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

项目摘要 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 在过去的十年中，机器人手术的总量增加了两倍，它用于最常见的全身性疾病。 外科手术（如腹股沟疝修补术或胆囊切除术）增加了24- 在这同一时期。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，使患者在对新手术的热情之间处于危险之中。 技术和证据不足，以证明在临床实践中的重大变化。现有观测 研究缺乏适当的对照，少数随机试验集中在狭窄的临床 领域（如直肠癌手术），精心挑选的患者和最有经验的 外科医生该提案使用医疗保险和私人付款人索赔数据的组合， 描述机器人手术在现实世界中的采用、结果和医疗保健支出， 普通外科手术。我们专注于腹股沟/腹疝修补术，胆囊切除术， 结肠癌和直肠癌的外科手术-这两个临床领域在2010年增长最大， 机器人手术我们利用机器人手术区域采用的自然变化作为 工具变量，以减轻限制先前观察性研究的选择偏倚问题 估计机器人手术的结果。我们用这种方法来探索短期的 相对安全性（例如术后并发症的发生率），手术事件的花费 的护理，和长期有效性（例如疝复发）的机器人手术相对于更多 为每例手术建立了腹腔镜和开放手术方法。我们评估了 具有不同程度机器人手术经验的外科医生之间的结果。的 这项研究的结果将直接与患者和提供者进行治疗有关。 决定最安全和最有效的手术方法。它还将为以下方面的工作提供信息： 政策制定者和专业团体在确保安全扩散方面有着共同的利益， 新的外科技术。最后，这些数据将提供公共和私人付款人-谁是共同的 更多地使用循证覆盖设计-利用数据提高 昂贵的外科手术。

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.