Department of Surgery and Cancer, Imperial College London, London, United kingdom.
Depatment of Surgery, St Mark's Hospital, London, United kingdom.
Ann Surg. 2019 Nov;270(5):768-774. doi: 10.1097/SLA.0000000000003537.
The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer.
SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable.
Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory.
Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT.
We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.
本研究旨在为 COLOR III 建立一个客观可靠的手术质量保证系统（SQA），该系统是一项国际多中心随机对照试验（RCT），比较经肛门全直肠系膜切除术（TaTME）与腹腔镜治疗直肠癌的效果。
SQA 会影响 RCT 的结果测量指标，如淋巴结采集、住院死亡率和局部癌症复发。然而，SQA 的水平存在差异。
对 TaTME 进行层次任务分析。采用四轮 Delphi 方法对 TaTME 步骤进行标准化。在第一轮中进行半结构化访谈，以确定关键步骤和任务，并在第二轮至第四轮中使用问卷将其评定为强制性、选择性或禁止性。开发了能力评估工具（CAT），并由专家外科医生对其内容有效性进行了检验。使用概化理论对 20 个未经编辑的视频进行评估，以测试可靠性。
确定的 101 个手术任务中有 83 个达到了 70%的一致性（26 个强制性、56 个选择性和 1 个禁止性）。创建了标准化 TaTME 的手术指南。CAT 是一个 9 个步骤和 4 个绩效质量的矩阵：暴露、执行、不良事件和最终产品。总体 G 系数为 0.883。组内和组间可靠性分别为 0.883 和 0.986。为了参加 COLOR III，提交了 2 个未经编辑的 TaTME 和 1 个腹腔镜 TME 视频，并由 2 名独立评估员使用 CAT 进行评估。
我们描述了一种在多中心 RCT 中开发客观 SQA 的迭代方法。该方法提供了标准化、可靠和有效的 CAT 的开发，以及试验准入标准和监测试验期间手术绩效的标准。
