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: 9275700
• 负责人: Kristina H Lewis
• 金额: $ 54.23万
• 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 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9275700
• 关键词: Accounting; Acute; 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; Comorbidity; Comparative Study; Data Set; Diabetes Mellitus; Disease; Disease remission; Effectiveness; Emergency department visit; Evidence based practice; Expenditure; Gastrectomy; Gastric Bypass; Gold; Guidelines; Health; Health Care Costs; Healthcare; High Prevalence; Insurance; Interruption; Length of Stay; Matched Group; Medical; 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; Pharmaceutical Preparations; 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; age group; bariatric surgery; base; clinical care; clinical decision-making; clinical practice; cost; effective therapy; evidence base; experience; follow-up; health service use; high risk; improved; lifestyle intervention; longitudinal design; mortality; personalized decision; risk minimization

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.项目总结 目前有1500多万美国人患有严重肥胖症，即体重指数(BMI)为35公斤/平方米。患有疾病的患者 严重肥胖者的2型糖尿病患病率是普通人的5倍，每年的医疗费用是 体重正常。减肥手术是治疗严重肥胖症的最有效的方法，但具有侵入性， 费用高昂，并伴随着短期和长期的并发症。垂直袖式胃切除术是一种 最近使用的较新的减肥手术大幅增加，目前约占 全球一半的手术。然而，人们对VSG术后的长期结果知之甚少，包括 它对糖尿病的影响的持久性，以及它降低心血管发病率和死亡率的潜力。的 对于考虑手术的患者来说尤为重要，VSG的风险和好处比 标准的胃旁路手术(RYGB)还没有被很好地理解。拟议中的研究将使用全国范围内的 商业保险索赔数据集，用于评估10,000多人的临床和医疗保健使用结果 接受VSG的患者，与2005至2017年间接受RYGB的10,000名患者相比， 术后随访8年。严格的观察性研究设计，具有倾向-分数匹配意愿 用于比较VSG和RYGB对临床结果的影响，包括糖尿病缓解和 复发、心肌梗死、中风和死亡；医疗保健使用结果，包括急诊科 就诊、住院天数和再手术或翻修手术；以及包括标准化总额在内的医疗保健费用， 处方和自付费用。此外，为了协助程序选择，探索性分析将 为具有某些关键特征(例如，按年龄组、糖尿病)的患者调查最佳手术类型 严重性)。为了将指示混淆的风险降至最低，尖端的倾向-分数匹配算法将 将采用严格的纵向设计，如中断时间序列和生存分析 建造的。这将是这两个程序最大的基于索赔的比较研究，有可能 对减肥外科的临床实践产生重大影响。研究结果可以为更多的循证实践提供参考 并通过提高患者和外科医生选择 根据患者喜好的健康结果和个人特征进行优化的手术方法。