Pub Date : 2026-01-29DOI: 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
{"title":"Intratumoral Radioenhancer Nanoparticle NBTXR3 Followed by Radiotherapy in Head and Neck Cancer: A Phase 1 Dose-Expansion Nonrandomized Clinical Trial.","authors":"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","doi":"10.1001/jamaoto.2025.4939","DOIUrl":"10.1001/jamaoto.2025.4939","url":null,"abstract":"<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","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12856740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146085944","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}
Pub Date : 2026-01-22DOI: 10.1001/jamaoto.2025.5090
Kaili Yang, Mu Wang, Bei Tan
{"title":"Progressive Left Mandibular Swelling in a Young Man.","authors":"Kaili Yang, Mu Wang, Bei Tan","doi":"10.1001/jamaoto.2025.5090","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.5090","url":null,"abstract":"","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":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-22DOI: 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.
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.
{"title":"Prognostic Value of Tumor-Informed Circulating Tumor DNA in HPV-Independent Head and Neck Squamous Cell Carcinoma.","authors":"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","doi":"10.1001/jamaoto.2025.4837","DOIUrl":"10.1001/jamaoto.2025.4837","url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the performance of a tumor-informed ctDNA-based MRD assay in patients with newly diagnosed locally advanced HNSCC.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Intervention: </strong>Tumor-informed ctDNA-based MRD testing.</p><p><strong>Main outcomes and measures: </strong>RFS and OS.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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.</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/PMC12828654/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018539","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}
Pub Date : 2026-01-22DOI: 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.
{"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}
Pub Date : 2026-01-15DOI: 10.1001/jamaoto.2025.4981
Claire M Lawlor, Alexandra Espinel
{"title":"Suggestions for Illustration and Inclusion of Afrin Use-Reply.","authors":"Claire M Lawlor, Alexandra Espinel","doi":"10.1001/jamaoto.2025.4981","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.4981","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145989487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-15DOI: 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.
{"title":"Cochlear Implant Candidacy Support Tool Using Conjunctive Consolidation.","authors":"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","doi":"10.1001/jamaoto.2025.4882","DOIUrl":"10.1001/jamaoto.2025.4882","url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study including adults with hearing loss was conducted at a single tertiary academic center.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12809416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145989480","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}
Pub Date : 2026-01-15DOI: 10.1001/jamaoto.2025.4982
Madelyn Frank, Nikila Raol
{"title":"Suggestions for Illustration and Inclusion of Afrin Use.","authors":"Madelyn Frank, Nikila Raol","doi":"10.1001/jamaoto.2025.4982","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.4982","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145989425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-08DOI: 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
{"title":"Cochlear Implant User Affect and Reported Quality of Life.","authors":"Sammy Y Gao, Brittany N Hand, Craig Salvador, Christian M Shannon, Priyanka Reddy, Judy R Dubno, Theodore R McRackan","doi":"10.1001/jamaoto.2025.4850","DOIUrl":"10.1001/jamaoto.2025.4850","url":null,"abstract":"<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","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12784261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145932764","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}
Pub Date : 2026-01-08DOI: 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.
{"title":"A Novel Application-Based Test for Rapid Screening of Olfactory Dysfunction.","authors":"Benjamin J Bernard, Omer Baker, Alena Pauley, Clifford Jiajun He, Vivian Vo, Derek Toomre, Jeremy S Rossman, Carol H Yan","doi":"10.1001/jamaoto.2025.4965","DOIUrl":"10.1001/jamaoto.2025.4965","url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the performance of a novel, self-administered mobile application-based olfactory screening tool.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Intervention: </strong>Completion of a 5-item, mobile application-based smell identification test. A subset of participants also completed a comparator test.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions and relevance: </strong>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.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12784269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933333","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}
Pub Date : 2026-01-02DOI: 10.1001/jamaoto.2025.4836
J M Warith Rahman, Micah Boyer, Victoria A Sanchez, Yaël Bensoussan
{"title":"Why Hearing Health Must Be Part of Voice Biomarker Research.","authors":"J M Warith Rahman, Micah Boyer, Victoria A Sanchez, Yaël Bensoussan","doi":"10.1001/jamaoto.2025.4836","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.4836","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6,"publicationDate":"2026-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145889263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}