TREATMENT DECISIONS AND PATIENT REPORTED OUTCOMES IN LOW RISK PROSTATE CANCER

描述(申请人提供)：前列腺特异性抗原(PSA)检测在20世纪80年代末出现，导致前列腺癌(PCa)发病率急剧上升。这是一个重大的公共卫生问题，因为35%-40%的新前列腺癌进展风险较低，而且不太可能从治疗中受益，这意味着每年有超过7.5万名美国男性。鉴于有证据表明PCa的过度诊断和过度治疗，人们对主动监测(AS)作为手术和放射治疗(AT)积极治疗的替代方法越来越感兴趣。低风险前列腺癌(由PSA水平10、格里森评分6和早期疾病定义)治疗对生活质量(QOL)和疾病相关功能的损害已被提议作为将损害降至最低的合法方法。尽管国家综合癌症网络和美国泌尿外科协会现在建议将AS用于低风险PCA，但AS在低风险疾病男性中被认为没有得到充分利用。然而，很少有研究考察影响AS使用的非临床因素，鉴于PCa治疗对公共卫生的影响，这是一个重要的问题。我们的具体目标是在低风险的PCa患者中进行一项前瞻性的纵向研究，在该研究中，我们将：1.评估临床、医生和患者相关的预测因素：a)AS与AT的初始治疗决定，以及b)继续AS与转向AT。2.在选择AS和AT的患者中，比较基线、6个月和24个月评估时患者报告结果(QOL、疾病特定功能、治疗满意度)的纵向变化。我们将在Kaiser Permanente North California(KPNC)医疗保健组织内进行这项研究，这项研究提供了定义明确的人群、实时病例确定、治疗前收集的全面患者报告数据以及易于访问的EMR系统等显著的实用优势。来自2010年美国人口普查的证据表明，15%-21%(N&GT；4100万)的参保人口参加了类似KPNC的团体模型HMO，另外3%(N=800万)接受退伍军人管理局的护理，这表明拟议的研究将在代表美国医疗保健市场相当一部分的环境中进行。我们将招募1465名新诊断的低风险PCa患者，并在诊断后1个月内进行基线电话访谈，并在基线后6个月和24个月进行两次随访评估。创新的核心是纳入三个数据来源：决策和心理患者结果、医生执业模式以及生物医学和利用电子病历数据，以全面评估对男性治疗决策和患者报告结果重要的因素。我们的研究还涉及国际移民组织关于比较有效性研究报告的5个最优先条件之一。最后，这一队列的建立将很容易用于未来对长期临床终点、总体卫生服务利用率以及开发以医生和患者为目标的干预措施的比较，这些干预措施旨在改善最终可能减少过度治疗低风险PCa的决策。

DESCRIPTION (provided by applicant): The advent of prostate-specific antigen (PSA) testing in the late 1980s has led to a dramatic rise in prostate cancer (PCa) incidence. This is a significant public health problem, as 35-40% of new prostate cancers have a low risk for progression and are unlikely to benefit from treatment, which translates into more than 75,000 U.S. men each year. In light of evidence indicating overdiagnosis and overtreatment of PCa, there has been increasing interest in active surveillance (AS) as an alternative to the active treatments (AT) of surgery and radiotherapy. AS has been proposed as a legitimate approach to minimizing the harms to quality of life (QOL) and disease-related function due to treatment of low-risk PCa (defined by PSA level < 10, Gleason score < 6, and early stage disease). Although AS is now recommended for low-risk PCa by the National Comprehensive Cancer Network and the American Urological Association, AS is considered to be underutilized among men with low-risk disease. However, there has been very little research examining non-clinical factors that affect use of AS, an important question given the public health implications for the treatment of PCa. Our specific aims are to conduct a longitudinal, prospective study among low-risk PCa patients in which we will: 1. Assess the clinical, physician- and patient-related predictors of a) the initial treatment decision of AS vs. AT and b) remaining on AS vs. switching to an AT. 2. Compare longitudinal changes in patient reported outcomes (QOL, disease specific function, treatment satisfaction) at the baseline, 6-, and 24-month assessments among those who chose AS vs. AT. We will conduct the study within the Kaiser Permanente Northern California (KPNC) HMO, which provides the significant practical advantages of a well-defined population, real-time case ascertainment, comprehensive patient reported data collected pre-treatment, and a readily accessible EMR system. Evidence from the 2010 U.S. Census indicates that 15-21% (N > 41 million) of the insured population is enrolled in a group model HMO similar to KPNC and an additional 3% (N = 8 million) receive care from the VA, indicating that the proposed study will be conducted in a setting that represents a substantial segment of the US healthcare market. We will enroll 1465 newly diagnosed, low-risk PCa patients and conduct a baseline telephone interview within 1 month post-diagnosis and two follow-up assessments at 6- and 24 -months post- baseline. Innovation centers on the inclusion of 3 sources of data: decisional and psychological patient outcomes, physician practice patterns, and biomedical and utilization EMR data, in order to fully assess the factors important to men's treatment decisions and patient reported outcomes. Our study also addresses one of the 5 top priority conditions of the IOM's report on comparative effectiveness research. Finally, the establishment of this cohort will easily lend itself to future comparisons of longer term clinical endpoints, overall health services utilization, and the development of physician- and patient-targeted interventions designed to improve decisions that may ultimately reduce the overtreatment of low-risk PCa.