Effectiveness of Radiotherapy for Prostate Cancer

前列腺癌放射治疗的有效性

• 批准号: 8383228
• 负责人: Justin Bekelman
• 金额: $ 17.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-16 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8383228
• 关键词: Address; Adopted; Advanced Malignant Neoplasm; Aftercare; Age; Age-Years; Androgens; Area; Award; Benchmarking; Biometry; Cancer Center; Clinical; Clinical Trials; Collaborations; Commit; Communities; Comorbidity; Complement; Data Sources; Databases; Decision Analysis; Diagnosis; Effectiveness; Enrollment; Ensure; Environment; Epidemiologist; Fellowship; Funding; Future; Goals; Grant; Growth; Health Care Costs; Health Policy; Health Services; Health Services Research; Imaging Techniques; Institutes; Instruction; Intensity-Modulated Radiotherapy; Internal Medicine; Intervention; Intestines; K-Series Research Career Programs; Light; Localized Disease; Malignant Neoplasms; Malignant neoplasm of prostate; Master of Science; Medical Surveillance; Medicare; Mentors; Mentorship; Metastatic Prostate Cancer; Methods; Modality; Morbidity - disease rate; NCI Scholars Program; Observational Study; Outcome; Patients; Pennsylvania; Physicians; Policies; Policy Maker; Policy Research; Population; Prostate Cancer therapy; Public Health; Published Comment; Publishing; Radiation; Radiation Oncology; Radiation therapy; Radical Prostatectomy; Randomized; Randomized Clinical Trials; Relative (related person); Research; Research Design; Research Methodology; Research Personnel; Research Proposals; Resources; Scientist; Selection Bias; Severity of illness; Source; Structure; Subgroup; Techniques; Training; Training Programs; Universities; Urologic Oncology; Wood material; Work; alternative treatment; base; cancer care; cancer diagnosis; cancer radiation therapy; career; career development; clinical effect; clinical epidemiology; clinically relevant; cohort; comparative effectiveness; cost; deprivation; effective therapy; effectiveness research; health economics; human old age (65+); information model; innovation; interest; member; men; mortality; older men; population based; professor; programs; proton beam; skills; treatment effect

DESCRIPTION (provided by applicant): This proposal describes a five year training program for an academic career in cancer health services and comparative effectiveness research with an emphasis on urologic oncology and radiotherapy. I am an Assistant Professor of Radiation Oncology, a member of the Abramson Cancer Center and a Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania. Clinically, I specialize in the treatment of prostate cancer (PCa). The unifying theme of my research is to generate evidence needed to support my patients' treatment decisions, thereby addressing the essential purpose of comparative effectiveness research (CER). I have completed an NCI F32 mentored research fellowship and now will expand my scientific skills through additional training in state-of-the-art statistical and econometric methods to estimate causal association in observational comparative effectiveness studies and decision-analytic approaches to prioritizing research designs. My long-term goal is to develop a career as an independent, grant-funded physician-investigator focused on advancing cancer comparative effectiveness research. The career development program outlined in this application contains formal mentorship, didactic coursework, and seminars structured around three methodological areas: 1) econometrics and decision analysis; 2) biostatistics for causal inference; and 3) cancer comparative effectiveness. I have assembled an interdisciplinary team of scientists at the University of Pennsylvania who are highly committed to my career development and will provide the expertise required to complete this proposal. The mentorship team will be directed by Katrina Armstrong, MD, MSCE. I will enroll in the Masters of Science Program in Health Policy Research, designed to prepare graduates for independent careers in health services research and jointly sponsored by the Leonard Davis Institute of Health Economics and the Robert Wood Johnson Clinical Scholars Program. Coursework will include instruction in econometrics/causal inference, decision analysis, value-of-information techniques, and clinical trials. These didactic courses will be complemented by independent study, seminars and small group sessions attended by an interdisciplinary group of health services researchers, economists, biostatisticians, epidemiologists, and physicians. The overall research goal of this Career Development Award is to examine the contribution of observational studies to the evidence gaps in external beam radiotherapy (EBRT) treatment for PCa. I will start by comparing results from an observational study to that of a clinical trial for question where randomized evidence is available, but will add evidence as to the relative effectiveness of EBRT across important subgroups in this population. I will then conduct two observational studies of EBRT, one focused on mortality and the other on morbidity, addressing questions for which there is no randomized evidence. Finally, with an interest in focusing the limited resources available for large studies on the evidence gaps of greatest value, I will incorporate these estimates into innovative value-of-information (VOI) models to explore the optimal research design for a future study of proton beam therapy (PBT) for PCa. The primary data source for this research is the Surveillance, Epidemiology and End Results (SEER)-Medicare database, a population-based source of information about patients 65 years and older with cancer. Based on our preliminary work, we estimate that the analytic cohorts will include a combined 111,000 patients with non-metastatic PCa diagnosed between 1995 and 2007, all followed through 2009. The secondary data source will be the National Cancer Data Base (NCDB), in which we will explore outcomes in men under 65 years of age. The scientific community at the University of Pennsylvania is outstanding and will provide the necessary resources to support my career development and the aims of this research proposal. The resources of the Center for Clinical Epidemiology and Biostatistics, the Leonard Davis Institute of Health Economics, the Department of General Internal Medicine, and the Department of Radiation Oncology provide a unique intellectual environment in which to train in innovative research methods for comparative effectiveness. These collaborations help to deepen understanding of the practical effects of clinical and policy decisions and ensure multiple viewpoints and perspectives are incorporated into health services research. Over 1.1 million men will be diagnosed with PCa in the next five years, the vast majority with localized disease. There are daunting gaps in evidence about the effectiveness of EBRT treatments. With PCa costs exceeding $12 billion per year and growing PCa mortality and morbidity as the US population ages, PCa comparative effectiveness research has the potential to impact public health. Thus, this proposal has strong clinical relevance. Through this award, I will leverage important new skills in advanced health services research methods to become an independent, grant-funded physician-scientist.

描述（由申请人提供）：该提案描述了为癌症卫生服务和比较有效性研究的五年培训计划，重点是泌尿外科肿瘤学和放射疗法。我是放射肿瘤学的助理教授，艾布拉姆森癌症中心的成员，宾夕法尼亚大学伦纳德·戴维斯卫生经济学研究所的高级研究员。临床上，我专门研究前列腺癌（PCA）。我的研究的统一主题是为支持我的患者的治疗决定提供所需的证据，从而解决了比较有效性研究（CER）的基本目的。我已经完成了NCI F32指导的研究奖学金，现在将通过最先进的培训来扩展我的科学技能 在观察性比较有效性研究中估计因果关系的统计和计量经济学方法，以及优先考虑研究设计的决策分析方法。我的长期目标是发展为独立的，赠款资助的医师评估者的职业，旨在推进癌症比较有效性研究。本申请中概述的职业发展计划包含正式的指导，教学课程和围绕三个方法论领域的研讨会：1）计量经济学和决策分析； 2）因果推断的生物统计学； 3）癌症比较有效性。我在宾夕法尼亚大学组建了一个科学家的跨学科团队，他们非常致力于我的职业发展，并将提供完成这项建议所需的专业知识。指导团队将由MSCE医学博士卡特里娜·阿姆斯特朗（Katrina Armstrong）执导。我将参加卫生政策研究硕士课程，旨在为卫生服务研究中的独立职业准备毕业生，并由伦纳德·戴维斯（Leonard Davis）卫生经济学研究所和罗伯特·伍德·约翰逊（Robert Wood Johnson）临床学者计划共同赞助。课程将包括计量经济学/因果推理的指导，决策分析，信息价值技术和临床试验。这些教学课程将由独立研究，研讨会和小组会议补充，由跨学科的卫生服务研究人员，经济学家，生物统计学家，流行病学家和医生参加。 该职业发展奖的总体研究目标是研究观察性研究对PCA外部光束放疗（EBRT）治疗中证据差距的贡献。我将首先将观察性研究的结果与可获得随机证据的问题的临床试验的结果进行比较，但会添加证据表明EBRT在该人群中重要的亚组的相对有效性。然后，我将对EBRT进行两项观察性研究，一个研究重点是死亡率，另一个侧重于发病率，解决了没有随机证据的问题。最后，由于有兴趣将有限的资源集中在大量研究上，因此我将将这些估计值纳入创新的信息价值（VOI）模型中，以探索PCA质子束治疗（PBT）未来研究的最佳研究设计。这项研究的主要数据来源是监视，流行病学和最终结果（SEER） - 梅迪卡雷数据库，这是一种基于人群的有关65岁及以上癌症患者的信息来源。基于我们的初步工作，我们估计分析队列将包括1995年至2007年间诊断为诊断为非静态PCA的111,000例，均在2009年之前诊断出来。次要数据来源将是国家癌症数据库（NCDB），在65岁以下的男性中，我们将探索其企业的现象。 宾夕法尼亚大学的科学界非常出色，将提供必要的资源来支持我的职业发展和这项研究建议的目标。临床流行病学与生物统计学中心，伦纳德·戴维斯卫生经济学研究所，通用内科医学系和放射肿瘤学系的资源提供了一个独特的知识环境，可以在其中培训创新研究方法，以提高比较效率。这些合作有助于加深对临床和政策决策的实际影响的理解，并确保将多种观点和观点纳入卫生服务研究中。 在未来五年中，将被诊断出110万人被诊断出患有PCA，这是绝大多数患有局部疾病的人。关于EBRT治疗的有效性的证据存在巨大的差距。随着美国人口年龄的增长，PCA的死亡率和发病率增加，PCA的成本超过120亿美元，PCA比较有效性研究有可能影响公共卫生。因此，该建议具有很强的临床意义。通过该奖项，我将利用高级卫生服务研究方法中的重要新技能成为一名独立的，赠款资助的医师科学家。