Department of Surgery, Division of Thoracic Surgery, McMaster University, Hamilton, ON, Canada.
Department of Surgery, Division of Thoracic Surgery, Rouen Normandy University, Rouen Cedex, France.
Ann Surg. 2023 Dec 1;278(6):841-849. doi: 10.1097/SLA.0000000000006073. Epub 2023 Aug 8.
The aim of this study was to determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage non-small cell lung cancer when compared with video-assisted thoracic surgery lobectomy (VATS-lobectomy).
Barriers against the adoption of RPL-4 in publicly funded health care include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery.
Patients were enrolled in a blinded, multicentered, randomized controlled trial in Canada, the United States, and France, and were randomized 1:1 to either RPL-4 or VATS-lobectomy. EuroQol 5 Dimension 5 Level (EQ-5D-5L) was administered at baseline and postoperative day 1; weeks 3, 7, 12; and months 6 and 12. Direct and indirect costs were tracked using standard methods. Seemingly Unrelated Regression was applied to estimate the cost effect, adjusting for baseline health utility. The incremental cost-effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations.
Of 406 patients screened, 186 were randomized, and 164 analyzed after the final eligibility review (RPL-4: n=81; VATS-lobectomy: n=83). Twelve-month follow-up was completed by 94.51% (155/164) of participants. The median age was 68 (60-74). There were no significant differences in body mass index, comorbidity, pulmonary function, smoking status, baseline health utility, or tumor characteristics between arms. The mean 12-week health utility score was 0.85 (0.10) for RPL-4 and 0.80 (0.19) for VATS-lobectomy ( P =0.02). Significantly more lymph nodes were sampled [10 (8-13) vs 8 (5-10); P =0.003] in the RPL-4 arm. The incremental cost/quality-adjusted life year of RPL-4 was $14,925.62 (95% CI: $6843.69, $23,007.56) at 12 months.
Early results of the RAVAL trial suggest that RPL-4 is cost-effective and associated with comparable short-term patient-reported health utility scores when compared with VATS-lobectomy.
本研究旨在确定与电视辅助胸腔镜手术肺叶切除术(VATS-肺叶切除术)相比,对于早期非小细胞肺癌患者,机器人辅助肺叶切除术(RPL-4)在成本效益方面是否具有优势,以及能否改善患者报告的健康效用。
在公共资助的医疗保健中采用 RPL-4 的障碍包括高质量前瞻性试验的缺乏,以及对机器人手术高成本的认知。
患者在加拿大、美国和法国参加了一项盲法、多中心、随机对照试验,并按 1:1 比例随机分配至 RPL-4 或 VATS-肺叶切除术组。在基线和术后第 1 天、第 3 周、第 7 周、第 12 周以及第 6 个月和第 12 个月进行 EuroQol 5 维度 5 级量表(EQ-5D-5L)评估。使用标准方法跟踪直接和间接成本。采用似乎不相关回归来估计调整基线健康效用后的成本效果。通过 10,000 次 bootstrap 抽样和多变量链方程插补生成增量成本效益比。
在筛选的 406 名患者中,有 186 名进行了随机分组,在最终资格审查后对 164 名患者进行了分析(RPL-4:n=81;VATS-肺叶切除术:n=83)。164 名患者中有 155 名(94.51%)完成了 12 个月的随访。中位年龄为 68(60-74)岁。两组间的体重指数、合并症、肺功能、吸烟状况、基线健康效用或肿瘤特征均无显著差异。RPL-4 组的 12 周健康效用平均得分为 0.85(0.10),VATS-肺叶切除术组为 0.80(0.19)(P=0.02)。RPL-4 组的淋巴结取样数显著更多[10(8-13)个 vs 8(5-10)个;P=0.003]。RPL-4 在 12 个月时的增量成本/质量调整生命年为 14,925.62 美元(95%CI:6843.69 美元,23,007.56 美元)。
RAVAL 试验的早期结果表明,与 VATS-肺叶切除术相比,RPL-4 在成本效益方面具有优势,并且与短期患者报告的健康效用评分相当。