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Using Real-World Data to Determine Acute Chemotherapy Emetogenicity in Pediatric Patients. 使用真实世界数据确定儿科患者的急性化疗致吐性。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-17 DOI: 10.1200/CCI-25-00140
L Lee Dupuis, Terrence Lo, Martin Yi, Lillian Sung, Mina Tadrous, Cherry Chu

Purpose: Direct pediatric information to inform chemotherapy emetogenicity in pediatric patients is limited. Therefore, the framework for antiemetic selection is uncertain. This study classified the acute emetogenicity of chemotherapy regimens in pediatric patients using data extracted from the electronic health record (EHR).

Methods: This retrospective, single-institution study extracted data from the EHR of patients age 0 to 18 years who received chemotherapy during an inpatient admission from July 1, 2018, through February 29, 2024. Data were organized by patient and chemotherapy block including patient demographics; date, time, and route of chemotherapy and antiemetic administration; and date and time of vomiting. When at least 30 patients received the same chemotherapy and antiemetics during a chemotherapy block, the proportion of chemotherapy blocks where patients experienced complete, partial, or failed chemotherapy-induced vomiting control was determined. Chemotherapy regimen emetogenicity was assigned using a revision of an accepted pediatric chemotherapy emetogenicity classification framework that adjusted for antiemetic administration.

Results: Seven thousand two hundred ninety-six chemotherapy blocks in 1,386 patients were identified. The emetogenicity of 25 chemotherapy regimens was classified: highly (7), moderately (5), low (10), and minimally (3) emetogenic. For 19 of these, no direct pediatric information was previously available. In five, our findings confirm the previous pediatric emetogenicity classification. Relative to emetogenicity classifications for adults, our findings led to classifications that were higher (seven regimens), lower (one regimen), or the same (four regimens).

Conclusion: We have applied a novel method, EHR data extraction, to provide direct pediatric evidence to classify chemotherapy emetogenicity. Increasing the certainty of chemotherapy emetogenicity facilitates effective antiemetic selection for pediatric patients. This method may be applied in multi-institution studies to increase the number of chemotherapy regimens whose emetogenicity is classified using direct pediatric evidence.

目的:直接的儿科信息告知儿科患者化疗致吐性是有限的。因此,止吐选择的框架是不确定的。本研究使用从电子健康记录(EHR)中提取的数据对儿科患者化疗方案的急性致吐性进行分类。方法:这项回顾性的单机构研究从2018年7月1日至2024年2月29日住院期间接受化疗的0至18岁患者的电子病历中提取数据。数据按患者和化疗区进行整理,包括患者人口统计学;化疗和止吐的日期、时间和途径;还有呕吐的日期和时间。当至少30名患者在化疗期间接受相同的化疗和止吐药时,确定患者经历完全,部分或化疗诱导呕吐控制失败的化疗块的比例。化疗方案的致吐性是根据对公认的儿科化疗致吐性分类框架的修订进行的,该框架调整了止吐药的使用。结果:在1386例患者中确定了7296个化疗区。25种化疗方案的致吐性分为:高致吐性(7)、中等致吐性(5)、低致吐性(10)和最低致吐性(3)。其中19个病例以前没有直接的儿科信息。第五,我们的发现证实了以前的儿童致吐性分类。相对于成人致泻性分类,我们的研究结果导致分类较高(7种方案),较低(1种方案)或相同(4种方案)。结论:我们采用了一种新颖的方法,电子病历数据提取,为化疗致吐性分类提供了直接的儿科证据。提高化疗致吐性的确定性有助于儿科患者有效地选择止吐药。该方法可应用于多机构研究,以增加使用直接儿科证据分类致吐性的化疗方案的数量。
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引用次数: 0
Feasibility of a Smart Label-Enabled Remote Therapeutic Monitoring Intervention to Support Cyclin-Dependent Kinase 4/6 Inhibitor Adherence in Breast Cancer Care. 支持周期蛋白依赖性激酶4/6抑制剂在乳腺癌护理中的依从性的智能标签远程治疗监测干预的可行性
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-19 DOI: 10.1200/CCI-25-00152
Ilana Graetz, Sara Arshad, Clara Cai, Samuel Hernandez, Tamar Sapir, Jeffrey Carter, Cherilyn Heggen, Kelly E McKinnon, Freddie Yang, Gelareh Sadigh, Jane Meisel

Purpose: Cyclin-dependent kinase 4 and 6 inhibitors (CDKIs) are effective breast cancer therapies but pose adherence challenges because of cost, side effects, and complexity of medication schedule. We assessed the feasibility and usability of a smart label-enabled remote therapeutic monitoring (RTM) mHealth intervention for women with breast cancer prescribed a CDKI. Exploratory adjusted analyses examined factors associated with usability and CDKI adherence.

Methods: Participants were recruited from a comprehensive cancer center between April and August 2024. For 3 months, participants used Tappt smart labels and web app to record CDKI doses, receive missed dose reminders, report symptoms biweekly, and complete baseline and follow-up surveys. Alerts were sent to oncology teams for nonadherence (>20% missed doses) or moderate-to-severe symptoms. Feasibility was defined as ≥70% of participants using the smart label >30 days and completing the follow-up survey. Usability was assessed using the System Usability Scale, with a benchmark score of ≥68. Linear regression was used to examine factors associated with usability and CDKI adherence.

Results: Among 168 screened, 107 were eligible and reached; 75.7% (81/107) consented; 90.1% (73/81) completed the follow-up survey, and 88.9% (72/81) used the intervention >30 days. Most participants self-identified as White (69.9%), were privately insured (72.6%), and had early-stage breast cancer (58.9%) and depression or anxiety (58.9%). The mean usability score was 75.8; participants who self-identified as Black reported 12.0 points higher usability than those who self-identified as White (P = .03). Mean CDKI adherence was 92.8%. A history of anxiety or depression was associated with an 8.6 percentage-point lower CDKI adherence rate (P = .02).

Conclusion: A smart label-enabled RTM mHealth intervention exceeded feasibility and usability benchmarks and showed promise for supporting CDKI adherence and symptom management.

目的:细胞周期蛋白依赖性激酶4和6抑制剂(CDKIs)是一种有效的乳腺癌治疗方法,但由于成本、副作用和用药计划的复杂性,其依从性面临挑战。我们评估了一种智能标签支持的远程治疗监测(RTM)移动健康干预乳腺癌妇女的可行性和可用性。探索性调整分析检查了与可用性和CDKI依从性相关的因素。方法:2024年4月至8月从一家综合性癌症中心招募参与者。在3个月的时间里,参与者使用Tappt智能标签和web应用程序记录CDKI剂量,接收遗漏剂量提醒,每两周报告症状,并完成基线和随访调查。如果出现不依从(漏给剂量20%)或中度至重度症状,将向肿瘤团队发出警报。可行性定义为≥70%的参与者使用智能标签30天并完成随访调查。可用性评估采用系统可用性量表,基准得分≥68分。线性回归用于检验与可用性和CDKI依从性相关的因素。结果:经筛选的168例中,符合条件的达到107例;75.7%(81/107)同意;90.1%(73/81)的患者完成了随访调查,88.9%(72/81)的患者在30天内使用了干预措施。大多数参与者自认为是白人(69.9%),有私人保险(72.6%),患有早期乳腺癌(58.9%)和抑郁症或焦虑症(58.9%)。平均可用性得分为75.8分;自认为是黑人的参与者报告的可用性比自认为是白人的参与者高12.0分(P = .03)。平均CDKI依从性为92.8%。焦虑或抑郁史与CDKI依从率降低8.6个百分点相关(P = 0.02)。结论:支持智能标签的RTM移动健康干预超过了可行性和可用性基准,并显示出支持CDKI依从性和症状管理的希望。
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引用次数: 0
Rapid Growth in Patient Portal Messages Underscores the Need for Actionable Paths Forward. 患者门户信息的快速增长强调了制定可行的前进路径的必要性。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-03 DOI: 10.1200/CCI-25-00283
A Jay Holmgren
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引用次数: 0
Reasoning Models for Text Mining in Oncology: A Comparison Between o1 Preview, GPT-4o, and GPT-5 at Different Reasoning Levels. 肿瘤学文本挖掘的推理模型:o1预览、gpt - 40和GPT-5在不同推理水平上的比较
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-06 DOI: 10.1200/CCI-24-00311
Paul Windisch, Fabio Dennstädt, Julia Weyrich, Christina Schröder, Daniel R Zwahlen, Robert Förster

Purpose: Chain-of-thought prompting is a method to make large language models generate intermediate reasoning steps when solving a complex problem. OpenAI's o1 preview and GPT-5 have been trained to create such a chain of thought internally before giving a response and have been claimed to surpass various benchmarks requiring complex reasoning. The purpose of this study was to evaluate their performance in text mining in oncology.

Methods: Six hundred trials from high-impact medical journals were classified depending on whether they allowed for the inclusion of patients with localized and/or metastatic disease. GPT-4o, o1 preview, and GPT-5 at different reasoning effort settings were instructed to do the same classification based on the publications' abstracts.

Results: For predicting whether patients with localized disease were enrolled, GPT-4o and o1 preview achieved F1 scores of 0.80 (0.76-0.83) and 0.91 (0.89-0.94), respectively. For predicting whether patients with metastatic disease were enrolled, GPT-4o and o1 preview achieved F1 scores of 0.97 (0.95-0.98) and 0.99 (0.99-1.00), respectively. For GPT-5, the F1 scores for predicting the eligibility of patients with localized disease increased from 0.84 to 0.93 and 0.94 with increased reasoning effort. F1 scores for metastatic disease were 0.97, 0.99, and 0.99.

Conclusion: o1 preview outperformed GPT-4o in extracting if people with localized and/or metastatic disease were eligible for a trial from its abstract. GPT-5 at high reasoning effort settings outperformed both GPT-4o and o1 preview, supporting the notion that reasoning models could become the new standard for text mining in medicine.

目的:思维链提示是在解决复杂问题时,使大型语言模型产生中间推理步骤的一种方法。OpenAI的o1预览版和GPT-5已经经过培训,可以在给出响应之前在内部创建这样的思维链,并声称超过了需要复杂推理的各种基准。本研究的目的是评估它们在肿瘤学文本挖掘中的表现。方法:根据是否允许纳入局部和/或转移性疾病患者,对来自高影响力医学期刊的600项试验进行分类。在不同的推理努力设置下,gpt - 40、o1预览和GPT-5被指示根据出版物的摘要进行相同的分类。结果:在预测患者是否入组时,gpt - 40和o1预览的F1评分分别为0.80(0.76-0.83)和0.91(0.89-0.94)。在预测是否有转移性疾病患者入组时,gpt - 40和o1预览的F1评分分别为0.97(0.95-0.98)和0.99(0.99-1.00)。对于GPT-5,预测局限性疾病患者资格的F1分数从0.84增加到0.93,随着推理努力的增加,F1分数增加到0.94。转移性疾病的F1评分分别为0.97、0.99和0.99。结论:o1预览在提取局部和/或转移性疾病患者是否有资格从摘要中进行试验方面优于gpt - 40。GPT-5在高推理努力设置下的表现优于gpt - 40和01预览,支持推理模型可能成为医学文本挖掘的新标准的观点。
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引用次数: 0
Augmenting Large Language Models With National Comprehensive Cancer Network Guidelines for Improved and Standardized Adjuvant Therapy Recommendations in Postoperative Breast Cancer Cases. 利用国家综合癌症网络指南增强大型语言模型,以改进和标准化乳腺癌术后辅助治疗建议。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-05 DOI: 10.1200/CCI-24-00243
Serene Si Ning Goh, Ragunathan Mariappan, Grace Soo Woon Tan, Jiali Yao, Fook Ming Hew, Yenshing Yeo, Samuel Guan Wei Ow, Wee Yao Koh, Nesaretnam Barr Kumarakulasingh, Teng Hwee Tan, Bee Choo Tai, Mikael Hartman, Kee Yuan Ngiam

Purpose: Multidisciplinary breast tumor boards (MTBs) are essential for optimizing breast cancer treatment but face challenges related to logistics, variability in expertise, and lack of standardization. Large language models may support clinical decision making. This study evaluates the accuracy of adjuvant therapy recommendations generated by an artificial intelligence (AI)-driven tool, TheSerenityBot (TSB), in comparison with Claude-2 and GPT-4, using expert MTB consensus as the reference.

Methods: Postoperative breast cancer cases reviewed at the National University Hospital, Singapore, between June and November 2023 were retrospectively analyzed. Eligible patients were women with invasive or preinvasive breast cancer who underwent surgery. Metastatic cases were excluded. TSB, a Claude-2-based model augmented with 2023 National Comprehensive Cancer Network guidelines, generated adjuvant therapy recommendations across seven treatment modalities. Outputs from TSB, Claude-2, and GPT-4 were evaluated for concordance with MTB recommendations. Model performance was assessed using generalized estimating equations.

Results: Fifty patients were included (mean age, 59.8 years); 75.5% had hormone receptor-positive tumors, and 60.0% underwent breast-conserving surgery. TSB demonstrated the highest overall accuracy (0.89), followed by Claude-2 (0.86) and GPT-4 (0.78). GPT-4 showed significantly lower accuracy in genetic testing recommendations (odds ratio [OR], 0.05 [95% CI, 0.015 to 0.149]; P < .001), whereas Claude-2 was less accurate in radiotherapy recommendations (OR, 0.41 [95% CI, 0.17 to 0.98]; P = .040).

Conclusion: A guideline-augmented AI tool such as TSB shows promise in supporting adjuvant therapy decisions in breast cancer. To improve clinical relevance, future iterations will incorporate individualized patient factors, broader guideline frameworks, and electronic health record integration. Prospective trials are ongoing to assess the real-world impact.

目的:多学科乳腺肿瘤委员会(MTBs)对优化乳腺癌治疗至关重要,但面临着与后勤、专业知识差异和缺乏标准化相关的挑战。大型语言模型可能支持临床决策。本研究评估了由人工智能(AI)驱动的工具thesenitybot (TSB)生成的辅助治疗建议的准确性,并与Claude-2和GPT-4进行了比较,使用专家MTB共识作为参考。方法:回顾性分析新加坡国立大学医院2023年6月至11月收治的乳腺癌术后病例。符合条件的患者是接受手术的侵袭性或侵袭性乳腺癌患者。排除转移病例。TSB是一个基于claude -2的模型,增强了2023年国家综合癌症网络指南,生成了七种治疗方式的辅助治疗建议。评估TSB、Claude-2和GPT-4的输出与MTB建议的一致性。使用广义估计方程评估模型性能。结果:纳入50例患者,平均年龄59.8岁;75.5%为激素受体阳性肿瘤,60.0%为保乳手术。TSB的总体准确率最高(0.89),其次是Claude-2(0.86)和GPT-4(0.78)。GPT-4在基因检测推荐中的准确性明显较低(优势比[OR], 0.05 [95% CI, 0.015至0.149];P < .001),而Claude-2在放疗推荐中的准确性较低(OR, 0.41 [95% CI, 0.17至0.98];P = .040)。结论:像TSB这样的指南增强人工智能工具在支持乳腺癌辅助治疗决策方面显示出希望。为了提高临床相关性,未来的迭代将纳入个性化的患者因素、更广泛的指导框架和电子健康记录集成。目前正在进行前瞻性试验,以评估其对现实世界的影响。
{"title":"Augmenting Large Language Models With National Comprehensive Cancer Network Guidelines for Improved and Standardized Adjuvant Therapy Recommendations in Postoperative Breast Cancer Cases.","authors":"Serene Si Ning Goh, Ragunathan Mariappan, Grace Soo Woon Tan, Jiali Yao, Fook Ming Hew, Yenshing Yeo, Samuel Guan Wei Ow, Wee Yao Koh, Nesaretnam Barr Kumarakulasingh, Teng Hwee Tan, Bee Choo Tai, Mikael Hartman, Kee Yuan Ngiam","doi":"10.1200/CCI-24-00243","DOIUrl":"10.1200/CCI-24-00243","url":null,"abstract":"<p><strong>Purpose: </strong>Multidisciplinary breast tumor boards (MTBs) are essential for optimizing breast cancer treatment but face challenges related to logistics, variability in expertise, and lack of standardization. Large language models may support clinical decision making. This study evaluates the accuracy of adjuvant therapy recommendations generated by an artificial intelligence (AI)-driven tool, TheSerenityBot (TSB), in comparison with Claude-2 and GPT-4, using expert MTB consensus as the reference.</p><p><strong>Methods: </strong>Postoperative breast cancer cases reviewed at the National University Hospital, Singapore, between June and November 2023 were retrospectively analyzed. Eligible patients were women with invasive or preinvasive breast cancer who underwent surgery. Metastatic cases were excluded. TSB, a Claude-2-based model augmented with 2023 National Comprehensive Cancer Network guidelines, generated adjuvant therapy recommendations across seven treatment modalities. Outputs from TSB, Claude-2, and GPT-4 were evaluated for concordance with MTB recommendations. Model performance was assessed using generalized estimating equations.</p><p><strong>Results: </strong>Fifty patients were included (mean age, 59.8 years); 75.5% had hormone receptor-positive tumors, and 60.0% underwent breast-conserving surgery. TSB demonstrated the highest overall accuracy (0.89), followed by Claude-2 (0.86) and GPT-4 (0.78). GPT-4 showed significantly lower accuracy in genetic testing recommendations (odds ratio [OR], 0.05 [95% CI, 0.015 to 0.149]; <i>P</i> < .001), whereas Claude-2 was less accurate in radiotherapy recommendations (OR, 0.41 [95% CI, 0.17 to 0.98]; <i>P</i> = .040).</p><p><strong>Conclusion: </strong>A guideline-augmented AI tool such as TSB shows promise in supporting adjuvant therapy decisions in breast cancer. To improve clinical relevance, future iterations will incorporate individualized patient factors, broader guideline frameworks, and electronic health record integration. Prospective trials are ongoing to assess the real-world impact.</p>","PeriodicalId":51626,"journal":{"name":"JCO Clinical Cancer Informatics","volume":"9 ","pages":"e2400243"},"PeriodicalIF":2.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12604537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145453462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Meta-Analysis of Bias in Non-Small Cell Lung Cancer External Control Arms That Use Real-World Progression-Free Survival as the End Point. 以真实世界无进展生存期为终点的非小细胞肺癌外部对照组偏倚荟萃分析
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-21 DOI: 10.1200/CCI-25-00198
Sanaa Bahmane, Chris Harbron, Devin Incerti, Thanh G N Ton, Michael T Bretscher

Purpose: Results from single-arm clinical trials can be contextualized by comparing against external controls (ECs) derived from real-world data (RWD). However, lack of randomization and differences in variable capture between data sources may introduce bias into estimates of treatment effect and standard error, the extent of which can be assessed via meta-analysis of comparisons between clinical trial control arms and their EC replicates.

Methods: Clinical trial progression-free survival (PFS) outcomes from the 14 chemotherapy control arms of 12 non-small cell lung cancer clinical trials were replicated using the US nationwide deidentified Flatiron Health electronic health record-derived database, with real-world PFS (rwPFS) as the end point. A meta-analysis of loge hazard ratios (HRs) comparing randomized controlled trial (RCT) and RWD control arms was conducted. For illustration, the meta-analysis results were used to restore correct operating characteristics of a hypothetical prospective single-arm study with EC.

Results: With the exception of one outlier, rwPFS outcomes were on average similar to PFS outcomes, albeit with substantial between-study variation. RCT compared with RWD arms differed by a mean loge HR of -0.001, with a standard deviation of 0.164 (including the outlier). Applying these estimates to adjust error probabilities in a hypothetical prospective EC study revealed that between-study variation of bias in this setting should be adjusted for, to avoid incorrect decision making.

Conclusion: The close alignment of results between RCT and RWD increases confidence that RWD ECs using the rwPFS end point in this disease setting can provide context for future single-arm clinical trials despite potential differences in end point assessment.

目的:单臂临床试验的结果可以通过与来自真实世界数据(RWD)的外部对照(ECs)进行比较来确定背景。然而,缺乏随机化和数据源之间变量捕获的差异可能会在治疗效果和标准误差的估计中引入偏差,其程度可以通过临床试验对照组与其EC重复组之间比较的荟萃分析来评估。方法:12项非小细胞肺癌临床试验的14个化疗对照组的临床试验无进展生存期(PFS)结果使用美国全国范围内确定的Flatiron Health电子健康记录衍生数据库进行复制,以真实世界的PFS (rwPFS)为终点。对随机对照试验(RCT)和RWD对照组的大风险比(hr)进行meta分析。为了说明,荟萃分析结果被用来恢复假设的前瞻性单臂研究EC的正确操作特征。结果:除了一个异常值外,rwPFS结果与PFS结果平均相似,尽管研究之间存在很大差异。与RWD组相比,RCT组的平均HR为-0.001,标准差为0.164(包括异常值)。在一项假设的前瞻性EC研究中,应用这些估计值来调整误差概率表明,在这种情况下,应该调整研究间偏差的变化,以避免错误的决策。结论:RCT和RWD结果的密切一致增加了RWD ECs在这种疾病环境中使用rwPFS终点的信心,尽管终点评估存在潜在差异,但可以为未来的单臂临床试验提供背景。
{"title":"Meta-Analysis of Bias in Non-Small Cell Lung Cancer External Control Arms That Use Real-World Progression-Free Survival as the End Point.","authors":"Sanaa Bahmane, Chris Harbron, Devin Incerti, Thanh G N Ton, Michael T Bretscher","doi":"10.1200/CCI-25-00198","DOIUrl":"10.1200/CCI-25-00198","url":null,"abstract":"<p><strong>Purpose: </strong>Results from single-arm clinical trials can be contextualized by comparing against external controls (ECs) derived from real-world data (RWD). However, lack of randomization and differences in variable capture between data sources may introduce bias into estimates of treatment effect and standard error, the extent of which can be assessed via meta-analysis of comparisons between clinical trial control arms and their EC replicates.</p><p><strong>Methods: </strong>Clinical trial progression-free survival (PFS) outcomes from the 14 chemotherapy control arms of 12 non-small cell lung cancer clinical trials were replicated using the US nationwide deidentified Flatiron Health electronic health record-derived database, with real-world PFS (rwPFS) as the end point. A meta-analysis of log<sub>e</sub> hazard ratios (HRs) comparing randomized controlled trial (RCT) and RWD control arms was conducted. For illustration, the meta-analysis results were used to restore correct operating characteristics of a hypothetical prospective single-arm study with EC.</p><p><strong>Results: </strong>With the exception of one outlier, rwPFS outcomes were on average similar to PFS outcomes, albeit with substantial between-study variation. RCT compared with RWD arms differed by a mean log<sub>e</sub> HR of -0.001, with a standard deviation of 0.164 (including the outlier). Applying these estimates to adjust error probabilities in a hypothetical prospective EC study revealed that between-study variation of bias in this setting should be adjusted for, to avoid incorrect decision making.</p><p><strong>Conclusion: </strong>The close alignment of results between RCT and RWD increases confidence that RWD ECs using the rwPFS end point in this disease setting can provide context for future single-arm clinical trials despite potential differences in end point assessment.</p>","PeriodicalId":51626,"journal":{"name":"JCO Clinical Cancer Informatics","volume":"9 ","pages":"e2500198"},"PeriodicalIF":2.8,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145574544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utilization of Lung Cancer Registries in Learning Health Systems for Health Care Improvement. 肺癌登记在学习卫生系统中对卫生保健改善的利用。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-10 DOI: 10.1200/CCI-25-00211
Rob G Stirling, David R Baldwin, David Heineman, Michel W J M Wouters, Neal Navani, Paul Dawkins, Angela Melder, John Zalcberg, Erik Jakobsen

Purpose: Lung cancer is the leading global cause of cancer mortality with substantial evidence of inequity, disparity in process and outcomes, and unwarranted clinical variation. Over the last decades, there has been major evolution and discovery in best evidence-based practice (EBP), enhancing diagnostics, management, and the delivery of precision medicine. However, questions remain about the completeness of translation of best EBP into delivered care.

Design: Learning health systems (LHSs) have been defined as improvement environments where knowledge generation processes are embedded into daily clinical practice to continually improve the quality, safety, and outcomes of health care delivery. Lung cancer clinical quality registries (CQRs) provide a rigorous infrastructure supporting LHS function through the collection, analysis, and reporting of care process and outcome information delivered by health service organizations. CQRs measure the appropriateness and effectiveness of delivered care and report on the degree of best EBP delivery by stakeholder providers. The provision of risk-adjusted, benchmark reporting to stakeholders describes equity, disparity, and unwarranted clinical variation and is a fundamental driver of improvement in the safety and quality of care provided to consumers.

Results: There is mounting international evidence of the positive impacts of CQR reporting on management processes, health care infrastructure, survival, quality improvement, and education within lung cancer communities. The use of implementation science approaches including the Knowledge to Action framework targets bridging the gaps between evidence-based knowledge and practice.

Conclusion: Registry evolution is exampled by the Danish Lung Cancer Registry, National Lung Cancer Audit (United Kingdom), Dutch Lung Cancer Audit, and Victorian Lung Cancer Registry (Australia), which identify innovation opportunities to close the evidence-practice gap, overcome service deficits, and lead to better decision making for health care improvement.

目的:肺癌是全球癌症死亡的主要原因,有大量证据表明在治疗过程和结果上存在不公平、差异以及无根据的临床差异。在过去的几十年里,在最佳循证实践(EBP)方面有了重大的发展和发现,加强了诊断、管理和精准医疗的提供。然而,关于最佳EBP转化为交付护理的完整性问题仍然存在。设计:学习型卫生系统(lhs)被定义为一种改进环境,在这种环境中,知识生成过程嵌入到日常临床实践中,以不断提高卫生保健服务的质量、安全性和结果。肺癌临床质量登记处(CQRs)通过收集、分析和报告卫生服务组织提供的护理过程和结果信息,为LHS功能提供了严格的基础设施。CQRs衡量所提供护理的适当性和有效性,并报告利益相关者提供者提供最佳EBP的程度。向利益相关者提供经风险调整的基准报告,描述了公平、差异和无根据的临床差异,是改善向消费者提供的医疗安全和质量的根本驱动力。结果:国际上有越来越多的证据表明,CQR报告对肺癌社区的管理流程、卫生保健基础设施、生存、质量改进和教育产生了积极影响。使用实施科学方法,包括“从知识到行动”框架,旨在弥合基于证据的知识与实践之间的差距。结论:登记制度的演变以丹麦肺癌登记制度、英国国家肺癌审计制度、荷兰肺癌审计制度和澳大利亚维多利亚州肺癌登记制度为例,它们确定了创新机会,以缩小证据与实践的差距,克服服务缺陷,并为改善卫生保健做出更好的决策。
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引用次数: 0
Longitudinal Synthetic Data Generation by Artificial Intelligence to Accelerate Clinical and Translational Research in Breast Cancer. 利用人工智能纵向合成数据生成加速乳腺癌临床和转化研究。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-06 DOI: 10.1200/CCI-25-00033
Elena Zazzetti, Saverio D'Amico, Flavia Jacobs, Rita De Sanctis, Lorenzo Chiudinelli, Mariangela Gaudio, Gianluca Asti, Mattia Delleani, Elisabetta Sauta, Mirco Quintavalla, Alessandro Bruseghini, Luca Lanino, Giulia Maggioni, Alessia Campagna, Victor Savevski, Matteo G Della Porta, Alberto Zambelli

Purpose: Real-world data (RWD) are critical for breast cancer (BC) research but are limited by privacy concerns, missing information, and data fragmentation. This study explores synthetic data (SD) generated through advanced generative models to address these challenges and create harmonized longitudinal data sets.

Methods: A data set of 1052 patients with human epidermal growth factor receptor 2-positive and triple-negative BC from the Informatics for Integrating Biology and the Bedside (i2b2) platform was used. Advanced generative models, including generative adversarial networks (GANs), variational autoencoders (VAEs), and language models (LMs), were applied to generate synthetic longitudinal data sets replicating disease progression, treatment patterns, and clinical outcomes. The Synthethic Validation Framework (SAFE) powered by Train was used to evaluate the fidelity, utility, and privacy. SD were tested across three settings: (1) integration with i2b2 for privacy-preserving data sets; (2) multistate disease modeling to predict clinical outcomes; and (3) generation of synthetic control groups for clinical trials.

Results: The synthetic data sets exhibited high fidelity (score 0.94) and ensured privacy, with temporal patterns validated through time-series analyses and Uniform Manifold Approximation and Projection embeddings. In setting A, SD accurately mirrored RWD on the i2b2 platform while maintaining privacy. In setting B, incorporating SD improved the predictive performance of a multistate disease progression model, increasing the C-index by up to 10%. In setting C, SD replicated the end points of the APT trial, demonstrating its feasibility for generating synthetic control arms with preserved statistical properties of the real data set.

Conclusion: AI-generated longitudinal SD effectively address key challenges in RWD use in BC. This approach can improve translational research and clinical trial design while ensuring robust privacy protection. Integration with platforms such as i2b2 highlights their scalability and potential for broader applications in oncology.

目的:真实世界数据(RWD)对乳腺癌(BC)研究至关重要,但受到隐私问题、信息缺失和数据碎片化的限制。本研究探讨了通过先进的生成模型生成的合成数据(SD),以解决这些挑战,并创建统一的纵向数据集。方法:使用来自Informatics for integrated Biology and the床边(i2b2)平台的1052例人表皮生长因子受体2阳性和三阴性BC患者的数据集。先进的生成模型,包括生成对抗网络(gan)、变分自动编码器(VAEs)和语言模型(lm),被用于生成复制疾病进展、治疗模式和临床结果的综合纵向数据集。使用由Train提供支持的综合验证框架(SAFE)来评估保真度、实用性和隐私性。SD通过三种设置进行测试:(1)与i2b2集成以保护隐私数据集;(2)建立多状态疾病模型,预测临床预后;(3)临床试验合成对照组的生成。结果:合成数据集具有高保真度(得分0.94)和保密性,通过时间序列分析和均匀流形逼近和投影嵌入验证了时间模式。在设置A中,SD准确地镜像了i2b2平台上的RWD,同时保持了隐私性。在组B中,纳入SD提高了多状态疾病进展模型的预测性能,将c指数提高了10%。在设置C中,SD复制了APT试验的终点,证明了其生成保留真实数据集统计特性的合成对照臂的可行性。结论:人工智能生成的纵向SD有效地解决了不列颠哥伦比亚省RWD使用中的关键挑战。这种方法可以改善转化研究和临床试验设计,同时确保强大的隐私保护。与i2b2等平台的集成突出了其可扩展性和在肿瘤学中更广泛应用的潜力。
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引用次数: 0
Leveraging the Rural-Urban Commuting Area Tool to Address Geographic Disparities in Cancer Care: A Dual-Application Framework for Institutional and National Initiatives. 利用城乡通勤区域工具解决癌症治疗中的地理差异:机构和国家倡议的双重应用框架。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-07 DOI: 10.1200/CCI-25-00122
Meredith C B Adams, Cody L Hudson, Matthew L Perkins, Robert W Hurley, Umit Topaloglu

Purpose: We developed and validated a dual-purpose, open-access Rural-Urban Commuting Area (RUCA) tool to standardize geographic coding for cancer disparities research, addressing National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative Common Data Element requirements while supporting institutional catchment area analyses.

Methods: This web-based tool16 integrates US Department of Agriculture RUCA codes with census tract data and electronic health record systems, meeting NIH HEAL Initiative Findable, Accessible, Interoperable, and Reusable (FAIR) data ecosystem requirements. We implemented the tool using Wake Forest Cancer Center's 2023 registry data (n = 21,219) and conducted systematic comparison with county-level Rural-Urban Continuum Code (RUCC) classifications using 18,714 cancer cases across 336 ZIP codes, focusing on breast, colon, and lung cancers to demonstrate enhanced geographic granularity.

Results: Among 21,219 patients with cancer, 19.51% (n = 4,140) resided in rural areas, with 4.81% (n = 1,022) in the most rural census tracts (RUCA codes 7-10). Comparative analysis revealed 9.4% disagreement between RUCA and RUCC classifications, affecting 1,765 patients. Twenty-eight ZIP codes classified as rural by RUCA were located within metropolitan counties according to RUCC, encompassing 109 patients with cancer who would be misclassified using county-level measures. As a separate use case, integration with NIH HEAL Initiative standardized rurality data collection across 15 research studies.

Conclusion: The RUCA tool addresses critical gaps in geographic data standardization by providing census tract-level precision that county-level classifications miss. This dual-application framework aligns institutional catchment analyses with national standardization efforts, identifying 109 patients with cancer who would be misclassified as urban residents using traditional county-level approaches, thereby enhancing targeted interventions for rural cancer care access.

目的:我们开发并验证了一种双重用途、开放获取的城乡通勤区(RUCA)工具,用于标准化癌症差异研究的地理编码,解决了美国国立卫生研究院(NIH)帮助结束长期成瘾(HEAL)倡议的公共数据元素要求,同时支持机构集水区分析。方法:这个基于网络的工具16将美国农业部RUCA代码与人口普查区数据和电子健康记录系统集成,满足NIH HEAL倡议可查找、可访问、可互操作和可重用(FAIR)数据生态系统的要求。我们使用威克森林癌症中心的2023年登记数据(n = 21,219)实施了该工具,并使用336个邮政编码的18,714例癌症病例与县级城乡连续编码(RUCC)分类进行了系统比较,重点是乳腺癌,结肠癌和肺癌,以展示增强的地理粒度。结果:在21219例癌症患者中,有19.51% (n = 4140)居住在农村地区,其中4.81% (n = 1022)居住在农村人口普查区(RUCA编码7-10)。对比分析发现,RUCA与RUCC分类差异达9.4%,共影响1765例患者。28个被RUCA归类为农村的邮政编码位于大都市县内,其中包括109名癌症患者,使用县级措施将被错误分类。作为一个单独的用例,与NIH HEAL计划的集成标准化了15项研究中的农村数据收集。结论:RUCA工具解决了地理数据标准化方面的关键差距,提供了县级分类无法提供的人口普查区级精度。这种双重应用框架将机构集水区分析与国家标准化工作相结合,确定了109名使用传统县级方法可能被错误分类为城市居民的癌症患者,从而加强了对农村癌症治疗可及性的针对性干预。
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引用次数: 0
Pilot Testing of a Multicomponent Cancer Pain-Cognitive Behavioral Therapy mHealth App for Patients With Advanced Cancer. 针对晚期癌症患者的多组件癌症疼痛认知行为治疗移动健康应用程序的试点测试。
IF 2.8 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-13 DOI: 10.1200/CCI-25-00228
Desiree R Azizoddin, Sara M DeForge, Jian Zhao, Meng Chen, Kyla Smith, Kristin L Schreiber, Robert R Edwards, Matthew Allsop, Ashton Baltazar, Ryan Nipp, Misty Walker, James A Tulsky, Michael Businelle, Andrea C Enzinger

Purpose: Patients with advanced cancer often experience pain symptoms. Pain-cognitive behavioral therapy (pain-CBT) represents an effective psychological treatment for chronic pain, yet access remains limited. We conducted a pilot study to assess the feasibility and acceptability of a mobile health (mHealth) intervention that integrates pain-CBT with opioid education and tracking to improve chronic pain management in patients with advanced cancer.

Methods: Adults with advanced cancer and pain (≥4/10, Numeric Rating Scale) using opioids tested the smartphone-based intervention for 28 days, completed baseline, end-of-study, and 2-week postintervention surveys, and participated in optional qualitative interviews. The intervention assessed pain, mood, catastrophizing, sleep, and opioid use, and provided tailored just-in-time adaptive interventions, and daily psychoeducation (articles, serious game). We assessed feasibility (≥50% app-use), acceptability (acceptability E-scale), and pre-post intervention changes in pain, and conducted thematic analysis of perceived impact and usefulness.

Results: Among 64 eligible patients, 32 (mean age, 55.41 years; 55% female; 32% rural-dwelling) enrolled. Of those, 59% (n = 19) used the app ≥50% of days on study, and rated the intervention with good acceptability (mean, 24.85; standard deviation, 3.72). Nonsignificant reductions in pain intensity, pain interference, and pain catastrophizing were observed from baseline to 4- and 6-week follow-ups. In debriefing interviews, patients described that the intervention contributed to pain self-management knowledge, promoted pain coping skills, and reduced opioid stigma.

Conclusion: Study results support feasibility and acceptability of a pain-CBT intervention for patients with advanced cancer pain. Although exploratory analyses showed nonsignificant improvements in pain outcomes, qualitative findings indicate meaningful engagement and skill development. Future testing is needed to determine intervention efficacy.

目的:晚期癌症患者经常出现疼痛症状。疼痛认知行为疗法(pain- cbt)是治疗慢性疼痛的一种有效的心理疗法,但其途径仍然有限。我们进行了一项试点研究,以评估移动健康(mHealth)干预的可行性和可接受性,该干预将疼痛- cbt与阿片类药物教育和跟踪相结合,以改善晚期癌症患者的慢性疼痛管理。方法:使用阿片类药物的晚期癌症和疼痛(≥4/10,数值评定量表)的成年人对基于智能手机的干预进行了28天的测试,完成了基线、研究结束和干预后2周的调查,并参加了可选的定性访谈。干预评估疼痛、情绪、灾难、睡眠和阿片类药物的使用,并提供量身定制的及时适应性干预和日常心理教育(文章、严肃游戏)。我们评估了可行性(应用程序使用率≥50%)、可接受性(可接受性e量表)和干预前后疼痛的变化,并对感知影响和有用性进行了专题分析。结果:在64例符合条件的患者中,纳入32例(平均年龄55.41岁,女性55%,农村居民32%)。其中59% (n = 19)在研究中使用app的天数≥50%,并认为干预措施可接受性较好(平均值24.85,标准差3.72)。从基线到4周和6周的随访,观察到疼痛强度、疼痛干扰和疼痛灾难化的无显著减少。在汇报访谈中,患者描述干预有助于疼痛自我管理知识,促进疼痛应对技能,并减少阿片类药物耻辱感。结论:研究结果支持疼痛- cbt干预晚期癌症疼痛患者的可行性和可接受性。虽然探索性分析显示疼痛结果没有显著改善,但定性研究结果表明有意义的参与和技能发展。需要进一步的测试来确定干预的效果。
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引用次数: 0
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JCO Clinical Cancer Informatics
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