Clinical and Health Care Use Outcomes for Vertical Sleeve Gastrectomy vs. Roux-en-Y Gastric Bypass Using a National Commercial Insurance Claims Dataset

使用国家商业保险索赔数据集进行垂直袖状胃切除术与 Roux-en-Y 胃绕道术的临床和医疗保健使用结果

• 批准号: 10189568
• 负责人: Kristina H Lewis
• 金额: $ 45.34万
• 依托单位: HARVARD PILGRIM HEALTH CARE, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10189568
• 关键词: Accounting; Address; Age; Algorithms; American; Bariatrics; Benefits and Risks; Body Weight; Body Weight decreased; Body mass index; Cardiovascular Diseases; Cardiovascular system; Caring; Categories; Cessation of life; Characteristics; Chronic; Chronic Disease; Clinical; Clinical Research; Comparative Study; Data Set; Diabetes Mellitus; Disease; Disease remission; Drug Prescriptions; Effectiveness; Emergency department visit; Evidence based practice; Expenditure; Gastrectomy; Gastric Bypass; Gold; Guidelines; Health; Health Care Costs; Healthcare; High Prevalence; Interruption; Length of Stay; Matched Group; Medical; Medical Care Costs; Morbid Obesity; Morbidity - disease rate; Myocardial Infarction; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Observational Study; Operative Surgical Procedures; Outcome; Outcome Measure; Outpatients; Patient-Focused Outcomes; Patients; Population; Postoperative Period; Prevalence; Procedures; Relapse; Repeat Surgery; Research; Research Design; Risk; Series; Severities; Standardization; Stroke; Subgroup; Surgeon; Survival Analysis; Time; United States; United States National Institutes of Health; Visit; acute care; age group; bariatric surgery; base; clinical care; clinical decision-making; clinical practice; comorbidity; cost; effective therapy; evidence base; experience; follow-up; health service use; high risk; improved; insurance claims; lifestyle intervention; longitudinal design; mortality; personalized decision; risk minimization; surgical risk

7. PROJECT SUMMARY Over 15 million Americans now have severe obesity, i.e. a body-mass index (BMI) ≥35 kg/m2. Patients with severe obesity have 5-times higher prevalence of type 2 diabetes, and twice the annual medical costs of those with normal body weights. Bariatric surgery is the most effective treatment for severe obesity, but is invasive, costly, and associated with short and longer-term complications. The vertical sleeve gastrectomy (VSG) is a newer bariatric procedure that has substantially increased in use recently, now accounting for approximately half of procedures worldwide. However, very little is known about longer-term outcomes after VSG, including the durability of its impact on diabetes, and its potential for reducing cardiovascular morbidity and mortality. Of particular importance for patients considering surgery, the risks and benefits of VSG compared to the “gold standard” gastric bypass (RYGB) procedure are not well understood. The proposed study will use a nationwide commercial insurance claims dataset to evaluate clinical and health care use outcomes among over 10,000 patients undergoing VSG, compared to 10,000 patients undergoing RYGB, between 2005 and 2017, with up to 8 years of post-operative follow-up. Rigorous observational study designs with propensity-score matching will be used to compare the effect of VSG and RYGB on: clinical outcomes, including diabetes remission and relapse, myocardial infarction, stroke and death; health care use outcomes including emergency department visits, hospital days, and reoperation or revisional surgery; and health care costs including standardized total, prescription and out-of-pocket costs. Furthermore, to assist with procedure selection, exploratory analyses will investigate the optimal surgical type for patients with certain key characteristics (e.g. by age group, diabetes severity). To minimize risk of confounding by indication, cutting-edge propensity-score matching algorithms will be employed and rigorous longitudinal designs such as interrupted time series and survival analysis will be constructed. This will be the largest claims-based comparative study of these two procedures, with potential to significantly impact clinical practice in bariatric surgery. Findings could inform more evidence-based practice and facilitate shared clinical decision-making by improving the ability of patients and surgeons to select a surgical approach that is optimized to patients’ preferred health outcomes and personal characteristics.

7。项目摘要 现在，超过1500万的美国人患有严重的肥胖症，即身体质量指数（BMI）≥35kg/m2。患者 严重的肥胖症患有2型糖尿病的患病率更高，是那些年度医疗费用的两倍 身体重量正常。减肥手术是严重肥胖的最有效治疗方法，但具有侵入性， 昂贵，并且与短期和长期并发症有关。垂直套筒焦点切除术（VSG）是 最近使用的新较新的减肥手术已大大增加，现在约占 全球一半的程序。但是，关于VSG之后的长期结局，知之甚少，包括 其对糖尿病的影响及其降低心血管发病率和死亡率的潜力。的 与“黄金”相比，考虑手术，VSG的风险和益处特别重要 标准“胃旁路（RYGB）程序尚不清楚。拟议的研究将在全国范围内使用 商业保险索赔数据集评估10,000多个临床和医疗保健使用结果 接受VSG的患者，而2005年至2017年之间正在接受RYGB的10,000例患者，最多可 8年的术后随访。严格的观察性研究设计，具有承诺得分匹配将会 用于比较VSG和RYGB对：临床结果的影响，包括糖尿病的缓解和 接力，心肌梗塞，中风和死亡；医疗保健使用结果，包括急诊室 访问，医院日以及重新手术或改革手术；以及包括标准化总数在内的医疗保健费用， 处方和自付费用。此外，为了协助进行程序选择，探索性分析将 研究具有某些关键特征患者的最佳手术类型（例如，按年龄组，糖尿病 严重性）。为了最大程度地降低通过指示混淆的风险，尖端的倾向得分匹配算法将 被采用和严格的纵向设计，例如中断时间序列，生存分析将是 构造。这将是这两个程序的最大基于索赔的比较研究，并有潜力 严重影响减肥手术的临床实践。调查结果可以告知更多循证实践 并通过提高患者和外科医生选择A的能力来促进共同的临床决策 为患者的首选健康结果和个人特征而优化的手术方法。

项目成果

Concurrent hiatal hernia repair and bariatric surgery: outcomes after sleeve gastrectomy and Roux-en-Y gastric bypass.

• DOI: 10.1016/j.soard.2020.08.035
• 发表时间: 2021-01
• 期刊: Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery
• 作者: Lewis KH;Callaway K;Argetsinger S;Wallace J;Arterburn DE;Zhang F;Fernandez A;Ross-Degnan D;Dimick JB;Wharam JF
• 通讯作者: Wharam JF

Comparison of Ambulatory Health Care Costs and Use Associated With Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy.

• DOI: 10.1001/jamanetworkopen.2022.9661
• 发表时间: 2022-05-02
• 期刊: JAMA NETWORK OPEN
• 影响因子: 13.8
• 作者: Lewis, Kristina H.;Argetsinger, Stephanie;Arterburn, David E.;Clemenzi, Jenna;Zhang, Fang;Kamusiime, Ronald;Fernandez, Adolfo;Ross-Degnan, Dennis;Wharam, James F.
• 通讯作者: Wharam, James F.

Response to "Why Gastric Bypass Might Not be a Good Choice for Type-2 Diabetes Treatment".

• DOI: 10.1097/sla.0000000000005269
• 发表时间: 2022-08-01
• 期刊: Annals of surgery
• 影响因子: 9

Acute Care Utilization and Costs Up to 4 Years After Index Sleeve Gastrectomy or Roux-en-Y Gastric Bypass: A National Claims-based Study.

• DOI: 10.1097/sla.0000000000004972
• 发表时间: 2023-01-01
• 期刊: Annals of surgery
• 影响因子: 9
• 作者: Callaway Kim K;Argetsinger S;Wharam JF;Zhang F;Arterburn DE;Fernandez A;Ross-Degnan D;Wallace J;Lewis KH
• 通讯作者: Lewis KH