Lubeck D P, Litwin M S, Henning J M, Stier D M, Mazonson P, Fisk R, Carroll P R
Department of Urology, University of California, Los Angeles, USA.
Urology. 1996 Nov;48(5):773-7. doi: 10.1016/s0090-4295(96)00226-9.
Implicit in the modern concept of patient outcome assessment is a shift from primary reliance on clinical indicators to a broader definition that includes physical, psychological, and social well-being. This is especially true of prostate cancer, where treatment can profoundly alter patient well-being. We have initiated a longitudinal observational database, CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) to document the impact of prostate cancer on resource utilization, clinical outcomes, health-related quality of life and survival in typical practice settings.
Observational databases have been used in the treatment of other conditions. We have incorporated many well-tested elements in our study. Data are collected from two sources: the physician and the patient. The urologist enrolls eligible patients into the study, completes a medical history, and records current status, treatment, and laboratory results at each office visit. Patients complete quarterly questionnaires on health-related quality of life, resource utilization, work loss, and satisfaction with care.
Currently 21 sites participate in CaPSURE with 1419 patients enrolled by April 1996. Twenty percent of patients are newly diagnosed with prostate cancer. Time since diagnosis averages 3.0 years (SD = 3.1); mean age at diagnosis is 68.9 years (SD = 7.9, range = 39.6 to 90.7). The majority of patients (72%) are diagnosed with Stage B cancer. Patients receive a variety of treatments including surgery, irradiation, hormonal therapy, and watchful waiting.
Information available from CaPSURE will assist practicing urologists who must make clinical decisions on the basis of data such as the results of treatment in typical care settings, the effect of prostate cancer and its treatment methods on patient quality of life, and the effect on health care costs of the early detection of prostate cancer.
现代患者预后评估概念中隐含着一种转变，即从主要依赖临床指标转向更广泛的定义，该定义涵盖身体、心理和社会福祉。前列腺癌尤其如此，其治疗会深刻改变患者的福祉。我们启动了一个纵向观察数据库CaPSURE（前列腺癌战略泌尿外科研究计划），以记录前列腺癌在典型临床环境中对资源利用、临床结局、健康相关生活质量和生存的影响。
观察数据库已用于其他疾病的治疗。我们在研究中纳入了许多经过充分测试的要素。数据从两个来源收集：医生和患者。泌尿科医生将符合条件的患者纳入研究，完成病史记录，并在每次门诊就诊时记录当前状况、治疗情况和实验室检查结果。患者每季度填写关于健康相关生活质量、资源利用、工作损失和护理满意度的问卷。
目前有21个研究点参与CaPSURE，截至1996年4月已招募了1419名患者。20%的患者是新诊断出的前列腺癌患者。自诊断以来的时间平均为3.0年（标准差=3.1）；诊断时的平均年龄为68.9岁（标准差=7.9，范围为39.6至90.7岁）。大多数患者（72%）被诊断为B期癌症。患者接受多种治疗，包括手术、放疗、激素治疗和观察等待。
CaPSURE提供的信息将有助于执业泌尿科医生，他们必须根据诸如典型护理环境中的治疗结果、前列腺癌及其治疗方法对患者生活质量的影响以及前列腺癌早期检测对医疗成本的影响等数据做出临床决策。
