Rapid Adoption of Robotic Surgery: Risks, Benefits, and Unintended Consequences

项目总结 美国现在进行的机器人手术比其他所有国家加起来还要多。而当 在过去的十年里，机器人手术的总量增加了两倍，它用于最常见的普通手术 外科手术(如腹股沟疝修补术或胆囊切除术)增加了24%以上- 在同一时期内折合。尽管如此，关于机器人的使用和临床结果的证据 这些手术的手术是有限的--将患者置于对新手术的热情之间的风险中 技术和证据不足，不足以证明临床实践中的重大变化是合理的。现有观测站 研究缺乏适当的对照，少数随机试验侧重于狭隘的临床 与精心挑选的患者和最有经验的人合作的领域(例如直肠癌手术) 外科医生。该提案使用联邦医疗保险和私人支付者索赔数据的组合来 描述机器人手术在现实世界中的采用率、结果和医疗费用 普通外科手术。我们专注于腹股沟/腹股沟疝修补术， 以及结肠癌和直肠癌的外科手术-这是#年增长最快的临床领域 机器人手术。我们利用机器人手术在地区采用中的自然变异作为 用于缓解限制先前观察性研究的选择偏差问题的工具变量 评估机器人手术的结果。我们使用这种方法来探索短期 相对安全性(如术后并发症发生率)、手术费用 机器人手术的护理和长期有效性(例如，疝气复发)相对于 为每一次手术建立了腹腔镜术和开腹手术入路。我们在以下方面评估异质性 具有不同程度执行机器人手术经验的外科医生的结果。这个 这项研究的结果将与患者和治疗提供者直接相关 围绕最安全和最有效的手术方法做出决定。它还将为以下工作提供信息 在确保安全扩散方面有共同利益的决策者和专业团体 新的外科技术。最后，这些数据将提供公共和私人支付者-他们共同 走向更多地使用基于证据的覆盖设计-通过数据来提高 在美国，昂贵的手术干预措施。

PROJECT SUMMARY The United States now performs more robotic surgery than all other countries combined. While the overall volume of robotic surgery has tripled in the past decade, its use for the most common general surgery operations (e.g. inguinal hernia repair or gallbladder removal) has increased more than 24- fold over this same period. Despite this, evidence regarding the use and clinical outcomes of robotic surgery for these operations is limited – putting patients at risk between enthusiasm for a new surgical technology and insufficient evidence to justify large changes in clinical practice. Existing observational studies lack appropriate controls and the small number of randomized trials focus on narrow clinical domains (e.g. surgery for rectal cancer) with carefully selected patients and the most experienced surgeons. This proposal uses a combination of Medicare and private payer claims data to characterize the real-world adoption, outcomes, and health care expenditures of robotic surgery for common general surgical operations. We focus on inguinal/ventral hernia repair, cholecystectomy, and surgery for colon and rectal cancer – the clinical domains experiencing the largest growth in robotic surgery. We leverage natural variation in the regional adoption of robotic surgery as an instrumental variable to mitigate issues of selection bias that limit prior observational studies estimating the outcomes of robotic surgery. We use this approach to explore the short-term comparative safety (e.g. incidence of postoperative complications), spending for the surgical episode of care, and long-term effectiveness (e.g. hernia recurrence) of robotic surgery relative to the more established laparoscopic and open approaches for each operation. We assess for heterogeneity in outcomes across surgeons with varying degrees of experience performing robotic surgeries. The results from this study will have immediate relevance to patients and providers making treatment decisions around the safest and most effective approach for surgery. It will also inform the work of policymakers and professional societies who share a common interest in ensuring the safe diffusion of new surgical technologies. Finally, these data will provide public and private payers – who are jointly moving towards greater use of evidence-based coverage design – with data to improve the value of expensive surgical interventions in the United States.