Urinary Diversion Among Bladder Cancer Survivors: Cost, Complications, and QOL

描述（由申请人提供）：很少有研究探讨癌症幸存者中与治疗相关的残疾，但对于许多幸存者来说，手术干预对日常生活有持续的影响。在肌肉浸润性膀胱癌的情况下，癌症治疗的手术涉及切除膀胱。在美国，每年有7,000名膀胱癌患者接受膀胱切除手术（膀胱切除）。他们的肠道部分被用来创造不同类型的尿液分流，这是新的管道和水库，创造新的方式，尿液从体内排出。尿流改道（UD）重建允许患者通过创建一个新的膀胱（新膀胱），使尿液流经尿道，或通过创建一个回肠导管，导致在腹部开口（尿道造口术）通过尿液。到目前为止，研究还没有提供明确的证据来指导患者和临床医生在新膀胱或回肠管道分流之间做出选择。这一选择对癌症幸存者及其家属有着深远的影响，回肠管道与新膀胱转移术的长期成本和并发症尚不清楚。这项混合方法、比较有效性研究将比较与UD相关的成本、并发症、以患者和家庭为中心的结局。研究参与者将包括三个Kaiser Permanente（KP）地区内接受膀胱癌切除术的膀胱癌患者及其家庭护理人员，会员人数超过600万。这一人群基础，沿着全面的电子病历数据，形成了一个独特的机会，在一个大型的，定义的膀胱癌患者队列中比较不同的结果在集成的交付系统。我们将收集2010-2015年期间进行膀胱切除术和UD的1，500例膀胱癌患者的大量数据。我们还将招募在2013-2015年期间进行细胞切除术的患者亚组，沿着他们的家庭护理人员，参与两项年度调查，以收集以患者为中心的护理和经济数据。我们的具体目标是：目标1：确定2010年至2015年接受膀胱切除术的膀胱癌患者（N= 1，500）中预测UD选择的社会人口统计学、临床和外科医生特征。（约20%为新膀胱患者。）目标2：比较回肠导管与新膀胱术患者（N= 1，500）因UD导致的医疗保健费用增加和晚期UD相关并发症（术后>90天）的发生率。目标3：确定UD类型对经济和以患者和家庭为中心的结局的影响，这些结果是在UD手术后5个月和17个月对375名患者和178名家庭护理人员进行的调查中收集的。 公共卫生相关性：美国每年有超过7000人因膀胱癌而切除膀胱。有两种不同的选择来创造新的排尿方式，但目前还不清楚哪种选择是最好的。这项研究将跟踪膀胱癌患者， 两年后他们的膀胱被切除。我们将比较与每种选择相关的成本和并发症，以及每种选择如何影响患者及其家属。

DESCRIPTION (provided by applicant): Few studies have explored treatment-related disabilities among cancer survivors, yet for many survivors, surgical interventions have persistent effects on everyday life. In the case of muscle-invasive bladder cancer, surgery for cancer treatment involves removing the bladder. Each year 7,000 people with bladder cancer in the United States have cystectomy surgery (bladder removal). Portions of their bowel are used to create different types of urinary diversions, which are new conduits and reservoirs that create new ways for urine to be eliminated from the body. Urinary diversion (UD) reconstructions allow patients to pass urine by creating a new bladder (neobladder) that allows urine to flow through the urethra, or by creating an ileal conduit leading to an opening in the abdomen (urostomy). To date, research has not provided clear evidence to guide patients' and clinicians' decision-making about choosing between a neobladder or ileal conduit diversion. The choice has profound implications for cancer survivors and their families, and the long-term costs and complications of ileal conduit vs. neobladder diversions are unknown. This mixed-method, comparative effectiveness study will compare costs, complications, patient- and family- centered outcomes related to UD. Study participants will include bladder cancer patients undergoing cystectomy and their family caregivers within three Kaiser Permanente (KP) regions with a membership base of over six million enrollees. This population base, along with comprehensive electronic medical record data, form a unique opportunity to compare varied outcomes in a large, defined cohort of bladder cancer patients treated in integrated delivery systems. We will collect extensive data on a cohort of 1,500 bladder cancer patients with cystectomies and UD performed in 2010-2015. We will also recruit the subgroup of patients whose cystectomies are performed during 2013-2015, along with their family caregivers, for participation in two annual surveys to gather patient-centered, care giving and economic data. Our specific aims are: AIM 1: Determine the socio-demographic, clinical, and surgeon characteristics that predict UD choice among bladder cancer patients receiving cystectomies from 2010 through 2015 (N=1,500). (Approximately 20% will be neobladder patients.) AIM 2: Compare incremental health care expenses attributable to UD and the incidence of late UD-related complications (>90 days post-op) for patients with ileal conduits vs. neobladders (N=1,500). AIM 3: Determine the impacts of UD type on economic and patient- and family-centered outcomes, as collected in surveys of 375 patients and 178 family caregivers 5 and 17 months after UD surgery. PUBLIC HEALTH RELEVANCE: Each year over 7000 people in the US have their bladders removed due to bladder cancer. There are two different options for creating new ways to pass urine, but it is not clear which option is best. This study will follow bladder cancer patients for two years after their bladders are removed. We will compare the costs and complications associated with each option, and how each option affects patients and their families.