Predictors for Success and Failure in Transoral Robotic Surgery-A Retrospective Study in the North of the Netherlands.

Transoral Robotic Surgery (TORS) is utilized for treating various malignancies, such as early-stage oropharyngeal cancer and lymph node metastasis of an unknown primary tumor (CUP), and also benign conditions, like obstructive sleep apnea (OSA) and chronic lingual tonsillitis. However, the success and failure of TORS have not been analyzed to date. In this retrospective observational multicenter cohort study, we evaluated patients treated with TORS using the da Vinci surgical system. Success criteria were defined as identification of the primary tumor for CUP, >2 mm resection margin for malignant conditions, and improvement on respiratory polygraphy and tonsillitis complaints for benign conditions. A total of 220 interventions in 211 patients were included. We identified predictors of success, such as low comorbidity status ACE-27, positive P16 status, and lower age for CUP, and female gender and OSA severity for benign conditions. For other malignancies, no predictors for success were found. Predictors of failure based on postoperative complications included high comorbidity scores (ASA) and anticoagulant use, and for postoperative pain, younger age and female gender were identified. This study provides valuable insights into the outcomes and predictors of success and failure in TORS procedures across various conditions and may also help in patient selection and counseling.

The cost evaluation of day-case compared to inpatient cochlear implantation in adults: subanalysis of a randomized controlled trial.

OBJECTIVE: To investigate the assumption that day-case cochlear implantation is associated with lower costs, compared to inpatient cochlear implantation, while maintaining equal quality of life (QoL) and hearing outcomes, for the Dutch healthcare setting. STUDY DESIGN: A single-center, non-blinded, randomized controlled trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group (i.e., one night admission). We performed an intention-to-treat evaluation of the difference of the total health care-related costs, hospital and out of hospital costs, between day-case and inpatient cochlear implantation, from a hospital and patient perspective over the course of one year. Audiometric outcomes, assessed using CVC scores, and QoL, assessed using the EQ-5D and HUI3 questionnaires, were taken into account. RESULTS: There were two drop-outs. The total health care-related costs were €41,828 in the inpatient group (n = 14) and €42,710 in the day-case group (n = 14). The mean postoperative hospital stay was 1.2 days (mean costs of €1,069) in the inpatient group and 0.7 days (mean costs of €701) for the day-case group. There were no statistically significant differences in postoperative hospital and out of hospital costs. The QoL at 2 months and 1 year postoperative, measured by the EQ-5D index value and HUI3 showed no statistically significant difference. The EQ-5D VAS score measured at 1 year postoperatively was statistically significantly higher in the inpatient group (84/100) than in the day-case group (65/100). There were no differences in postoperative complications, objective hearing outcomes, and number of postoperative hospital and out of hospital visits. CONCLUSION: A day-case approach to cochlear implant surgery does not result in a statistically significant reduction of health care-related costs compared to an inpatient approach and does not affect the surgical outcome (complications and objective hearing measurements), QoL, and postoperative course (number of postoperative hospital and out of hospital visits).

Quality of life, hearing results, patient satisfaction and postoperative complications of day-case versus inpatient unilateral cochlear implantation in adults: a randomized controlled, equivalence trial.

OBJECTIVE: To investigate the hypothesis that day-case cochlear implantation is associated with equal quality of life, hearing benefits and complications rates, compared to inpatient cochlear implantation. STUDY DESIGN: A single-center, non-blinded, randomized controlled, equivalence trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on general quality of life, patient satisfaction, (subjective) hearing improvement, postoperative complications and causes of crossover and/or readmission were assessed using questionnaires, auditory evaluations and patients' charts over a follow-up period of 1 year. RESULTS: Overall quality of life measured by the HUI3 was equal between the day-case (n = 14) and inpatient group (n = 14). The overall patients' satisfaction showed a slight favor towards an inpatient approach. There was no significant difference in the subjective and objective hearing improvement between both treatment groups. During the 1-year follow-up period no major complications occurred. Minor complications occurred intraoperatively in three day-case patients resulting in three out of nine admissions of day-case patients. Other causes of admission of day-case patients were nausea and vomiting (n = 1), drowsiness (n = 1), late scheduled surgery (n = 2), social reasons (n = 1), or due to an unclear reason (n = 1). No patients required readmission. CONCLUSION: We found equal outcomes of QoL, patient satisfaction, objective, and subjective hearing outcomes between day-case and inpatient unilateral cochlear implantation. Nine out of 14 day-case patients were admitted for at least one night postoperatively (crossover). No major complications occurred in both groups. A day-case approach seems feasible when using specific patient selection, surgical planning and the preoperative provision of patient information into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team can increase the feasibility of day-case surgery.

The effect of piston diameter in primary stapes surgery on surgical success.

PURPOSE: To evaluate the effect of piston diameter in patients undergoing primary stapes surgery on audiometric results and postoperative complications. METHODS: A retrospective single-center cohort study was performed. Adult patients who underwent primary stapes surgery between January 2013 and April 2022 and received a 0.4-mm-diameter piston or a 0.6-mm-diameter piston were included. The primary and secondary outcomes were pre- and postoperative pure-tone audiometry, pre- and postoperative speech audiometry, postoperative complications, intraoperative anatomical difficulties, and the need for revision stapes surgery. The pure-tone audiometry included air conduction, bone conduction, and air-bone gap averaged over 0.5, 1, 2 and 3 kHz. RESULTS: In total, 280 otosclerosis patients who underwent 321 primary stapes surgeries were included. The audiometric outcomes were significantly better in the 0.6 mm group compared to the 0.4 mm group in terms of gain in air conduction (median = 24 and 20 dB, respectively), postoperative air-bone gap (median = 7.5 and 9.4 dB, respectively), gain in air-bone gap (median = 20.0 and 18.1 dB, respectively), air-bone gap closure to 10 dB or less (75% and 59%, respectively) and 100% speech reception (median = 75 and 80 dB, respectively). We found no statistically significant difference in postoperative dizziness, postoperative complications and the need for revision stapes surgery between the 0.4 and 0.6 mm group. The incidence of anatomical difficulties was higher in the 0.4 mm group. CONCLUSION: The use of a 0.6-mm-diameter piston during stapes surgery seems to provide better audiometric results compared to a 0.4-mm-diameter piston, and should be the preferred piston size in otosclerosis surgery. We found no statistically significant difference in postoperative complications between the 0.4- and 0.6-mm-diameter piston. Based on the results, we recommend always using a 0.6-mm-diameter piston during primary stapes surgery unless anatomical difficulties do not allow it.

Systematic review: Validity, reliability, and diagnostic accuracy of the electrogustometer.

Objective: What are the electrogustometer's (EGM) validity, reliability, and diagnostic accuracy in assessing taste sensation in adults compared to other taste tests? Data Sources: PubMed Medline, Elseviers's Embase, and the six databases of Cochrane Library. Methods: We conducted a systematic search on December 20, 2022, consisting of synonyms for EGM. We considered randomized controlled trials and observational studies with original data for inclusion if they included adults who underwent electrogustometry. Articles were excluded if no analysis regarding validity, reliability, or diagnostic accuracy had been performed or if these analyses could not be performed with the published data. Results: Nineteen articles discussing 18 studies were included for data extraction. The included studies carry a high risk of bias. Overall, the association between a variety of reference taste tests and EGM was moderate or weak with correlation coefficients ranging from -0.51 to 0.40 with one outlier of -0.74 found in one study correlating EGM and taste solutions. Test-retest reliability was good with reported correlation coefficients between 0.78 and 1.0. The sensitivity, specificity, PPV, and NPV of EGM in identifying abnormal taste function varied widely between the four studies on diagnostic accuracy. Conclusion: The included studies in this review lack the required standards regarding study design to draw firm conclusions about the validity, reliability, and diagnostic accuracy of the EGM. Future research is needed to assess these measurement properties. Based on the reported results, we would not recommend using the EGM as a screening test for taste disturbance in clinical practice. Level of Evidence: NA.

The impact of injury of the chorda tympani nerve during primary stapes surgery or cochlear implantation on taste function, quality of life and food preferences: A study protocol for a double-blind prospective prognostic association study.

BACKGROUND: The chorda tympani nerve (CTN) is a mixed nerve, which carries sensory and parasympathetic fibres. The sensory component supplies the taste sensation of the anterior two-thirds of the ipsilateral side of the tongue. During middle ear surgery the CTN is exposed and frequently stretched or sacrificed, because it lacks a bony covering as it passes through the middle ear. Injury may cause hypogeusia, ageusia or altered taste sensation of the ipsilateral side of the tongue. To date, there is no consensus regarding which type of CTN injury (sacrificing or stretching), during middle ear surgery, leads to the least burden for the patient. METHODS: A double-blind prospective prognostic association study was designed in a single medical centre in the Netherlands to determine the effect of CTN injury on postoperative taste disturbance and quality of life. 154 patients, who will undergo primary stapes surgery or cochlear implantation will be included. The taste sensation, food preferences and quality of life of these patients will be evaluated preoperatively and at one week, six weeks and six months postoperatively using the Taste Strip Test, Electrogustometry, supplementary questionnaire on taste disturbance, Macronutrient and Taste Preference Ranking Task, Appetite, Hunger and Sensory Perception questionnaire and Questionnaire of Olfactory Disorders to assess the association of these outcomes with CTN injury. Evaluation of olfactory function will only take place preoperatively and at one week postoperatively using the Sniffin' Sticks. The patient and outcome assessor are blinded to the presence or absence of CTN injury. DISCUSSION: This study is the first to validate and quantify the effect of chorda tympani nerve injury on taste function. The findings of this study may lead to evidence-based proof of the effect of chorda tympani injury on taste function with consequences for surgical strategies. TRIAL REGISTRATION: Netherlands Trial Register NL9791. Registered on 10 October 2021.

Endoscopic vs. microscopic stapes surgery: An anatomical feasibility study.

Objectives: To investigate the feasibility of the endoscopic approach vs. microscopic approach during stapes surgery, focusing on the visualization of the important anatomical structures of the middle ear, the volume of the resected scutum and chorda tympani (CT) injury. Methods: Fresh frozen human cadaveric heads underwent two stapes surgeries using an operating microscope on one ear and an endoscope on the other ear. The surgeon documented the visualization of critical landmarks, as well as exposure and injury of the CT. The volume of resected scutum was evaluated using cone beam computed tomography scanning and three-dimensional imaging. Results: We performed endoscopic stapes surgery in 10 ears and microscopic stapes surgery in 11 ears. A stapes prosthesis was placed in all ears. The volume of bony scutum resection was significantly lower in the endoscopic group (median = 2.20 mm3, IQR = 4.17) than in the microscopic group (median 13.25 mm3, IQR = 8.71). No scutum was removed in two endoscopic ears, while scutum was removed in all microscopic ears. The endoscopic and microscopic group had similar CT injury. Conclusions: This study showed that the endoscopic stapes surgery procedure is feasible and might be less invasive than microscopic stapes surgery. Future clinical prospective and functional studies will be needed to support our findings.

Sex-Specific Cut-Off Values for Low Skeletal Muscle Mass to Identify Patients at Risk for Treatment-Related Adverse Events in Head and Neck Cancer.

A low skeletal muscle index (SMI), defined with cut-off values, is a promising predictor for adverse events (AEs) in head and neck squamous cell cancer (HNSCC) patients. The aim was to generate sex-specific SMI cut-off values based on AE to diagnose low SMI and to analyse the relationship between low SMI and AEs in HNSCC patients. In this present study, HNSCC patients were prospectively included in a large oncological data-biobank and SMI was retrospectively measured using baseline neck scans. In total, 193 patients were included and were stratified according to treatment modality: (chemo-)radiotherapy ((C)RT) (n = 135) and surgery (n = 61). AE endpoints were based on the occurrence of clinically relevant toxicities (Common Terminology Criteria for Adverse Events grade ≥ III) and postoperative complications (Clavien-Dindo Classification grade ≥ II). Sex-specific SMI cut-off values were generated with receiver operating characteristic curves, based on the AE endpoints. The relationship of the baseline characteristics and AEs was analysed with logistic regression analysis, with AEs as the endpoint. Multivariable logistic analysis showed that low SMI (OR 3.33, 95%CI 1.41-7.85) and tumour stage (OR 3.45, 95%CI 1.28-9.29) were significantly and independently associated to (C)RT toxicity. Low SMI was not related to postoperative complications. To conclude, sex-specific SMI cut-off values, were generated based on the occurrence of AEs. Low SMI and tumour stage were independently related to (C)RT toxicity in HNSCC patients.

Hearing Results, Quality of Life, Patient Satisfaction, and Postoperative Complications of Day-case Versus Inpatient Stapes Surgery for Otosclerosis in Adults: A Randomized Controlled Trial.

Objective: To investigate the effect of day-case stapes surgery on hearing results, quality of life, patient satisfaction, and complications rates, compared with inpatient stapes surgery. Study Design: A single-center, nonblinded, randomized controlled trial in a tertiary referral center. Methods: One hundred twelve adult patients planned for primary or revision stapes surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on hearing outcomes (primarily), hearing benefits, quality of life, patient satisfaction, postoperative complications, and causes of crossover or readmission (secondarily) were assessed using auditory evaluations, questionnaires, and patients' charts over a follow-up period of 1 year. Results: Audiometric measurements and postoperative success rates were not different between the inpatient and day-case group. There were no statistically significant differences between both groups regarding the overall quality of life (QoL) (HUI3), disease-specific QoL (GHSI), change in postoperative health status (GBI), and postoperative complications rate. We found a high patient satisfaction toward the day-case approach. Six patients allocated to the inpatient group requested same-day discharge. Of the day-case patients, there was a crossover rate to inpatient care of 38% (20 patients), mainly due to postoperative nausea and vomiting (25%), vertigo (20%), or dizziness (40%). Conclusion: We found no significant differences in outcomes of audiometric measurements, QoL, patient satisfaction and postoperative complications following day-case, and inpatient stapes surgery. Therefore, stapes surgery in a day-case setting seems to be a feasible approach in terms of postoperative outcome, safety, and desirability when taking patient selection and surgical planning into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team, will increase the acceptance and feasibility of day-case stapes surgery.

Feasibility of assessment of skeletal muscle mass on a single cross-sectional image at the level of the fourth thoracic vertebra.

BACKGROUND: Skeletal muscle mass (SMM) determined on computed tomography (CT) is emerging as a novel imaging biomarker. Cross-sectional area (CSA) of SMM at the level of the third lumbar vertebra (L3) on abdominal imaging is considered the clinical reference standard for measuring SMM. In certain patient groups, such as those with oncological or non-oncological lung disease like COVID-19, a chest CT may be available while an abdominal CT is not. The purpose of this study was to investigate whether determining SMM on a chest CT is a feasible alternative to abdominal CT. RESEARCH QUESTION: What is the correlation between SMM measurements at the level of L3 and the level of the fourth thoracic vertebra (Th4)? STUDY DESIGN AND METHODS: In this study we retrospectively analyzed abdominal and thoracic series of whole-body CT-scans of trauma patients (N = 47) and head and neck cancer patients (N = 194). All abdominal muscles were delineated on a single axial slice at the level of L3. The erector spinae, levator scapulae, rhomboideus minor and major and pectoralis minor and major muscles were delineated on a single axial slice at the level of Th4. CSA of the muscles at Th4 and the L3 level were compared using linear regression, and a multivariate linear regression model was established. RESULTS: Muscle CSA at level Th4 strongly correlates with L3 muscle CSA (r = 0.791, p < 0.05). A multivariate model incorporating the patient characteristics arm positioning, age, sex, and weight achieved a stronger correlation (r = 0.856, p < 0.05). INTERPRETATION: Skeletal muscle CSA measured at the level of Th4 is a feasible alternative to measurements at L3. This allows diagnosing low SMM using clinically available thoracic CT-scans. SMM measurements at the level of Th4 may become a prognostic or triage tool when faced with mechanical ventilator shortage.

Admission Rates Following Day-Case Major Otologic Surgery: A Systematic Review.

OBJECTIVE: To assess whether day-case major otologic ear surgery is a safe and feasible alternative to inpatient surgery, while maintaining equal complication rates, and to identify causes of admission after day-case surgery. DATA SOURCES: PubMed, Embase, and Cochrane. REVIEW METHODS: A systematic search was conducted. Studies reporting original data on the effect of day-case ear surgery on admission rate, patient satisfaction, and/or postoperative complications were included. Risk of bias of the selected articles was assessed using criteria based on the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: A total of 1,734 unique studies were retrieved of which 35 articles discussing 34 studies were eligible for data extraction. The admission rates ranged from 0% to 88% following day-case endaural surgery, 0% to 13% following day-case stapes surgery, 0% to 82% following day-case mastoid surgery, and 0% to 15% following day-case cochlear implant surgery. Patient and parent satisfaction regarding day-case surgery ranged from 67% to 99%. Five studies comparing day-case and inpatient otologic surgery showed no difference in hearing outcome, postoperative complications, or patient satisfaction. CONCLUSION: The highest pooled admission rate was seen following day-case mastoid surgery. Studies comparing day-case and inpatient care suggest hearing results and postoperative complication rates in day-case otologic surgery are similar to inpatient otologic surgery in both children and adults. Therefore, day-case major otologic surgery seems to be a safe and feasible alternative to inpatient surgery for both children and adults.

Patterns, Predictors, and Prognostic Value of Skeletal Muscle Mass Loss in Patients with Locally Advanced Head and Neck Cancer Undergoing Cisplatin-Based Chemoradiotherapy.

Low skeletal muscle mass (SMM) is associated with toxicities and decreased survival in head and neck cancer (HNC). Chemoradiotherapy (CRT) may exaggerate loss of SMM. We investigated the changes in SMM, their predictors, and prognostic impact of SMM in patients treated with CRT between 2012 and 2018. Skeletal muscle area (SMA) segmentation was performed on pre- and post-CRT imaging. Observed changes in SMM were categorized into: (I) Stable, (II) moderate gain (III), moderate loss, (IV) large gain, and (V) large loss. In total, 235 HNC patients were included, of which 39% had stable SMM, 55% moderate loss, 13% moderate gain, 0.4% large loss, and 0.4% large gain of SMM. After CRT, SMA decreased compared to pre-CRT (31.6 cm2 versus 33.3 cm2, p < 0.01). The key predictor was a body mass index (BMI) of ≥30 kg/m2 (OR 3.6, 95% CI 1.4-9.3, p < 0.01). Low SMM at diagnosis (HR 2.1; 95% CI 1.1-4.1, p = 0.03) and an HPV-positive oropharyngeal tumor (HR 0.1; 95% CI 0.01-0.9, p = 0.04) were prognostic for overall survival. Changes in SMM were not prognostic for survival. Loss of SMM is highly prevalent after CRT and a high BMI before treatment may aid in identifying patients at risk.

HIF-1a expression and differential effects on survival in patients with oral cavity, larynx, and oropharynx squamous cell carcinomas.

BACKGROUND: Hypoxia is a negative prognostic factor in head and neck squamous cell carcinomas. Under hypoxia, the hypoxia-inducible factor (HIF)-1a transcription factor is overexpressed. We investigated whether there were site differences in HIF-1a expression and its effect on patient outcomes per subsite. DESIGN/METHOD: A total of 941 patients with HNSCC in the squamous cell carcinoma of the oropharynx (OPSCC, n = 302), oral cavity (OSCC, n = 391), or larynx (LSCC, n = 248) were included. Expression of HIF-1a in tissue samples was investigated using immunohistochemistry. Overall survival (OS), disease-free survival (DFS), and locoregional control (LRC) were analyzed. RESULTS: HIF-1a expression was higher in OSCC than in LSCC and OPSCC. High HIF-1a expression led to worse prognosis in OPSCC (OS P = .029, DFS P = .085) and LSCC (OS P = .041, DFS P = .011) and better in OSCC (OS P = .055, DFS P = .012). There was no association between HIF-1a and LRC. CONCLUSIONS: High HIF-1a expression is related to poor outcome in OPSCC and LSCC and better outcome in OSCC.

Scalar Translocation Comparison Between Lateral Wall and Perimodiolar Cochlear Implant Arrays - A Meta-Analysis.

OBJECTIVES/HYPOTHESIS: Two types of electrode arrays for cochlear implants (CIs) are distinguished: lateral wall and perimodiolar. Scalar translocation of the array can lead to intracochlear trauma by penetrating from the scala tympani into the scala vestibuli or scala media, potentially negatively affecting hearing performance of CI users. This systematic review compares the lateral wall and perimodiolar arrays with respect to scalar translocation. STUDY DESIGN: Systematic review. METHODS: PubMed, Embase, and Cochrane databases were reviewed for studies published within the last 11 years. No other limitations were set. All studies with original data that evaluated the occurrence of scalar translocation or tip fold-over (TF) with postoperative computed tomography (CT) following primary cochlear implantation in bilateral sensorineuronal hearing loss patients were considered to be eligible. Data were extracted independently by two reviewers. RESULTS: We included 33 studies, of which none were randomized controlled trials. Meta-analysis of five cohort studies comparing scalar translocation between lateral wall and perimodiolar arrays showed that lateral wall arrays have significantly lower translocation rates (7% vs. 43%; pooled odds ratio = 0.12). Translocation was negatively associated with speech perception scores (weighted mean 41% vs. 55%). Tip fold-over of the array was more frequent with perimodiolar arrays (X2  = 6.8, P < .01). CONCLUSIONS: Scalar translocation and tip fold-overs occurred more frequently with perimodiolar arrays than with lateral wall arrays. In addition, translocation of the array negatively affects hearing with the cochlear implant. Therefore, if one aims to minimize clinically relevant intracochlear trauma, lateral wall arrays would be the preferred option for cochlear implantation. Laryngoscope, 131:1358-1368, 2021.

Protocol for a validation study of the translated stapesplasty outcome test 25 for measurement of disease-specific quality of life in Dutch patients with otosclerosis.

INTRODUCTION: Otosclerosis is a common cause of acquired conductive hearing loss and can be treated using hearing aids or surgically. Surgical success rates or surgical results are usually reported using pure-tone audiometric thresholds and/or speech discrimination scores. Audiometric results and patient-reported quality of life after stapes surgery do not seem to correlate well. It is therefore our opinion that health-related quality of life measurements should be implemented as an additional outcome measure after stapes surgery. So far, there is a lack of a valid, reliable and clinically feasible measuring tool for determining health-related quality of life in Dutch patients with otosclerosis who undergo stapes surgery. METHODS AND ANALYSIS: A prospective validation study was designed to translate and validate the disease-specific Stapesplasty Outcome Test 25 (SPOT-25) in a population of Dutch patients with otosclerosis who undergo primary stapes surgery. A total of 125 patients with otosclerosis who will be undergoing primary stapes surgery and 50 healthy controls will be included. The patients with otosclerosis will fulfil several questionnaires preoperatively, 6 to 8 weeks postoperatively and 8 to 10 weeks postoperatively with a 2-week interval between the postoperative administrations. The patients' audiometric results, which are measured routinely before and after undergoing primary stapes surgery, will also be used. The healthy controls will fulfil the translated SPOT-25 once. First, the original SPOT-25 will be translated from German to Dutch in a six-step process. Second, the translated SPOT-25 will be pilot-tested in a subset of patients. Lastly, validity, reliability and responsiveness of the translated SPOT-25 will be analysed. ETHICS AND DISSEMINATION: The research protocol was approved by the Institutional Review Board of the University Medical Center Utrecht (protocol 18-768/C; V.1, November 2018). Initially, we planned to include 50 patients. At a later stage we decided to increase the sample size to 100 patients. We notified the Institutional Review Board of this change to the protocol. The trial results will be disseminated through peer-reviewed medical journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: NL7586.

Revision Stapes Surgery in a Tertiary Referral Center: Surgical and Audiometric Outcomes.

OBJECTIVES: To evaluate pure-tone audiometric results in otosclerosis patients undergoing revision stapes surgery following previous middle ear interventions. METHODS: A retrospective cohort study was performed in a tertiary referral center. Consecutive otosclerosis patients who underwent revision stapes surgeries, following previous middle ear interventions, for persistent conductive hearing loss, recurrent conductive hearing loss, or vertigo and had available postoperative pure-tone audiometry were included. Mean pre- and postoperative air conduction, bone conduction, and air-bone gap averaged over 0.5, 1, 2, and 3 kHz were obtained. Audiometric outcomes were obtained at 7 weeks postoperatively. RESULTS: In total, 63 consecutive otosclerosis patients who underwent 66 revision stapes surgeries were included. Air-bone gap improved significantly with a mean gain of 19 dB (95% CI, 15-22). Air conduction improved significantly with a mean gain of 18 dB (95% CI, 14-23). Bone conduction did not change significantly, with a mean deterioration of 0 dB (95% CI, -2 to 1). Air-bone gap closure to 10 dB or less was achieved in 38% of cases and to 20 dB or less in 80% of cases. Indication for surgery, previous type of procedure, primary cause of failure, and current surgical technique were not significantly associated with air-bone gap closure to 10 dB or less. Indication for surgery and primary cause of failure were associated with one another. CONCLUSIONS: Compared to the available literature, a slightly larger gain in air conduction and air-bone gap was achieved in our study. Air-bone gap closure to 10 dB or less was achieved less often in our study.

An internally validated prognostic model for success in revision stapes surgery for otosclerosis.

OBJECTIVES/HYPOTHESIS: To develop a prediction model that can accurately predict the chance of success following revision stapes surgery in patients with recurrent or persistent otosclerosis at 2- to 6-months follow-up and to validate this model internally. STUDY DESIGN: A retrospective cohort study of prospectively gathered data in a tertiary referral center. METHODS: The associations of 11 prognostic factors with treatment success were tested in 705 cases using multivariable logistic regression analysis with backward selection. Success was defined as a mean air-bone gap closure to 10 dB or less. The most relevant predictors were used to derive a clinical prediction rule to determine the probability of success. Internal validation by means of bootstrapping was performed. Model performance indices, including the Hosmer-Lemeshow test, the area under the receiver operating characteristics curve (AUC), and the explained variance were calculated. RESULTS: Success was achieved in 57.7% of cases at 2- to 6-months follow-up. Certain previous surgical techniques, primary causes of failure leading up to revision stapes surgery, and positions of the prosthesis placed during revision surgery were associated with higher success percentages. The clinical prediction rule performed moderately well in the original dataset (Hosmer-Lemeshow P = .78; AUC = 0.73; explained variance = 22%), which slightly decreased following internal validation by means of bootstrapping (AUC = 0.69; explained variance = 13%). CONCLUSIONS: Our study established the importance of previous surgical technique, primary cause of failure, and type of the prosthesis placed during the revision surgery in predicting the probability of success following stapes surgery at 2- to 6-months follow-up. LEVEL OF EVIDENCE: 2b. Laryngoscope, 128:2390-2396, 2018.

Betahistine for tinnitus.

BACKGROUND: Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy, cognitive behavioural therapy, sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as sleep difficulties, anxiety or depression. As yet, no drug has been approved for tinnitus by a regulatory body. Nonetheless, over 100,000 prescriptions for betahistine are being filled every month in England, and nearly 10% of general practitioners prescribe betahistine for tinnitus. OBJECTIVES: To assess the effects of betahistine in patients with subjective idiopathic tinnitus. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 July 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting patients of any age with acute or chronic subjective idiopathic tinnitus were included. We included studies where the intervention involved betahistine and this was compared to placebo, no intervention or education and information. We included all courses of betahistine, regardless of dose regimens or formulations and for any duration of treatment. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes included tinnitus loudness and significant adverse effects (upper gastrointestinal discomfort). Our secondary outcomes included tinnitus symptom severity as measured by the global score on a multi-item tinnitus questionnaire, depressive symptoms, symptoms of generalised anxiety, health-related quality of life, other adverse effects (e.g. headache, drowsiness, allergic skin reactions (pruritis, rashes) and exacerbation of tinnitus) and tinnitus intrusiveness. We used GRADE to assess the quality of evidence for each outcome; this is indicated in italics. MAIN RESULTS: This review included five studies (with a total of 303 to 305 participants) comparing the effects of betahistine with placebo in adults with subjective idiopathic tinnitus. Four studies were parallel-group RCTs and one had a cross-over design. The risk of bias was unclear in all of the included studies.Due to heterogeneity in the outcomes measured and measurement methods used, very limited data pooling was possible. When we pooled the data from two studies for the primary outcome tinnitus loudness, the mean difference on a 0- to 10-point visual analogue scale at one-month follow-up was not significant between betahistine and placebo (-0.16, 95% confidence interval (CI) -1.01 to 0.70; 81 participants) (very low-quality evidence). There were no reports of upper gastrointestinal discomfort (significant adverse effect) in any study.As a secondary outcome, one study found no difference in the change in the Tinnitus Severity Index between betahistine and placebo (mean difference at 12 weeks 0.02, 95% CI -1.05 to 1.09; 50 participants) (moderate-quality evidence). None of the studies reported the other secondary outcomes of changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life as measured by a validated instrument, nor tinnitus intrusiveness.Other adverse effects that were reported were not treatment-related. AUTHORS' CONCLUSIONS: There is an absence of evidence to suggest that betahistine has an effect on subjective idiopathic tinnitus when compared to placebo. The evidence suggests that betahistine is generally well tolerated with a similar risk of adverse effects to placebo treatments. The quality of evidence for the reported outcomes, using GRADE, ranged from moderate to very low.If future research into the effectiveness of betahistine in patients with tinnitus is felt to be warranted, it should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the development of validated, patient-centred outcome measures for research in the field of tinnitus.