Comparative Effectiveness of Localized Prostate Cancer Treatments (Pilot Study)

局部前列腺癌治疗的比较有效性（试点研究）

• 批准号: 8196612
• 负责人: Austin B. Frakt
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8196612
• 关键词: Adverse effects; Affect; Age; Age-Years; Ambulatory Care; Autopsy; Benefits and Risks; Biopsy; Brachytherapy; Caring; Categories; Cessation of life; Characteristics; Clinical; Comorbidity; County; Critiques; Data; Data Element; Diagnosis; Diagnostic Neoplasm Staging; Diagnostic tests; Disease; Education; Elderly man; Eligibility Determination; Environment; Ethnic Origin; External Beam Radiation Therapy; Failure; Familiarity; Future; Gleason Grade for Prostate Cancer; Guidelines; Health Care Costs; Healthcare; Histopathologic Grade; Impotence; Incidence; Income; Incontinence; Individual; Indolent; Institutional Review Boards; Intervention; Life; Life Expectancy; Life Style; Malignant Neoplasms; Malignant neoplasm of prostate; Measurement; Measures; Medical center; Medicare; Methods; Modality; Modeling; Operative Surgical Procedures; Outcome; Palliative Care; Pathologic; Pathology; Patient Care; Patient observation; Patients; Pattern; Pharmaceutical Preparations; Pilot Projects; Practice Pattern Variations; Probability; Prostate; Prostate-Specific Antigen; Provider; Quality of life; Race; Radiation; Radical Prostatectomy; Relative (related person); Reliance; Research Design; Research Personnel; Residual state; Risk; Sampling; Screening for Prostate Cancer; Selection for Treatments; Services; Statistical Models; System; Text; Time; Transfer Agreement; Treatment outcome; Variant; Veterans; active method; base; cancer therapy; cohort; common treatment; comparative effectiveness; cost; demographics; density; effectiveness research; evidence based guidelines; high risk; indexing; instrument; interest; lifetime risk; male; men; mortality; neoplasm registry; older men; screening; trend; tumor

DESCRIPTION (provided by applicant): Anticipated Impacts on Veteran's Healthcare: Comparative effectiveness research is a high priority for the Department of Veterans Affairs. The full study this pilot will support will help implement VA's commitment by investigating the comparative effectiveness of major modes of treatment for localized prostate cancer. Though prostate cancer is common, it is infrequently deadly. All treatment options are associated with significant side effects that relate to quality of life. Yet, there is a paucity of comparative effectiveness research to guide patients and providers as to the timing and choice of treatment. The results of the full study will be of interest to VA clinicians who need to assess the risks and benefits of prostate cancer treatment for each patient. It will provide valuable context in general and useful guidance for targeting and timing treatment. There will be benefits for VA researchers as well because this project would be among the first VA comparative effectiveness study to use local practice patterns as instruments in an instrumental variables analysis of the effects of medication choice on outcomes. Project Background: Clinically insignificant localized prostate cancer (indolent cancer) is common and over- diagnosis/over-treatment is a concern. Thus, a principal clinical challenge is presented by screening and diagnostic tests that are not conclusive about whether treatment will be beneficial. Because of the lifestyle implications of side effects (including impotence and incontinence), choice of treatment is difficult for many patients. Unfortunately there is a paucity of comparative effectiveness research to guide patients and providers. Evidence-based recommendations for the precise timing of intervention in patients with long life expectancy do not exist. Consequently, life-altering decisions about prostate cancer treatment are made in a relatively low-information environment. Project Objectives: Our aim in this pilot proposal is to gain familiarity with two key aspects of data required for the full study. The two objectives of the pilot study are: Objective P1: Extract and validate Gleason scores from 2000-2004 VA Central Cancer Registry (VACCR) data. Objective P2: For years 2000-2004, demonstrate geographic practice pattern variation in probability of treatment type as a function of medical center effects. Project Methods: Methods will be quantitative. VACCR Gleason score information is available in 2004 as a numerical variable and in prior years in a pathology text field. We will extract Gleason score from the pre-2004 text data and compare distributions with that obtained from the 2004 numerical field. Based on our pilot sample, we will estimate a model of prostate cancer treatment across the main treatment modalities: radical prostatectomy (RP), external beam radiation therapy (EBRT), brachytherapy (BT), and active surveillance (AS). Independent variables will include age, co-morbidities, county-level demographics (education, income, provider density), facility quality and VAMC fixed effects.

描述（由申请人提供）： 对退伍军人医疗保健的预期影响：比较有效性研究是退伍军人事务部的高度优先事项。该试点将支持的全面研究将通过调查局部前列腺癌主要治疗模式的比较有效性来帮助实现VA的承诺。虽然前列腺癌很常见，但很少致命。所有治疗方案都与生活质量相关的显著副作用有关。然而，缺乏比较有效性研究来指导患者和提供者选择治疗的时机和选择。完整研究的结果将对VA临床医生感兴趣，他们需要评估每个患者前列腺癌治疗的风险和益处。它将提供有价值的背景一般和有用的指导目标和时间治疗。VA研究人员也将受益，因为该项目将是第一个VA比较有效性研究，使用当地实践模式作为工具，分析药物选择对结果的影响。项目背景：临床上无意义的局限性前列腺癌（惰性癌）很常见，过度诊断/过度治疗是一个问题。因此，主要的临床挑战是筛查和诊断测试，这些测试无法确定治疗是否有益。由于副作用（包括阳痿和尿失禁）对生活方式的影响，许多患者很难选择治疗。不幸的是，缺乏指导患者和提供者的比较有效性研究。对于预期寿命较长的患者，没有基于证据的确切干预时机建议。因此，有关前列腺癌治疗的改变生活的决定是在相对低信息的环境中做出的。项目目标：我们在这个试点提案中的目标是熟悉完整研究所需数据的两个关键方面。初步研究的两个目标是：目标P1：从2000-2004年VA中央癌症登记处（VACCR）数据中提取并验证Gleason评分。目标P2：2000-2004年，证明地理实践模式的变化，在概率的治疗类型作为一个功能的医疗中心的影响。项目方法：方法将是定量的。VACCR Gleason评分信息在2004年作为数值变量提供，在前几年在病理学文本字段中提供。我们将从2004年以前的文本数据中提取格里森分数，并将其分布与2004年的数值字段进行比较。基于我们的试点样本，我们将评估前列腺癌治疗的主要治疗方式模型：根治性前列腺切除术（RP），外束放射治疗（EBRT），近距离放射治疗（BT）和主动监测（AS）。自变量将包括年龄、合并症、县级人口统计学（教育、收入、提供者密度）、设施质量和VAMC固定效应。