Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Ann Surg Oncol. 2021 Jun;28(6):3075-3089. doi: 10.1245/s10434-021-09646-z. Epub 2021 Mar 8.
The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated.
Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo-Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network.
Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms 'poor appetite', 'fatigue', 'exhaustion' and 'sleeping problems' increased after surgery and climaxed 10-30 days postoperatively. At 3-6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher 'social functioning' (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met.
The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training.
患者报告结局（PRO）版通用不良事件术语标准（PRO-CTCAE）和 EORTC 生活质量问卷 QLQ-C30 的计算机自适应测试（CAT）版已被提议作为肿瘤学中的新 PRO 测量方法；然而，它们在接受癌症手术的患者中的实施尚未得到评估。
接受择期腹部癌症手术的患者被纳入一项前瞻性多中心研究，并根据 Dindo-Clavien 分类记录术后并发症。患者使用 CAT EORTC QLQ-C30 和 PRO-CTCAE 报告 PRO 数据，以测量 12 个核心癌症症状。患者在术后 6 个月进行随访。该研究由 CHIR-Net SIGMA 研究网络的医学生进行。
在 15 个地点获得了 303 名患者的数据并进行了分析。PRO-CTCAE 症状“食欲不振”、“疲劳”、“疲惫”和“睡眠问题”在手术后增加，并在术后 10-30 天达到高峰。在术后 3-6 个月，与基线相比，没有 PRO-CTCAE 症状有显著差异。与基线水平相比，癌症手术后 6 个月患者报告的“社会功能”（p=0.021）和总体生活质量评分更高（p<0.05）。术后并发症或死亡与评估的任何 PRO 项目之间没有相关性。以学生为主导的研究的可行性终点得到满足。
两种新的 PRO 问卷在外科肿瘤学中得到了成功应用。术后并发症不会影响重大癌症手术后的健康报告生活质量或常见癌症症状。以学生为主导的多中心临床研究的可行性得到了证明，但通过改进学生培训可以得到增强。
