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Smartwatch Biometrics in the Electronic Medical Record: Time for a New Vital Sign? 电子病历中的智能手表生物识别技术:是时候采用新的生命体征了吗?
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 Epub Date: 2024-09-30 DOI: 10.1200/CCI-24-00161
Srishti Sankaran, Rahul Banerjee

Smartphone biometrics in the EMR: is the 5th vital sign here? @JCOCCI_ASCO commentary by Sankaran and @RahulBanerjeeMD here.

EMR 中的智能手机生物识别技术:第五个生命体征出现了吗?这里是 Sankaran 和 @RahulBanerjeeMD 的 @JCOCCI_ASCO 评论。
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引用次数: 0
Large Language Models to Help Appeal Denied Radiotherapy Services. 大语言模型帮助上诉被拒绝的放疗服务。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1200/CCI.24.00129
Kendall J Kiser, Michael Waters, Jocelyn Reckford, Christopher Lundeberg, Christopher D Abraham

Purpose: Large language model (LLM) artificial intelligences may help physicians appeal insurer denials of prescribed medical services, a task that delays patient care and contributes to burnout. We evaluated LLM performance at this task for denials of radiotherapy services.

Methods: We evaluated generative pretrained transformer 3.5 (GPT-3.5; OpenAI, San Francisco, CA), GPT-4, GPT-4 with internet search functionality (GPT-4web), and GPT-3.5ft. The latter was developed by fine-tuning GPT-3.5 via an OpenAI application programming interface with 53 examples of appeal letters written by radiation oncologists. Twenty test prompts with simulated patient histories were programmatically presented to the LLMs, and output appeal letters were scored by three blinded radiation oncologists for language representation, clinical detail inclusion, clinical reasoning validity, literature citations, and overall readiness for insurer submission.

Results: Interobserver agreement between radiation oncologists' scores was moderate or better for all domains (Cohen's kappa coefficients: 0.41-0.91). GPT-3.5, GPT-4, and GPT-4web wrote letters that were on average linguistically clear, summarized provided clinical histories without confabulation, reasoned appropriately, and were scored useful to expedite the insurance appeal process. GPT-4 and GPT-4web letters demonstrated superior clinical reasoning and were readier for submission than GPT-3.5 letters (P < .001). Fine-tuning increased GPT-3.5ft confabulation and compromised performance compared with other LLMs across all domains (P < .001). All LLMs, including GPT-4web, were poor at supporting clinical assertions with existing, relevant, and appropriately cited primary literature.

Conclusion: When prompted appropriately, three commercially available LLMs drafted letters that physicians deemed would expedite appealing insurer denials of radiotherapy services. LLMs may decrease this task's clerical workload on providers. However, LLM performance worsened when fine-tuned with a task-specific, small training data set.

目的:大语言模型(LLM)人工智能可以帮助医生对保险公司拒绝提供医疗服务的情况提出上诉,这项工作会延误对病人的护理,并导致职业倦怠。我们评估了 LLM 在拒绝放射治疗服务这项任务中的表现:我们评估了生成式预训练转换器 3.5(GPT-3.5;OpenAI,加利福尼亚州旧金山)、GPT-4、具有互联网搜索功能的 GPT-4 (GPT-4web)和 GPT-3.5ft。后者是通过 OpenAI 应用程序编程接口对 GPT-3.5 进行微调后开发的,其中包含 53 个由放射肿瘤专家撰写的呼吁书范例。在程序中向 LLMs 演示了 20 个带有模拟患者病史的测试提示,并由三位双盲放射肿瘤学家对输出的上诉信进行评分,包括语言表达、临床细节包含、临床推理有效性、文献引用和保险公司提交的整体准备情况:放射肿瘤专家的评分在所有领域的观察者间一致性均为中等或更好(科恩卡帕系数:0.41-0.91)。GPT-3.5、GPT-4和GPT-4web撰写的信函平均语言清晰,对所提供的临床病史进行了总结,无混淆,推理恰当,且评分有助于加快保险上诉流程。与 GPT-3.5 相比,GPT-4 和 GPT-4web 信件的临床推理能力更强,更易于提交(P < .001)。与所有领域的其他 LLM 相比,微调增加了 GPT-3.5ft 的混淆性并降低了性能(P < .001)。包括 GPT-4web 在内的所有 LLM 都不善于用现有的、相关的和适当引用的主要文献来支持临床论断:结论:在适当的提示下,三种市售 LLMs 起草了医生认为可以加快对保险公司拒绝放疗服务进行上诉的信件。LLM 可以减轻医疗服务提供者的文书工作量。然而,当使用特定任务的小型训练数据集进行微调时,LLM 的性能会下降。
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引用次数: 0
Validation of Non-Small Cell Lung Cancer Clinical Insights Using a Generalized Oncology Natural Language Processing Model. 使用通用肿瘤学自然语言处理模型验证非小细胞肺癌临床见解。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1200/CCI.23.00099
Rachel C Kenney, Xiaoren Chen, Kazuki Shintani, Clara Gagnon, John Liu, Stacey DaCosta Byfield, Lorre Ochs, Anne-Marie Currie

Purpose: Limited studies have used natural language processing (NLP) in the context of non-small cell lung cancer (NSCLC). This study aimed to validate the application of an NLP model to an NSCLC cohort by extracting NSCLC concepts from free-text medical notes and converting them to structured, interpretable data.

Methods: Patients with a lung neoplasm, NSCLC histology, and treatment information in their notes were selected from a repository of over 27 million patients. From these, 200 were randomly selected for this study with the longest and the most recent note included for each patient. An NLP model developed and validated on a large solid and blood cancer oncology cohort was applied to this NSCLC cohort. Two certified tumor registrars and a curator abstracted concepts from the notes: neoplasm, histology, stage, TNM values, and metastasis sites. This manually abstracted gold standard was compared with the NLP model output. Precision and recall scores were calculated.

Results: The NLP model extracted the NSCLC concepts with excellent precision and recall with the following scores, respectively: Lung neoplasm 100% and 100%, NSCLC histology 99% and 88%, histology correctly linked to neoplasm 98% and 79%, stage value 98.8% and 92%, stage TNM value 93% and 98%, and metastasis site 97% and 89%. High precision is related to a low number of false positives, and therefore, extracted concepts are likely accurate. High recall indicates that the model captured most of the desired concepts.

Conclusion: This study validates that Optum's oncology NLP model has high precision and recall with clinical real-world data and is a reliable model to support research studies and clinical trials. This validation study shows that our nonspecific solid tumor and blood cancer oncology model is generalizable to successfully extract clinical information from specific cancer cohorts.

目的:将自然语言处理(NLP)用于非小细胞肺癌(NSCLC)的研究非常有限。本研究旨在通过从自由文本医疗笔记中提取 NSCLC 概念并将其转换为结构化、可解释的数据,验证 NLP 模型在 NSCLC 队列中的应用:从超过 2700 万名患者的资料库中选取了笔记中包含肺部肿瘤、NSCLC 组织学和治疗信息的患者。从这些患者中随机抽取 200 名患者进行研究,每名患者都包含最长和最近的病历。我们将在大型实体肿瘤和血液肿瘤队列中开发和验证的 NLP 模型应用于 NSCLC 队列。两名经过认证的肿瘤登记员和一名馆长从笔记中抽取了概念:肿瘤、组织学、分期、TNM 值和转移部位。人工抽取的金标准与 NLP 模型输出进行了比较。结果:结果:NLP 模型提取 NSCLC 概念的精确度和召回率非常高,分别达到了以下分数:肺肿瘤 100%和 100%,NSCLC 组织学 99%和 88%,组织学与肿瘤正确关联 98%和 79%,分期值 98.8%和 92%,分期 TNM 值 93%和 98%,转移部位 97%和 89%。高精确度与低误报率有关,因此提取的概念很可能是准确的。高召回率表明模型捕捉到了大部分所需的概念:本研究验证了 Optum 的肿瘤学 NLP 模型在临床实际数据中具有较高的精确度和召回率,是支持研究和临床试验的可靠模型。这项验证研究表明,我们的非特异性实体肿瘤和血液肿瘤肿瘤学模型具有通用性,可以成功地从特定的癌症队列中提取临床信息。
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引用次数: 0
Development and Optimization of a Bladder Cancer Algorithm Using SEER-Medicare Claims Data. 利用 SEER-Medicare 索赔数据开发和优化膀胱癌算法。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1200/CCI.24.00073
John L Gore, Phoebe Wright, Vanessa Shih, Nancy N Chang, Sina Noshad, Gabriel G Rey, Steven Wang, Sujata Narayanan

Purpose: Categorizing patients with cancer by their disease stage can be an important tool when conducting administrative claims-based studies. As claims databases frequently do not capture this information, algorithms are increasingly used to define disease stage. To our knowledge, to date, no study has used an algorithm to categorize patients with bladder cancer (BC) by disease stage (non-muscle-invasive BC [NMIBC], muscle-invasive BC [MIBC], or locally advanced/metastatic urothelial carcinoma [la/mUC]) in a US-based health care claims database.

Methods: A claims-based algorithm was developed to categorize patients by disease stage on the basis of the administrative claims portion of the SEER-Medicare linked data. The algorithm was validated against a reference SEER registry, and the algorithm's parameters were iteratively modified to improve its performance. Patients were included if they had an initial diagnosis of BC between January 2016 and December 2017 recorded in SEER registry data. Medicare claims data were available for these patients until December 31, 2019. The algorithm was evaluated by assessing percentage agreement, Cohen's kappa (κ), specificity, positive predictive value (PPV), and negative predictive value (NPV) against the SEER categorization.

Results: A total of 15,484 patients with SEER-confirmed BC were included: 10,991 (71.0%) with NMIBC, 3,645 (23.5%) with MIBC, and 848 (5.5%) with la/mUC. After multiple rounds of algorithm optimization, the final algorithm had an agreement of 82.5% with SEER, with a κ of 0.58, a PPV of 87.0% for NMIBC, and 76.8% for MIBC and a high NPV for la/mUC of 98.0%.

Conclusion: This claims-based algorithm could be a useful approach for researchers conducting claims-based studies categorizing patients with BC at diagnosis.

目的:在进行以行政报销为基础的研究时,按疾病分期对癌症患者进行分类是一项重要工具。由于理赔数据库经常无法捕捉到这些信息,因此越来越多地使用算法来定义疾病分期。据我们所知,迄今为止,还没有一项研究在基于美国的医疗索赔数据库中使用算法按疾病分期(非肌浸润性膀胱癌[NMIBC]、肌浸润性膀胱癌[MIBC]或局部晚期/转移性尿路上皮癌[la/mUC])对膀胱癌(BC)患者进行分类:方法:根据 SEER-Medicare 链接数据中的行政索赔部分,开发了一种基于索赔的算法,按疾病分期对患者进行分类。该算法根据 SEER 登记参考数据进行了验证,并对算法参数进行了反复修改,以提高其性能。如果患者在 2016 年 1 月至 2017 年 12 月期间被初步诊断为 BC 并记录在 SEER 登记数据中,则将其纳入研究范围。这些患者的医疗保险理赔数据有效期至 2019 年 12 月 31 日。通过评估与 SEER 分类的一致性百分比、Cohen's kappa (κ)、特异性、阳性预测值 (PPV) 和阴性预测值 (NPV),对算法进行评估:共纳入 15,484 名 SEER 确诊的 BC 患者:其中10991例(71.0%)为NMIBC,3645例(23.5%)为MIBC,848例(5.5%)为la/mUC。经过多轮算法优化后,最终算法与 SEER 的一致性为 82.5%,κ 为 0.58,NMIBC 的 PPV 为 87.0%,MIBC 为 76.8%,la/mUC 的 NPV 高达 98.0%:这种基于索赔的算法对于研究人员在诊断时对 BC 患者进行分类的索赔研究来说是一种有用的方法。
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引用次数: 0
Deep Learning Features Can Improve Radiomics-Based Prostate Cancer Aggressiveness Prediction. 深度学习特征可改进基于放射组学的前列腺癌侵袭性预测
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1200/CCI.23.00180
Nuno M Rodrigues, José Guilherme de Almeida, Ana Rodrigues, Leonardo Vanneschi, Celso Matos, Maria V Lisitskaya, Aycan Uysal, Sara Silva, Nickolas Papanikolaou

Purpose: Emerging evidence suggests that the use of artificial intelligence can assist in the timely detection and optimization of therapeutic approach in patients with prostate cancer. The conventional perspective on radiomics encompassing segmentation and the extraction of radiomic features considers it as an independent and sequential process. However, it is not necessary to adhere to this viewpoint. In this study, we show that besides generating masks from which radiomic features can be extracted, prostate segmentation and reconstruction models provide valuable information in their feature space, which can improve the quality of radiomic signatures models for disease aggressiveness classification.

Materials and methods: We perform 2,244 experiments with deep learning features extracted from 13 different models trained using different anatomic zones and characterize how modeling decisions, such as deep feature aggregation and dimensionality reduction, affect performance.

Results: While models using deep features from full gland and radiomic features consistently lead to improved disease aggressiveness prediction performance, others are detrimental. Our results suggest that the use of deep features can be beneficial, but an appropriate and comprehensive assessment is necessary to ensure that their inclusion does not harm predictive performance.

Conclusion: The study findings reveal that incorporating deep features derived from autoencoder models trained to reconstruct the full prostate gland (both zonal models show worse performance than radiomics only models), combined with radiomic features, often lead to a statistically significant increase in model performance for disease aggressiveness classification. Additionally, the results also demonstrate that the choice of feature selection is key to achieving good performance, with principal component analysis (PCA) and PCA + relief being the best approaches and that there is no clear difference between the three proposed latent representation extraction techniques.

目的:新的证据表明,使用人工智能可以帮助及时发现前列腺癌患者并优化治疗方法。传统的放射线组学观点认为,放射线组学包括分割和提取放射线组学特征,是一个独立和连续的过程。然而,我们没有必要坚持这种观点。在本研究中,我们发现前列腺分割和重建模型除了能生成可从中提取放射特征的掩膜外,还能在其特征空间中提供有价值的信息,从而提高用于疾病侵袭性分类的放射特征模型的质量:我们利用从使用不同解剖区域训练的 13 种不同模型中提取的深度学习特征进行了 2,244 次实验,并分析了深度特征聚合和降维等建模决策对性能的影响:结果:虽然使用来自全腺体和放射学特征的深度特征的模型始终能提高疾病侵袭性预测性能,但其他模型则不利于疾病侵袭性预测。我们的研究结果表明,使用深度特征可能是有益的,但有必要进行适当而全面的评估,以确保纳入深度特征不会损害预测性能:研究结果表明,结合放射组学特征,使用从重建整个前列腺(两个分区模型的性能都比仅使用放射组学模型差)的自动编码器模型中提取的深度特征,往往会在统计学上显著提高模型的疾病侵袭性分类性能。此外,研究结果还表明,特征选择是取得良好性能的关键,其中主成分分析(PCA)和 PCA + 浮雕是最好的方法,而三种拟议的潜在表征提取技术之间并无明显差异。
{"title":"Deep Learning Features Can Improve Radiomics-Based Prostate Cancer Aggressiveness Prediction.","authors":"Nuno M Rodrigues, José Guilherme de Almeida, Ana Rodrigues, Leonardo Vanneschi, Celso Matos, Maria V Lisitskaya, Aycan Uysal, Sara Silva, Nickolas Papanikolaou","doi":"10.1200/CCI.23.00180","DOIUrl":"https://doi.org/10.1200/CCI.23.00180","url":null,"abstract":"<p><strong>Purpose: </strong>Emerging evidence suggests that the use of artificial intelligence can assist in the timely detection and optimization of therapeutic approach in patients with prostate cancer. The conventional perspective on radiomics encompassing segmentation and the extraction of radiomic features considers it as an independent and sequential process. However, it is not necessary to adhere to this viewpoint. In this study, we show that besides generating masks from which radiomic features can be extracted, prostate segmentation and reconstruction models provide valuable information in their feature space, which can improve the quality of radiomic signatures models for disease aggressiveness classification.</p><p><strong>Materials and methods: </strong>We perform 2,244 experiments with deep learning features extracted from 13 different models trained using different anatomic zones and characterize how modeling decisions, such as deep feature aggregation and dimensionality reduction, affect performance.</p><p><strong>Results: </strong>While models using deep features from full gland and radiomic features consistently lead to improved disease aggressiveness prediction performance, others are detrimental. Our results suggest that the use of deep features can be beneficial, but an appropriate and comprehensive assessment is necessary to ensure that their inclusion does not harm predictive performance.</p><p><strong>Conclusion: </strong>The study findings reveal that incorporating deep features derived from autoencoder models trained to reconstruct the full prostate gland (both zonal models show worse performance than radiomics only models), combined with radiomic features, often lead to a statistically significant increase in model performance for disease aggressiveness classification. Additionally, the results also demonstrate that the choice of feature selection is key to achieving good performance, with principal component analysis (PCA) and PCA + relief being the best approaches and that there is no clear difference between the three proposed latent representation extraction techniques.</p>","PeriodicalId":51626,"journal":{"name":"JCO Clinical Cancer Informatics","volume":"8 ","pages":"e2300180"},"PeriodicalIF":3.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300540","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
Harnessing Natural Language Processing to Assess Quality of End-of-Life Care for Children With Cancer. 利用自然语言处理技术评估癌症儿童临终关怀的质量。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1200/CCI.24.00134
Meghan E Lindsay, Sophia de Oliveira, Kate Sciacca, Charlotta Lindvall, Prasanna J Ananth

Purpose: Data on end-of-life care (EOLC) quality, assessed through evidence-based quality measures (QMs), are difficult to obtain. Natural language processing (NLP) enables efficient quality measurement and is not yet used for children with serious illness. We sought to validate a pediatric-specific EOLC-QM keyword library and evaluate EOLC-QM attainment among childhood cancer decedents.

Methods: In a single-center cohort of children with cancer who died between 2014 and 2022, we piloted a rule-based NLP approach to examine the content of clinical notes in the last 6 months of life. We identified documented discussions of five EOLC-QMs: goals of care, limitations to life-sustaining treatments (LLST), hospice, palliative care consultation, and preferred location of death. We assessed performance of NLP methods, compared with gold standard manual chart review. We then used NLP to characterize proportions of decedents with documented EOLC-QM discussions and timing of first documentation relative to death.

Results: Among 101 decedents, nearly half were minorities (Hispanic/Latinx [24%], non-Hispanic Black/African American [20%]), female (48%), or diagnosed with solid tumors (43%). Through iterative refinement, our keyword library achieved robust performance statistics (for all EOLC-QMs, F1 score = 1.0). Most decedents had documented discussions regarding goals of care (83%), LLST (83%), and hospice (74%). Fewer decedents had documented discussions regarding palliative care consultation (49%) or preferred location of death (36%). For all five EOLC-QMs, first documentation occurred, on average, >30 days before death.

Conclusion: A high proportion of decedents attained specified EOLC-QMs more than 30 days before death. Our findings indicate that NLP is a feasible approach to measuring quality of care for children with cancer at the end of life and is ripe for multi-center research and quality improvement.

目的:通过循证质量测量(QMs)评估生命末期护理(EOLC)质量的数据很难获得。自然语言处理(NLP)可实现高效的质量测量,但尚未用于重症儿童。我们试图验证儿科专用的EOLC-QM关键词库,并评估儿童癌症死者的EOLC-QM达标情况:在 2014 年至 2022 年期间死亡的癌症儿童单中心队列中,我们试用了一种基于规则的 NLP 方法来检查生命最后 6 个月的临床笔记内容。我们确定了五项生命最后阶段质量管理(EOLC-QMs)的讨论记录:护理目标、维持生命治疗的限制(LLST)、临终关怀、姑息治疗咨询和首选死亡地点。与黄金标准人工病历审查相比,我们评估了 NLP 方法的性能。然后,我们使用 NLP 分析了有记录的 EOLC-QM 讨论的死者比例以及相对于死亡的首次记录时间:在 101 位死者中,近一半为少数族裔(西班牙裔/拉丁裔[24%]、非西班牙裔黑人/非洲裔美国人[20%])、女性(48%)或确诊为实体瘤患者(43%)。通过迭代改进,我们的关键词库实现了强大的性能统计(对于所有 EOLC-QM,F1 分数 = 1.0)。大多数死者都有关于护理目标(83%)、LLST(83%)和临终关怀(74%)的讨论记录。较少死者记录了有关姑息治疗咨询(49%)或首选死亡地点(36%)的讨论。对于所有五项临终关怀-质量指标,首次记录平均发生在死亡前 30 天以上:结论:很高比例的死者在死前30多天就达到了指定的临终关怀质量标准。我们的研究结果表明,NLP是衡量癌症儿童临终护理质量的一种可行方法,多中心研究和质量改进的时机已经成熟。
{"title":"Harnessing Natural Language Processing to Assess Quality of End-of-Life Care for Children With Cancer.","authors":"Meghan E Lindsay, Sophia de Oliveira, Kate Sciacca, Charlotta Lindvall, Prasanna J Ananth","doi":"10.1200/CCI.24.00134","DOIUrl":"https://doi.org/10.1200/CCI.24.00134","url":null,"abstract":"<p><strong>Purpose: </strong>Data on end-of-life care (EOLC) quality, assessed through evidence-based quality measures (QMs), are difficult to obtain. Natural language processing (NLP) enables efficient quality measurement and is not yet used for children with serious illness. We sought to validate a pediatric-specific EOLC-QM keyword library and evaluate EOLC-QM attainment among childhood cancer decedents.</p><p><strong>Methods: </strong>In a single-center cohort of children with cancer who died between 2014 and 2022, we piloted a rule-based NLP approach to examine the content of clinical notes in the last 6 months of life. We identified documented discussions of five EOLC-QMs: goals of care, limitations to life-sustaining treatments (LLST), hospice, palliative care consultation, and preferred location of death. We assessed performance of NLP methods, compared with gold standard manual chart review. We then used NLP to characterize proportions of decedents with documented EOLC-QM discussions and timing of first documentation relative to death.</p><p><strong>Results: </strong>Among 101 decedents, nearly half were minorities (Hispanic/Latinx [24%], non-Hispanic Black/African American [20%]), female (48%), or diagnosed with solid tumors (43%). Through iterative refinement, our keyword library achieved robust performance statistics (for all EOLC-QMs, F1 score = 1.0). Most decedents had documented discussions regarding goals of care (83%), LLST (83%), and hospice (74%). Fewer decedents had documented discussions regarding palliative care consultation (49%) or preferred location of death (36%). For all five EOLC-QMs, first documentation occurred, on average, >30 days before death.</p><p><strong>Conclusion: </strong>A high proportion of decedents attained specified EOLC-QMs more than 30 days before death. Our findings indicate that NLP is a feasible approach to measuring quality of care for children with cancer at the end of life and is ripe for multi-center research and quality improvement.</p>","PeriodicalId":51626,"journal":{"name":"JCO Clinical Cancer Informatics","volume":"8 ","pages":"e2400134"},"PeriodicalIF":3.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11407740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300542","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
Increasing Power in Phase III Oncology Trials With Multivariable Regression: An Empirical Assessment of 535 Primary End Point Analyses. 利用多变量回归提高 III 期肿瘤学试验的有效性:对 535 项主要终点分析的经验评估。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-09-01 DOI: 10.1200/CCI.24.00102
Alexander D Sherry, Adina H Passy, Zachary R McCaw, Joseph Abi Jaoude, Timothy A Lin, Ramez Kouzy, Avital M Miller, Gabrielle S Kupferman, Esther J Beck, Pavlos Msaouel, Ethan B Ludmir

Purpose: A previous study demonstrated that power against the (unobserved) true effect for the primary end point (PEP) of most phase III oncology trials is low, suggesting an increased risk of false-negative findings in the field of late-phase oncology. Fitting models with prognostic covariates is a potential solution to improve power; however, the extent to which trials leverage this approach, and its impact on trial interpretation at scale, is unknown. To that end, we hypothesized that phase III trials using multivariable PEP analyses are more likely to demonstrate superiority versus trials with univariable analyses.

Methods: PEP analyses were reviewed from trials registered on ClinicalTrials.gov. Adjusted odds ratios (aORs) were calculated by logistic regressions.

Results: Of the 535 trials enrolling 454,824 patients, 69% (n = 368) used a multivariable PEP analysis. Trials with multivariable PEP analyses were more likely to demonstrate PEP superiority (57% [209 of 368] v 42% [70 of 167]; aOR, 1.78 [95% CI, 1.18 to 2.72]; P = .007). Among trials with a multivariable PEP model, 16 conditioned on covariates and 352 stratified by covariates. However, 108 (35%) of 312 trials with stratified analyses lost power by categorizing a continuous variable, which was especially common among immunotherapy trials (aOR, 2.45 [95% CI, 1.23 to 4.92]; P = .01).

Conclusion: Trials increasing power by fitting multivariable models were more likely to demonstrate PEP superiority than trials with unadjusted analysis. Underutilization of conditioning models and empirical power loss associated with covariate categorization required by stratification were identified as barriers to power gains. These findings underscore the opportunity to increase power in phase III trials with conventional methodology and improve patient access to effective novel therapies.

目的:之前的一项研究表明,大多数 III 期肿瘤学试验的主要终点(PEP)的(未观察到的)真实效应的功率很低,这表明在晚期肿瘤学领域出现假阴性结果的风险增加了。利用预后协变量拟合模型是一种提高功率的潜在解决方案;然而,试验利用这种方法的程度及其对大规模试验解释的影响尚不清楚。为此,我们假设,与采用单变量分析的试验相比,采用多变量PEP分析的III期试验更有可能显示出优越性:我们审查了在 ClinicalTrials.gov 上注册的试验的 PEP 分析。通过逻辑回归计算调整后的几率比(aORs):在有 454824 名患者参与的 535 项试验中,69%(n = 368)的试验采用了多变量 PEP 分析。采用多变量 PEP 分析的试验更有可能显示出 PEP 的优越性(57% [368 项试验中的 209 项] 对 42% [167 项试验中的 70 项];aOR,1.78 [95% CI,1.18 至 2.72];P = .007)。在采用多变量 PEP 模型的试验中,16 项试验以协变量为条件,352 项试验以协变量为分层条件。然而,在312项进行分层分析的试验中,有108项(35%)的试验因对连续变量进行分类而失去了作用力,这在免疫疗法试验中尤为常见(aOR,2.45 [95% CI,1.23~4.92];P = .01):结论:与采用未调整分析的试验相比,通过拟合多变量模型来提高功率的试验更有可能证明PEP的优越性。未充分利用调节模型和分层所需的协变量分类造成的经验功率损失被认为是提高功率的障碍。这些发现强调了在采用传统方法的III期试验中提高功率的机会,并改善了患者获得有效新型疗法的机会。
{"title":"Increasing Power in Phase III Oncology Trials With Multivariable Regression: An Empirical Assessment of 535 Primary End Point Analyses.","authors":"Alexander D Sherry, Adina H Passy, Zachary R McCaw, Joseph Abi Jaoude, Timothy A Lin, Ramez Kouzy, Avital M Miller, Gabrielle S Kupferman, Esther J Beck, Pavlos Msaouel, Ethan B Ludmir","doi":"10.1200/CCI.24.00102","DOIUrl":"10.1200/CCI.24.00102","url":null,"abstract":"<p><strong>Purpose: </strong>A previous study demonstrated that power against the (unobserved) true effect for the primary end point (PEP) of most phase III oncology trials is low, suggesting an increased risk of false-negative findings in the field of late-phase oncology. Fitting models with prognostic covariates is a potential solution to improve power; however, the extent to which trials leverage this approach, and its impact on trial interpretation at scale, is unknown. To that end, we hypothesized that phase III trials using multivariable PEP analyses are more likely to demonstrate superiority versus trials with univariable analyses.</p><p><strong>Methods: </strong>PEP analyses were reviewed from trials registered on ClinicalTrials.gov. Adjusted odds ratios (aORs) were calculated by logistic regressions.</p><p><strong>Results: </strong>Of the 535 trials enrolling 454,824 patients, 69% (n = 368) used a multivariable PEP analysis. Trials with multivariable PEP analyses were more likely to demonstrate PEP superiority (57% [209 of 368] <i>v</i> 42% [70 of 167]; aOR, 1.78 [95% CI, 1.18 to 2.72]; <i>P</i> = .007). Among trials with a multivariable PEP model, 16 conditioned on covariates and 352 stratified by covariates. However, 108 (35%) of 312 trials with stratified analyses lost power by categorizing a continuous variable, which was especially common among immunotherapy trials (aOR, 2.45 [95% CI, 1.23 to 4.92]; <i>P</i> = .01).</p><p><strong>Conclusion: </strong>Trials increasing power by fitting multivariable models were more likely to demonstrate PEP superiority than trials with unadjusted analysis. Underutilization of conditioning models and empirical power loss associated with covariate categorization required by stratification were identified as barriers to power gains. These findings underscore the opportunity to increase power in phase III trials with conventional methodology and improve patient access to effective novel therapies.</p>","PeriodicalId":51626,"journal":{"name":"JCO Clinical Cancer Informatics","volume":"8 ","pages":"e2400102"},"PeriodicalIF":3.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11371366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114636","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
Interinstitutional Approach to Advancing Geospatial Technologies for US Cancer Centers. 为美国癌症中心推进地理空间技术的机构间方法。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-08-01 DOI: 10.1200/CCI.24.00099
Todd Burus, Josh Martinez, Peter DelNero, Sam Pepper, Isuru Ratnayake, Debora L Oh, Christopher McNair, Hope Krebill, Dinesh Pal Mudaranthakam
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引用次数: 0
Natural Language Processing Accurately Differentiates Cancer Symptom Information in Electronic Health Record Narratives. 自然语言处理技术准确区分电子健康记录叙述中的癌症症状信息。
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-08-01 DOI: 10.1200/CCI.23.00235
Alaa Albashayreh, Anindita Bandyopadhyay, Nahid Zeinali, Min Zhang, Weiguo Fan, Stephanie Gilbertson White

Purpose: Identifying cancer symptoms in electronic health record (EHR) narratives is feasible with natural language processing (NLP). However, more efficient NLP systems are needed to detect various symptoms and distinguish observed symptoms from negated symptoms and medication-related side effects. We evaluated the accuracy of NLP in (1) detecting 14 symptom groups (ie, pain, fatigue, swelling, depressed mood, anxiety, nausea/vomiting, pruritus, headache, shortness of breath, constipation, numbness/tingling, decreased appetite, impaired memory, disturbed sleep) and (2) distinguishing observed symptoms in EHR narratives among patients with cancer.

Methods: We extracted 902,508 notes for 11,784 unique patients diagnosed with cancer and developed a gold standard corpus of 1,112 notes labeled for presence or absence of 14 symptom groups. We trained an embeddings-augmented NLP system integrating human and machine intelligence and conventional machine learning algorithms. NLP metrics were calculated on a gold standard corpus subset for testing.

Results: The interannotator agreement for labeling the gold standard corpus was excellent at 92%. The embeddings-augmented NLP model achieved the best performance (F1 score = 0.877). The highest NLP accuracy was observed in pruritus (F1 score = 0.937) while the lowest accuracy was in swelling (F1 score = 0.787). After classifying the entire data set with embeddings-augmented NLP, we found that 41% of the notes included symptom documentation. Pain was the most documented symptom (29% of all notes) while impaired memory was the least documented (0.7% of all notes).

Conclusion: We illustrated the feasibility of detecting 14 symptom groups in EHR narratives and showed that an embeddings-augmented NLP system outperforms conventional machine learning algorithms in detecting symptom information and differentiating observed symptoms from negated symptoms and medication-related side effects.

目的:利用自然语言处理(NLP)技术识别电子健康记录(EHR)叙述中的癌症症状是可行的。然而,需要更高效的 NLP 系统来检测各种症状,并将观察到的症状与否定症状和药物相关副作用区分开来。我们评估了 NLP 在以下方面的准确性:(1) 检测 14 组症状(即疼痛、疲劳、肿胀、情绪低落、焦虑、恶心/呕吐、瘙痒、头痛、气短、便秘、麻木/刺痛、食欲下降、记忆力减退、睡眠紊乱);(2) 区分癌症患者电子病历叙述中的观察到的症状:我们提取了 11,784 名癌症患者的 902,508 份笔记,并开发了一个由 1,112 份笔记组成的金标准语料库,标注了 14 个症状组的存在与否。我们训练了一个嵌入式增强 NLP 系统,该系统集成了人类智能、机器智能和传统机器学习算法。在黄金标准语料子集上计算了 NLP 指标,以进行测试:结果:对黄金标准语料进行标注时,标注者之间的一致性非常好,达到 92%。嵌入式增强 NLP 模型取得了最佳性能(F1 分数 = 0.877)。瘙痒症的 NLP 准确率最高(F1 分数 = 0.937),而肿胀症的准确率最低(F1 分数 = 0.787)。使用嵌入式增强 NLP 对整个数据集进行分类后,我们发现 41% 的笔记包含症状记录。疼痛是记录最多的症状(占所有笔记的 29%),而记忆受损是记录最少的症状(占所有笔记的 0.7%):我们展示了在电子病历叙述中检测 14 个症状组的可行性,并表明在检测症状信息以及区分观察到的症状与否定症状和药物相关副作用方面,嵌入式增强 NLP 系统优于传统的机器学习算法。
{"title":"Natural Language Processing Accurately Differentiates Cancer Symptom Information in Electronic Health Record Narratives.","authors":"Alaa Albashayreh, Anindita Bandyopadhyay, Nahid Zeinali, Min Zhang, Weiguo Fan, Stephanie Gilbertson White","doi":"10.1200/CCI.23.00235","DOIUrl":"10.1200/CCI.23.00235","url":null,"abstract":"<p><strong>Purpose: </strong>Identifying cancer symptoms in electronic health record (EHR) narratives is feasible with natural language processing (NLP). However, more efficient NLP systems are needed to detect various symptoms and distinguish observed symptoms from negated symptoms and medication-related side effects. We evaluated the accuracy of NLP in (1) detecting 14 symptom groups (ie, pain, fatigue, swelling, depressed mood, anxiety, nausea/vomiting, pruritus, headache, shortness of breath, constipation, numbness/tingling, decreased appetite, impaired memory, disturbed sleep) and (2) distinguishing observed symptoms in EHR narratives among patients with cancer.</p><p><strong>Methods: </strong>We extracted 902,508 notes for 11,784 unique patients diagnosed with cancer and developed a gold standard corpus of 1,112 notes labeled for presence or absence of 14 symptom groups. We trained an embeddings-augmented NLP system integrating human and machine intelligence and conventional machine learning algorithms. NLP metrics were calculated on a gold standard corpus subset for testing.</p><p><strong>Results: </strong>The interannotator agreement for labeling the gold standard corpus was excellent at 92%. The embeddings-augmented NLP model achieved the best performance (F1 score = 0.877). The highest NLP accuracy was observed in pruritus (F1 score = 0.937) while the lowest accuracy was in swelling (F1 score = 0.787). After classifying the entire data set with embeddings-augmented NLP, we found that 41% of the notes included symptom documentation. Pain was the most documented symptom (29% of all notes) while impaired memory was the least documented (0.7% of all notes).</p><p><strong>Conclusion: </strong>We illustrated the feasibility of detecting 14 symptom groups in EHR narratives and showed that an embeddings-augmented NLP system outperforms conventional machine learning algorithms in detecting symptom information and differentiating observed symptoms from negated symptoms and medication-related side effects.</p>","PeriodicalId":51626,"journal":{"name":"JCO Clinical Cancer Informatics","volume":"8 ","pages":"e2300235"},"PeriodicalIF":3.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908282","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
Development and Validation of a Natural Language Processing Algorithm for Extracting Clinical and Pathological Features of Breast Cancer From Pathology Reports. 从病理报告中提取乳腺癌临床和病理特征的自然语言处理算法的开发与验证
IF 3.3 Q2 ONCOLOGY Pub Date : 2024-08-01 DOI: 10.1200/CCI.24.00034
Elisabetta Munzone, Antonio Marra, Federico Comotto, Lorenzo Guercio, Claudia Anna Sangalli, Martina Lo Cascio, Eleonora Pagan, Davide Sangalli, Ilaria Bigoni, Francesca Maria Porta, Marianna D'Ercole, Fabiana Ritorti, Vincenzo Bagnardi, Nicola Fusco, Giuseppe Curigliano

Purpose: Electronic health records (EHRs) are valuable information repositories that offer insights for enhancing clinical research on breast cancer (BC) using real-world data. The objective of this study was to develop a natural language processing (NLP) model specifically designed to extract structured data from BC pathology reports written in natural language.

Methods: During the initial phase, the algorithm's development cohort comprised 193 pathology reports from 116 patients with BC from 2012 to 2016. A rule-based NLP algorithm was applied to extract 26 variables for analysis and was compared with the manual extraction of data performed by both a data entry specialist and an oncologist. Following the first approach, the data set was expanded to include 513 reports, and a Named Entity Recognition (NER)-NLP model was trained and evaluated using K-fold cross-validation.

Results: The first approach led to a concordance analysis, which revealed an 82.9% agreement between the algorithm and the oncologist, whereas the concordance between the data entry specialist and the oncologist was 90.8%. The second training approach introduced the definition of an NER-NLP model, in which the accuracy showed remarkable potential (97.8%). Notably, the model demonstrated remarkable performance, especially for parameters such as estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2, and Ki-67 (F1-score 1.0).

Conclusion: The present study aligns with the rapidly evolving field of artificial intelligence (AI) applications in oncology, seeking to expedite the development of complex cancer databases and registries. The results of the model are currently undergoing postprocessing procedures to organize the data into tabular structures, facilitating their utilization in real-world clinical and research endeavors.

目的:电子健康记录(EHR)是宝贵的信息库,可为利用真实世界数据加强乳腺癌(BC)临床研究提供见解。本研究的目的是开发一种自然语言处理(NLP)模型,专门用于从以自然语言编写的乳腺癌病理报告中提取结构化数据:在初始阶段,该算法的开发队列包括2012年至2016年期间116名BC患者的193份病理报告。应用基于规则的 NLP 算法提取了 26 个变量进行分析,并与数据录入专家和肿瘤学家的手动数据提取进行了比较。在第一种方法之后,数据集扩大到包括513份报告,并使用K倍交叉验证对命名实体识别(NER)-NLP模型进行了训练和评估:第一种方法进行了一致性分析,结果显示算法与肿瘤学家的一致性为 82.9%,而数据录入专家与肿瘤学家的一致性为 90.8%。第二种训练方法引入了 NER-NLP 模型的定义,该模型的准确率显示出显著的潜力(97.8%)。值得注意的是,该模型表现出了卓越的性能,尤其是在雌激素受体、孕酮受体、人表皮生长因子受体 2 和 Ki-67 等参数方面(F1 分数为 1.0):本研究与人工智能(AI)在肿瘤学应用领域的快速发展相一致,旨在加快复杂癌症数据库和登记册的开发。目前正在对模型结果进行后处理,将数据整理成表格结构,以便在实际临床和研究工作中加以利用。
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引用次数: 0
期刊
JCO Clinical Cancer Informatics
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