Alexandra Gey, Clemens Honeder, Julia Reiber, Robert Honigmann, Jonas Zirkler, Andreas Wienke, Torsten Rahne, Stefan K Plontke
{"title":"Tympanoplasty With Eustachian Tube Balloon Dilation for Chronic Inflammatory Middle Ear Disease: A Randomized Clinical Trial.","authors":"Alexandra Gey, Clemens Honeder, Julia Reiber, Robert Honigmann, Jonas Zirkler, Andreas Wienke, Torsten Rahne, Stefan K Plontke","doi":"10.1001/jamaoto.2025.0904","DOIUrl":"10.1001/jamaoto.2025.0904","url":null,"abstract":"<p><strong>Importance: </strong>Eustachian tube balloon dilation (ETBD) is increasingly used to treat Eustachian tube (ET) dysfunction, but its benefit in patients requiring tympanoplasty for chronic inflammatory middle ear disease is unclear.</p><p><strong>Objective: </strong>To evaluate the efficacy of additional ETBD on the Eustachian Tube Score (ETS), hearing outcomes, and subjective ET function in patients with obstructive ET dysfunction undergoing tympanoplasty.</p><p><strong>Design, setting, and participants: </strong>This parallel-group, single-blind, monocentric, randomized clinical trial included patients with chronic inflammatory middle ear disease and ET dysfunction seen at a tertiary referral center and scheduled for tympanoplasty between January 2015 and November 2019. Data were analyzed between June 2022 and December 2023.</p><p><strong>Intervention: </strong>Patients were randomized to tympanoplasty only or an additional ETBD of the affected side.</p><p><strong>Main outcomes and measures: </strong>The main outcome was the change in ETS, and secondary outcome measures were change in the air-bone gap (ABG) and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) scores.</p><p><strong>Results: </strong>From 76 randomized participants, 68 were included in the intention-to-treat analysis. Of the 34 patients in the tympanoplasty group, 20 participants (59%) were female, and the mean (SD) age was 53.4 (12.5) years. Of the 34 patients in the tympanoplasty plus ETBD group, 13 participants (38%) were female, and the mean (SD) age was 51.4 (14.5) years. During the first 12 months after the procedure, the difference in mean ETS changes between the tympanoplasty (1.62 [95% CI, 0.66-2.59]) and the tympanoplasty plus ETBD group (1.41 [95% CI, 0.43-2.39]) was 0.21 (95% CI, -1.17 to 1.59). These results rule out the possibility of a clinically meaningful difference of 3 points or more in ETS. Twelve months after the procedure, ABG improved from 26.1 dB to 19.0 dB hearing loss in the tympanoplasty group and from 30.1 dB to 20.1 dB hearing loss in the tympanoplasty plus ETBD group. The difference in ABG changes between the groups was -2.8 dB (95% CI, -9.1 dB to 3.5 dB), and the difference in mean ETDQ-7 changes was -0.2 (95% CI, -3.4 to 3.1).</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial, the addition of ETBD to tympanoplasty in patients with chronic inflammatory middle ear disease and ET dysfunction did not improve the outcome regarding ETS, ABG, or subjective long-term ET function. ETBD should, therefore, not be routinely performed as an add-on procedure to tympanoplasty for this indication. Larger multicentric randomized trials could provide more insights into the efficacy of ETBD in patients with chronic inflammatory middle ear disease undergoing tympanoplasty and would allow for specific subgroup analyses.</p><p><strong>Trial registration: </strong>German Clinical Trials Register Identifier: DRKS00031807.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082485/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078102","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}
Yu-Hsiang Wu, Elizabeth Stangl, Kjersten Branscome, Jacob Oleson, Todd Ricketts
{"title":"Hearing Aid Service Models, Technology, and Patient Outcomes: A Randomized Clinical Trial.","authors":"Yu-Hsiang Wu, Elizabeth Stangl, Kjersten Branscome, Jacob Oleson, Todd Ricketts","doi":"10.1001/jamaoto.2025.1008","DOIUrl":"10.1001/jamaoto.2025.1008","url":null,"abstract":"<p><strong>Importance: </strong>The poor affordability of hearing aids (HAs) limits their adoption. To justify higher costs, HAs fitted by audiologists (AUD service model) and high-end HAs should deliver better outcomes than over-the-counter (OTC) service models and low-end HAs.</p><p><strong>Objective: </strong>To determine the effect of HA service models (AUD, OTC, and a hybrid OTC+ model) and technology levels (high end and low end) on patient outcomes.</p><p><strong>Design, setting, and participants: </strong>This randomized clinical trial was conducted at the University of Iowa and Vanderbilt University Medical Center in research laboratories from February 2019 to December 2023 and included adults older than 55 years with mild to moderate hearing loss and no previous HA experience who were randomly assigned to 1 of 6 parallel groups, representing factorial combinations of 3 service models and 2 technology levels. The data were analyzed between January 2024 and March 2024.</p><p><strong>Interventions: </strong>The trial included 3 service models: AUD, in which audiologists fitted prescription HAs following best practices; OTC+, in which audiologists provided limited services for OTC HAs; and OTC, in which participants independently used OTC HAs. OTC HAs were simulated using prescription HAs. Two models of prescription HAs were used throughout the trial: a high-end HA with advanced features and a low-end HA.</p><p><strong>Main outcomes and measures: </strong>The primary outcome measure was the Glasgow Hearing Aid Benefit Profile (GHABP), which was administered using ecological momentary assessment (EMA). EMA-GHABP was conducted preintervention and throughout the seventh week postintervention.</p><p><strong>Results: </strong>A total of 245 participants completed the study (121 women [49.4%]; mean [SD] age, 67.7 [8.1] years). After controlling for preintervention scores, the postintervention EMA-GHABP global score (ranging from 1 to 5) for AUD was significantly higher (indicating better outcomes) than for OTC+ and OTC by 0.33 points (95% CI, 0.14-0.52) and 0.32 points (95% CI, 0.13-0.51), respectively. The difference between OTC+ and OTC was not significant (0.02 points, 95% CI, -0.21 to 0.18). Nevertheless, EMA-GHABP global scores for OTC+ and OTC were close to 4 points, indicating positive outcomes. The effect of technology level and interaction between service model and technology level were not significant.</p><p><strong>Conclusions and relevance: </strong>The trial results suggest that while OTC+ and OTC were effective, they did not achieve the same outcomes as AUD. As high-end and low-end HAs yielded similar outcomes, support for the higher cost of high-end HAs was not identified for individuals with mild to moderate hearing loss.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03579563.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12082484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078084","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}
Melissa C White, Rong Jiang, Nosayaba Osazuwa-Peters
{"title":"Insights on Distress Measurement in Head and Neck Cancer-Reply.","authors":"Melissa C White, Rong Jiang, Nosayaba Osazuwa-Peters","doi":"10.1001/jamaoto.2025.0891","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0891","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078092","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}
Connor K Klingele, Alexander J Straughan, Neal R Godse
{"title":"Sinus Wall Changes in a Patient With Chronic Rhinosinusitis.","authors":"Connor K Klingele, Alexander J Straughan, Neal R Godse","doi":"10.1001/jamaoto.2025.0926","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0926","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078096","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}
{"title":"Insights on Distress Measurement in Head and Neck Cancer.","authors":"Ching-Nung Wu, Wei-Chih Chen, Sheng-Dean Luo","doi":"10.1001/jamaoto.2025.0888","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0888","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078090","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}
Linda X Yin, Cecelia M Hidalgo, Aaron W Bogan, Danielle E Hunter, Kathleen R Bartemes, Kendall K Tasche, Eric J Moore, Daniel L Price, Daniel J Ma, Michelle A Neben-Wittich, Scott C Lester, Katharine A Price, Patrick W McGarrah, Harry E Fuentes Bayne, David M Routman, Kathryn M Van Abel
{"title":"Postoperative ctHPVDNA Kinetics in Patients With HPV-Related Oropharyngeal Cancer.","authors":"Linda X Yin, Cecelia M Hidalgo, Aaron W Bogan, Danielle E Hunter, Kathleen R Bartemes, Kendall K Tasche, Eric J Moore, Daniel L Price, Daniel J Ma, Michelle A Neben-Wittich, Scott C Lester, Katharine A Price, Patrick W McGarrah, Harry E Fuentes Bayne, David M Routman, Kathryn M Van Abel","doi":"10.1001/jamaoto.2025.1606","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.1606","url":null,"abstract":"<p><strong>Importance: </strong>Circulating tumor human papillomavirus DNA (ctHPVDNA) is an important biomarker for the presence of HPV-associated oropharyngeal squamous cell carcinoma (OPSCC), but little is known about early postoperative kinetics of ctHPVDNA clearance.</p><p><strong>Objective: </strong>To investigate early postoperative kinetics of ctHPVDNA in patients with HPV-associated OPSCC.</p><p><strong>Design, setting, and participants: </strong>This prospective cohort study was conducted at a single tertiary care center from January 4, 2020, to January 26, 2023. Patients with newly diagnosed HPV-associated OPSCC undergoing surgical management were enrolled. HPV status was defined as positive if findings of p16 immunohistochemistry and/or HPV DNA in situ hybridization and/or E6/E7 RNA in situ hybridization were positive. Exclusion criteria included history of prior head and neck cancer and metastatic disease at presentation. Data were analyzed from September 1, 2024, to April 25, 2025.</p><p><strong>Exposures: </strong>Transoral robotic surgery with concurrent neck dissection.</p><p><strong>Main outcomes and measures: </strong>Blood was drawn prior to surgery (pretreatment), 1 to 2 days after surgery (postoperative days 1 to 2), and approximately 2 weeks after surgery (postoperative week 2; range, 8 to 20 days). ctHPVDNA was quantified by a tumor tissue-modified viral (TTMV) HPV DNA test. Correlations were tested between the pretreatment and postoperative day 1 to 2 TTMV HPV DNA levels using Gaussian regression. Concordance between detectability at postoperative day 1 to 2 and postoperative week 2 was explored using negative predictive value and positive predictive value.</p><p><strong>Results: </strong>Of 57 included patients with detectable pretreatment TTMV HPV DNA, 51 (89%) were male, and the median (IQR) age was 59 (54-66) years. A total of 35 patients (61%) had blood draws at all 3 time points; 16 (28%) had detectable TTMV HPV DNA on postoperative day 1 to 2. Pretreatment and postoperative day 1 to 2 TTMV HPV DNA levels had a medium positive linear correlation (r = 0.31; 95% CI, 0.04-0.54). Undetectable TTMV HPV DNA on postoperative day 1 to 2 blood draw had a negative predictive value of 0.95 (95% CI, 0.74-1.00) for an undetectable level on postoperative week 2 blood draw, but a detectable level on postoperative day 1 to 2 blood draw only had a positive predictive value of 0.19 (95% CI, 0.04-0.46). Of the 16 patients with detectable TTMV HPV DNA pretreatment and at postoperative day 1 to 2, only 3 (19%) continued to have detectable TTMV HPV DNA at postoperative week 2. One patient had undetectable levels at postoperative day 1 to 2 and detectable levels at postoperative week 2.</p><p><strong>Conclusions and relevance: </strong>In this study, ctHPVDNA detectability early after surgery did not predict detectability at 2 weeks after surgery. ctHPVDNA clearance early after surgery could predict a negative test at 2 weeks. A negative b","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078093","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}
Molly E Heft Neal, Richard L Bakst, Raymond L Chai
{"title":"Considerations and Cautions in Postoperative HPV Circulating Tumor DNA Kinetics.","authors":"Molly E Heft Neal, Richard L Bakst, Raymond L Chai","doi":"10.1001/jamaoto.2025.1612","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.1612","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078080","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}
Haley Hullfish, Emily Kistner-Griffin, Stacey Maurer, Wendy Balliet, Jessica Vanderlan, Olga Slavin-Spenny, Lynne Padgett, Angie Rush, Brad Johnson, Taylor McLeod, Ella J Starr, Kenneth J Ruggiero, Katherine R Sterba, Evan M Graboyes
{"title":"Efficacy of a Brief Cognitive Behavioral Treatment Across Body Image Distress Domains: Secondary Outcomes of the BRIGHT Randomized Clinical Trial.","authors":"Haley Hullfish, Emily Kistner-Griffin, Stacey Maurer, Wendy Balliet, Jessica Vanderlan, Olga Slavin-Spenny, Lynne Padgett, Angie Rush, Brad Johnson, Taylor McLeod, Ella J Starr, Kenneth J Ruggiero, Katherine R Sterba, Evan M Graboyes","doi":"10.1001/jamaoto.2025.0965","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0965","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12079557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078082","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}
Shao Hui Huang, Jie Su, Shlomo A Koyfman, David Routman, Frank Hoebers, Houda Bahig, Eugene Yu, Eric Bartlett, Anna Spreafico, Jonathan Lee, Sarah Stock, Robin Davis, Neil M Woody, Kristoff Nelson, Danny Lavigne, Phuc Felix Nguyen-Tan, Laurent Létourneau-Guillon, Edith Filion, Alex A Nagelschneider, Daniel Ma, Kathryn M Van Abel, Alida A Postma, Walter M Palm, Ann Hoeben, William Lydiatt, Snehal G Patel, Melvin L K Chua, Wei Xu, Brian O'Sullivan
{"title":"A Proposal for HPV-Associated Oropharyngeal Carcinoma in the Ninth Edition Clinical TNM Classification.","authors":"Shao Hui Huang, Jie Su, Shlomo A Koyfman, David Routman, Frank Hoebers, Houda Bahig, Eugene Yu, Eric Bartlett, Anna Spreafico, Jonathan Lee, Sarah Stock, Robin Davis, Neil M Woody, Kristoff Nelson, Danny Lavigne, Phuc Felix Nguyen-Tan, Laurent Létourneau-Guillon, Edith Filion, Alex A Nagelschneider, Daniel Ma, Kathryn M Van Abel, Alida A Postma, Walter M Palm, Ann Hoeben, William Lydiatt, Snehal G Patel, Melvin L K Chua, Wei Xu, Brian O'Sullivan","doi":"10.1001/jamaoto.2025.0848","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.0848","url":null,"abstract":"<p><strong>Importance: </strong>A subset of Union for International Cancer Control (UICC)/American Joint Committee on Cancer (AJCC) eighth edition TNM stage I and II human papillomavirus-positive oropharyngeal carcinoma has undesirable outcomes, which might have contributed to a lack of success in phase III deintensification trials. Refining clinical stage groups, especially in the overabundant cN1/stage I group, has become important for treatment selection.</p><p><strong>Objective: </strong>To assess the prognostic importance of pretreatment lymph node (LN) characteristics to optimize case distribution and outcome homogeneity within the N classification system.</p><p><strong>Design, setting, and participants: </strong>This is an international multi-institutional retrospective prognostic cohort study. Analysis of human papillomavirus-positive oropharyngeal carcinoma treated curatively from 4 institutions (International Collaboration of Oropharyngeal Cancer Network for N-Classification [ICON-N] dataset) provided a refined clinical staging proposal; an independent dataset (Centre Hospitalier de l'Université de Montréal [CHUM] dataset) validated the proposal. Neuroradiologists reviewed pretreatment computed tomography and/or magnetic resonance imaging for nodal features, including presence or absence of abnormal LN(s), retropharyngeal LN, laterality, number of abnormal LN, and imaging-detected extranodal extension (iENE). Data were collected from February to May 2023, and data were analyzed from June to July 2023.</p><p><strong>Exposures: </strong>Definitive chemoradiotherapy/radiotherapy or definitive surgery with or without postoperative chemoradiotherapy/radiotherapy.</p><p><strong>Main outcomes and measures: </strong>The primary end point was overall survival. A Cox proportional hazards multivariable model was used to estimate adjusted hazard ratios (AHRs) and to derive an optimal clinical TNM stage classification (AHR-stage schema) incorporating the strongest prognostic nodal features within the UICC/AJCC eighth edition TNM framework after confirming the prognostication of iENE status. The performance (according to overall normalized scores and ranking) of the AHR-stage schema against the current UICC/AJCC eighth edition TNM staging system was evaluated for hazard consistency, hazard discrimination, prognostic importance, and sample size balance. Validation was performed in the CHUM dataset.</p><p><strong>Results: </strong>The ICON-N dataset comprised 2053 patients, including 1898 (92.5%) with cN-positive disease and 155 (7.5%) with cN0 disease; a total of 298 (14.5%) were female, and the mean (SD) age was 60.6 (9.3) years. iENE-positive disease was identified in 710 of 1898 patients with cN-positive disease (37.4%). The median (range) follow-up was 5.1 (0.1-14.7) years. iENE was the strongest prognostic nodal feature in multivariable analysis; the AHR for iENE-positive vs iENE-positive disease was 2.43 (95% CI, 1.96-3.03) in the ICON-N dataset","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":6.0,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12062977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144017952","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}