首页 > 最新文献

JAMA otolaryngology-- head & neck surgery最新文献

英文 中文
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。
{"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":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess whether affect and CIQOL domain scores change over time and whether affect is associated with CIQOL domain scores.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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}
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。
{"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}
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
{"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}
引用次数: 0
Individualized Prognostic Counseling for Decision-Making in Head and Neck Cancer: A Nonrandomized Clinical Trial. 头颈癌决策的个体化预后咨询:一项非随机临床试验。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-02 DOI: 10.1001/jamaoto.2025.4838
Maarten C Dorr, Arta Hoesseini, Aniel Sewnaik, Emilie A C Dronkers, Robert J Baatenburg de Jong, Marinella P J Offerman
<p><strong>Importance: </strong>Managing head and neck squamous cell carcinoma (HNSCC) involves complex decision-making, requiring a balance between optimizing prognosis and preserving quality of life. However, the role of individualized prognostic counseling in the decision-making process is not well known.</p><p><strong>Objective: </strong>To assess the association of individualized prognostic counseling with the decision-making process in patients with primary HNSCC.</p><p><strong>Design, setting, and participants: </strong>This prospective nonrandomized clinical trial with sequential cohorts was conducted at an academic tertiary referral center. Patients with newly diagnosed primary HNSCC who were eligible for curative treatment were enrolled between January 2014 and August 2018 (cohort 1; standard) and between October 2019 and January 2022 (cohort 2; intervention). Data were analyzed between January and August 2023.</p><p><strong>Intervention: </strong>Cohort 1 received standard counseling from the treating physician, while cohort 2 received additional individualized prognostic counseling through an online prognostic model. Both cohorts were divided into small laryngeal squamous cell carcinoma (SLSCC) and other HNSCC groups.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was decisional conflict, measured using the Decisional Conflict Scale. Secondary outcomes included perceived role in decision-making (Control Preferences Scale), decisional regret, treatment choice, and quality of life.</p><p><strong>Results: </strong>A total of 458 patients were enrolled (258 in cohort 1 and 200 in cohort 2; mean [SD] age, 66.1 [8.8] years; 79% [362 of 458] men). Decisional conflict was lower following individualized prognostic counseling for both SLSCC (Cohen d = 0.19; 95% CI, -0.10 to 0.49) and other HNSCC groups (Cohen d = 0.34; 95% CI, 0.10-0.58). Among patients with other HNSCC, the largest and most precise effect sizes were seen in the informed, values clarity, and support subscales of the Decisional Conflict Scale. Decisional regret was lower at 3 to 6 months after individualized counseling (cohort 2 median, 5 [IQR. 0-20] and cohort 1 median, 20 [IQR, 1-29]; rank-biserial r = 0.15 for SLSCC; cohort 2 median, 10 [IQR. 0-20] and cohort 1 median, 20 [IQR, 10-25]; rank-biserial r = 0.29 for other HNSCC), indicating small to moderate improvements. These differences were minimal at 12 months. An association between individualized counseling and more active or shared decision-making roles was observed in the other HNSCC group (Cramer V = 0.21). No relevant differences in quality-of-life outcomes were identified.</p><p><strong>Conclusions and relevance: </strong>This nonrandomized clinical trial found that individualized prognostic counseling with an online prognostic model was associated with improvements in decisional conflict and decisional regret and promoted a more active and shared decision-making role among patients with head a
重要性:头颈部鳞状细胞癌(HNSCC)的治疗涉及复杂的决策,需要在优化预后和保持生活质量之间取得平衡。然而,个性化预后咨询在决策过程中的作用尚不为人所知。目的:评估个体化预后咨询与原发性HNSCC患者决策过程的关系。设计、环境和参与者:该前瞻性非随机临床试验在一个学术三级转诊中心进行。2014年1月至2018年8月(队列1,标准)和2019年10月至2022年1月(队列2,干预)招募了符合根治性治疗条件的新诊断原发性HNSCC患者。数据分析时间为2023年1月至8月。干预:队列1接受治疗医师的标准咨询,而队列2通过在线预测模型接受额外的个性化预后咨询。两组均分为小喉部鳞状细胞癌(SLSCC)组和其他HNSCC组。主要结果和测量:主要结果是决策冲突,使用决策冲突量表测量。次要结果包括在决策中的感知角色(控制偏好量表)、决策后悔、治疗选择和生活质量。结果:共纳入458例患者(队列1 258例,队列2 200例;平均[SD]年龄66.1[8.8]岁;男性79%(458例中有362例)。在SLSCC (Cohen d = 0.19; 95% CI, -0.10至0.49)和其他HNSCC组(Cohen d = 0.34; 95% CI, 0.10-0.58)进行个体化预后咨询后,决策冲突较低。在其他HNSCC患者中,最大和最精确的效应量出现在决策冲突量表的知情、价值观清晰度和支持分量表中。在个体化咨询后3 - 6个月,决定后悔的比例较低(队列2中位数,5)。0-20]和队列1中位数,20 [IQR, 1-29];SLSCC的秩-双列r = 0.15;队列2中位数,10 [IQR]。0-20]和队列1中位数,20 [IQR, 10-25];其他HNSCC的秩双列r = 0.29),表明有小到中度的改善。这些差异在12个月时最小。在其他HNSCC组中观察到个性化咨询与更积极或共同决策角色之间的关联(Cramer V = 0.21)。未发现生活质量结果的相关差异。结论和相关性:这项非随机临床试验发现,使用在线预后模型的个性化预后咨询与决策冲突和决策后悔的改善有关,并促进头颈癌患者更积极和共同的决策角色。研究结果表明,将个性化预后信息整合到常规会诊中可以提高患者参与度,加强共同决策,并减少复杂治疗选择的不确定性。试验注册:荷兰试验注册:NTR4106。
{"title":"Individualized Prognostic Counseling for Decision-Making in Head and Neck Cancer: A Nonrandomized Clinical Trial.","authors":"Maarten C Dorr, Arta Hoesseini, Aniel Sewnaik, Emilie A C Dronkers, Robert J Baatenburg de Jong, Marinella P J Offerman","doi":"10.1001/jamaoto.2025.4838","DOIUrl":"10.1001/jamaoto.2025.4838","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Managing head and neck squamous cell carcinoma (HNSCC) involves complex decision-making, requiring a balance between optimizing prognosis and preserving quality of life. However, the role of individualized prognostic counseling in the decision-making process is not well known.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the association of individualized prognostic counseling with the decision-making process in patients with primary HNSCC.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This prospective nonrandomized clinical trial with sequential cohorts was conducted at an academic tertiary referral center. Patients with newly diagnosed primary HNSCC who were eligible for curative treatment were enrolled between January 2014 and August 2018 (cohort 1; standard) and between October 2019 and January 2022 (cohort 2; intervention). Data were analyzed between January and August 2023.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Intervention: &lt;/strong&gt;Cohort 1 received standard counseling from the treating physician, while cohort 2 received additional individualized prognostic counseling through an online prognostic model. Both cohorts were divided into small laryngeal squamous cell carcinoma (SLSCC) and other HNSCC groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;The primary outcome was decisional conflict, measured using the Decisional Conflict Scale. Secondary outcomes included perceived role in decision-making (Control Preferences Scale), decisional regret, treatment choice, and quality of life.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 458 patients were enrolled (258 in cohort 1 and 200 in cohort 2; mean [SD] age, 66.1 [8.8] years; 79% [362 of 458] men). Decisional conflict was lower following individualized prognostic counseling for both SLSCC (Cohen d = 0.19; 95% CI, -0.10 to 0.49) and other HNSCC groups (Cohen d = 0.34; 95% CI, 0.10-0.58). Among patients with other HNSCC, the largest and most precise effect sizes were seen in the informed, values clarity, and support subscales of the Decisional Conflict Scale. Decisional regret was lower at 3 to 6 months after individualized counseling (cohort 2 median, 5 [IQR. 0-20] and cohort 1 median, 20 [IQR, 1-29]; rank-biserial r = 0.15 for SLSCC; cohort 2 median, 10 [IQR. 0-20] and cohort 1 median, 20 [IQR, 10-25]; rank-biserial r = 0.29 for other HNSCC), indicating small to moderate improvements. These differences were minimal at 12 months. An association between individualized counseling and more active or shared decision-making roles was observed in the other HNSCC group (Cramer V = 0.21). No relevant differences in quality-of-life outcomes were identified.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;This nonrandomized clinical trial found that individualized prognostic counseling with an online prognostic model was associated with improvements in decisional conflict and decisional regret and promoted a more active and shared decision-making role among patients with head a","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":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12761760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145889298","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
A Patient With Recurrent Pleomorphic Adenomas. 复发性多形性腺瘤1例。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-02 DOI: 10.1001/jamaoto.2025.4777
Justis J Freeley, Alex W Yang, Nancy Judd
{"title":"A Patient With Recurrent Pleomorphic Adenomas.","authors":"Justis J Freeley, Alex W Yang, Nancy Judd","doi":"10.1001/jamaoto.2025.4777","DOIUrl":"https://doi.org/10.1001/jamaoto.2025.4777","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":"145889286","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}
引用次数: 0
Clinical Trial Termination or Withdrawal in Head and Neck Squamous Cell Carcinoma. 头颈部鳞状细胞癌的临床试验终止或退出。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-02 DOI: 10.1001/jamaoto.2025.4766
Janice J Huang, Alex S Reznik, Stephen Sonis, Elizabeth J Franzmann, Alessandro Villa

Importance: Innovative clinical trials (CTs) are needed to address the rising incidence of head and neck squamous cell carcinoma (HNSCC). Despite adequate trial initiation, HNSCC CTs experience high failure rates, and the factors driving these trends remain unclear.

Objective: To assess the characteristics associated with failure (termination or withdrawal) in CTs for the treatment of HNSCC.

Design and setting: HNSCC CTs were identified on ClinicalTrials.gov from January 1, 2000, to December 31, 2024, and trial failures were defined as early termination or withdrawal. Trial characteristics were compared between failed CTs and completed CT controls. Data were analyzed from June to August 2025.

Main outcomes and measures: The primary outcome was trial failure. The association between failure and CT characteristics, including phase, enrollment, funding source, intervention type, and age-eligibility criteria, was analyzed using descriptive statistics and multivariable regression models.

Results: A total of 692 matched trials were analyzed, including 346 trial failures and 346 completed control trials. The overall leading reasons for failure were strategic decisions (defined as nonscientific, sponsor-driven choices; 102 trials [29.5%]) and poor recruitment (90 trials [26.0%]). The reasons for failure varied by trial characteristics. Strategic decisions were the predominant reason for failure in phase 1 trials, industry-sponsored trials, and immunotherapy and targeted therapy trials. In contrast, poor recruitment was a more common reason in later-phase trials, non-industry-sponsored trials, and trials investigating chemotherapy, radiation, chemoradiation, combination treatments, and supportive care. Temporal analysis revealed a growing failure rate among CTs since 2000. Increased log-transformed actual enrollment safeguarded against trial failure, whereas industry funding was an independent risk factor.

Conclusions and relevance: In this study, HNSCC CTs were terminated early or withdrawn for a variety of reasons, most commonly due to strategic decisions or poor recruitment. Careful attention to trial characteristics associated with early failure is needed to overcome new barriers to drug development and adapt trial design to common reasons for failure.

重要性:需要创新的临床试验(ct)来解决头颈部鳞状细胞癌(HNSCC)发病率上升的问题。尽管进行了充分的试验,但HNSCC ct的失败率很高,导致这种趋势的因素尚不清楚。目的:评估ct治疗HNSCC失败(终止或退出)的相关特征。设计和背景:从2000年1月1日至2024年12月31日,在ClinicalTrials.gov网站上确定了HNSCC ct,试验失败被定义为提前终止或退出。比较失败CT组和完成CT组的试验特征。数据分析时间为2025年6月至8月。主要结局和指标:主要结局为试验失败。使用描述性统计和多变量回归模型分析失败与CT特征(包括阶段、入组、资金来源、干预类型和年龄资格标准)之间的关系。结果:共分析692个匹配试验,其中失败试验346个,完成对照试验346个。总体而言,失败的主要原因是战略决策(定义为非科学的、赞助商驱动的选择;102项试验[29.5%])和招募不良(90项试验[26.0%])。试验失败的原因因试验特点而异。战略决策是导致i期试验、行业赞助试验、免疫治疗和靶向治疗试验失败的主要原因。相比之下,在后期试验、非行业赞助的试验以及研究化疗、放疗、放化疗、联合治疗和支持性护理的试验中,招募不良是更常见的原因。时间分析显示,自2000年以来,ct的失败率不断上升。增加对数转换的实际注册人数可以防止试验失败,而行业资金是一个独立的风险因素。结论和相关性:在本研究中,HNSCC ct由于各种原因被提前终止或撤回,最常见的是由于战略决策或招募不当。需要仔细关注与早期失败相关的试验特征,以克服药物开发的新障碍,并使试验设计适应失败的常见原因。
{"title":"Clinical Trial Termination or Withdrawal in Head and Neck Squamous Cell Carcinoma.","authors":"Janice J Huang, Alex S Reznik, Stephen Sonis, Elizabeth J Franzmann, Alessandro Villa","doi":"10.1001/jamaoto.2025.4766","DOIUrl":"10.1001/jamaoto.2025.4766","url":null,"abstract":"<p><strong>Importance: </strong>Innovative clinical trials (CTs) are needed to address the rising incidence of head and neck squamous cell carcinoma (HNSCC). Despite adequate trial initiation, HNSCC CTs experience high failure rates, and the factors driving these trends remain unclear.</p><p><strong>Objective: </strong>To assess the characteristics associated with failure (termination or withdrawal) in CTs for the treatment of HNSCC.</p><p><strong>Design and setting: </strong>HNSCC CTs were identified on ClinicalTrials.gov from January 1, 2000, to December 31, 2024, and trial failures were defined as early termination or withdrawal. Trial characteristics were compared between failed CTs and completed CT controls. Data were analyzed from June to August 2025.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was trial failure. The association between failure and CT characteristics, including phase, enrollment, funding source, intervention type, and age-eligibility criteria, was analyzed using descriptive statistics and multivariable regression models.</p><p><strong>Results: </strong>A total of 692 matched trials were analyzed, including 346 trial failures and 346 completed control trials. The overall leading reasons for failure were strategic decisions (defined as nonscientific, sponsor-driven choices; 102 trials [29.5%]) and poor recruitment (90 trials [26.0%]). The reasons for failure varied by trial characteristics. Strategic decisions were the predominant reason for failure in phase 1 trials, industry-sponsored trials, and immunotherapy and targeted therapy trials. In contrast, poor recruitment was a more common reason in later-phase trials, non-industry-sponsored trials, and trials investigating chemotherapy, radiation, chemoradiation, combination treatments, and supportive care. Temporal analysis revealed a growing failure rate among CTs since 2000. Increased log-transformed actual enrollment safeguarded against trial failure, whereas industry funding was an independent risk factor.</p><p><strong>Conclusions and relevance: </strong>In this study, HNSCC CTs were terminated early or withdrawn for a variety of reasons, most commonly due to strategic decisions or poor recruitment. Careful attention to trial characteristics associated with early failure is needed to overcome new barriers to drug development and adapt trial design to common reasons for failure.</p>","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":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12761761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145889326","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
Gingival Swelling and Frequent Epistaxis in an Older Woman. 老年妇女牙龈肿胀和频繁鼻出血。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1001/jamaoto.2025.3587
Giuseppe Colella, Ciro Emiliano Boschetti, Nicola Cirillo
{"title":"Gingival Swelling and Frequent Epistaxis in an Older Woman.","authors":"Giuseppe Colella, Ciro Emiliano Boschetti, Nicola Cirillo","doi":"10.1001/jamaoto.2025.3587","DOIUrl":"10.1001/jamaoto.2025.3587","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":"89-90"},"PeriodicalIF":5.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145400712","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}
引用次数: 0
Balloon Sinus Dilation Use. 使用球囊扩张鼻窦。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1001/jamaoto.2025.4024
Matthew P Sáenz, Nyssa Fox Farrell, Alexander Romashko, Kristine A Smith, Dorina Kallogjeri, Jay F Piccirillo
{"title":"Balloon Sinus Dilation Use.","authors":"Matthew P Sáenz, Nyssa Fox Farrell, Alexander Romashko, Kristine A Smith, Dorina Kallogjeri, Jay F Piccirillo","doi":"10.1001/jamaoto.2025.4024","DOIUrl":"10.1001/jamaoto.2025.4024","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":"95-96"},"PeriodicalIF":5.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12616527/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145504421","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
A 13-Year-Old Male With Parotid Region Mass. 13岁男性腮腺区肿块。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1001/jamaoto.2025.3895
Rong-Hui Xia, Jia-Jun Qian, Jiang Li
{"title":"A 13-Year-Old Male With Parotid Region Mass.","authors":"Rong-Hui Xia, Jia-Jun Qian, Jiang Li","doi":"10.1001/jamaoto.2025.3895","DOIUrl":"10.1001/jamaoto.2025.3895","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":"93-94"},"PeriodicalIF":5.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145504475","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}
引用次数: 0
Woman Presenting With Calvarial Mass. 女性出现头颅肿块。
IF 5.6 1区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1001/jamaoto.2025.3474
Carine Tamamian, Jingjing Hu, Theresa Guo
{"title":"Woman Presenting With Calvarial Mass.","authors":"Carine Tamamian, Jingjing Hu, Theresa Guo","doi":"10.1001/jamaoto.2025.3474","DOIUrl":"10.1001/jamaoto.2025.3474","url":null,"abstract":"","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":"83-84"},"PeriodicalIF":5.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345241","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}
引用次数: 0
期刊
JAMA otolaryngology-- head & neck surgery
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1