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Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer: A Phase 1 Dose-Expansion Nonrandomized Clinical Trial. 肿瘤内放疗增强剂纳米颗粒NBTXR3放疗头颈癌:一项1期剂量扩展非随机临床试验
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-29 DOI: 10.1001/jamaoto.2025.4939
Christophe Le Tourneau, Xavier Liem, France Nguyen, Simon Deraedt, Sébastien Salas, Valentin Calugaru, Maria Plana Serrahima, Stéphanie Wong Hee Kam, Caroline Hoffmann, Maria Lesnik, Pierre Blanchard, Gilles Poissonnet, Alexandre Bozec, Esma Saada-Bouzid, Franck Jégoux, Joël Castelli, Kiran Devisetty, Yann Lelonge, Eric Jadaud, Laetitia Houdas, Anais Debard, Omar I Vivar, Laetitia Finzi, Alessandra Serra, Isabel Linares, Carlos Arranz Obispo, Juliette Thariat, Audrey Rambeau, Nicolas Fakhry, Laure Santini, Jordi Giralt, Irene Braña García, Manuel Sáez Barba, Philippe Gorphe, Frigyes Helfferich, Adrienn Herczeg, Zsuzsanna Papai, Jacek Fijuth, Zoltán Takácsi-Nagy
<p><strong>Importance: </strong>Intratumoral delivery of NBTXR3 radioenhancer followed by radiation therapy (RT) previously demonstrated safety and feasibility in cisplatin-ineligible and cetuximab-ineligible patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in a dose-escalation phase 1 study.</p><p><strong>Objective: </strong>To evaluate safety and preliminary efficacy of NBTXR3 followed by RT in patients with locally advanced HNSCC ineligible to receive concurrent systemic therapy.</p><p><strong>Design, setting, and participants: </strong>This single-arm, phase 1 dose-expansion nonrandomized clinical trial was conducted across 20 centers in Europe between March 4, 2019, and January 10, 2022. Patients were ineligible for cisplatin and cetuximab per investigator's judgement and had unresectable T3-4 or overall stage III/IVA HNSCC (per the American Joint Committee on Cancer Staging Manual, eighth edition) of the oral cavity or oropharynx. Data were analyzed from July to August 2023.</p><p><strong>Interventions: </strong>Patients received a single intratumoral administration of NBTXR3 in the primary tumor at the recommended dose of 22% of estimated tumor volume (ETV) followed by RT (70 Gy over 35 fractions).</p><p><strong>Main outcomes and measures: </strong>Primary outcomes were safety and efficacy assessed by the objective response rate (ORR) of the NBTXR3-injected primary tumor. Other outcomes included ORR of all lesions (injected primary tumor and noninjected involved lymph nodes), progression-free survival, and overall survival.</p><p><strong>Results: </strong>Of the 56 patients treated, the median (range) age was 72 (44-89) years, 40 (71%) were men, 34 (61%) were 70 years and older, and 36 (64%) had a substantial burden of comorbidities (age-adjusted Charlson Comorbidity Index score of 4 or greater). Median (range) follow-up was 33.0 (0.7-44.6) months. NBTXR3-related treatment-emergent adverse events occurred in 9 patients (16%), of which 6 (11%) were grade 3 or higher, the most frequent being stomatitis (2 [4%]). Objective tumor response was assessed in 44 patients, as 12 patients were unable to complete RT or did not have posttreatment tumor assessment. In this evaluable patient population, the ORR of the injected primary tumor and ORR of all lesions were 82% (95% CI, 67-92) and 80% (95% CI, 65-90), respectively. Among all 56 treated patients, the median progression-free survival was 11.4 months (95% CI, 6.7 to not reached), and the median overall survival was 18.1 months (95% CI, 9.7 to not reached).</p><p><strong>Conclusions and relevance: </strong>This dose-expansion phase 1 nonrandomized clinical trial demonstrated that intratumoral NBTXR3 followed by RT in a high-risk patient population unable to receive cisplatin or cetuximab was feasible and had a preliminary efficacy signal that supports a benefit-risk profile being evaluated in an ongoing randomized phase III trial.</p><p><strong>Trial registration: </str
重要性:在一项剂量递增的1期研究中,在不适合顺铂和西妥昔单抗治疗的局部晚期头颈部鳞状细胞癌(HNSCC)患者中,瘤内给予NBTXR3放射增强剂后进行放射治疗(RT)已经证明了安全性和可行性。目的:评价NBTXR3联合RT治疗局部晚期HNSCC不适合同时接受全身治疗的患者的安全性和初步疗效。设计、环境和参与者:这项单臂、一期剂量扩张非随机临床试验于2019年3月4日至2022年1月10日在欧洲的20个中心进行。根据研究者的判断,患者不适合顺铂和西妥昔单抗,并且口腔或口咽的T3-4期或III/IVA期HNSCC(根据美国癌症分期手册联合委员会,第八版)不可切除。数据分析时间为2023年7月至8月。干预措施:患者在原发肿瘤中接受单次瘤内给药,推荐剂量为估计肿瘤体积(ETV)的22%,然后接受RT (70 Gy / 35份)。主要结局和指标:主要结局以nbtxr3注射原发肿瘤的客观缓解率(ORR)评价安全性和有效性。其他结果包括所有病变(注射原发肿瘤和非注射受累淋巴结)的ORR、无进展生存期和总生存期。结果:56例接受治疗的患者中位(范围)年龄为72岁(44-89岁),40例(71%)为男性,34例(61%)为70岁及以上,36例(64%)有严重的合并症负担(年龄调整的Charlson共病指数评分为4或更高)。中位(范围)随访时间为33.0(0.7-44.6)个月。9例(16%)患者发生nbtxr3相关治疗不良事件,其中6例(11%)为3级及以上,最常见的是口炎(2例[4%])。目的:对44例患者的肿瘤反应进行评估,其中12例患者无法完成RT或未进行治疗后肿瘤评估。在这个可评估的患者群体中,注射原发肿瘤的ORR和所有病变的ORR分别为82% (95% CI, 67-92)和80% (95% CI, 65-90)。在所有56例接受治疗的患者中,中位无进展生存期为11.4个月(95% CI, 6.7至未达到),中位总生存期为18.1个月(95% CI, 9.7至未达到)。结论和相关性:这项剂量扩大的1期非随机临床试验表明,在无法接受顺铂或西妥昔单抗的高风险患者群体中,瘤内NBTXR3随后进行RT治疗是可行的,并且具有初步的疗效信号,支持正在进行的随机III期试验评估的获益-风险特征。试验注册:ClinicalTrials.gov标识符:NCT01946867。
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引用次数: 0
Progressive Left Mandibular Swelling in a Young Man. 进行性左下颌骨肿胀1例。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-22 DOI: 10.1001/jamaoto.2025.5090
Kaili Yang, Mu Wang, Bei Tan
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引用次数: 0
Prognostic Value of Tumor-Informed Circulating Tumor DNA in HPV-Independent Head and Neck Squamous Cell Carcinoma. 肿瘤信息循环肿瘤DNA在不依赖hpv的头颈部鳞状细胞癌中的预后价值。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-22 DOI: 10.1001/jamaoto.2025.4837
Daniel A Ruiz-Torres, Thomas J Roberts, Pan Du, Julia Mendel, Saskia Neagele, Giancarlo Bonora, Frank Zhang, Vasileios Efthymiou, Ross D Merkin, Derrick T Lin, Jonathan J Paly, Mark A Varvares, Daniel G Deschler, Allen L Feng, Jeremy D Richmon, Adam S Fisch, Shidong Jia, Daniel L Faden

Importance: Recurrence rates for locally advanced human papillomavirus (HPV)-independent head and neck squamous cell carcinoma (HNSCC) are high. Circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) assays have shown promise to improve management and surveillance in several tumor types, but their clinical utility in HPV-independent HNSCC remains understudied.

Objective: To evaluate the performance of a tumor-informed ctDNA-based MRD assay in patients with newly diagnosed locally advanced HNSCC.

Design, setting, and participants: Between December 2020 and March 2022, among patients newly diagnosed with locally advanced HNSCC treated with surgery followed by risk-adjusted adjuvant treatment at a large referral center specializing in treatment of HNSCC, ctDNA was assessed before surgery, before the start of adjuvant treatment, within 6 weeks of completion of treatment, and during surveillance. Patients were followed up for at least 12 months after treatment completion. Kaplan-Meier survival analyses were used to compare recurrence-free survival (RFS) and overall survival (OS) between patients who were MRD positive and those who were MRD negative during each time window. Multivariable Cox hazard regressions were used to assess the association between MRD status and outcomes while controlling for established risk factors. Data were analyzed from August 2024 to March 2025.

Intervention: Tumor-informed ctDNA-based MRD testing.

Main outcomes and measures: RFS and OS.

Results: Of 40 included patients, 29 (73%) were male, 38 (95%) had HPV-independent disease, and the median (IQR) age at diagnosis was 63 (28-85) years. A total of 142 samples from 40 patients. A total of 20 patients (50%) experienced recurrence. The presurgery ctDNA detection rate was 97% (35 of 36). MRD positivity within 6 weeks of completion of treatment was associated with worse OS (hazard ratio [HR], 7.15; 95% CI, 1.44-35.34) and RFS (HR, 5.39; 95% CI, 1.98-21.07). MRD positivity during surveillance was associated with worse RFS (HR, 8.27; 95% CI, 2.03-33.64). The median (range) time from first MRD detection to clinical detection of recurrence was 5 (0.2-21.6) months. In multivariable analyses, MRD positivity was associated with worse RFS (HR, 13.84; 95% CI, 2.92-65.68) and worse OS (HR, 18.93; 95% CI, 2.27-157.70).

Conclusions and relevance: In this study, tumor-informed ctDNA MRD positivity was associated with worse RFS and OS in patients with HNSCC. MRD testing could serve as a noninvasive, prognostic biomarker in patients with HPV-independent HNSCC.

重要性:局部晚期人乳头瘤病毒(HPV)不依赖的头颈部鳞状细胞癌(HNSCC)的复发率很高。基于循环肿瘤DNA (ctDNA)的最小残留病(MRD)检测已经显示出改善几种肿瘤类型的管理和监测的希望,但其在hpv非依赖性HNSCC中的临床应用仍有待研究。目的:评价基于ctdna的MRD检测在新诊断的局部晚期HNSCC患者中的表现。设计、环境和参与者:在2020年12月至2022年3月期间,在专门治疗HNSCC的大型转诊中心接受手术后风险调整辅助治疗的新诊断的局部晚期HNSCC患者中,在手术前、辅助治疗开始前、治疗完成后6周内和监测期间评估ctDNA。患者在治疗结束后至少随访12个月。Kaplan-Meier生存分析用于比较MRD阳性和MRD阴性患者在每个时间窗内的无复发生存期(RFS)和总生存期(OS)。在控制既定危险因素的同时,采用多变量Cox风险回归来评估MRD状态与结局之间的关系。数据分析时间为2024年8月至2025年3月。干预:肿瘤知情ctdna为基础的MRD检测。主要结果和指标:RFS和OS。结果:在纳入的40例患者中,29例(73%)为男性,38例(95%)患有hpv非独立性疾病,诊断时的中位(IQR)年龄为63(28-85)岁。40例患者共142份样本。20例(50%)复发。手术ctDNA检出率为97%(35 / 36)。治疗完成6周内MRD阳性与较差的OS(风险比[HR], 7.15; 95% CI, 1.44-35.34)和RFS(风险比[HR], 5.39; 95% CI, 1.98-21.07)相关。监测期间MRD阳性与较差的RFS相关(HR, 8.27; 95% CI, 2.03-33.64)。从首次MRD检测到临床发现复发的中位(范围)时间为5(0.2-21.6)个月。在多变量分析中,MRD阳性与较差的RFS (HR, 13.84; 95% CI, 2.92-65.68)和较差的OS (HR, 18.93; 95% CI, 2.27-157.70)相关。结论和相关性:在本研究中,肿瘤通知ctDNA MRD阳性与HNSCC患者较差的RFS和OS相关。MRD检测可作为非hpv依赖型HNSCC患者的无创预后生物标志物。
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引用次数: 0
Proportion, Morbidity, and Mortality of Acute Invasive Fungal Rhinosinusitis in Immunocompromised Populations: A Systematic Review and Meta-analysis. 免疫功能低下人群急性侵袭性真菌性鼻窦炎的比例、发病率和死亡率:一项系统综述和荟萃分析。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-22 DOI: 10.1001/jamaoto.2025.5077
Estephania Candelo, Srivatsa Surya Vasudevan, Gene C Osuoha, Isaac Elijah, Alaa Alhalabi, Byron A Ward, Oriana Arias-Valderrama, Cynthia Chelf, Jorge A Abello-Vaamonde, Abigail Verez, Angela M Donaldson

Importance: Acute invasive fungal rhinosinusitis (AIFRS) is a rapidly progressive and potentially life-threatening infection that predominantly affects immunocompromised patients. Recent advances in diagnostic imaging, antifungal therapy, and surgical techniques may have altered its incidence, morbidity, and mortality.

Objective: To evaluate temporal trends in the pooled proportion, morbidity, and mortality of AIFRS in immunocompromised patients and assess the association of diagnostic and therapeutic advances.

Data sources: Systematic searches of Ovid MEDLINE, Ovid Embase, PubMed, Scopus, Web of Science, Cochrane, and Google Scholar from 1977 through October 20, 2025, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Study selection: Prospective, retrospective, and cross-sectional studies and case series reporting pooled proportion, morbidity, or mortality of AIFRS in immunocompromised patients were included. Non-English articles, reviews, editorials, and studies with fewer than 10 patients were excluded.

Data extraction and synthesis: Two independent reviewers extracted data using standardized templates; disagreements were resolved by consensus. Risk of bias was assessed using the Newcastle-Ottawa Scale and Murad tool for case series. Random-effects meta-analysis generated pooled proportion, morbidity, and mortality rates with 95% CIs. Heterogeneity was quantified using I2 statistics. Meta-regression and sensitivity analyses evaluated temporal trends and study-level effects.

Main outcomes and measures: Pooled proportion, morbidity, and mortality rates of AIFRS stratified by publication period (1983-2012 vs 2013-2025).

Results: A total of 205 studies comprising 48 437 immunocompromised patients (median [range] age, 49.4 [5.2-68.8] years), including 10 311 (21.3%) with AIFRS, were analyzed. The pooled proportion was 11.8% (95% CI, 7.9%-17.2%), rising to 16.6% (95% CI, 8.7%-29.2%) in studies from 2013 to 2025. Overall mortality was 31.2% (95% CI, 28.3%-34.3%), declining from 41.9% (95% CI, 35.0%-49.1%) before 2013 to 28.2% (95% CI, 25.1%-31.4%) after 2013. Morbidity was 37.0% (95% CI, 32.9%-41.4%), with similar rates across periods (39.3% before 2013 vs 36.4% after 2013). The most common complications were vision loss, exophthalmos/proptosis, and orbital exenteration.

Conclusions and relevance: This systematic review and meta-analysis suggests that the pooled proportion of AIFRS among immunocompromised patients has increased while mortality has declined, reflecting advances in diagnostic and therapeutic approaches. Early detection and aggressive management remain critical to improving outcomes.

重要性:急性侵袭性真菌性鼻窦炎(AIFRS)是一种快速进展且可能危及生命的感染,主要影响免疫功能低下的患者。诊断成像、抗真菌治疗和手术技术的最新进展可能改变了其发病率、发病率和死亡率。目的:评估免疫功能低下患者AIFRS的合并比例、发病率和死亡率的时间趋势,并评估诊断和治疗进展的相关性。数据来源:系统搜索Ovid MEDLINE, Ovid Embase, PubMed, Scopus, Web of Science, Cochrane和谷歌Scholar,从1977年到2025年10月20日,遵循系统评价和元分析指南的首选报告项目。研究选择:纳入前瞻性、回顾性和横断面研究,以及报告免疫功能低下患者AIFRS合并比例、发病率或死亡率的病例系列。非英语文章、评论、社论和少于10例患者的研究被排除在外。数据提取和综合:两名独立审稿人使用标准化模板提取数据;分歧通过协商一致得到解决。使用纽卡斯尔-渥太华量表和Murad工具对病例系列进行偏倚风险评估。随机效应荟萃分析得出95% ci的合并比例、发病率和死亡率。异质性采用I2统计量进行量化。meta回归和敏感性分析评估了时间趋势和研究水平的影响。主要结局和指标:按出版期(1983-2012 vs 2013-2025)对AIFRS进行分层的合并比例、发病率和死亡率。结果:共分析了205项研究,包括48 437例免疫功能低下患者(年龄中位数为49.4[5.2-68.8]岁),其中10 311例(21.3%)为AIFRS患者。合并比例为11.8% (95% CI, 7.9%-17.2%),在2013年至2025年的研究中上升至16.6% (95% CI, 8.7%-29.2%)。总死亡率为31.2% (95% CI, 28.3% ~ 34.3%),从2013年前的41.9% (95% CI, 35.0% ~ 49.1%)下降到2013年后的28.2% (95% CI, 25.1% ~ 31.4%)。发病率为37.0% (95% CI, 32.9%-41.4%),各时期的发病率相似(2013年之前为39.3%,2013年之后为36.4%)。最常见的并发症是视力丧失、眼球突出/突出和眼窝剜出。结论和相关性:本系统综述和荟萃分析表明,免疫功能低下患者中AIFRS的总比例有所增加,而死亡率有所下降,反映了诊断和治疗方法的进步。早期发现和积极治疗对于改善预后仍然至关重要。
{"title":"Proportion, Morbidity, and Mortality of Acute Invasive Fungal Rhinosinusitis in Immunocompromised Populations: A Systematic Review and Meta-analysis.","authors":"Estephania Candelo, Srivatsa Surya Vasudevan, Gene C Osuoha, Isaac Elijah, Alaa Alhalabi, Byron A Ward, Oriana Arias-Valderrama, Cynthia Chelf, Jorge A Abello-Vaamonde, Abigail Verez, Angela M Donaldson","doi":"10.1001/jamaoto.2025.5077","DOIUrl":"10.1001/jamaoto.2025.5077","url":null,"abstract":"<p><strong>Importance: </strong>Acute invasive fungal rhinosinusitis (AIFRS) is a rapidly progressive and potentially life-threatening infection that predominantly affects immunocompromised patients. Recent advances in diagnostic imaging, antifungal therapy, and surgical techniques may have altered its incidence, morbidity, and mortality.</p><p><strong>Objective: </strong>To evaluate temporal trends in the pooled proportion, morbidity, and mortality of AIFRS in immunocompromised patients and assess the association of diagnostic and therapeutic advances.</p><p><strong>Data sources: </strong>Systematic searches of Ovid MEDLINE, Ovid Embase, PubMed, Scopus, Web of Science, Cochrane, and Google Scholar from 1977 through October 20, 2025, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.</p><p><strong>Study selection: </strong>Prospective, retrospective, and cross-sectional studies and case series reporting pooled proportion, morbidity, or mortality of AIFRS in immunocompromised patients were included. Non-English articles, reviews, editorials, and studies with fewer than 10 patients were excluded.</p><p><strong>Data extraction and synthesis: </strong>Two independent reviewers extracted data using standardized templates; disagreements were resolved by consensus. Risk of bias was assessed using the Newcastle-Ottawa Scale and Murad tool for case series. Random-effects meta-analysis generated pooled proportion, morbidity, and mortality rates with 95% CIs. Heterogeneity was quantified using I2 statistics. Meta-regression and sensitivity analyses evaluated temporal trends and study-level effects.</p><p><strong>Main outcomes and measures: </strong>Pooled proportion, morbidity, and mortality rates of AIFRS stratified by publication period (1983-2012 vs 2013-2025).</p><p><strong>Results: </strong>A total of 205 studies comprising 48 437 immunocompromised patients (median [range] age, 49.4 [5.2-68.8] years), including 10 311 (21.3%) with AIFRS, were analyzed. The pooled proportion was 11.8% (95% CI, 7.9%-17.2%), rising to 16.6% (95% CI, 8.7%-29.2%) in studies from 2013 to 2025. Overall mortality was 31.2% (95% CI, 28.3%-34.3%), declining from 41.9% (95% CI, 35.0%-49.1%) before 2013 to 28.2% (95% CI, 25.1%-31.4%) after 2013. Morbidity was 37.0% (95% CI, 32.9%-41.4%), with similar rates across periods (39.3% before 2013 vs 36.4% after 2013). The most common complications were vision loss, exophthalmos/proptosis, and orbital exenteration.</p><p><strong>Conclusions and relevance: </strong>This systematic review and meta-analysis suggests that the pooled proportion of AIFRS among immunocompromised patients has increased while mortality has declined, reflecting advances in diagnostic and therapeutic approaches. Early detection and aggressive management remain critical to improving outcomes.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12828657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Suggestions for Illustration and Inclusion of Afrin Use-Reply. 关于说明和包含Afrin用法的建议-回复。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-15 DOI: 10.1001/jamaoto.2025.4981
Claire M Lawlor, Alexandra Espinel
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引用次数: 0
Cochlear Implant Candidacy Support Tool Using Conjunctive Consolidation. 使用结体巩固的人工耳蜗候选性支持工具。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-15 DOI: 10.1001/jamaoto.2025.4882
Kevin Chen, William Bray, Dorina Kallogjeri, Jay F Piccirillo, Cole Pavelchek, Mona Jawad, Amanda Ortmann, Shannon Lefler, Nedim Durakovic, Pawina Jiramongkolchai, Jacques A Herzog, Craig A Buchman, Matthew A Shew

Importance: Despite the proven benefits of a cochlear implant, utilization rates remain low. Current screening tools have improved awareness but rely on binary classification (candidate vs noncandidate), limiting individualized counseling and shared decision-making.

Objective: To develop a risk stratification system for cochlear implant candidacy based on routine audiometric data, enabling individualized estimates of cochlear implant candidacy likelihood, supporting improved shared decision-making.

Design, setting, and participants: This retrospective cohort study including adults with hearing loss was conducted at a single tertiary academic center.

Methods: Consonant-nucleus-consonant (CNC) scores of 50% or lower were used as candidacy criteria. A conjunctive consolidation approach was used to classify patients into 4 audiometric severity stages, combining pure tone average (PTA) and word recognition score (WRS) cutoffs. Groups were informed by clinical judgment and statistical isometry. Discriminative power was assessed using the C statistic. A secondary stratification system was developed using AzBio sentences (≤60% in quiet or +10 dB on signal-to-noise ratio examination) to define candidacy.

Results: Among 1312 patients with complete data and PTA below 100 dB, 782 (59.6%) met cochlear implant candidacy criteria based on CNC scores of 50% or lower. The 4-stage classification system showed a clear gradient of candidacy likelihood, ranging from 2.8% in stage 0 to 88.5% in stage 3, with strong discriminative power (C = 0.83; 95% CI, 0.81-0.85). Similar trends were observed when candidacy was defined by AzBio scores, with strong model discrimination (C = 0.80; 95% CI, 0.77-0.83). Demographic factors such as age and duration of hearing loss did not enhance model performance and were excluded.

Conclusion: This cohort study found that patients with hearing loss can be effectively stratified by likelihood of cochlear implant candidacy using routine audiometric data. This 4-level classification system offers a simple, clinically intuitive method to estimate candidacy probability, moving beyond binary screening and supporting personalized, data-driven decision-making between clinicians and patients.

重要性:尽管人工耳蜗的益处已被证实,但其使用率仍然很低。目前的筛查工具提高了人们的认识,但依赖于二元分类(候选人与非候选人),限制了个性化咨询和共同决策。目的:建立基于常规听力学数据的人工耳蜗候选风险分层系统,实现人工耳蜗候选可能性的个性化评估,支持改进的共同决策。设计、环境和参与者:这项回顾性队列研究包括听力损失的成年人,在一个单一的三级学术中心进行。方法:以辅音-核-辅音(CNC)分数在50%及以下为候选标准。结合纯音平均(PTA)和单词识别评分(WRS)临界值,采用联合巩固法将患者分为4个听力严重程度阶段。各组采用临床判断和统计等距法。判别能力采用C统计量进行评定。使用AzBio语句(安静≤60%或信噪比检查+10 dB)开发了二级分层系统来确定候选资格。结果:在1312例数据完整且PTA低于100 dB的患者中,782例(59.6%)符合基于CNC评分为50%或更低的人工耳蜗候选标准。4阶段分类系统显示出明显的候选可能性梯度,从0阶段的2.8%到3阶段的88.5%,具有较强的判别能力(C = 0.83; 95% CI, 0.81-0.85)。当候选资格由AzBio分数定义时,观察到类似的趋势,具有很强的模型歧视(C = 0.80; 95% CI, 0.77-0.83)。年龄和听力损失持续时间等人口统计学因素不能提高模型的性能,因此被排除在外。结论:这项队列研究发现,听力损失患者可以通过常规听力测量数据有效地分层人工耳蜗候选的可能性。这个4级分类系统提供了简单的、临床直观的方法来估计候选概率,超越了二元筛选,并支持临床医生和患者之间个性化的、数据驱动的决策。
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引用次数: 0
Suggestions for Illustration and Inclusion of Afrin Use. 说明和包含Afrin使用的建议。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-15 DOI: 10.1001/jamaoto.2025.4982
Madelyn Frank, Nikila Raol
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引用次数: 0
Cochlear Implant User Affect and Reported Quality of Life. 人工耳蜗使用者的影响和报告的生活质量。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-08 DOI: 10.1001/jamaoto.2025.4850
Sammy Y Gao, Brittany N Hand, Craig Salvador, Christian M Shannon, Priyanka Reddy, Judy R Dubno, Theodore R McRackan
<p><strong>Importance: </strong>The use of patient-reported outcome measures to assess outcomes in adults who use cochlear implants has increased, as highlighted by the inclusion of the Cochlear Implant Quality of Life (CIQOL) instruments in the Minimal Speech Testing Battery, version 3. However, the self-reported nature of these instruments raises questions regarding how psychosocial characteristics impact responses.</p><p><strong>Objective: </strong>To assess whether affect and CIQOL domain scores change over time and whether affect is associated with CIQOL domain scores.</p><p><strong>Design, setting, and participants: </strong>Prospective longitudinal cohort study in adult cochlear implant candidates (aged 18-89 years) meeting indications for cochlear implantation based on bilateral moderate to profound hearing loss with aided sentence recognition scores 60% or less between September 19, 2019, and October 8, 2021, in a single tertiary otolaryngology referral center. Patients receiving a second cochlear implant and those without Montreal Cognitive Assessment scores were excluded. Follow-up duration was 1 year. Data analysis was performed between October 15, 2023, and August 5, 2025.</p><p><strong>Main outcomes and measures: </strong>Standard speech recognition tasks, the CIQOL-35 Profile, and the Positive Affect and Negative Affect Schedule (PANAS) at 4 time points were used: pre-cochlear implantation and at 3, 6, and 12 months post activation. Cohen d was used to calculate effect sizes of changes in PANAS and CIQOL domain scores. Multivariable repeated-measure mixed-effect linear models were applied to determine how positive affect and negative affect scores were associated with CIQOL domain scores.</p><p><strong>Results: </strong>Initially, 60 participants were enrolled, and 45 participants (75%) completed the study (25 female [55.6%]; median age at implantation, 67.0 [IQR, 55.0-72.0] years). From pre-cochlear implant to 12 months post activation, all CIQOL-35 domains improved. The smallest median increase was 17.7 points in listening effort domain (baseline median, 20.6 [IQR, 9.3-28.3] compared with end point median, 38.3 [IQR, 31.7-51.8]; Cohen d = 1.12; 95% CI, 0.67-1.57) and the largest was 27.8 points in the environment domain (baseline median, 31.2 [IQR, 20.6-45.1] compared with end point median, 59.0 [IQR, 48.9-65.7]; Cohen d = 1.25; 95% CI, 0.79-1.72). Positive affect increased by a median of 2 points (baseline median, 35.0 [IQR, 28.0-38.0] compared with end point median, 37.0 [IQR, 33.0-41.0]; Cohen d = 0.61; 95% CI, 0.17-1.05), and negative affect decreased by a median of 5 points (baseline median, 19.0 [IQR, 16.0-23.0] compared with end point median, 14.0 [IQR, 10.0-19.0]; Cohen d = -0.60; 95% CI, -1.04 to -0.16). In multivariable models, the regression coefficients for positive and negative affect were associated with CIQOL domain scores. For positive affect, coefficients ranged from 0.7 (95% CI, 0.4-1.0) in the communication dom
重要性:使用患者报告的结果测量来评估使用人工耳蜗的成人的结果已经增加,正如在最小语音测试电池版本3中纳入了人工耳蜗生活质量(CIQOL)仪器所强调的那样。然而,这些工具的自我报告性质提出了关于社会心理特征如何影响反应的问题。目的:评估情感和CIQOL域评分是否随时间变化,以及情感是否与CIQOL域评分相关。设计、环境和参与者:在2019年9月19日至2021年10月8日期间,在单一三级耳鼻喉科转诊中心,对符合人工耳蜗植入指征的成人人工耳蜗候选人(年龄18-89岁)进行前瞻性纵向队列研究,该研究基于双侧中度至重度听力损失,辅助句子识别评分为60%或以下。接受第二次人工耳蜗植入的患者和没有蒙特利尔认知评估评分的患者被排除在外。随访时间为1年。数据分析时间为2023年10月15日至2025年8月5日。主要结果和测量方法:采用标准语音识别任务、CIQOL-35量表和4个时间点的积极情绪和消极情绪量表(PANAS):人工耳蜗植入前和激活后3、6和12个月。采用Cohen d计算PANAS和CIQOL域评分变化的效应量。采用多变量重复测量混合效应线性模型来确定积极影响和消极影响评分与CIQOL域评分之间的关系。结果:最初,60名受试者入组,45名受试者(75%)完成研究(25名女性[55.6%],植入时中位年龄67.0岁[IQR, 55.0-72.0]岁)。从人工耳蜗植入前到激活后12个月,所有CIQOL-35结构域均有改善。听力努力领域的中位数增幅最小,为17.7分(基线中位数为20.6 [IQR, 9.3-28.3],终点中位数为38.3 [IQR, 31.7-51.8]; Cohen d = 1.12; 95% CI, 0.67-1.57);环境领域的中位数增幅最大,为27.8分(基线中位数为31.2 [IQR, 20.6-45.1],终点中位数为59.0 [IQR, 48.9-65.7]; Cohen d = 1.25; 95% CI, 0.79-1.72)。积极影响中位数增加了2个点(基线中位数为35.0 [IQR, 28.0-38.0],终点中位数为37.0 [IQR, 33.0-41.0]; Cohen d = 0.61; 95% CI, 0.17-1.05),消极影响中位数减少了5个点(基线中位数为19.0 [IQR, 16.0-23.0],终点中位数为14.0 [IQR, 10.0-19.0]; Cohen d = -0.60; 95% CI, -1.04至-0.16)。在多变量模型中,积极和消极影响的回归系数与CIQOL域得分相关。对于积极影响,系数范围从0.7 (95% CI, 0.4-1.0)在沟通领域到1.4 (95% CI, 1.0-1.9)在社会领域。对于负面影响,环境领域的系数范围为-0.8 (95% CI, -1.2至-0.4),社会领域的系数范围为-1.6 (95% CI, -2.1至-1.2),这代表了在所有领域观察到的最高回归系数,两者都影响测量。结论和相关性:在本研究中,患者情感与CIQOL-35域得分相关,尤其是在社会和情感领域。然而,由于回归系数较低,影响的变化不太可能与CIQOL域评分的临床有意义的变化相关。
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引用次数: 0
A Novel Application-Based Test for Rapid Screening of Olfactory Dysfunction. 一种新的基于应用的嗅觉功能障碍快速筛查方法。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-08 DOI: 10.1001/jamaoto.2025.4965
Benjamin J Bernard, Omer Baker, Alena Pauley, Clifford Jiajun He, Vivian Vo, Derek Toomre, Jeremy S Rossman, Carol H Yan

Importance: Olfactory dysfunction (OD) is a common and underdiagnosed condition that is associated with increased morbidity and mortality. However, existing smell tests can be costly and time intensive and can lack scalability.

Objective: To evaluate the performance of a novel, self-administered mobile application-based olfactory screening tool.

Design, setting, and participants: This diagnostic study was conducted at a tertiary academic medical center in the US between June 1 and December 31, 2024, to assess the performance of a novel olfactory test for the detection of OD. English-speaking individuals who were 18 years or older were recruited for the study.

Intervention: Completion of a 5-item, mobile application-based smell identification test. A subset of participants also completed a comparator test.

Main outcomes and measures: Diagnostic performance of a novel smell identification test in detecting OD compared with that of a comparator test. Secondary outcomes included correlation with subjective olfactory function.

Results: The study included 484 participants, 243 (50.2%) of whom were men. The mean (SD) age was 53.4 (18.5) years; 160 participants (33.1%) were 65 years or older. Seventy-four participants (15.3%) reported having subjective OD. Participants with self-reported OD had significantly lower novel test scores than those with normosmia (2.54 vs 3.50; mean difference, -0.96 [95% CI, -1.24 to -0.68]). At a cut point of less than 3, the novel test achieved an area under the curve of 0.87 (95% CI, 0.78-0.96), a sensitivity of 74% (95% CI, 51%-88%), and a specificity of 86% (95% CI, 72%-93%). Novel test scores correlated with comparator test scores (r = 0.74 [95% CI, 0.59-0.83]) as well as self-reported smell (r = 0.34 [95% CI, 0.25-0.41]), with acceptable internal consistency (Cronbach α = 0.70-0.71). Novel test scores declined with age, and women aged 18 to 29 years had higher scores than men in the same age group.

Conclusions and relevance: The findings of this diagnostic study suggest that the novel study test is a rapid and reliable olfactory screening tool that correlates well with validated smell tests and has potential for longitudinal screening of OD in the clinical setting.

重要性:嗅觉功能障碍(OD)是一种常见的未被诊断的疾病,与发病率和死亡率增加有关。然而,现有的气味测试既昂贵又耗时,而且缺乏可伸缩性。目的:评价一种新颖的、自我管理的、基于移动应用程序的嗅觉筛查工具的性能。设计、环境和参与者:这项诊断研究于2024年6月1日至12月31日在美国的一家三级学术医疗中心进行,以评估一种新型嗅觉测试检测OD的性能。这项研究招募了18岁以上说英语的人。干预:完成5项基于移动应用程序的气味识别测试。一部分参与者还完成了比较测试。主要结果和措施:一种新的气味识别测试在检测OD的诊断性能与比较试验的比较。次要结果包括与主观嗅觉功能的相关性。结果:共纳入484例受试者,其中243例(50.2%)为男性。平均(SD)年龄为53.4(18.5)岁;160名参与者(33.1%)年龄在65岁或以上。74名参与者(15.3%)报告主观吸毒过量。自我报告吸毒成瘾的参与者的新测试分数显著低于正常缺失的参与者(2.54 vs 3.50;平均差异为-0.96 [95% CI, -1.24至-0.68])。在小于3的切点处,新检验的曲线下面积为0.87 (95% CI, 0.78-0.96),灵敏度为74% (95% CI, 51%-88%),特异性为86% (95% CI, 72%-93%)。新测试分数与比较测试分数(r = 0.74 [95% CI, 0.59-0.83])以及自我报告的气味(r = 0.34 [95% CI, 0.25-0.41])相关,具有可接受的内部一致性(Cronbach α = 0.70-0.71)。新测试的得分随着年龄的增长而下降,18到29岁的女性得分高于同年龄段的男性。结论和相关性:本诊断研究的结果表明,新的研究测试是一种快速可靠的嗅觉筛查工具,与经过验证的嗅觉测试具有良好的相关性,并且在临床环境中具有纵向筛查OD的潜力。
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引用次数: 0
Why Hearing Health Must Be Part of Voice Biomarker Research. 为什么听力健康必须成为声音生物标志物研究的一部分。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-02 DOI: 10.1001/jamaoto.2025.4836
J M Warith Rahman, Micah Boyer, Victoria A Sanchez, Yaël Bensoussan
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引用次数: 0
期刊
JAMA otolaryngology-- head & neck surgery
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