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)：本提案描述了一项为期五年的培训计划，该计划旨在为癌症健康服务和比较有效性研究领域的学术生涯提供培训，重点是泌尿外科、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，宾夕法尼亚大学伦纳德·戴维斯健康经济研究所高级研究员。临床上，我专门从事前列腺癌(PCa)的治疗。我研究的统一主题是产生支持我的患者治疗决定所需的证据，从而解决比较有效性研究(CER)的基本目的。我已经完成了NCI F32指导研究奖学金，现在将通过额外的最先进的培训来扩展我的科学技能 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自己的职业生涯，成为一名独立的、由赠款资助的医生兼研究员，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括正式的指导、教学课程和围绕三个方法论领域构建的研讨会：1)计量经济学和决策分析；2)因果推断的生物统计学；3)癌症的比较有效性。我已经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，并将提供完成这项提案所需的专业知识。指导小组将由医学博士卡特里娜·阿姆斯特朗指导。我将报名参加卫生政策研究理学硕士项目，该项目由伦纳德·戴维斯卫生经济研究所和罗伯特·伍德·约翰逊临床学者项目联合赞助，旨在为毕业生在卫生服务研究领域的独立职业生涯做准备。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教学。这些教学课程将与独立研究、研讨会和小组会议相辅相成，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。这一职业发展奖的总体研究目标是检验观察性研究对体外放射治疗(EBRT)治疗前列腺癌的证据空白的贡献。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，以寻找可获得随机证据的问题，但我将补充证据，说明EBRT在该人群中重要亚组中的相对有效性。然后，我将对EBRT进行两项观察性研究，一项侧重于死亡率，另一项侧重于发病率，解决没有随机证据的问题。最后，为了将有限的可用于大型研究的有限资源集中在最有价值的证据差距上，我将把这些估计纳入创新的信息价值(VOI)模型，以探索未来用于前列腺癌的质子束疗法(PBT)研究的最佳研究设计。这项研究的主要数据来源是监测、流行病学和最终结果(SEER)-医疗保险数据库，这是一个关于65岁及以上癌症患者的基于人群的信息来源。基于我们的初步工作，我们估计分析队列将包括1995至2007年间确诊的111,000名非转移性前列腺癌患者，所有患者都跟踪调查到2009年。次要数据来源将是国家癌症数据库(NCDB)，在其中我们将探索65岁以下男性的结果。 宾夕法尼亚大学的科学界是杰出的，他们将提供必要的资源来支持我的职业发展和这项研究提案的目标。临床流行病学和生物统计中心、伦纳德·戴维斯卫生经济研究所、普通内科和放射肿瘤科的资源提供了一个独特的知识环境，可在其中培训创新的研究方法，以提高比较效果。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视角纳入卫生服务研究。在接下来的五年里，将有超过110万男性被诊断出患有前列腺癌，其中绝大多数患有局限性疾病。关于EBRT治疗的有效性，证据上存在着令人望而生畏的差距。由于PCA费用每年超过120亿美元，而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众健康。因此，这一建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、由赠款资助的医生兼科学家。