Clinically-Integrated Randomized Trial of Radical Prostatectomy

根治性前列腺切除术的临床综合随机试验

• 批准号: 7529142
• 负责人: Andrew J Vickers
• 金额: $ 32.94万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-05 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7529142
• 关键词: Adjuvant; Adjuvant Chemotherapy; Binding; Caring; Case-Mix Adjustments; Characteristics; Classification; Clinical; Clinical Research; Computerized Medical Record; Confidence Intervals; Data; Data Collection; Eligibility Determination; Gold; Grant; Hospitals; Incontinence; Institution; Investigation; Leadership; Malignant Neoplasms; Methodology; Modification; Numbers; Online Systems; Operative Surgical Procedures; Outcome; Patient Outcomes Assessments; Patients; Procedures; Protocols documentation; Public Health; Questionnaires; Radical Prostatectomy; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Rate; Recurrence; Reporting; Research; Research Ethics Committees; Research Personnel; Risk; Side; Specific qualifier value; Standards of Weights and Measures; Surgeon; System; Techniques; Testing; Work; cancer surgery; cost; design; experience; functional outcomes; novel; trial comparing

DESCRIPTION (provided by applicant): Copious evidence has recently emerged to suggest that the outcomes of cancer surgery vary importantly between different surgeons. The magnitude of the difference in outcome between surgeons is often comparable to that we expect from treatments such as adjuvant chemotherapy. It is likely that differences in outcome between surgeons are attributable, at least in part, to identifiable aspects of surgical technique. This suggests that randomized trials to compare different surgical techniques would be of value; there is, however, a dearth of such trials. This is related to the serious practical challenges associated with implementing adequately powered studies. In this proposal, we propose a novel methodology - the "clinically-integrated randomized trial" - for surgery research. This has been developed by systematic identification of the problems associated with surgery trials. The core principle is that the experience of the patient, doctor and other hospital staff is virtually indistinguishable irrespective of randomization. In particular, because outcome data are obtained directly from the patient electronic medical record, there is no requirement for burdensome questionnaires, forms or other procedures. Other key aspects of the clinically-integrated randomized trial include: minimal eligibility criteria; randomization of every patient as a routine part of clinical care; the use of a single "master" protocol; factorial design such that several modifications to surgical technique can be evaluated simultaneously. We propose to pilot a clinically-integrated randomized trial testing three modifications to radical prostatectomy at a single institution. This would provide "proof of principle" that trials on cancer surgery with high accrual rates can be conducted at low cost. The proposal has the enthusiastic support from the surgical leadership at the host institution, with the Chair of Surgery acting as key investigator of this grant and co-PI of the IRB protocol. PUBLIC HEALTH RELEVANCE: This is copious evidence that the outcomes of cancer surgery vary importantly between surgeons, likely due to differences in surgical technique. Yet there is dearth of randomized trials comparing different techniques of cancer surgery. We propose a novel methodology for surgery research developed by systematic identification of the practical problems associated with surgery trials. We intend to pilot this methodology in a trial comparing modifications to radical prostatectomy.

描述（由申请人提供）：最近出现了大量证据，表明癌症手术的结果在不同的外科医生之间有所不同。外科医生之间预后差异的大小通常与我们期望的辅助化疗等疗法相当。外科医生之间的结局差异至少部分归因于手术技术的可识别方面。这表明比较不同手术技术的随机试验将具有价值。但是，这种试验缺乏。这与与实施足够动力的研究相关的严重实际挑战有关。在此提案中，我们提出了一种新的方法论 - “临床综合随机试验” - 用于手术研究。这是通过系统地识别与手术试验相关的问题而开发的。核心原则是，与随机分组无关，患者，医生和其他医院工作人员的经历几乎无法区分。特别是，由于结果数据直接从患者的电子病历中获得，因此不需要繁重的问卷，表格或其他程序。临床综合随机试验的其他关键方面包括：最低资格标准；每位患者作为临床护理的常规部分的随机化；使用单个“主”协议；阶乘设计可以同时评估对手术技术的几种修改。我们建议在单个机构中试用对临床上综合的随机试验测试对根治性前列腺切除术进行三个修饰。这将提供“原则证明”，即可以低成本进行高应计率的癌症手术试验。该提案得到了东道机构外科机构的热情支持，外科主席是IRB协议的这项拨款和Co-PI的主要研究员。公共卫生相关性：这是大量证据表明，外科医生之间癌症手术的结果有所不同，这可能是由于手术技术的差异。然而，比较了不同的癌症手术技术的随机试验缺乏。我们提出了一种通过系统地识别与手术试验相关的实际问题开发的新方法，以进行手术研究。我们打算在一项试验中试用该方法，将修饰与根治性前列腺切除术进行比较。