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

机器人手术的快速采用：风险、益处和意外后果

• 批准号: 10553669
• 负责人: Justin Brigham Dimick
• 金额: $ 50.33万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-21 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10553669
• 关键词: Adoption; Anatomy; Cholecystectomy; Clinical; Clinical Data; Colon Carcinoma; Complication; Country; Data; Decision Making; Diffusion; Effectiveness; Ensure; Expenditure; Goals; Growth; Health Expenditures; Hernia; Heterogeneity; Hospitals; Incidence; Inguinal Hernia; Laparoscopic Surgical Procedures; Learning; Medical; Medicare; Observational Study; Operative Surgical Procedures; Outcome; Patient Selection; Patients; Perioperative; Policy Maker; Postoperative Complications; Privatization; Procedures; Professional Organizations; Provider; Records; Rectal Cancer; Recurrence; Reporting; Risk; Robotics; Safety; Selection Bias; Surgeon; System; Technology; Time trend; United States; Variant; Ventral Hernia; Work; cancer surgery; care episode; clinical practice; colon surgery; comparative; comparative safety; cost; design; evidence base; experience; improved; interest; new technology; operation; population based; randomized trial; repaired; robotic system; skills; standard of care; treatment effect; trend

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.

项目摘要 现在，美国的机器人手术比所有其他国家的合并都要多。而 在过去的十年中，机器人手术的总体量增加了两倍，用于最常见的一般 手术手术（例如腹股沟疝修复或去除胆囊）已增加了24-- 在同一时期折叠。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 - 使患者在新手术的热情之间处于危险之中 技术和证据不足以证明临床实践的重大变化是合理的。现有的观察 研究缺乏适当的控制，少量随机试验集中于狭窄的临床 精心挑选的患者和经验最丰富的患者的结构域（例如直肠癌手术） 外科医生。该建议将Medicare和私人付款人索赔的组合结合到 描述了现实世界中的采用，成果和机器人手术的医疗保健支出 普通的一般手术手术。我们专注于腹股沟/腹性疝修复，胆囊切除术， 和结肠癌和直肠癌的手术 - 经历最大生长的临床领域 机器人手术。我们利用机器人手术区域采用的自然变化 仪器变量可减轻限制先前观察性研究的选择偏差问题 估计机器人手术的结果。我们使用这种方法来探索短期 比较安全性（例如术后并发症的事件），手术发作的支出 相对于更多的护理和长期有效性（例如疝气复发）相对于更多 为每个操作建立了腹腔镜和开放方法。我们评估异质性 具有不同程度的机器人手术经验的外科医生的结果。这 这项研究的结果将与患者和提供者进行治疗有关 围绕最安全，最有效的手术方法的决定。它还将告知 政策制定者和专业社会具有共同利益，以确保安全扩散 新的手术技术。最后，这些数据将为共同的公共和私人付款人提供 朝着更多地利用循证覆盖范围设计 - 具有数据来提高 美国昂贵的手术干预措施。