Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

晚期癌症患者面临影响生活质量(QOL)的挑战。作为国家癌症政策 委员会发现，针对无法治愈的癌症患者需求的研究严重不足 而有效性很少通过前瞻性试验来展示。恶性肠梗阻(MBO)是一种 晚期癌症患者的常见问题，涉及相当大的痛苦。有两个主要的 MBO的治疗方法：手术治疗和内科治疗 药物。为大多数患者选择最佳临床护理的循证信息很少。 通过管理层收购。这些患者的目标可能包括进食能力、缓解恶心、疼痛控制、 家，并伴随着生存的增加。治疗可能会改善许多人的生活质量结果，但没有 定义改进的一致衡量标准。这项研究的目的是比较当前的治疗算法 在减少住院天数和改善生活质量方面，手术和非手术方法对MBO的影响。 这将是一项为期五年的多部位前瞻性比较有效性研究，研究对象为入院患者。 有管理层收购的医院。我们设计了一项混合设计研究，研究对象是一个较小的随机总体和一个 更大的观测队列，以确保观测结果的有效性，同时实现足够的应计利润。至 要实现这一目标，我们将需要增加180名患者(50名随机分组研究，130名观察性研究 研究)。MBO患者的优势将被累积到使用一般情况下的前瞻性跟踪 建模策略和倾向评分技术，以比较治疗方法。此外，我们 将有一小部分患者被随机分为手术和非手术干预。我们的 数据收集策略旨在通过这种替代研究方法将患者负担降至最低 临床上有意义的结果衡量标准以及有限的与健康相关的生活质量调查。 这项研究的主要纳入标准是是否正在考虑手术方案 管理层收购，结果是均衡的。要比较的干预措施是初始外科手术与 非手术入路治疗MBO。数据表单将包括人口统计和病史、住院天数、 使用NG管，TPN和其他水化，进食或饮用的能力，有饮食病史，并发症，复发， 总计住院天数和存活率。此外，研究协调员将连续获取主观生活质量数据 来自MD Anderson症状清单-胃肠道，应该不会超过10分钟 完成。主要的结果衡量标准是“好日子”，定义为在家(不在医院)。 而且还活着。我们希望发现的差异是90天跨度中的两周(差异20%)。次要的 终点包括使用NG管的天数，静脉补液天数，吃固体食物的天数，饮酒的天数， 摄入量、复发率、发病率和存活率。我们还将包括一份成本分析计划。我们 期望结果对护理MBO患者的从业者具有临床实用价值。

Patients with advanced cancer face challenges affecting quality of life (QOL). As the National Cancer Policy Board has identified, research addressing the needs of patients with incurable cancers is severely deficient and effectiveness has rarely been displayed by prospective trials. Malignant bowel obstruction (MBO) is a common problem for advanced cancer patients that involves considerable suffering. There are two major treatment approaches for MBO: surgical management and medical management with specific classes of medications. There is little evidence-based information to choose the optimal clinical care for most patients with a MBO. Goals for these patients may include the ability to eat, relief of nausea, pain control, being at home, and along with an increase in survival. Treatments may improve QOL outcomes in many, but there is no consistent measure defining improvement. The aim of this study is to compare the current treatment algorithms of surgical and non-surgical approaches to MBO in terms of minimizing days in hospital and improving QOL. This will be a five-year multi-site prospective comparative effectiveness study of patients who are admitted to the hospital with an MBO. We have devised a mixed-design study of a smaller randomized population and a larger observational cohort to ensure validity of observational results while enabling adequate accrual. To accomplish this goal we will need to accrue 180 patients (50 in randomized sub-study, 130 in observational study). The preponderance of MBO patients will be accrued to be prospectively followed utilizing general modeling strategy along with propensity score techniques to compare treatment approaches. In addition, we will have a smaller subset of patients who will be randomized to surgical versus non-surgical interventions. Our data collection strategies are designed to minimize patient burden by this alternate research approach with clinically meaningful outcome measures as well as limited health-related quality of life surveys. The primary inclusion criteria for the study is whether a surgical option is being considered in the setting of MBO and there is equipoise to outcomes. The interventions to be compared are an initial surgical versus a non-surgical approach for MBO. Data forms will include demographic and disease history, hospital stay, days with NG tubes, TPN and other hydration, ability to eat or drink with dietary histories, complications, recurrence, total hospital days, and survival. In addition, research coordinators will serially acquire subjective QOL data from the MD Anderson Symptom Inventory - Gastrointestinal, which should not take more than 10 minutes to complete. The primary outcome measure will be "good days", defined as being at home (out of the hospital) and alive. The difference we hope to find is two weeks in a 90 day span (20% difference). Secondary endpoints include days with NG tube, days of intravenous hydration, days eating solid foods, days drinking, and amount of intake, recurrence, morbidity, and survival. We will include a cost analysis plan as well. We anticipate results to be clinically useful to practitioners caring for MBO patients.