Optimizing Colorectal Cancer and Polyp Surveillance after Colorectal Polypectomy

优化结直肠息肉切除术后结直肠癌和息肉监测

• 批准号: 9145517
• 负责人: Samir Gupta
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145517
• 关键词: Accounting; Address; Adenomatous Polyps; Adenomatous Polyps; Advisory Committees; Advisory Committees; Age; Age; Algorithms; Algorithms; Area; Area; Aspirin; Aspirin; Budgets; Budgets; Calibration; Calibration; Cancer Etiology; Cancer Etiology; Caring; Caring; Cessation of life; Cessation of life; Characteristics; Characteristics; Clinical; Clinical; Clinical Data; Clinical Data; Colon; Colon; Colon Carcinoma; Colonoscopy; Colonoscopy; Colorectal; Colorectal; Colorectal Cancer; Colorectal Cancer; Colorectal Neoplasms; Colorectal Neoplasms; Colorectal Polyp; Colorectal Polyp; Data; Data; Data Element; Data Element; Data Set; Data Set; Detection; Detection; Diet; Diet; Discrimination; Discrimination; Disease; Disease; Documentation; Documentation; Dysplasia; Dysplasia; Effectiveness; Effectiveness; Ensure; Ensure; Excision; Excision; Family; Family; Feedback; Feedback; Fees; Fees; Frequencies; Frequencies; Gastroenterology; Gastroenterology; Goals; Goals; Growth; Growth; Guidelines; Guidelines; Health; Health; Healthcare; Healthcare; Histology; Histology; Human Subject Research; Human Subject Research; Hyperplastic Polyp; Hyperplastic Polyp; Individual; Individual; Informatics; Informatics; Intervention; Intervention; Intestines; Intestines; Investments; Investments; Label; Label; Leadership; Leadership; Location; Location; Malignant Neoplasms; Manuals; Manuals; Measures; Measures; Medical; Medical; Medical Records; Medical Records; Methods; Methods; Minority; Minority; Modeling; Modeling; Monitor; Monitor; National Comprehensive Cancer Network; National Comprehensive Cancer Network; National Health Interview Survey; National Health Interview Survey; Natural Language Processing; Natural Language Processing; Neoplasms; Neoplasms; Outcome; Outcome; Outcomes Research; Outcomes Research; Pathologic; Pathologic; Pathology; Pathology; Patients; Patients; Performance; Performance; Pharmaceutical Preparations; Pharmaceutical Preparations; Polypectomy; Polypectomy; Polyps; Polyps; Population; Population; Preparation; Preparation; Prevention; Prevention; Provider; Provider; Publications; Publications; Recommendation; Recommendation; Recording of previous events; Recording of previous events; Records; Records; Recurrence; Recurrence; Reporting; Reporting; Research; Research; Research Infrastructure; Research Infrastructure; Research Personnel; Research Personnel; Resources; Resources; Risk; Risk; Risk Assessment; Risk Assessment; Risk Factors; Risk Factors; Risk stratification; Sampling; Sampling; Science; Science; Sensitivity and Specificity; Sensitivity and Specificity; Site; Site; Smoking; Smoking; Specificity; Specificity; Stratification; Techniques; Techniques; Testing; Testing; Text; Text; Therapeutic; Therapeutic; Training; Training; United States; United States; Validation; Validation; Veterans; Veterans; Villous; Villous; Visual; Visual; Woman; Woman; Work; Work; adenoma; adenoma; base; base; cancer diagnosis; cancer diagnosis; cancer prevention; cancer prevention; cancer risk; cancer risk; clinical practice; clinical practice; clinically relevant; cohort; cohort; colon cancer prevention; colon cancer screening; colorectal cancer prevention; colorectal cancer prevention; colorectal cancer risk; colorectal cancer screening; colorectal cancer screening; computerized; computerized; data warehouse; experience; experience; follow-up; follow-up; high risk; high risk; human subject protection; impression; impression; improved; improved; innovation; innovation; interest; interest; meetings; novel; novel; personalized strategies; personalized strategies; predictive modeling; predictive modeling; primary endpoint; primary outcome; primary outcome; red meat consumption; red meat consumption; response; response; screening; screening; sex; sex

 DESCRIPTION (provided by applicant): Colorectal cancer (CRC) is the 2nd leading cause of cancer death nationally, and the 3rd most commonly diagnosed cancer among Veterans. To reduce cancer risk, small growths in the colon called polyps found at colonoscopy are routinely removed. Current guidelines recommend repeat colonoscopy in 3, 5, or 10 years based on select features of polyps removed. However, the current approach is not accurate for cancer risk prediction. Late colonoscopy (in 5 or 10 years) is often recommended for individuals who go on to develop cancer or high-risk polyps. Conversely, early colonoscopy (in 3 years) is often recommended for individuals who go on to develop only low-risk findings. The result is suboptimal cancer prevention. The overall goal of this project is to develop a new, more personalized and comprehensive strategy for assessing risk for new polyps and CRC after initial polyp removal, including patient factors (such as age), baseline polyp factors (such as number, size, location), and quality factors (such as average polyp detection rate of the doctor performing colonoscopy). To develop the strategy, national VA colonoscopy and medical record data will be accessed to identify Veterans who have had polyp removal and at least one follow up colonoscopy between 1999 and 2012. At least 30,000 Veterans are expected to meet these criteria. Next, computerized Natural Language Processing (NLP) techniques will be developed to extract risk and outcome data of interest from colonoscopy and pathology records. These innovative techniques are required because the most valuable information available for risk prediction is only available in "free text" format witin these clinical reports. The alternative approach to data extraction (manual review of each Veteran's medical chart) is impractical, and indeed it is for this reason that research in this are has previously not been possible on a large-scale. Application of these NLP techniques will allow creation of a large, representative dataset of all Veterans who have had colonoscopy with polyp removal. In the third part of this research, a statistical risk stratification strategy to prdict risk for polyps and CRC after initial polyp removal will be developed using this dataset. Performance of the new strategy will be compared to current guidelines for predicting risk for CRC and high-risk polyps after initial polyp removal. The project is significant because Veterans are at high risk for CRC, but strategies for managing cancer risk are suboptimal. The project is innovative because we will apply cutting edge NLP methods to make use of data that is representative of all Veterans who have had polyp removal within the VA, and develop risk prediction models that go beyond current guidelines by using more personalized risk measures. The research team's expertise and significant prior work specific to CRC and polyps, and the rigorous approach proposed, ensure that the project is feasible and will be successful. Ultimately, investment in this Merit Review has great potential to improve CRC prevention for Veterans, and beyond. CRITIQUE 1 1. Significance. NCCN guidelines take into account age (>50) and family history and only recommends a 10 year interval for patients without a FH and with no polyp identified or if hyperplastic polyps are identified. For patients with an adenomatous polyp removed the recommendation varies between 3 years and 5 years based on polyp number, size, and histology (villous or presence of high grade dysplasia). The assertion that colonoscopy is suboptimal for cancer prevention is in part true but primarily due to access issues and compliance with screening and less so due to surveillance intervals . The idea of a personalized interval is already in place and while a little more difficult in the veteran population, providers still make their recommendations based on individual factors in concert with national guidelines. Efforts to develop a computerized entry form to quantify and record needed information seem more important. 2. Approach It is unclear if Aim 1 will use path records to only evaluate adenomatous polyps and if so the recommendations only differ by 2 years. Accepting a low detection rate from a provider/site and/or using that as a risk factor to increase screening frequency seems like a "work around" and more direct quality interventions to monitor and raise detection rates seem more valuable. The primary endpoint consists of polyp size, polyp number and histology. The discrepancy between endoscopic visual size and pathologic size needs to worked out 3. Impact and Innovation. Given that the utilization of colon cancer screening is only around 50% nationally (2005 National Health Interview Survey) and with documented capacity issues at some VAs who have limited screening colonoscopy (fee basis) and prioritized therapeutic colonoscopy. Any study findings calling for increased screening may be unfulfilled. This study will evaluate veterans who have had at least two colonoscopies. 4. Investigator Qualifications, and Facilities and Resources. This is an experienced team. 5. Multiple PI Leadership Plan. N/A 6. Adequacy of Response to Previous Feedback Provided by HSR&D Regarding the Proposed Study. 7. Protection of Human Subjects from Research Risk. Adequate 8. Inclusion of Women and Minorities in Research. Adequate 9. Budget. Adequate 10. Overall Impression. 11. Key Strengths. 1. Colon cancer prevention is an important area. 2. Good collaborative team with extensive experience 12. Key Weaknesses. 1. This seems like a validation of NLP in a large cohort 2. Information on preventative medications such as aspirin or other dietary risks factors such as red meat consumption and BMI are not addressed

 描述（由申请人提供）： 结直肠癌（CRC）是全国癌症死亡的第二大原因，也是退伍军人中最常见的癌症。为了降低癌症的风险，常规去除结肠镜检查中发现的称为息肉的结肠中的少量生长。当前的指南建议根据去除的息肉的某些特征在3、5或10年中重复结肠镜检查。但是，目前的方法对于癌症风险预测不准确。相反，晚结肠镜检查（在5年或10年内），通常建议对仅开发低风险发现的人进行早期结肠镜检查（3年内）。结果是预防癌症。该项目的总体目标是制定一种新的，更个性化和全面的策略，以评估初始息肉去除后新息肉和CRC的风险，包括患者因素（例如年龄），基线息肉因素（例如数量，大小，位置）和质量因素（例如医生表演结肠镜检查的平均息肉检测率）。为了制定该战略，将获取国家弗吉尼亚州的结肠镜检查和病历数据，以识别已清除息肉的退伍军人，并且在1999年至2012年之间至少进行了一次随访结肠镜检查。预计至少有30,000名退伍军人将符合这些标准。接下来，将开发计算机化的自然语言处理（NLP）技术，以从结肠镜检查和病理记录中提取风险和结果数据。需要这些创新的技术，因为可用于风险预测的最有价值的信息仅在“自由文本”格式中可用。数据提取的替代方法（对每个退伍军人的医学图表的手动审查）是不切实际的，实际上是出于这个原因，以前在大规模上不可能进行研究。这些NLP技术的应用将允许创建所有具有结肠镜检查并去除息肉的老兵的大型代表性数据集。在这项研究的第三部分中，将使用此数据集开发针对息肉和CRC风险的统计风险分层策略。将新策略的性能与当前预测CRC和高风险息肉风险的指南进行比较。该项目很重要，因为退伍军人对CRC有很高的风险，但是管理癌症风险的策略是最佳的。该项目具有创新性，因为我们将采用最先进的NLP方法来利用代表所有在VA内息肉去除息肉的退伍军人的数据，并开发通过使用更多个性化的风险措施来超越当前准则的风险预测模型。研究团队的专业知识和特定于CRC和息肉的重要工作以及提出的严格方法，确保该项目是可行的，并且将是成功的。最终，对这项功绩审查的投资具有改善退伍军人及其他地区的CRC预防的巨大潜力。批评1 1。意义。 NCCN指南考虑了年龄（> 50）和家族史，并且仅建议没有FH的患者10年间隔，没有发现息肉，或者是否确定了增生性息肉。对于腺瘤息肉的患者，根据息肉数量，大小和组织学（绒毛或高级发育不全），取消了3年至5年的建议范围。关于预防癌症的结肠镜检查次优的断言是正确的，但主要是由于访问问题和遵守筛查，而较少是由于监视间隔所致。个性化间隔的想法已经到位，虽然有点 在退伍军人人口中，供应商仍然根据国家准则协同的个人因素提出建议。为量化和记录所需信息的计算机输入表的努力似乎更为重要。 2。方法 目前尚不清楚AIM 1是否会使用路径记录来评估腺瘤息肉，如果这样，建议仅在2年之前就不同。 接受提供商/站点的低检测率和/或将其用作增加筛查频率的风险因素似乎是“围绕”的“工作”，并且更直接的质量干预措施以监视和提高检测率似乎更有价值。 主要终点由息肉大小，息肉数和组织学组成。内窥镜视觉尺寸和病理大小之间的差异需要解决 3。影响力和创新。 鉴于结肠癌筛查的利用仅在全国50％左右（2005年全国健康访谈调查），并且在某些VAS上有记录的容量问题，这些VA的结肠镜检查有限（费用基础）并优先考虑治疗结肠镜检查。任何需要增加筛查的研究结果都无法实现。这项研究将评估至少有两个结肠镜检查的退伍军人。 4。调查员资格，设施和资源。 这是一支经验丰富的团队。 5。多重PI领导计划。 N/A 6。关于拟议研究的HSR＆D提供了对先前反馈的反应。 7。保护人类受试者免受研究风险。 足够的8。妇女和少数群体的研究。 足够的 9。预算。 足够10。总体印象。 11。关键优势。 1。预防结肠癌是一个重要领域。 2。拥有丰富经验的良好合作团队 12。关键弱点。 1。这似乎是大型队列中NLP的验证 2。有关预防性药物（例如阿司匹林或其他饮食风险因素）的信息，例如消耗红肉和BMI