Lessons from rhinology and facial plastic surgery clinical negligence claims in England 2013-2018.

OBJECTIVE: This study reviewed all rhinology clinical negligence claims in the National Health Service in England between 2013 and 2018. METHOD: All clinical negligence claims held by National Health Service Resolution relating to rhinology in England between 1 April 2013 and 1 April 2018 were reviewed. RESULTS: There were 171 rhinology related claims with a total estimated potential cost of £13.6 million. There were 119 closed claims (70 per cent) with a total cost of £2.3 million, of which 55 claims resulted in payment of damages. Over three quarters of all rhinology claims were associated with surgery (n = 132). Claims associated with endoscopic sinus surgery had the highest mean cost per claim (£172 978). Unnecessary pain (33.9 per cent) and unnecessary operation (28.1 per cent) were the most commonly cited patient injuries. CONCLUSION: Patient education and consent have been highlighted as key areas for improvement from this review of rhinology related clinical negligence claims. A shift in clinical practice towards shared decision making could reduce litigation in rhinology.

The internal nasal valve: a validated grading system and operative guide.

PURPOSE: Nasal obstruction is a highly subjective and commonly reported symptom. The internal nasal valve (INV) is the rate limiting step to nasal airflow. A static INV grading score was devised with regard to visibility of the middle turbinate. METHODS: A prospective study of all patients who underwent primary external functional septorhinoplasty in 2017 for nasal obstruction. All patients' INV score was assessed pre- and postoperatively in a blinded and independent fashion by surgeons of varying seniority. RESULTS: Twenty-eight patients were studied, with mean age 30.9 years and follow-up 18.8 weeks. Inter-rater and test-retest reliability of INV grading were excellent, with Cronbach's alpha 0.936 and 0.920, respectively. There was also statistically significant improvement in both subjective and objective postoperative outcome measures including nasal inspiratory peak flows. CONCLUSIONS: We demonstrate a novel, easy to interpret, clinically valuable grading system of the static internal nasal valve that is reliable and reproducible.

Peak nasal inspiratory flow correlates with quality of life in functional endoscopic sinus surgery.

OBJECTIVES: Whilst nasal function and airflow improve subjectively following functional endoscopic sinus surgery (FESS), a clinically useful and objective tool for quantifying such improvement is lacking. The peak nasal inspiratory flow (PNIF) metre offers convenient and objective measures of nasal patency. However, it has not yet been established whether changes in PNIF after surgery reflect changes in subjective disease burden. In this study we aimed to determine whether changes in PNIF correlate with commonly used subjective symptom and quality of life outcome measures following FESS for chronic rhinosinusitis (CRS). DESIGN: Prospective cohort. SETTING: Royal National Throat Nose and Ear Hospital. PARTICIPANTS: Thirty-seven patients undergoing FESS for CRS, with or without polyps (21 male, mean age 48.8). MAIN OUTCOME MEASURES: PNIF, "SNOT-22", "NOSE" and "VAS" questionnaires were performed before and after surgery. RESULTS: In all patients, there was a strong negative correlation between change in PNIF and change in "SNOT-22" score following surgery (Pearson r=-.64, P<.0001). Strong negative correlations were also seen during subgroup analysis of patients with and without polyps (r=-.57, P=.006 and r=-.67, P=.005, respectively). Change in PNIF correlated significantly with change in "NOSE" score following surgery in all patients and those without polyps (r=-.54, P=.0005 and r=-.68, P=.003). There were no significant correlations between PNIF and VAS (nasal obstruction). CONCLUSIONS: Changes in PNIF after FESS appear to best reflect improvements in quality of life in CRS as measured using the "SNOT-22" questionnaire.

2016 Comprehensive Update of the Banff Working Group on Liver Allograft Pathology: Introduction of Antibody-Mediated Rejection.

The Banff Working Group on Liver Allograft Pathology reviewed and discussed literature evidence regarding antibody-mediated liver allograft rejection at the 11th (Paris, France, June 5-10, 2011), 12th (Comandatuba, Brazil, August 19-23, 2013), and 13th (Vancouver, British Columbia, Canada, October 5-10, 2015) meetings of the Banff Conference on Allograft Pathology. Discussion continued online. The primary goal was to introduce guidelines and consensus criteria for the diagnosis of liver allograft antibody-mediated rejection and provide a comprehensive update of all Banff Schema recommendations. Included are new recommendations for complement component 4d tissue staining and interpretation, staging liver allograft fibrosis, and findings related to immunosuppression minimization. In an effort to create a single reference document, previous unchanged criteria are also included.

The outcome of septorhinoplasty surgery on olfactory function.

OBJECTIVES: To assess olfactory outcomes in patients undergoing septorhinoplasty surgery in our unit. DESIGN: Prospective cohort study. SETTING: The Royal National Throat Nose and Ear Hospital, London. PARTICIPANTS: Forty-three patients undergoing functional septorhinoplasty (Males = 26; mean age = 34.1 ± 12.2) were recruited into the study. MAIN OUTCOME MEASURES: The primary outcome of olfactory function was assessed using 'Sniffin sticks'. Our secondary outcomes were assessment of patient quality of life using the disease specific Sino-nasal Outcome Test-23 questionnaire (SNOT-23) and a visual analogue scale for sense of smell. These measures were repeated at 12 weeks post operatively. RESULTS: There was a significant change in the Sniffin' sticks score post-operatively (8.3 versus 9.6; P < 0.001). The SNOT-23 score also showed a significant improvement post-operatively (53.5 versus 40.4; P < 0.001). A significant improvement was not found in the smell/taste question (question 21) of the SNOT-23 questionnaire as well as the visual analogue scale for sense of smell. A difference in olfactory outcome was not found between open versus closed approaches, primary versus revision surgery and traumatic versus non traumatic cases. CONCLUSIONS: The results show a measured significant improvement in olfaction following functional Septorhinoplasty but not a subjective improvement in the patients perception of their sense of smell and hence not a clinically significant difference. The reasons for the measured improvement are not clear and are likely to be multifactorial.

The need for an objective measure in septorhinoplasty surgery: are we any closer to finding an answer?

OBJECTIVES: To assess the reliability of nasal inspiratory peak flow (NIPF) in providing a clinically accurate objective measure following functional septorhinoplasty by comparing it to the validated disease-specific quality-of-life questionnaire, SNOT-22. Studies so far have demonstrated poor correlation between bilateral NIPF and symptom-specific nasal questionnaires following septorhinoplasty. DESIGN: To perform a prospective comparative analysis between NIPF and the validated disease-specific quality-of-life questionnaire SNOT-22 and to determine whether a correlation exists following septorhinoplasty surgery. SETTING: The Royal National Throat Nose and Ear Hospital, London. PARTICIPANTS: A total of 122 patients (78 males, 44 females; mean age 33.5 ± 12.2 years) were recruited from the senior authors rhinology clinic and underwent functional septorhinoplasty surgery. MAIN OUTCOME MEASURES: Preoperative and postoperative nasal inspiratory peak flow (NIPF) measurements were performed in addition to the completion of three subjective quality-of-life and symptom assessment tool questionnaires; Sinonasal Outcome Test 22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE) and Visual Analogue Scale (VAS: 0-10). RESULTS: The mean preoperative NIPF was 88.2 L/min, and the postoperative value was 101.6 L/min and showed a significant improvement following surgery (P = 0.0064). The mean total SNOT-22 score improved significantly from 48.6 to 26.6 (P < 0.0001); the NOSE score from 14.1 to 6.6 (P < 0.0001); and the Visual Analogue Scale (VAS) blockage score from 6.9 to 3.2 (P < 0.0001). All individual domains assessed showed improvements postoperatively, but no correlation was found between the NIPF and SNOT-22 score. Equally, we did not find a correlation between NIPF and the symptom-specific NOSE questionnaire and the nasal blockage domain on the Visual Analogue Scale (VAS) scale. CONCLUSION: We have demonstrated that NIPF does not correlate with the SNOT-22 disease-specific questionnaire, although both outcomes significantly improve postoperatively. At present, we are still lacking a clinically accurate objective measure of nasal function for the evaluation of patients undergoing septorhinoplasty surgery.

Validation of the sino-nasal outcome test-23 in septorhinoplasty surgery.

BACKGROUND: There has been a great expansion in patient-based outcome measures to face the ever-increasing demand to demonstrate surgical efficacy. However, surgeons have not adopted until now any systematic outcome instrument. The 22-item Sino-Nasal Outcome Test (SNOT-22) is a validated sinonasal outcome score in sinonasal and septorhinoplasty surgery but does not measure aesthetic outcome. The aim of this paper is to validate a modification to the Sino-Nasal Outcomes Test-22 (SNOT-22) with a new question regarding the shape of the nose (SNOT-23). METHODOLOGY: We conducted a prospective cohort study on 69 consecutive patients undergoing septorhinoplasty and a control group of healthy volunteers. Reproducibility, responsiveness to treatment, known group differences and validity of the SNOT-23 were analysed. Scores were compared to visual analogue scales, nasal obstruction symptoms evaluation (NOSE) score and nasal inspiratory peak flow. RESULTS: SNOT-23 has good test-retest reliability and is a valid outcome measure for assessing response to surgery especially with regards to shape of the nose and nasal obstruction when compared to other patient reported measures. CONCLUSION: SNOT-23 is a valid and reliable tool that can be easily used in routine clinical practice to assess the functional and aesthetic outcomes from septorhinoplasty surgery. The SNOT-23 could be adopted as a universal, easy to use tool in rhinology clinics for the assessment of response to septorhinoplasty and sinus surgery.

Endolymphatic sac tumour: case report and literature review.

OBJECTIVE: To increase awareness of the presentation, diagnostic difficulties and management of endolymphatic sac tumours. CASE REPORTS: A 79-year-old man with a 6-month history of unilateral hearing loss, tinnitus and vertigo, who was suspected to have an endolymphatic sac tumour on imaging, underwent successful transmastoid-translabyrinthine resection. A 53-year-old man with unilateral hearing loss and pulsatile tinnitus underwent subtotal resection of a suspected paraganglioma, which was identified histologically. Due to interval growth, gamma knife radiosurgery was performed followed by subtotal petrosectomy, at which juncture an endolymphatic sac tumour was reported. METHODS: A review of the world literature was carried out using Medline, which identified less than 150 reported cases of endolymphatic sac tumour. CONCLUSION: Endolymphatic sac tumours are rare lesions of the petrous temporal bone. Although benign, they can be locally destructive. At present, there is no consensus regarding the management and long-term follow up of these tumours. Surgical resection is usually favoured, although treatment with radiotherapy and gamma knife surgery has also been reported.

Pharmacokinetics of low-dose cidofovir in kidney transplant recipients with BK virus infection.

BACKGROUND: BK virus (BKV) infection in kidney transplant recipients is associated with progressive graft dysfunction and graft loss. Cidofovir, an antiviral agent with known nephrotoxicity, has been used in low doses to treat BKV infections. However, the systemic exposure and disposition of the low-dose cidofovir regimen are not known in kidney transplant recipients. METHODS: We investigated the pharmacokinetics (PK) of low-dose cidofovir (0.24 - 0.62 mg/kg) both without and with oral probenecid in 9 transplant patients with persistent BK viremia without nephropathy in a crossover design. RESULTS: The mean estimated glomerular filtration rate (eGFR) of the study participants was 46.2 mL/min/1.73 m(2) (range: 17-75 mL/min/1.73 m(2) ). The contribution of active renal secretion to cidofovir total body clearance was assessed by evaluating the effect of probenecid on cidofovir PK. Maximum cidofovir plasma concentrations, which averaged approximately 1 µg/mL, were significantly below the 36 µg/mL 50% effective concentration in vitro for cidofovir against BKV. The plasma concentration of cidofovir declined with an overall disposition half-life of 5.1 ± 3.5 and 5.3 ± 2.9 h in the absence and in the presence of probenecid, respectively (P > 0.05). CONCLUSIONS: Cidofovir clearance and eGFR were linearly related irrespective of probenecid administration (r(2) = 0.8 without probenecid; r(2) = 0.7 with probenecid). This relationship allows for the prediction of systemic cidofovir exposure in individual patients and may be utilized to evaluate exposure-response relationships to optimize the cidofovir dosing regimen for BKV infection.

Long-term quality-of-life outcomes in children undergoing adenotonsillectomy for obstructive sleep apnoea: a longitudinal study.

OBJECTIVES: To assess a cohort of patients who underwent adenotonsillectomy for obstructive sleep apnoea, 4 years after surgery for evidence of continued and long-term improvement in quality of life. We also sought to compare our results to Child Health Questionnaire scores obtained from our previous study. We also compared our data with a healthy UK children population from normative data available. DESIGN: Longitudinal study. SETTINGS: University Hospital Tertiary Referral Centre. PARTICIPANTS: A 4-year follow-up study of 37 children who underwent adenotonsillectomy for obstructive sleep apnoea confirmed on polysomnography. There were 19 boys and 18 girls from our initial cohort. The primary caregiver completed the validated Child Health Questionnaire Parental Form version-28, 4 years after initial surgery. Our control group consist of 221 healthy children aged 6-18 that were included as 'normal' controls in a study looking at children with juvenile arthritis. The children were defined as healthy by a physician and/or after declaration by the parent. MAIN OUTCOME MEASURE: Child Health Questionnaire Parental Form version-28 scores. RESULTS: A total of 33 patients (89%) from our initial cohort were contacted. The mean age was 10.6 (median, 11; range, 5-16). When compared with results obtained 3 months postoperatively, the mean scores were higher in five domains and were statistically significant in three subscales (Role Limitations P < 0.00001; Bodily Pain P < 0.002; and Global Health P < 0.02). There was a significant deterioration in Behaviour subscale (P < 0.0007) in spite of surgery. Compared with controls, 4-year follow-up scores were higher in five domains with the Global Health domain (P < 0.0004) being statistically significant. When the 4-year follow-up scores were compared with preoperative values, these were higher in all 13 domains with statistically significant improvements in nine domains, indicating that improvements had persisted 4 years after surgery. At 4 years, however, the means scores in many domains remain lower when compared with controls. CONCLUSION: Quality-of-life data are an important measure when deciding on a specific clinical intervention. In the short term, quality-of-life measures have been shown to improve after adenotonsillectomy for obstructive sleep apnoea. Our study demonstrates that the benefits of surgery are still persistent and the children continue to improve in the long term.

Evaluation of human polyomavirus BK as a potential cause of villitis of unknown etiology and spontaneous abortion.

Polyomavirus BK (BKV) is a widely latent pathogen in man. Although viral reactivation during pregnancy has been demonstrated, and polyomaviruses have been linked to chromosomal abnormalities, a pathogenic role for BKV in fetoplacental disease has not been explored. We performed in situ hybridization studies with BKV probes on cases of villitis of unknown etiology (102), diffuse villitis (25), and spontaneous abortion (22). We found no evidence that BKV plays a role in the pathogenesis of these common fetoplacental disorders.

Validation of the Clinical COPD Questionnaire as a psychophysical outcome measure in adult laryngotracheal stenosis.

OBJECTIVES: To validate the Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ), a patient-administered instrument developed for bronchopulmonary disease as a disease-specific psychophysical outcome measure for adult laryngotracheal stenosis. DESIGN: Prospective observational study. SETTINGS: Tertiary/National referral airway reconstruction centre. PARTICIPANTS: Thirty-three tracheostomy-free patients undergoing endoscopic laryngotracheoplasty. MAIN OUTCOME MEASURES: CCQ and the Medical Research Council (MRC) Dyspnoea scale, a previously validated but more limited scale, were administered to patients 2 weeks before surgery, preoperatively, and 2 weeks after endoscopic laryngotracheoplasty. Pulmonary function was assessed preoperatively. Internal consistency was assessed with Cronbach alpha statistics and test-retest reliability was determined using intraclass correlation. Correlations between CCQ and MRC scale, and pulmonary function were used to assess convergent and divergent validity respectively. Instrument responsiveness was assessed by correlating total and domain-specific CCQ scores with anatomical disease severity and post-treatment effect size. RESULTS: There were 12 males and 21 females. Mean age was 44 +/- 15 years. Cronbach alpha coefficient and intraclass correlation coefficient were 0.88 and 0.95 respectively. Total and domain-specific CCQ scores significantly correlated with the MRC scores (P < 0.001) and significant correlations between CCQ and peak expiratory flow rate and FEV(1) were identified (P < 0.03). There were statistically significant changes in total and domain-specific CCQ scores when different stenosis severities were compared. Clinical COPD Questionnaire scores also changed significantly and congruently following surgery (P < 0.05 in both cases). DISCUSSION: Clinical COPD Questionnaire is a valid and sensitive instrument for assessing symptom severity and levels of function and well-being in adult patients with laryngotracheal stenosis and can be used as a patient-centred disease-specific outcome measure for this condition.

Intra-operative parathyroid hormone monitoring using a laboratory based multichannel analyser.

Parathyroid hormone has a short half life in vivo. Intraoperative parathyroid hormone measurement can guide the surgeon by confirming successful removal of parathyroid adenomas. Point of care testing with a dedicated analyser and technician in theatre is expensive. This study shows that intraoperative parathyroid hormone is feasible using a central laboratory based analyser available in most hospitals. There are potential cost savings when compared with point of care testing.

Foreign body reaction to polymethylsiloxane gel (Bioplastique) after vocal fold augmentation.

STATEMENT OF PROBLEM: The consequences of vocal fold paralysis include voice change, airway problems and difficulty swallowing. Medialisation procedures using injected material have been used for many decades, with varying outcomes, mainly secondary to lifespan, tissue reaction or migration. Newer materials have recently become clinically available which are easier to manage and supposedly less likely to elicit foreign body reaction. METHOD OF STUDY: Case report. RESULTS: We report a case of foreign body reaction and possible migration of polymethylsiloxane gel (Bioplastique), one such material, after vocal fold injection. To our knowledge, this is the second such case described. CONCLUSIONS: This case highlights the fact that the risk of foreign body reaction and migration is still present for this material, albeit low. We also highlight the fact that, although this material can cause foreign body reactions and may possibly migrate, it is removable by microlaryngoscopy via the microflap technique, with vocal improvement.

Sensitivity and responsiveness of the Medical Research Council dyspnoea scale to the presence and treatment of adult laryngotracheal stenosis.

OBJECTIVES: To assess the sensitivity and responsiveness of the Medical Research Council (MRC) scale, a psychophysical dyspnoea assessment instrument to the presence and treatment of adult laryngotracheal stenosis. DESIGN: Prospective observational study. SETTINGS: Tertiary/National referral airway reconstruction centre. PARTICIPANTS: Fourty tracheostomy-free patients undergoing endoscopic airway examination/laryngotracheoplasty. MAIN OUTCOME MEASURES: Demographic and clinical information, obtained from patient records, lesion severity, which was recorded intraoperatively, standard spirometry, which was measured preoperatively, and the MRC dyspnoea scale, which was administered preoperatively and at the first outpatient visit 4-6 weeks later. RESULTS: There were 16 males and 24 females. Mean age at presentation was 44 +/- 14 years (+/- SD). Postintubation stenosis was the commonest aetiology (73%) followed by idiopathic subglottic stenosis and Wegener's Granulomatosis. Six patients were examined post-treatment and had minimal residual stenosis and the remaining patients had glottic stenosis (n = 11) or Myer-Cotton Grade I (n = 8), II (n = 7) or III (n = 8) tracheal stenoses. Pre-treatment MRC dyspnoea scores and the degree of change in the MRC score following treatment strongly correlated with pre-treatment stenosis severity (r = 0.75 and r = -0.71 respectively; P < .001). Moreover statistically significant correlations existed between preoperative peak expiratory flow and forced expiratory volume in 1 s and preoperative MRC dyspnoea scores (r = -0.34 and r = -0.35 respectively; P < 0.05). DISCUSSION: Exertional dyspnoea is the hallmark symptom of laryngotracheal stenosis and for many patients it is the primary cause of disability. These findings confirm that the MRC dyspnoea scale is an appropriate outcome instrument for assessing dyspnoea associated with this condition.

Primary hyperparathyroidism: do perioperative biochemical variables correlate with parathyroid adenoma weight or volume?

OBJECTIVES: To investigate the relationship between clinical variables and biochemical markers of calcium homeostasis and parathyroid adenoma size, in patients undergoing surgery for primary hyperparathyroidism. To determine the potential clinical utility of the findings in preoperative planning and prediction of postoperative hypocalcaemia. DESIGN: Retrospective data analysis. PARTICIPANTS: Ninety-two patients treated surgically for primary hyperparathyroidism caused by a solitary parathyroid adenoma between 1996 and 2006. MAIN OUTCOME MEASURES: Complete data was obtained for 77 participants including patient demographics, perioperative calcium, parathyroid hormone and phosphate levels, adenoma weight and histological dimensions. Multiple and binary logistic regression analyses were used to investigate the relationship between clinical and biochemical variables and adenoma weight and volume. Similar analysis was used to identify predictors of postoperative hypocalcaemia. SETTING: University Teaching Hospital Otolaryngology Department. RESULTS: The mean age at presentation was 59 years. The mean preoperative calcium and PTH levels were 2.86 +/- 0.2 mmol/L and 17.2 +/- 12.3 ng/L, respectively, falling to 2.3 +/- 0.01 and 4.1 +/- 2.7 postoperatively. The mean adenoma weight was 1.71 +/- 1.41 g. No correlation existed between clinical variables and preoperative biochemical markers of calcium homeostasis and adenoma weight or volume. There was a weak correlation between the preoperative to postoperative change in calcium and PTH levels {[deltaCa(2)+] vs. [deltaPTH]} (r = 0.24; P < 0.05) but no predictors of postoperative hypocalcaemia could be identified. CONCLUSIONS: Biochemical parameters will not accurately predict the size of a parathyroid adenoma. The size of a parathyroid adenoma does not correlate with postoperative calcium levels and is therefore not useful as a predictor of postoperative hypocalcaemia.

Acute cellular rejection with CD20-positive lymphoid clusters in kidney transplant patients following lymphocyte depletion.

Lymphoid clusters (LC) containing CD20-positive B cells in kidney allografts undergoing acute cellular rejection (ACR) have been identified in small studies as a prognostic factor for glucocorticoid resistance and graft loss. Allograft biopsies obtained during the first episode of ACR in 120 recipients were evaluated for LC, immunostained with CD20 antibody, and correlated with conventional histopathologic criteria, response to treatment and outcome. LC were found in 71 (59%) of the 120 biopsies. All contained CD20 positive B cells that accounted for 5-90% of the LC leukocyte content. The incidence of LC was highest in the patients who had no lymphoid depletion or had been treated with Thymoglobulin preconditioning (79% vs. 75%, respectively) compared to 37% in patients pretreated with Campath (p = 0.0001). Banff 1a/1b ACR were more frequent in the LC-positive than the LC-negative group (96% vs. 80%, respectively; p = 0.0051). With a posttransplant follow-up of 953 +/- 430 days, no significant differences were detected between LC-postitive and LC-negative groups in time to ACR, steroid resistance, serum creatinine and graft loss. CD20+LC did not portend glucocorticoid resistance or worse short to medium term outcomes. CD20+LC may represent a heterogenous collection in which there may be a small still to be fully defined unfavorable subgroup.