Comparative Effectiveness of Localized Prostate Cancer Treatments (Pilot Study)

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。这项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方式的比较有效性来帮助落实退伍军人管理局的承诺。尽管前列腺癌很常见，但它很少致命。所有的治疗方案都与与生活质量有关的严重副作用有关。然而，缺乏比较有效性的研究来指导患者和提供者的治疗时机和选择。这项全面研究的结果将引起退伍军人管理局临床医生的兴趣，他们需要评估每个患者前列腺癌治疗的风险和好处。它将为靶向和时机治疗提供有价值的总体背景和有用的指导。这也将给退伍军人管理局的研究人员带来好处，因为该项目将是第一个使用当地实践模式作为工具变量分析药物选择对结果的影响的退伍军人管理局比较有效性研究之一。项目背景：临床意义不大的局限性前列腺癌(惰性癌)很常见，过度诊断/过度治疗是一个令人担忧的问题。因此，一个主要的临床挑战是通过筛查和诊断测试提出的，这些测试不能确定治疗是否有益。由于副作用(包括阳萎和大小便失禁)对生活方式的影响，许多患者很难选择治疗方法。不幸的是，很少有比较有效性的研究来指导患者和提供者。对于预期寿命较长的患者的确切干预时机，尚不存在循证建议。因此，关于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：我们在这一试点提案中的目标是熟悉全面研究所需数据的两个关键方面。先导研究的两个目标是：目标P1：从2000-2004年退伍军人事务部癌症登记中心(VACCR)数据中提取和验证格里森评分。目的P2：在2000-2004年间，展示治疗类型概率的地理实践模式作为医疗中心效应的函数的变化。项目方法：方法将是定量的。VACCR Gleason评分信息在2004年作为数字变量可用，并在前几年的病理学文本字段中可用。我们将从2004年前的文本数据中提取Gleason分数，并将其分布与2004年的数值场得到的分布进行比较。基于我们的试点样本，我们将评估前列腺癌的主要治疗模式：根治性前列腺癌切除术(RP)、外照射(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(教育、收入、提供者密度)、设施质量和VAMC固定效果。

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.