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This research aims to enhance the understanding of the acoustic processes occurring during sonotubometry, a method used to assess the Eustachian tube (ET) function. Recent advancements in digital signal processing enable a more comprehensive data analysis. In this project, a silicone model of the ET was developed to systematically study the existing noise and sound sources. These measurements were then compared with recordings from human subjects. Three distinct 'noise sources' were identified, which can influence the assessment of the ET opening using transmission measurements of the imposed signal: sound leakage from the speaker, a clicking noise at the initiation of ET opening, and rumbling/swallowing noise. Through spectral analysis, it was also possible to ascertain the spectral and temporal occurrence of these sound and noise types. The silicone model exhibited remarkable similarity to the healthy human ET, making it a robust experimental model for investigating the acoustics of sonotubometry. The findings underscore the significance of delving deeper into the analysed sound, as the noise occurring during sonotubometry can be easily misconstrued as an actual ET opening. Particularly, careful consideration is warranted when evaluating data involving clicking and swallowing noise.
Subject(s)
Eustachian Tube , Noise , Eustachian Tube/physiology , Eustachian Tube/physiopathology , Humans , Sound , Models, Biological , Acoustics , Male , FemaleABSTRACT
Idiopathic sudden sensorineural hearing loss (ISSNHL) is the rapid onset of reduced hearing due to loss of function of the inner ear or hearing nerve of unknown aetiology. Evidence supports improved hearing recovery with early steroid treatment, via oral, intravenous, intratympanic or a combination of routes. The STARFISH trial aims to identify the most clinically and cost-effective route of administration of steroids as first-line treatment for ISSNHL. STARFISH is a pragmatic, multicentre, assessor-blinded, three-arm intervention, superiority randomised controlled trial (1:1:1) with an internal pilot (ISRCTN10535105, IRAS 1004878). 525 participants with ISSNHL will be recruited from approximately 75 UK Ear, Nose and Throat units. STARFISH will recruit adults with sensorineural hearing loss averaging 30dBHL or greater across three contiguous frequencies (confirmed via pure tone audiogram), with onset over a ≤3-day period, within four weeks of randomisation. Participants will be randomised to 1) oral prednisolone 1mg/Kg/day up to 60mg/day for 7 days; 2) intratympanic dexamethasone: three intratympanic injections 3.3mg/ml or 3.8mg/ml spaced 7±2 days apart; or 3) combined oral and intratympanic steroids. The primary outcome will be absolute improvement in pure tone audiogram average at 12-weeks following randomisation (0.5, 1.0, 2.0 and 4.0kHz). Secondary outcomes at 6 and 12 weeks will include: Speech, Spatial and Qualities of hearing scale, high frequency pure tone average thresholds (4.0, 6.0 and 8.0kHz), Arthur Boothroyd speech test, Vestibular Rehabilitation Benefit Questionnaire, Tinnitus Functional Index, adverse events and optional weekly online speech and pure tone hearing tests. A health economic assessment will be performed, and presented in terms of incremental cost effectiveness ratios, and cost per quality-adjusted life-year. Primary analyses will be by intention-to-treat. Oral prednisolone will be the reference. For the primary outcome, the difference between group means and 97.5% confidence intervals at each time-point will be estimated via a repeated measures mixed-effects linear regression model.
Subject(s)
Ear, Inner , Hearing Loss, Sensorineural , Adult , Humans , Audiometry, Pure-Tone , Hearing , Hearing Loss, Sensorineural/drug therapy , Multicenter Studies as Topic , Prednisolone/therapeutic use , Randomized Controlled Trials as TopicABSTRACT
Objective An operative workflow systematically compartmentalizes operations into hierarchal components of phases, steps, instrument, technique errors, and event errors. Operative workflow provides a foundation for education, training, and understanding of surgical variation. In this Part 2, we present a codified operative workflow for the translabyrinthine approach to vestibular schwannoma resection. Methods A mixed-method consensus process of literature review, small-group Delphi's consensus, followed by a national Delphi's consensus was performed in collaboration with British Skull Base Society (BSBS). Each Delphi's round was repeated until data saturation and over 90% consensus was reached. Results Seventeen consultant skull base surgeons (nine neurosurgeons and eight ENT [ear, nose, and throat]) with median of 13.9 years of experience (interquartile range: 18.1 years) of independent practice participated. There was a 100% response rate across both the Delphi rounds. The translabyrinthine approach had the following five phases and 57 unique steps: Phase 1, approach and exposure; Phase 2, mastoidectomy; Phase 3, internal auditory canal and dural opening; Phase 4, tumor debulking and excision; and Phase 5, closure. Conclusion We present Part 2 of a national, multicenter, consensus-derived, codified operative workflow for the translabyrinthine approach to vestibular schwannomas. The five phases contain the operative, steps, instruments, technique errors, and event errors. The codified translabyrinthine approach presented in this manuscript can serve as foundational research for future work, such as the application of artificial intelligence to vestibular schwannoma resection and comparative surgical research.
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Objective An operative workflow systematically compartmentalizes operations into hierarchal components of phases, steps, instrument, technique errors, and event errors. Operative workflow provides a foundation for education, training, and understanding of surgical variation. In this Part 1, we present a codified operative workflow for the retrosigmoid approach to vestibular schwannoma resection. Methods A mixed-method consensus process of literature review, small-group Delphi's consensus, followed by a national Delphi's consensus, was performed in collaboration with British Skull Base Society (BSBS). Each Delphi's round was repeated until data saturation and over 90% consensus was reached. Results Eighteen consultant skull base surgeons (10 neurosurgeons and 8 ENT [ear, nose, and throat]) with median 17.9 years of experience (interquartile range: 17.5 years) of independent practice participated. There was a 100% response rate across both Delphi's rounds. The operative workflow for the retrosigmoid approach contained three phases and 40 unique steps as follows: phase 1, approach and exposure; phase 2, tumor debulking and excision; phase 3, closure. For the retrosigmoid approach, technique, and event error for each operative step was also described. Conclusion We present Part 1 of a national, multicenter, consensus-derived, codified operative workflow for the retrosigmoid approach to vestibular schwannomas that encompasses phases, steps, instruments, technique errors, and event errors. The codified retrosigmoid approach presented in this manuscript can serve as foundational research for future work, such as operative workflow analysis or neurosurgical simulation and education.
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OBJECTIVES: To estimate the prevalence of, and risk factors associated with electrode migration (EM) in cochlear implant (CI) recipients. DESIGN: Historical cohort study of all CIs performed between 1 January 2018 and 1 August 2021 in a single tertiary adult and paediatric CI centre in the UK. MAIN OUTCOME MEASURES: The primary aim is to determine the prevalence of electrode migration, comparing intraoperative surgeon report and examination of a routine plain radiograph performed 2 weeks after surgery. EM is defined as the detection of movement of two or more electrodes out of the cochlea from the time of surgery. Multivariate analysis was performed to investigate preoperative and intraoperative risk factors that might predispose to migration. RESULTS: Four hundred and sixty-five patients, having 516 distinct surgeries, with 628 implants were analysed. EM occurred following 11.5% of implant operations. Pre-existing cochlear abnormality was an independent associated risk factor for EM (OR: 3.40 ⟨1.20-9.62⟩ p = .021). Demographics, surgical technique, usage of a precurved electrode, CSF leak, surgeon seniority and intraoperative telemetry did not influence risk of migration. There were 5 implants (0.8%) which migrated later than 2 weeks, with a median date of imaging diagnosis (x-ray or CT scan) of 263 days ⟨IQR:198⟩, for which head injury was a common precipitating factor. There were differences in the risk of migration between different lateral wall electrodes. CONCLUSION: EM in the early postoperative period is a common occurrence and is more likely in implant recipients with obstructed or malformed cochleae.
Subject(s)
Cochlear Implantation , Cochlear Implants , Child , Adult , Humans , Cochlear Implantation/methods , Cohort Studies , Electrodes, Implanted , Retrospective Studies , Cochlear Implants/adverse effects , Postoperative PeriodABSTRACT
OBJECTIVES: Nurses are increasingly providing routine and emergency ENT care; yet there are often limited training opportunities. The aim of this study was to validate an intensive 1-day ENT emergency simulation course for nurses. METHODS: The course included short lectures, practical skills stations and mannequin simulation scenarios. Sixteen nurse participants were video-recorded managing simulated scenarios before and after the course. Two assessors scored individual participant performance on a 15-point competency grid (maximum score 30), blinded to the timing of the recording. Participants also rated their confidence and skill before and immediately following the course across 11 items using a 5-point Likert score (maximum score 55). RESULTS: Blinded assessor ratings for performance were significantly improved after the course compared to baseline (overall score 12 vs 7, respectively; P = .015). There was strong assessor inter-rater reliability (R = 0.965). Self-rated skills and confidence also increased following the course (46.7 vs 24.4 at baseline; P < .01). CONCLUSION: Simulation-based training is an effective and desirable method of teaching ENT emergency management to nurses, with greatest impact on participant confidence. Future courses need to refine the content and increase the validation sample size using a nurse-specific scoring system.
Subject(s)
Internship and Residency , Nurses , Simulation Training , Humans , Reproducibility of Results , Simulation Training/methods , Education, Medical, Graduate/methods , Clinical CompetenceABSTRACT
Objective Cystic vestibular schwannomas (VS) in contrast to solid VS tend to have accelerated growth, larger volume, rapid/atypical presentation, lobulated/adherent surface, and unpredictable course of the cranial nerves. Cystic VS are surgically challenging, with worse clinical outcomes and higher rate of subtotal resection (STR). Methods We retrospectively analyzed postoperative outcomes of 125 patients with cystic VS, operated between years 2005 and 2019 in our center. We confronted the extent of the resection and House-Brackmann (HB) grade of facial palsy with the results of comparable cohort of patients with solid VS operated in our center and literature review by Thakur et al. 1 Results Translabyrinthine approach was preferred for resection of large, cystic VS (97.6%). Gross-total resection (GTR) was achieved in 78 patients (62.4%), near-total resection (NTR) with remnant (<4 × 4 × 2 mm) in 43 patients (34.4%), and STR in 4 patients (3.2%). NTR/STR were significantly associated with higher age, tumor volume >5 cm 3 , retrosigmoid approach, high-riding jugular bulb, tumor adherence to the brain stem, and facial nerve ( p = 0.016; 0.003; 0.005; 0.025; 0.001; and <0.00001, respectively). One year after the surgery, 76% of patients had HB grades 1 to 2, 16% had HB grades 3 to 4, and 8% had HB grades 5 to 6 palsy. Worse outcome (HB grades 3 to 6) was associated with preoperative facial palsy, tumor volume >25 cm 3 , and cyst over the brain stem ( p = 0.045; 0.014; and 0.05, respectively). Comparable solid VS operated in our center had significantly higher HB grades 1 to 2 rate than our cystic VS (94% versus 76%; p = 0.03). Comparing our results with literature review, our HB grades 1 to 2 rate was significantly higher (76% versus 39%; p = 0.0001). Tumor control rate 5 years after surgery was 95.8%. Conclusion Our study confirmed that microsurgery of cystic VS has worse outcomes of facial nerve preservation and extent of resection compared with solid VS. Greater attention should be paid to the above-mentioned risk factors.
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OBJECTIVE: To investigate the value of scalp surface potentials to identify and manage partial short circuits to ground in cochlear implant electrodes. DESIGN: A retrospective review of patients with suspected partial short circuits. MAIN OUTCOME MEASURE: Electrical output of individual electrodes was measured using scalp surface potentials for patients reporting a change in hearing function. Electrical output was compared to functional performance and impedance measurements to determine if devices with suspected partial short circuits were experiencing a decrease in performance as a result of reduced electrical output. Electrical output was checked in an artificial cochlea for two implants following explant surgery to confirm scalp surface potential results. RESULTS: All patients with suspected partial short circuits (n = 49) had reduced electrical output, a drop in impedances to approximately ½ of previously stable measurements or to below 2 kΩ, an atypical electrical field measurement (EFI) and a decline in hearing function. Only devices with an atypical EFI showed reduced electrical output. Results of scalp based surface potentials could be replicated in an artificial cochlea following explantation of the device. All explant reports received to date (n = 42) have confirmed partial short circuits, with an additional four devices failing integrity tests. CONCLUSION: Surface potential measurements can detect partial shorts and had 100% correlation with atypical EFI measurements, which are characteristic of a partial short to ground in this device. Surface potentials can help determine the degree to which the electrode array is affected, particularly when behavioural testing is limited or not possible.
Subject(s)
Cochlear Implantation , Cochlear Implants , Cochlea , Cochlear Implantation/methods , Electric Impedance , Hearing Tests , Humans , Scalp/surgeryABSTRACT
OBJECTIVE: To analyse the 2 and 5-year outcomes of a cohort of patients with newly diagnosed vestibular schwannoma patients. STUDY DESIGN: Longitudinal cohort study. SETTING: Tertiary skull base referral unit. PATIENTS: Six hundred and seventy-one consecutive patients referred to the Cambridge Skull Base Unit between 2005 and 2010. MAIN OUTCOME MEASURES: 1) Treatment outcomes, 2) hearing preservation, 3) facial nerve function, and 4) gross tumor control. RESULTS: At initial diagnosis, 440/671(65.6%) of patients entered a watch, wait and rescan (WWR) pathway, 208/671 (31%) underwent primary microsurgical excision and 23/671 (3.4%) primary radiotherapy. Of patients who entered WWR, 144/440 (32.7%) exhibited tumor growth necessitating secondary intervention at a mean of 22.7 months; 67.4% had radiotherapy and 32.6% surgery. Radiotherapy was successful at achieving tumor control in 95% of cases. Primary surgery via the translabyrinthine route was performed in the majority of cases allowing for a radiologically clear surgical resection in 93% of cases. CONCLUSION: The Cambridge philosophy of treating the newly diagnosed vestibular schwannoma aims at preserving functional status where possible. In patients with small tumors it is recommended that they are placed on to a WWR pathway, of which 67.3% will not exhibit any growth by 5 years. If small tumors grow more than 2 mm by serial scanning, radiotherapy offers a high rate of tumor control. In patients with larger tumors more than 20 mm we would advocate microsurgical excision by the translabyrinthine route which offers excellent functional outcomes and gross tumor control.
Subject(s)
Neuroma, Acoustic , Hearing , Humans , Longitudinal Studies , Retrospective Studies , Treatment OutcomeABSTRACT
OBJECTIVE: To review the outcomes of cochlear implants (CI) in patients with neurofibromatosis type 2 (NF2) in a large cohort, and identify factors associated with poor hearing benefit. STUDY DESIGN: Fifteen-year retrospective national observational case series. SETTING: United Kingdom regional NF2 multidisciplinary teams. PATIENTS: Consecutive patients with NF2 receiving a CI. INTERVENTIONS: CI for hearing rehabilitation. MAIN OUTCOME MEASURES: 1) Audiometric performance at 9 to 12âmonths after implantation using City University of New York (CUNY) sentence recognition score, and Bamford- Kowal-Bench (BKB) word recognition score in quiet (BKBq), and in noise (BKBn). 2) CI use at most recent review. RESULTS: Sixty four consecutive patients, median age 43âyears, were included. Nine to 12âmonths mean audiometric scores were: CUNY 60.9%, BKBq 45.8%, BKBn 41.6%. There was no difference in audiometric outcomes between VS treatment modalities. At most recent review (median 3.6âyears from implantation), 84.9% with device in situ/available data were full or part-time users. Between 9 and 12âmonths and most recent review there was an interval reduction in mean audiometric scores: CUNY -12.9%, BKBq -3.3%, BKBn -4.9%. Larger tumor size and shorter duration of profound hearing loss were the only variables associated with poorer audiometric scores. Tumor growth at the time of surgery was the only variable associated with CI non-use. Individual patient response was highly variable. CONCLUSIONS: CI can provide significant and sustained auditory benefits to patients with NF2 independent of tumor treatment modality, with the majority of those implanted becoming at least part-time users. Larger datasets are required to reliably assess the role of independent variables.
Subject(s)
Cochlear Implantation , Cochlear Implants , Neurofibromatosis 2 , Neuroma, Acoustic , Speech Perception , Adult , Humans , Neurofibromatosis 2/complications , Neurofibromatosis 2/surgery , Neuroma, Acoustic/complications , Neuroma, Acoustic/surgery , Retrospective Studies , Speech Perception/physiology , Treatment Outcome , United KingdomABSTRACT
OBJECTIVE: The growth characteristics of vestibular schwannomas (VSs) under surveillance can be studied using a Bayesian method of growth risk stratification by time after surveillance onset, allowing dynamic evaluations of growth risks. There is no consensus on the optimum surveillance strategy in terms of frequency and duration, particularly for long-term growth risks. In this study, the long-term conditional probability of new VS growth was reported for patients after 5 years of demonstrated nongrowth. This allowed modeling of long-term VS growth risks, the creation of an evidence-based surveillance protocol, and the proposal of a cost-benefit analysis decision aid. METHODS: The authors performed an international multicenter retrospective analysis of prospectively collected databases from five tertiary care referral skull base units. Patients diagnosed with sporadic unilateral VS between 1990 and 2010 who had a minimum of 10 years of surveillance MRI showing VS nongrowth in the first 5 years of follow-up were included in the analysis. Conditional probabilities of growth were calculated according to Bayes' theorem, and nonlinear regression analyses allowed modeling of growth. A cost-benefit analysis was also performed. RESULTS: A total of 354 patients were included in the study. Across the surveillance period from 6 to 10 years postdiagnosis, a total of 12 tumors were seen to grow (3.4%). There was no significant difference in long-term growth risk for intracanalicular versus extracanalicular VSs (p = 0.41). At 6 years, the residual conditional probability of growth from this point onward was seen to be 2.28% (95% CI 0.70%-5.44%); at 7 years, 1.35% (95% CI 0.25%-4.10%); at 8 years, 0.80% (95% CI 0.07%-3.25%); at 9 years, 0.47% (95% CI 0.01%-2.71%); and at 10 years, 0.28% (95% CI 0.00%-2.37%). Modeling determined that the remaining lifetime risk of growth would be less than 1% at 7 years 7 months, less than 0.5% at 8 years 11 months, and less than 0.25% at 10 years 4 months. CONCLUSIONS: This multicenter study evaluates the conditional probability of VS growth in patients with long-term VS surveillance (6-10 years). On the basis of these growth risks, the authors posited a surveillance protocol with imaging at 6 months (t = 0.5), annually for 3 years (t = 1.5, 2.5, 3.5), twice at 2-year intervals (t = 5.5, 7.5), and a final scan after 3 years (t = 10.5). This can be used to better inform patients of their risk of growth at particular points along their surveillance timeline, balancing the risk of missing late growth with the costs of repeated imaging. A cost-benefit analysis decision aid was also proposed to allow units to make their own decisions regarding the cessation of surveillance.
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OBJECTIVES: To investigate the combined effect of changing pulse shape and grounding configuration to manage facial nerve stimulation (FNS) in cochlear implant (CI) recipients. PATIENTS: Three adult CI recipients with severe FNS were offered a replacement implant when standard stimulation strategies and programming adjustments did not resolve symptoms. Our hypothesis was that the facial nerve was less likely to be activated when using anodic pulses with "mixed-mode" intra-cochlear and extra-cochlear current return. INTERVENTION: All patients were reimplanted with an implant that uses a pseudo-monophasic anodic pulse shape, with mixed-mode grounding (stimulus mixed-mode anodic)-the Neuro Zti CI (Oticon Medical). This device also allows measurements of neural function and loudness with monopolar, symmetric biphasic pulses (stimulus MB), the clinical standard used by most CIs as a comparison. MAIN OUTCOME MEASURES: The combined effect of pulse shape and grounding configuration on FNS was monitored during surgery. Following CI activation, FNS symptoms and performance with the Neuro Zti implant were compared with outcomes before reimplantation. RESULTS: FNS could only be recorded using stimulus MB for all patients. In clinical use, all patients reported reduced FNS and showed an improvement in Bamford-Kowal-Bench sentences recognition compared with immediately before reimplantation. Bamford-Kowal-Bench scores with a male speaker were lower compared with measurements taken before the onset of severe FNS for patients 1 and 2. CONCLUSIONS: In patients where CI auditory performance was severely limited by FNS, charge-balanced pseudo-monophasic stimulation mode with a mixed-mode grounding configuration limited FNS and improved loudness percept compared with standard biphasic stimulation with monopolar grounding.
Subject(s)
Cochlear Implantation , Cochlear Implants , Adult , Cochlea , Cochlear Implantation/adverse effects , Cochlear Implants/adverse effects , Cochlear Nerve , Electric Stimulation , Facial Nerve/surgery , Humans , Male , ReplantationABSTRACT
INTRODUCTION: The prevalence of hearing loss and its consequences is increasing as the elderly population grows. As the guidelines for cochlear implantation (CI) expand, the number of elderly CI recipients is also increasing. We report complication rates, survival duration, and audiological outcomes for CI recipients aged 80 years and over and discuss the cost utility of CI in this age group. METHODS: A retrospective cohort study was undertaken of all CI recipients (126 cases), aged 80 years and over at the time of their surgery, implanted at our institution (Cambridge University Hospitals) during a period from January 1, 2001, to March 31, 2019. Data on survival at 1, 3, and 5 years post-implantation, post-operative complications and functional hearing outcomes including audiometric and speech discrimination outcomes (Bamford-Kowal-Bench sentence test) have been reported. RESULTS: The mean age at implantation was 84 years. The mean audiometric score improved from 108 dB HL to 28 dB HL post-implantation. The mean Bamford-Kowal-Bench score improved from 14% to 66% and 73% at 2 and 12 months post-implantation, respectively. The complication rate was 15.3%. The survival probability at 1 year post-implantation was 0.95 for females and 0.93 for males, at 3 years was 0.89 for females and 0.81 for males, and at 5 years was 0.74 for females and 0.54 for males. CONCLUSION: CI is safe and well-tolerated in this age group and elderly patients gain similar audiometric and functional benefit as found for younger age groups.
Subject(s)
Cochlear Implantation , Cochlear Implants , Speech Perception , Aged , Cochlear Implantation/adverse effects , Female , Hearing , Humans , Male , Postoperative Complications , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Otomycosis is a fungal infection of the outer ear, which may be treated with topical antifungal medications. There are many types, with compounds belonging to the azole group ('azoles') being among the most widely used. OBJECTIVES: To evaluate the benefits and harms of topical azole treatments for otomycosis. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The search date was 11 November 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in adults and children with otomycosis comparing any topical azole antifungal with: placebo, no treatment, another type of topical azole or the same type of azole but applied in different forms. A minimum follow-up of two weeks was required. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were: 1) clinical resolution as measured by the proportion of participants with complete resolution at between two and four weeks after treatment (however defined by the authors of the studies) and 2) significant adverse events. Secondary outcomes were 3) mycological resolution and 4) other less serious adverse effects. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included four studies with 559 participants from Spain, Mexico and India. Three studies included children and adults; one included only adults. The duration of symptoms was not always explicitly stated. Mycological resolution results were only reported in one study. The studies assessed two comparisons: one type of topical azole versus another and the same azole but administered in different forms (cream versus solution). A. Topical azoles versus placebo None of the studies assessed this comparison. B. Topical azoles versus no treatment None of the studies assessed this comparison. C. One type of topical azole versus another type of topical azole i) Clotrimazole versus other types of azoles (eberconazole, fluconazole, miconazole) Three studies examined clotrimazole versus other types of azoles. The evidence is very uncertain about the difference between clotrimazole and other types of azole in achieving complete clinical resolution at four weeks (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.59 to 1.07; 3 studies; 439 participants; very low-certainty evidence). The anticipated absolute effects are 668 per 1000 for clotrimazole versus 835 per 1000 for other azoles. One study planned a safety analysis and reported no significant adverse events in either group. The evidence is therefore very uncertain about any differences between clotrimazole and other types of azole (no events in either group; 1 study; 174 participants; very low-certainty evidence). Clotrimazole may result in little or no difference in mycological resolution at two weeks follow-up (RR 1.01, 95% CI 0.96 to 1.06; 1 study; 174 participants; low-certainty evidence) or in other (less serious) adverse events at two weeks follow-up (36 per 1000, compared to 45 per 1000, RR 0.79, 95% CI 0.18 to 3.41; 1 study; 174 participants; very low-certainty evidence). ii) Bifonazole cream versus bifonazole solution One study compared bifonazole 1% cream with solution. Bifonazole cream may have little or no effect on clinical resolution at two weeks follow-up when compared to solution, but the evidence is very uncertain (RR 1.07, 95% CI 0.73 to 1.57; 1 study; 40 ears; very low-certainty evidence). Bifonazole cream may achieve less mycological resolution compared to solution at two weeks after the end of therapy, but the evidence for this is also very uncertain (RR 0.53, 95% CI 0.29 to 0.96; 1 study; 40 ears; very low-certainty evidence). Five out of 35 patients sustained severe itching and burning from the bifonazole solution but none with the bifonazole cream (very low-certainty evidence). AUTHORS' CONCLUSIONS: We found no studies that evaluated topical azoles compared to placebo or no treatment. The evidence is very uncertain about the effect of clotrimazole on clinical resolution of otomycosis, on significant adverse events or other (non-serious) adverse events when compared with other topical azoles (eberconazole, fluconazole, miconazole). There may be little or no difference between clotrimazole and other azoles in terms of mycological resolution. It may be difficult to generalise these results because the range of ethnic backgrounds of the participants in the studies is limited.
Subject(s)
Antifungal Agents/administration & dosage , Otomycosis/drug therapy , Administration, Topical , Adult , Antifungal Agents/adverse effects , Bias , Child , Clotrimazole/administration & dosage , Clotrimazole/adverse effects , Cycloheptanes/administration & dosage , Cycloheptanes/adverse effects , Fluconazole/administration & dosage , Fluconazole/adverse effects , Humans , Imidazoles/administration & dosage , Imidazoles/adverse effects , Miconazole/administration & dosage , Miconazole/adverse effects , Placebos/therapeutic use , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
OBJECTIVE: To determine if cochlear implantation without removal of inner ear schwannomas (IES) is an effective treatment option for Neurofibromatosis 2 (NF2) patients. To determine how the presence of an intracochlear schwannoma might impact cochlear implant (CI) outcomes and programming parameters. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary center for cochlear and auditory brainstem implantation. PATIENTS: Of 10 NF2 patients with IES, 8 are reported with no previous tumor removal on the implanted ear. INTERVENTIONS: Cochlear implant without tumor removal. MAIN OUTCOME MEASURES: Performance outcomes with CI at least 1-year post intervention. Programming parameters, including impedances, for patients with IES. RESULTS: All patients had full insertion of the electrode arrays with round window approaches. Performance outcomes ranged from 0 to 100% for Bamford-Kowal-Bench sentences. Impedance measurements for active electrodes for patients with IES were comparable to those measured in patients without vestibular schwannoma (VS). Only patients who had radiation treatment before receiving their implant had elevated threshold requirements for CI programming compared with CI recipients without VS. CONCLUSION: Cochlear implantation without tumor removal is an effective option for treating NF2 patients with IES. The presence of an intracochlear tumor did not have an impact on CI performance or programming requirements compared with patients without VS; however, previous treatment with radiation may be related to elevated current requirements in the CI settings.
Subject(s)
Auditory Brain Stem Implantation , Cochlear Implantation , Cochlear Implants , Neurofibromatosis 2 , Humans , Neurofibromatosis 2/complications , Neurofibromatosis 2/surgery , Retrospective StudiesABSTRACT
OBJECTIVE: It has been suggested that the presence of tumor-infiltrating lymphocytes (TILs) in the tumor microenvironment is associated with a better prognosis in different types of cancer. In this systematic review and meta-analysis, we investigated the prognostic role of CD4+ and CD8+ TILs in head and neck squamous cell carcinoma (HNSCC). METHODS: PubMed, Cochrane, Embase, Scopus, and Web of Science were searched up to September 2020. This study was conducted following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) checklist. Risk ratios from individual studies were displayed in forest plots and the pooled hazard ratios (HR) of death and corresponding confidence intervals (CI) were calculated according to random-effects models. Risk of bias of the included studies was assessed through the Newcastle-Ottawa scale. RESULTS: 28 studies met the inclusion criteria. Studies conducted on HNSCC subsites combined reported a significant reduction in the risk of death for both high CD4+ (HR: 0.77; 95% CI: 0.65-0.93) and high CD8+ TILs (HR: 0.64; 95% CI: 0.47-0.88). High CD4+ TILs were associated with significantly better overall survival among oropharyngeal HNSCC (HR: 0.52; 95% CI: 0.31-0.89), as well as high CD8+ TILS in Human papillomavirus -ve and +ve cancers (HR: 0.39; 95% CI: 0.16-0.93 and HR: 0.40; 95% CI 0.21-0.76 respectively). CD8+ TILs were also associated with improved survival in hypopharyngeal cancers (HR = 0.43 CI: 0.30-0.63). No significant association emerged for patients with cancer of the oral cavity or larynx. CONCLUSIONS: The findings from this meta-analysis demonstrate the prognostic significance of CD8+ and CD4+ TILs in HNSCC and variation in tumor subsite warrants further focused investigation. We highlight how TILs may serve as predictive biomarkers to risk stratify patients into treatment groups, with applications in immune-checkpoint inhibitors notable areas for further research.