1-11), the mean prostate volume reduced from 36.1 cm3 [standard deviation (SD) 14.2] pre-radiotherapy to 31.3 cm3 (SD 13.0) post radiotherapy and this difference was significant (p = 0.0004). Conclusion: Radiotherapy may cause shrinkage in volume of normal (non-malignant) prostate. Further research is required in this field, since these results may be of some comfort to men contemplating the consequences of radiotherapy on their quality of life. The authors suggest recording flow-rate and international prostate symptom score (IPSS) during rectal radiotherapy as a next step.

Macrophage scavenger receptor 1 mediates lipid-induced inflammation in non-alcoholic fatty liver disease.

BACKGROUND & AIMS: Obesity-associated inflammation is a key player in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). However, the role of macrophage scavenger receptor 1 (MSR1, CD204) remains incompletely understood. METHODS: A total of 170 NAFLD liver biopsies were processed for transcriptomic analysis and correlated with clinicopathological features. Msr1-/- and wild-type mice were subjected to a 16-week high-fat and high-cholesterol diet. Mice and ex vivo human liver slices were treated with a monoclonal antibody against MSR1. Genetic susceptibility was assessed using genome-wide association study data from 1,483 patients with NAFLD and 430,101 participants of the UK Biobank. RESULTS: MSR1 expression was associated with the occurrence of hepatic lipid-laden foamy macrophages and correlated with the degree of steatosis and steatohepatitis in patients with NAFLD. Mice lacking Msr1 were protected against diet-induced metabolic disorder, showing fewer hepatic foamy macrophages, less hepatic inflammation, improved dyslipidaemia and glucose tolerance, and altered hepatic lipid metabolism. Upon induction by saturated fatty acids, MSR1 induced a pro-inflammatory response via the JNK signalling pathway. In vitro blockade of the receptor prevented the accumulation of lipids in primary macrophages which inhibited the switch towards a pro-inflammatory phenotype and the release of cytokines such as TNF-ɑ. Targeting MSR1 using monoclonal antibody therapy in an obesity-associated NAFLD mouse model and human liver slices resulted in the prevention of foamy macrophage formation and inflammation. Moreover, we identified that rs41505344, a polymorphism in the upstream transcriptional region of MSR1, was associated with altered serum triglycerides and aspartate aminotransferase levels in a cohort of over 400,000 patients. CONCLUSIONS: Taken together, our data suggest that MSR1 plays a critical role in lipid-induced inflammation and could thus be a potential therapeutic target for the treatment of NAFLD. LAY SUMMARY: Non-alcoholic fatty liver disease (NAFLD) is a chronic disease primarily caused by excessive consumption of fat and sugar combined with a lack of exercise or a sedentary lifestyle. Herein, we show that the macrophage scavenger receptor MSR1, an innate immune receptor, mediates lipid uptake and accumulation in Kupffer cells, resulting in liver inflammation and thereby promoting the progression of NAFLD in humans and mice.

Evaluation of Spontaneous Swallow Frequency in Healthy People and Those With, or at Risk of Developing, Dysphagia: A Review.

Dysphagia is a common and frequently undetected complication of many neurological disorders and of sarcopoenia in ageing persons. Spontaneous swallowing frequency (SSF) has been mooted as a possible tool to classify dysphagia risk. We conducted a review of the literature to describe SSF in both the healthy population and in disease-specific populations, in order to consider its utility as a screening tool to identify dysphagia. We searched Medline, Embase, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials databases. Metadata were extracted, collated and analysed to give quantitative insight. Three hundred and twelve articles were retrieved, with 19 meeting inclusion and quality criteria. Heterogeneity between studies was high (I2 = 99%). Mean SSF in healthy younger sub-groups was 0.98/min [CI: 0.67; 1.42]. In the Parkinson's sub-group, mean SSF was 0.59/min [0.40; 0.87]. Mean SSF in healthy older, higher risk and dysphagic populations were similar (0.21/min [0.09; 0.52], 0.26/min [0.10; 0.72] and 0.30/min [0.16; 0.54], respectively). SSF is a novel, non-invasive clinical variable which warrants further exploration as to its potential to identify persons at risk of dysphagia. Larger, well-conducted studies are needed to develop objective, standardised methods for detecting SSF, and develop normative values in healthy populations.

Conducting invasive urodynamics in primary care: qualitative interview study examining experiences of patients and healthcare professionals.

BACKGROUND: Invasive urodynamics is used to investigate the causes of lower urinary tract symptoms; a procedure usually conducted in secondary care by specialist practitioners. No study has yet investigated the feasibility of carrying out this procedure in a non-specialist setting. Therefore, the aim of this study was to explore, using qualitative methodology, the feasibility and acceptability of conducting invasive urodynamic testing in primary care. METHODS: Semi-structured interviews were conducted during the pilot phase of the PriMUS study, in which men experiencing bothersome lower urinary tract symptoms underwent invasive urodynamic testing along with a series of simple index tests in a primary care setting. Interviewees were 25 patients invited to take part in the PriMUS study and 18 healthcare professionals involved in study delivery. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach. RESULTS: Patients generally found the urodynamic procedure acceptable and valued the primary care setting due to its increased accessibility and familiarity. Despite some logistical issues, facilitating invasive urodynamic testing in primary care was also a positive experience for urodynamic nurses. Initial issues with general practitioners receiving and utilising the results of urodynamic testing may have limited the potential benefit to some patients. Effective approaches to study recruitment included emphasising the benefits of the urodynamic test and maintaining contact with potential participants by telephone. Patients' relationship with their general practitioner was an important influence on study participation. CONCLUSIONS: Conducting invasive urodynamics in primary care is feasible and acceptable and has the potential to benefit patients. Facilitating study procedures in a familiar primary care setting can impact positively on research recruitment. However, it is vital that there is a support network for urodynamic nurses and expertise available to help interpret urodynamic results.

Development and reliability of the revised Patterson Edema Scale.

OBJECTIVE: The Patterson Edema scale was developed in 2007 to address the lack of a reliable, sensitive scale to measure laryngeal and pharyngeal oedema in patients with head and neck cancer. The objective of this study was to revise the existing Patterson scale to improve its reliability and utility. DESIGN: Prospective investigation. SETTING: Academic medical center. PARTICIPANTS: Speech-Language Pathologists, Otolaryngologists, and Radiation Oncologists. MAIN OUTCOME MEASURES: Ratings using the Revised Patterson Edema Scale. METHODS: A consensus group reviewed existing literature regarding the performance of the original Patterson scale and revised the existing scale in regard to items to be included and descriptors for each severity level. The scale was then utilised by 18 speech language pathologists from the US and UK with >2 years-experience working with dysphagia and dysphonia with endoscopy. Each SLP rated a total of eight parameters (epiglottis, vallecula, pharyngoepiglottic folds, aryepiglottic folds, arytenoids, false vocal folds, true vocal folds and pyriform sinuses) using the Revised Patterson Edema Scale. Feedback was solicited from raters regarding areas where clarity was lacking for further scale revision. Scale revisions were completed and additional ratings were completed by otolaryngologists, radiation oncologists and less experienced SLP providers to establish reliability across disciplines. Quadratic weighted Kappa values were obtained to establish interrater reliability. RESULTS: Feedback received from raters included suggestions for clarification of how to rate unilateral oedema, use of a standard task battery to visualise and rate structures consistently, and clarification of true vocal fold oedema rating parameters. Overall interrater reliability was established using quadratic weighted Kappa with good agreement noted for the epiglottis, vallecula, arytenoids and false vocal folds; moderate agreement noted for aryepiglottic folds, pharyngoepiglottic folds and pyriform sinuses; and fair agreement noted for true vocal folds. CONCLUSIONS: The Revised Patterson Edema Scale demonstrates moderate-substantial interrater reliability for most parameters across multiple disciplines and experience levels, with the exception of the true vocal folds where agreement was fair. We believe the Revised Patterson Oedema Scale provides a reliable tool for clinicians and researchers to rate oedema in the supraglottic larynx and pharynx following treatment for head and neck cancer.

Development of a smart-fit system for CPAP interface selection.

Continuous Positive Airway Pressure (CPAP) therapy is commonly prescribed for longstanding, acute cases of Obstructive Sleep Apnea (OSA) during which patients must wear a tight-fitting breathing mask overnight for the duration of the treatment. Because this condition frequently leads to the permanent use of CPAP masks, interface selection is a crucial factor influencing the treatment quality and effectiveness. Masks/interface selection is normally performed on a trial an error basis with clinicians informing their selection based on OSA-related factors with basic fitting feedback from patients. However, it is not uncommon for patients to abandon the treatment or request additional consultations due to ill-fitting CPAP mask with the main sources of discomfort being perceived air leakage and mask/strap overtightening leading to skin damage. This work introduces a novel system (Smart-Fit), for CPAP interface selection using advanced digital technologies, such as Reverse Engineering and Computational Modeling (Finite Element Analysis) which are paired to evaluate and determine the best fitting interface for each clinical case. The model simplifies the number of 3D facial landmarks to 12 and established that a 2 mm scan resolution is enough for accurate scans. The Von Mises stress map in ANSYS serves as an indicator of potential high-pressure areas, triggering the need for a chance of mask size. Current results indicate the Smart Fit System can enable a "best fit CPAP interface" to be selected considering individual's physical characteristics and existing CPAP interface configurations. The development of the Smart Fit System is an evolution compared to traditional CPAP interface selection approach, which optimizes the CPAP interface selection process.

PRImary care Management of lower Urinary tract Symptoms in men: protocol for development and validation of a diagnostic and clinical decision support tool (the PriMUS study).

INTRODUCTION: Lower urinary tract symptoms (LUTS) is a bothersome condition affecting older men which can lead to poor quality of life. General practitioners (GPs) currently have no easily available assessment tools to help effectively diagnose causes of LUTS and aid discussion of treatment with patients. Men are frequently referred to urology specialists who often recommend treatments that could have been initiated in primary care. GP access to simple, accurate tests and clinician decision tools are needed to facilitate accurate and effective patient management of LUTS in primary care. METHODS AND ANALYSIS: PRImary care Management of lower Urinary tract Symptoms (PriMUS) is a prospective diagnostic accuracy study based in primary care. The study will determine which of a number of index tests used in combination best predict three urodynamic observations in men who present to their GP with LUTS. These are detrusor overactivity, bladder outlet obstruction and/or detrusor underactivity. Two cohorts of participants, one for development of the prototype diagnostic tool and other for validation, will undergo a series of simple index tests and the invasive reference standard (invasive urodynamics). We will develop and validate three diagnostic prediction models based on each condition and then combine them with management recommendations to form a clinical decision support tool. ETHICS AND DISSEMINATION: Ethics approval is from the Wales Research Ethics Committee 6. Findings will be disseminated through peer-reviewed journals and conferences, and results will be of interest to professional and patient stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN10327305.

Elective neck dissection for salvage total laryngectomy: A systematic review, meta-analysis and "decision-to-treat" approach.

INTRODUCTION: The authors provide an updated, systematic and comprehensive summary of the literature concerning management of the N0 neck in patients for whom primary irradiation for squamous cell carcinoma of the larynx has been unsuccessful and salvage surgery in the form of total laryngectomy (TL) advocated. METHODS: Bibliographic databases MEDLINE, Cochrane, PubMed and Embase were searched from inception to April 2019, with no language restrictions. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Risk of bias was defined using the Joanna Briggs Institute guidelines. Outcome measures were defined as the impact of END on locoregional control, complication rate, disease-specific and overall survival (DSS and OS). RESULTS: The primary search identified 19 eligible articles, comprising 1353 patients, (1552 ENDs). The overall risk of occult metastases was 14% (9% of ENDs). The relative risk (RR) of developing complications was 1.29 when END was performed, compared to observation of the neck (CI 0.86-1.92). Contrariwise, patients in whom the neck was managed with neck dissection had a decreased risk of developing regional recurrence (RR 0.62, CI 0.35-1.08). There was no statistically significant variation between DSS and OS between END and neck observation groups, respectively. SUMMARY: END during salvage TL may reduce the rate of regional recurrence, but not at the expense of improving DSS or OS. Rates of occult metastases, regional recurrence and "cure" through salvage neck dissection are not equivalent. Significant bias in all collated manuscripts should encourage the reader to interpret conclusions with caution. Patients should be fully involved in the decision-making process and their performance status and co-morbidities taken carefully into account when deciding to increase the extent of surgery, which we believe should remain limited to TL in the majority of cases.

A Novel Laryngeal Palpatory Scale (LPS) in Patients with Muscle Tension Dysphonia.

OBJECTIVES: Laryngeal palpation is a routine clinical method for evaluation of patients with muscle tension dysphonia (MTD). The aim of this study was to develop a new comprehensive valid and reliable "laryngeal palpatory scale" (LPS), based on psychometric criteria. METHODS: The scale items were selected based on an in-depth analysis of the literature and an expert focus group. Scale item generation and item reduction were followed by a psychometric assessment. Qualitative and quantitative content validity (the content validity ratio (CVR), content validity index (CVI)), the qualitative face validity, and the inter-rater reliability were determined. For this purpose, 531 patients were assessed and finally 55 patients with primary MTD (26 women, mean age: 40.8 years, SD: 12.5; 29 male, mean age: 41.6 years, SD: 11.8) participated in the study. A weighted kappa (k*) statistic was used to examine the inter-rater reliability for each single item. RESULTS: Based on the CVR, three items were omitted because they had a score of less than 0.62. The CVI for all remaining items was greater than 0.79 and the scale CVI was equal to 0.96. The final 45 items were a result of the study. The inter-rater reliability for each single item ranged from 0.41 to 1, indicating moderate to almost perfect agreement. CONCLUSIONS: The LPS is a reliable and valid instrument for assessing patients with MTD. However, future studies are needed to provide adequate data on sensitivity, specificity, concurrent validity, and cutoff scores.