Comparative Effectiveness of Split-dose Colonoscopy Bowel Preparation Regimens

分剂量结肠镜检查肠道准备方案的比较效果

• 批准号: 9293611
• 负责人: YU-XIAO YANG
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-10-01 至 2021-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9293611
• 关键词: 18 year old; Address; Adherence; Advisory Committees; Affect; Age; Benchmarking; Cancer Etiology; Cessation of life; Client satisfaction; Clinical; Colonoscopy; Colorectal; Colorectal Cancer; Computerized Medical Record; Constipation; Data; Detection; Diabetes Mellitus; Dose; Effectiveness; Electrolytes; Endoscopy; Enrollment; Frequencies; Health Care Costs; Health system; Healthcare; Healthcare Systems; Incidence; Informed Consent; Instruction; Intention; Intestines; Knowledge; Learning; Methods; Movement; Outcome; Outpatients; Palate; Patient Preferences; Patients; Physicians; Policies; Polyethylene Glycols; Population; Practice Guidelines; Preparation; Procedures; Process; Provider; Randomized; Randomized Controlled Trials; Recording of previous events; Regimen; Research Design; Resources; Safety; Schedule; Services; Societies; Solid; Subgroup; Taste Perception; Testing; Time; Veterans; adenoma; base; colorectal cancer risk; comparative effectiveness; cost; economic evaluation; effectiveness trial; experience; follow-up; gatorade; improved; innovation; mortality; non-compliance; novel; patient oriented; patient population; point of care; practice setting; pragmatic trial; primary endpoint; prospective; purge; satisfaction; screening; secondary endpoint; sex; theories; trial comparing; trial design; waiver; willingness

Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation regimen which is the most effective in real-world VA practice and can be immediately implemented on a VA-wide scale, the proposed study will maximize the effectiveness of colonoscopy in reducing colorectal cancer (CRC) risk among veterans, increase veteran satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of cancer-related death among veterans. Colonoscopy can effectively reduce CRC incidence and mortality. However, non-adherence to screening colonoscopy substantially undermines this benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading barrier to completing a colonoscopy from the patients' perspective. The taste and the volume of the bowel preparation determine patient tolerability and compliance to the preparation instructions, which in turn affects the incompletion (e.g., cancellation/no- show/reschedule) rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies and patient satisfaction. The two most commonly used preparations currently in the US are the split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations. While a high- volume regimen may in theory be more effective than a lower volume one, it may be associated with lower tolerability and adherence in real-world practice. Three small trials have compared these two preparations. However, data from these explanatory trials cannot inform policy decisions because they were conducted under artificial conditions, restricted among narrow patient populations, and most importantly not designed to capture the full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To address this critical knowledge gap, we are proposing a pragmatic trial to determine the optimal split-dose bowel preparation in the general veteran population. Objectives: to compare the real-world effectiveness of the two most commonly used split-dose colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with respect to the completion rate of scheduled colonoscopies, adenoma detection rate and secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes (e.g., willingness to repeat the preparation). Methods: the study will be a pragmatic randomized controlled trial comparing the two existing bowel preparation regimens in a large regional VA healthcare system. All veterans who are > 18 years of age and undergoing an outpatient elective colonoscopy are eligible. This pragmatic trial will be conducted with a waiver of informed consent. Providers who are ordering a colonoscopy at the point of care will be asked to choose between allowing the patient to be enrolled in the study or continuing with the current standard 4L PEG within the context of the VA electronic medical records (EMR) ordering menu. Enrolled patients will be automatically randomized through the EMR at the point of care to one of the two bowel preparation regimens, and a pre-populated order for the assigned preparation will then be presented instantaneously to the provider in the EMR for signature. Outcomes and covariates data will be collected directly from the EMR. The primary endpoints are overall completion rate of scheduled colonoscopy and adenoma detection rate, and the secondary endpoints are cancellation/no-show rate, bowel preparation quality and patient-oriented outcomes. Analysis will be based on intention-to-treat. We will also prospectively collect cost data in order to perform an economic evaluation of the two bowel preparation options.

通过确定结肠镜检查肠道准备方案对退伍军人医疗保健的预期影响 这在现实世界的退伍军人管理局实践中是最有效的，并且可以立即在退伍军人管理局范围内实施， 拟议的研究将最大限度地发挥结肠镜检查在降低结直肠癌(CRC)风险方面的有效性。 在退伍军人中，提高退伍军人满意度，降低退伍军人医疗成本。背景：CRC是一家领先的 退伍军人癌症相关死亡原因。结肠镜检查可有效降低结直肠癌的发生率 死亡率。然而，不坚持筛查结肠镜检查大大削弱了这一好处。现有 证据表明，令人不快的肠道准备是完成结肠镜检查的主要障碍 从病人的角度来看。肠道制剂的味道和体积决定了患者的耐受性和 遵守准备说明，这反过来又影响未完成(例如，取消/不 显示/重新安排)预定结肠镜检查的比率以及完成检查的效果 结肠镜检查和患者满意度。目前在美国最常用的两种制剂是 分剂4L聚乙二醇(PEG)和分剂2L米拉帕米/佳得乐制剂。当一个高的- 从理论上讲，容量疗法可能比低容量疗法更有效，这可能与低容量疗法有关 在现实世界实践中的容忍性和坚持性。三项小型试验对这两种制剂进行了比较。 然而，这些解释性试验的数据不能为政策决策提供信息，因为它们是进行的 在人工条件下，限制在狭窄的患者群体中，最重要的是不是被设计成 全面了解肠道准备对结肠镜检查完成率或有效性的影响。致信地址 这一关键的知识差距，我们建议进行一项务实的试验，以确定最佳的分割剂量肠道 在普通老兵群体中做好准备。目标：比较两者在现实世界中的有效性 美国最常用的分剂结肠镜检查肠道准备方案(即4L聚乙二醇和2L Miralax/Gatorade)关于预定结肠镜检查的完成率、腺瘤的发现率 其次是准备质量、取消/缺勤率和以患者为导向的结果(例如，意愿 以重复准备)。方法：这项研究将是一项务实的随机对照试验，比较 在一个大型地区性退伍军人保健系统中，现有的两种肠道准备方案。所有18岁的退伍军人 年龄和接受门诊选择性结肠镜检查的患者均符合条件。这场务实的审判将是 在放弃知情同意的情况下进行。在看护点订购结肠镜检查的提供者 将被要求在允许患者参加研究或继续当前的研究之间做出选择 退伍军人事务部电子病历(EMR)订购菜单中的标准4L聚乙二醇组分。已注册 患者将在护理时通过EMR被自动随机分配到两个肠道中的一个 准备方案，然后将提交所分配的准备的预填订单 即时提交给电子病历中的提供者进行签名。将收集结果和协变量数据 直接从电子病历。主要终点是预定的结肠镜检查的总体完成率和 腺瘤的发现率、次要终点分别为消失率/未显影率、肠道准备质量 和以病人为导向的结果。分析将以意向治疗为基础。我们还将前瞻性地收集 成本数据，以便对两种肠道准备方案进行经济评估。