Clinical trials in otology:Examining trends and framework for prioritization

Objective:To characterize otologic clinical trials and examine otologic clinical trial trends from 2008 to 2018 using the clinicaltrials.gov database.Methods:Data was collected from clinicaltrials.gov and included all clinical trials that focused on otology from 2008 to 2018.Outcome measures include status of trials,funding sources,details regarding otologic conditions studied,and trends in clinical trials.Results:There were 992 otology clinical trials from 2008 to 2018.457(46.1%)were completed and 94(9.5%)were discontinued.Industry remained the highest(76.5%)contributor to otology clinical trials.The otologic conditions studied,from most common to least common,include hearing loss(40.6%),vestibulopathy(18.8%),tinnitus(18.8%),and otitis media(15.1%).The number of otology clinical trials increased by an average of 12.0 trials per year from 2008 to 2018(p<0.001).The number of otology clinical trials focusing on hearing loss and vestibulopathy significantly increased over the studied period(p<0.001),while those focusing on tinnitus and otitis media did not(p=0.09 and p=0.20,respectively).The majority of clinical trials on each of these four conditions focused on treatment options.Conclusion:Our study describes trends in otology clinical trials registered on clinicaltrials.gov from 2008 through 2018.The total number of clinical trials over this time period increased significantly,driven by trials investigating hearing loss and vestibulopathy.Furthermore,most clinical trials were industrysponsored and focused on treatment modalities.Our study provides an outline of otology clinical trials registered in a US web-based database,which may be of use for the development of future clinical trials.

Development of otology specific outcome measure:Ear Outcome Survey-16 (EOS-16)

Purpose An important outcome measure of patient care is the impact on the patient’s health-related quality of life(HRQoL).Current ear-specific HRQoL instruments are designed for one diagnosis and emphasize different subdivisions such as symptoms,hearing problems,psychosocial impact,and the need for care.The optimal length of the recall period has not been studied.For these reasons,a new survey is needed that would cover most chronic ear diseases.Methods A preliminary 24-item survey(EOS-24)was created.Untreated adult patients(included n=186)with one of seven different chronic otologic conditions from all university hospitals in Finland were recruited to respond to EOS-24 and the 15D general HRQoL instrument.The recruiting otologists evaluated the severity of the disease and the disability caused by it.A control group was recruited.Based on the patients’responses in different diagnosis groups,the items were reduced according to pre-defined criteria.The resulting survey was validated using a thorough statistical analysis.Results The relevance and necessity of the original 24 items were thoroughly investigated,leading to the exclusion of 8 items and the modification of 1.The remaining 16 items were well-balanced between subdivisions and were useful in all seven diagnosis groups,thus constituting the final instrument,EOS-16.The most suitable recall period was three months.Conclusions EOS-16 has been created according to the HRQoL survey guidelines with a versatile nationwide patient population.The survey has been validated and can be used for a wide range of chronic ear diseases as a HRQoL instrument.

第二届Journal of Otology暨第三届中华耳科学杂志编委会在北京召开

2008年10月25-26日,第二届Journal of Otology暨第三届《中华耳科学杂志》编委会在北京召开,来自国内外编委165位。杨伟炎总编致开幕词,编辑部主任张晶平汇报了两刊杂志的工作和今后的发展方向。在欢快的乐曲声中杨伟炎和韩东一主编向新聘的两刊杂志主编、副主编颁发了聘书,接着宣布了《中华耳科学杂志》

Journal of Otology创刊欢迎投稿

Journal of Otology于2006年6月创刊,由国家新闻出版署批准发行的英文专业学术期刊(中国标准刊号:中文CN11-4883/R ISS1672-2930)。由中国人民解放军总医院主管,由技术力量雄厚,国家重点学科点,解放军耳鼻咽喉研究所主办。

第三届《中华耳科学杂志》暨第二届Journal of Otology编委会第一轮通知

《中华耳科学杂志》已创刊五年,出刊20期,《Journal of Otology》已创刊两年,出刊四期,在广大编委的热情支持下,杂志逐步形成了自己的特色和品牌,得到了广大读者的认可与喜爱。为了更好地集思广益,使杂志更快更好地向前发展,两刊编委会决定,

第三届《中华耳科学杂志》暨第二届Journal of Otology编委会第一轮通知

《中华耳科学杂志》已创刊五年,出刊20期,Journal of Otology已创刊两年,出刊四期,在广大编委的热情支持下,杂志逐步形成了自己的特色和品牌,得到了广大读者的认可与喜爱。为了更好地集思广益。

Endoscopic push through tragal cartilage tympanoplasty: A 10-year retrospective review of our technique and outcomes

BACKGROUND Endoscopic ear surgery(EES)provides a magnified,high-definition view of the otological surgical field.EES allows otologists to avoid surgical incisions and associated postoperative complications.It is an ideal technique for the perfor-mance and teaching of tympanoplasty.AIM To examine the efficacy of total Endoscopic Push Through Tragal Cartilage Tympanoplasty(EPTTCT),at our institution over a 10-year period.METHODS A retrospective analysis of 168 cases of EPTTCT for closure of small to medium tympanic membrane perforations from 2013-2023 was conducted.Patient sex,age range(pediatric vs adult),etiology of injury,success rate,complications,and postoperative hearing status were collected.RESULTS Graft uptake results indicated success in 94%of patients,with less than a 2%complication rate.Postoperative pure tone audiometry demonstrated hearing status improvement in 69%of patients.CONCLUSION EPTTCT has been shown to be effective in tympanic membrane perforation closures with minimal complications.This study further demonstrates the efficacy and safety of these procedures in a single-center review.

Rare Presentation of Meningioma as an External Auditory Canal Mass

This is a case of a 60-year-old male with a history of prior left middle fossa meningioma that was partially resected with an operative report noting diffuse attachment to the middle fossa floor. Gamma knife was recommended but he never completed this management. He then presented about eight years later with a mass from his left external auditory canal. It was reported that two years prior another surgeon operated on the left ear for a cholesteatoma. CT temporal bone showed complete opacification of left EAC, mastoid bowl, and remaining mastoid air cells. In addition, there were irregular bony/hyperostotic changes seen within the left sphenoid and temporal bone. There was dural thickening within the middle fossa adjacent to the previously described hyperostotic bony changes. A mastoidectomy and excision of mass revealed extensive adhesive tissue throughout the middle ear, and mastoid up to the tegmen. Pathology of the portions that were resected confirmed Grade 1 meningioma. Stereotactic gamma knife radiation was completed to the area to prevent further growth. This case highlights extracranial meningioma that did not have definitive management for prior middle fossa floor meningioma. It also highlights the need to think of less common pathology in the middle ear and external auditory canal.

Current trends and applications in endoscopy for otology and neurotology

There has been a rapid increase in endoscopic ear surgery for the management of middle ear and lateral skull base disease in children and adults over the last decade.In this review paper,we discuss the current trends and applications of the endoscope in the field of otology and neurotology.Advantages of the endoscope include excellent ergonomics,compatibility with pediatric anatomy,and improved access to the middle ear through the external auditory canal.Transcanal endoscopic ear surgery has demonstrated comparable outcomes in the management of cholesteatoma,tympanic membrane perforations,and otosclerosis as compared to microscopic approaches,while utilizing less invasive surgical corridors and reducing the need for postauricular incisions.When a postauricular approach is required,the endoscopic-assisted transmastoid approach can avoid a canal wall down mastoidectomy in cases of cholesteatoma.The endoscope also has utility in treatment of superior canal dehiscence and various skull base lesions including glomus tumors,meningiomas,and vestibular schwannomas.Outside of the operating room,the endoscope can be used during examination of the outer and middle ear and for debridement of complex mastoid cavities.For these reasons,the endoscope is currently poised to transform the field of otology and neurotology.

Validation of a 3D-printed human temporal bone model for otology surgical skill training

Hypothesis:Three-dimensional(3D)printed temporal bones are comparable to cadaveric temporal bones as a training tool for otologic surgery.Background:Cadaveric temporal bone dissection is an integral part of otology surgical training.Unfortunately,availability of cadaveric temporal bones is becoming much more limited and concern regarding chemical and biological risks persist.In this study,we examine the validity of 3D-printed temporal bone model as an alternative training tool for otologic surgery.Methods:Seventeen otolaryngology trainees participated in the study.They were asked to complete a series of otologic procedures using 3D-printed temporal bones.A semi-structured questionnaire was used to evaluate their dissection experience on the 3D-printed temporal bones.Results:Participants found that the 3D-printed temporal bones were anatomically realistic compared to cadaveric temporal bones.They found that the 3D-printed temporal bones were useful as a surgical training tool in general and also for specific otologic procedures.Overall,participants were enthusiastic about incorporation of 3D-printed temporal bones in temporal bone dissection training courses and would recommend them to other trainees.Conclusion:3D-printed temporal bone model is a viable alternative to human cadaveric temporal bones as a teaching tool for otologic surgery.

33例耳廓化脓性软骨膜炎诊治经验

目的总结分析33例不同病因引起的耳廓化脓性软骨膜炎的治疗体会。方法回顾性分析南昌大学第一附属医院耳鼻咽喉头颈外科2015年1月~2020年6月收治的不同病因的耳廓化脓性软骨膜炎患者33例,分析总结病因及诊治经验。结果33例患者中行药物保守治疗者9例,治疗后9例均痊愈,未出现耳廓畸形等并发症;行局麻下脓肿切开引流治疗者4例,治疗后4例均痊愈,未出现耳廓畸形等并发症;行全麻下耳廓软骨清创缝合术者20例,术后痊愈20例,出现耳廓“菜花样”畸形1例。33例患者,取得脓液样本细菌培养及药敏者24例,微生物检出者20例,4例培养后未见微生物生长,检出金黄色葡萄球菌9例,检出率45%,检出铜绿假单胞菌12例,检出率60%,真菌均未检出。检出微生物舒普深均敏感。结论耳廓化脓性软骨膜炎病因较多,诊断相对简单,治疗上首选针对铜绿假单胞菌及金黄色葡萄球菌敏感的抗生素,病情较轻的可行药物保守治疗,病变严重时则应切开引流及清除病变的软骨,同时超短波辅助治疗也是十分有效的治疗手段。

Auditory function in symptomatic patients recovered from SARS-CoV-2 and unexposed patients:An analytical cross-sectional study

Objective:To describe audiological symptoms,audiometric profile,and distortion product otoacoustic emission in symptomatic patients recovering from SARS-CoV-2 infection(positive RT-PCR test)and asymptomatic patients(negative RT-PCR test).Methods:An analytical cross-sectional study was conducted using data obtained from clinical charts,physical examination,audiometry,and distortion product otoacoustic emission on 40 patients[case patients(CP)]recovering from SARS-CoV-2 infection diagnosed by a positive RT-PCR test and 22asymptomatic participants with a negative RT-PCR test[non-case(NC)].Results:Sixty-two patients(mean age:31.1 and 28.2 years in the CP and NC groups,respectively)were included.All participants were young without significant comorbidities,risk factors for hearing loss or otological history.Vertigo(5%),tinnitus(17.5%)and aural fullness/hearing loss(35%)were found in the CP group.A statistically significant difference was found in specific frequencies(1000,4000,and 8000 Hz)and pure tone average(low and high conversational frequencies with increased threshold in the PC group compared with the NC group),which was not found in distortion product otoacoustic emission.Conclusion:Audiovestibular symptoms are frequent in symptomatic patients recovering from SARS-CoV-2 infection.SARS-CoV-2 infection was consistently associated with an increased audiometric hearing threshold at specific frequencies and low tone average.

Overview of Child Otological Care at the Reference Health Center of Commune V, Bamako

Aim: To profile the diagnostic and the care provided for otological conditions in children. Method: This was a prospective cross-sectional study carried out from March 1, 2022 to May 30, 2022 at the ENT Unit of the Reference Health Center of Commune V (Bamako). This study concerned the records of children with an otological condition. They were at their first consultation within the unit. The month of March was devoted to recruitment. The follow-up was done until the end of May. The parameters studied included epidemiological, clinical and therapeutic aspects. Results: We identified 184 children suffering from otological conditions out of a total of 559 patients that consulted during March 2022, i.e. an hospital prevalence of 32.9%. This study found ear infections in 60.3%. Earwax and epidermal plugs accounted for 32.60%. Traumatic injuries were 4.3%. Pre-lingual deafness was found in 1.1% of cases. Antibiotics were used for treatment in 66.3% of children without any complications detected. Conclusion: The otological affections of the child were frequent with a predominance of otitis.

11例听骨链畸形的回顾性分析

目的探讨先天性听骨链畸形的手术治疗效果。方法回顾性分析11例听骨链畸形患者术前行颞骨CT、声导抗及纯音测听检查,对不同畸形部位或类型者行不同术式人工听骨听骨链重建术,术后随访2个月～1年,评估患者术后听力情况。结果术前气导平均听阈(0.5、1、2和4 kHz)为(59.6±10.0)dB HL,骨气导差(38.9±8.0)dB HL。术后2个月～1年复查气导平均听阈(45.3±16.0)dB HL,骨气导差为(22.5±10.0)dB HL。术后气导增益(14.3±9.0)dB HL,骨气导差增益(16.4±8.0)dB HL。11例中7例(64%)术后气导增益≥15 dB HL,4例(36%)术后气导增益<15 dB HL;8例(73%)术后骨气导差增益≥15 dB HL,3例(27%)术后骨气导差增益<15 dB HL。结论人工听骨听骨链重建术是治疗听骨链畸形的方法之一。

耳垂瘢痕疙瘩的综合治疗

耳垂瘢痕疙瘩是一种病理现象,表现为成纤维细胞活性异常增高,大量结缔组织沉积而导致瘢痕过度增生,质地如软骨样,形态大小不一,表面凸凹不平,单纯手术切除易复发,术后结合激素及核素照射是治疗耳垂瘢痕疙瘩的有效方法,现将我科近2年来收治的15例病例报道如下。

外耳道成形术的应用

外耳道成形术是为了恢复外耳道正常宽度和轮廓而采取的措施,包括以正常健康皮肤替代病变的外耳道皮肤。虽然该术式在耳外科治疗中应用广泛,但处理不当仍会出现面神经瘫痪、外耳道再次狭窄、闭锁等严重并发症[1],本文分析52耳外耳道成形术的手术方式及术后处理。

慢性化脓性中耳炎再次手术及原因分析

慢性化脓性中耳炎是耳科常见疾病,临床表现主要为耳流脓及不同程度的听力损失。乳突改良根治术是治疗胆脂瘤型及骨疡型中耳炎的主要方法,手术目的是清除病变组织,获得干耳;但术后仍有部分患者出现持续或间断流脓,

耳甲腔转移皮瓣联合耳甲腔成形术

2011年我科采用耳甲腔转移皮瓣联合耳甲腔成形术，治疗外耳道13狭窄，扩大外耳道口13例，疗效满意，现报道3例典型病例如下。1临床资料病例1，男性，19岁，因左侧外耳道胆脂瘤、中耳乳突炎人院。

小儿感染期先天性耳前瘘管的手术治疗

我院自2006年6月～2008年12月,开展小儿感染期先天性耳前瘘管的手术治疗共计32例（34耳）,经半年以上的随访观察效果满意,无复发。现报道如下。

外耳道胆脂瘤临床分析

外耳道胆脂瘤是一种阻塞于外耳道骨部的含有胆固醇结晶的脱落上皮团块,病变不仅限于外耳道,部分病变可侵及乳突或鼓室等。现将我科2004年1月～2008年1月收治的24例外耳道胆脂瘤患者资料报道如下。