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机器人和腹腔镜妇科手术:英格兰的一项前瞻性多中心观察队列研究和经济评估。

Robotic and laparoscopic gynaecological surgery: a prospective multicentre observational cohort study and economic evaluation in England.

机构信息

Department of Nursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK

Department of Nursing, Midwifery and Health, Northumbria University, Newcastle upon Tyne, UK.

出版信息

BMJ Open. 2023 Sep 28;13(9):e073990. doi: 10.1136/bmjopen-2023-073990.

Abstract

OBJECTIVE

To compare the health-related quality of life and cost-effectiveness of robot-assisted laparoscopic surgery (RALS) versus conventional 'straight stick' laparoscopic surgery (CLS) in women undergoing hysterectomy as part of their treatment for either suspected or proven gynaecological malignancy.

DESIGN

Multicentre prospective observational cohort study.

SETTING

Patients aged 16+ undergoing hysterectomy as part of their treatment for gynaecological malignancy at 12 National Health Service (NHS) cancer units and centres in England between August 2017 and February 2020.

PARTICIPANTS

275 patients recruited with 159 RALS, 73 CLS eligible for analysis.

OUTCOME MEASURES

Primary outcome was the European Organisation for Research and Treatment of Cancer Quality of Life measure (EORTC). Secondary outcomes included EuroQol-5 Dimension (EQ-5D-5L) utility, 6-minute walk test (6MWT), NHS costs using pounds sterling (£) 2018-2019 prices and cost-effectiveness. The cost-effectiveness evaluation compared EQ-5D-5L quality adjusted life years and costs between RALS and CLS.

RESULTS

No difference identified between RALS and CLS for EORTC, EQ-5D-5L utility and 6MWT. RALS had unadjusted mean cost difference of £556 (95% CI -£314 to £1315) versus CLS and mean quality adjusted life year (QALY) difference of 0.0024 (95% CI -0.00051 to 0.0057), non-parametric incremental cost-effectiveness ratio of £231 667per QALY. For the adjusted cost-effectiveness analysis, RALS dominated CLS with a mean cost difference of -£188 (95% CI -£1321 to £827) and QALY difference of 0.0024 (95% CI -0.0008 to 0.0057).

CONCLUSIONS

Findings suggest that RALS versus CLS in women undergoing hysterectomy (after adjusting for differences in morbidity) is cost-effective with lower costs and QALYs. Results are highly sensitive to the usage of robotic hardware with higher usage increasing the probability of cost-effectiveness. Non-inferiority randomised controlled trial would be of benefit to decision-makers to provide further evidence on the cost-effectiveness of RALS versus CLS but may not be practical due to surgical preferences of surgeons and the extensive roll out of RALS.

摘要

目的

比较机器人辅助腹腔镜手术(RALS)与传统“直棒”腹腔镜手术(CLS)在接受子宫切除术治疗疑似或确诊妇科恶性肿瘤的女性中的健康相关生活质量和成本效益。

设计

多中心前瞻性观察队列研究。

地点

2017 年 8 月至 2020 年 2 月期间,英格兰 12 个国民保健服务(NHS)癌症单位和中心的 16 岁及以上接受子宫切除术治疗妇科恶性肿瘤的患者。

参与者

招募了 275 名患者,其中 159 名接受 RALS,73 名接受 CLS 分析。

主要结局

主要结局为欧洲癌症研究与治疗组织生活质量量表(EORTC)。次要结局包括欧洲五维健康量表(EQ-5D-5L)效用、6 分钟步行试验(6MWT)、使用 2018-2019 年英镑的国民保健服务成本和成本效益。成本效益评估比较了 RALS 和 CLS 的 EQ-5D-5L 质量调整生命年和成本。

结果

RALS 和 CLS 在 EORTC、EQ-5D-5L 效用和 6MWT 方面没有差异。RALS 与 CLS 的未调整平均成本差异为 556 英镑(95%CI-314 至 1315 英镑),平均质量调整生命年(QALY)差异为 0.0024(95%CI-0.00051 至 0.0057),非参数增量成本效益比为 231667 英镑/QALY。对于调整后的成本效益分析,RALS 以 -188 英镑的平均成本差异(95%CI-1321 至 827 英镑)和 0.0024 的 QALY 差异主导 CLS(95%CI-0.0008 至 0.0057)。

结论

研究结果表明,在接受子宫切除术治疗的女性中,RALS 与 CLS 相比具有成本效益,因为其成本较低,QALYs 较高。结果对机器人硬件的使用高度敏感,使用量的增加增加了成本效益的可能性。由于外科医生的手术偏好和机器人辅助腹腔镜手术的广泛推广,非劣效性随机对照试验将有助于决策者提供关于 RALS 与 CLS 的成本效益的进一步证据,但由于外科医生的手术偏好和机器人辅助腹腔镜手术的广泛推广,可能不切实际。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1243/10546163/d985bce07185/bmjopen-2023-073990f01.jpg

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