Effectiveness of Radiotherapy for Prostate Cancer

前列腺癌放射治疗的有效性

• 批准号: 8532663
• 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/8532663
• 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）：该提案描述了癌症健康服务和比较有效性研究学术生涯的五年培训计划，重点是泌尿肿瘤学和放射治疗。我是放射肿瘤学助理教授、艾布拉姆森癌症中心成员以及宾夕法尼亚大学伦纳德·戴维斯健康经济研究所的高级研究员。在临床上，我专注于前列腺癌（PCa）的治疗。我研究的统一主题是生成支持患者治疗决策所需的证据，从而实现比较有效性研究 (CER) 的基本目的。我已经完成了 NCI F32 指导的研究奖学金，现在将通过额外的最先进的培训来扩展我的科学技能 用于估计观察比较有效性研究中因果关系的统计和计量经济学方法以及用于确定研究设计优先顺序的决策分析方法。我的长期目标是发展成为一名独立的、受资助的医师研究员，专注于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围绕三个方法领域构建的正式指导、教学课程和研讨会：1）计量经济学和决策分析； 2）用于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跨学科的科学家团队，他们高度致力于我的职业发展，并将提供完成此提案所需的专业知识。导师团队将由 Katrina Armstrong（医学博士、理学硕士）领导。我将报名参加卫生政策研究理学硕士项目，该项目旨在为毕业生从事卫生服务研究的独立职业做好准备，由伦纳德·戴维斯健康经济研究所和罗伯特·伍德·约翰逊临床学者计划联合赞助。课程将包括计量经济学/因果推理、决策分析、信息价值技术和临床试验方面的指导。这些教学课程将辅以独立研究、研讨会和小组会议，由卫生服务研究人员、经济学家、生物统计学家、流行病学家和医生组成的跨学科小组参加。 该职业发展奖的总体研究目标是检验观察性研究对前列腺癌外照射放疗 (EBRT) 治疗证据差距的贡献。我将首先将观察性研究的结果与临床试验的结果进行比较，以了解随机证据是否可用的问题，但我将添加关于 EBRT 在该人群的重要亚组中的相对有效性的证据。然后，我将进行两项 EBRT 观察性研究，一项关注死亡率，另一项关注发病率，解决没有随机证据的问题。最后，为了将可用于大型研究的有限资源集中在最具价值的证据差距上，我将把这些估计纳入创新的信息价值（VOI）模型中，以探索未来质子研究的最佳研究设计PCa 的束治疗 (PBT)。这项研究的主要数据源是监测、流行病学和最终结果 (SEER)-医疗保险数据库，这是一个基于人群的关于 65 岁及以上癌症患者的信息来源。根据我们的初步工作，我们估计分析队列将包括 1995 年至 2007 年间诊断的总共 111,000 名非转移性 PCa 患者，所有患者均随访至 2009 年。辅助数据源将是国家癌症数据库 (NCDB)，我们将探讨 65 岁以下男性的结果。 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本研究计划的目标。临床流行病学和生物统计学中心、伦纳德戴维斯健康经济研究所、普通内科医学系和放射肿瘤学系的资源提供了一个独特的智力环境，可以在其中培训创新研究方法以实现比较有效性。这些合作有助于加深对临床和政策决策实际效果的理解，并确保将多种观点和视角纳入卫生服务研究。 未来五年内将有超过 110 万名男性被诊断出患有 PCa，其中绝大多数患有局部疾病。关于 EBRT 治疗有效性的证据存在巨大差距。由于 PCa 费用每年超过 120 亿美元，并且随着美国人口老龄化，PCa 死亡率和发病率不断上升，PCa 比较有效性研究有可能影响公共健康。因此，该提议具有很强的临床意义。通过这个奖项，我将利用先进卫生服务研究方法中的重要新技能，成为一名独立的、受资助的医师科学家。