Long-Term Comparative Safety and Economic Outcomes of Sleeve Gastrectomy

袖状胃切除术的长期安全性和经济结果比较

基本信息

批准号：
9925222
负责人：
Justin Brigham Dimick
金额：
$ 61.29万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-01 至 2022-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9925222
关键词：
Abdomen Address Advisory Committees Bariatrics Biological Body Weight decreased Characteristics Data Data Set Decision Making Disabled Persons Disease Effectiveness Emergency department visit Ethnic Origin Exclusion Expenditure Fee-for-Service Plans Gastrectomy Gastric Bypass Gastroesophageal reflux disease Gold Health Health Expenditures Health Status Healthcare Heterogeneity Insurance Carriers Insurance Coverage Length of Stay Medicaid Medicare Morbid Obesity Natural experiment Non-Insulin-Dependent Diabetes Mellitus Older Population Operative Surgical Procedures Outcome Outpatients Patients Play Policies Population Population Study Postoperative Period Privatization Procedures Provider Race Repeat Surgery Role Safety Second Look Surgery Subgroup Surgeon United States United States Centers for Medicare and Medicaid Services Visit Woman bariatric surgery base beneficiary burden of illness comorbidity comparative comparative effectiveness economic outcome follow-up health care service utilization improved men multiple chronic conditions operation patient subsets population based preference procedure safety randomized trial safety outcomes secondary outcome sex

项目摘要

Abstract: In the past few years, sleeve gastrectomy has rapidly emerged as the most common weight loss procedure in the United States, displacing the gastric bypass procedure. However, there is shockingly little evidence of the procedure's long-term outcomes. There are growing concerns about the long-term safety and durability of the procedure. The best existing evidence on sleeve gastrectomy is from small randomized trials that have several limitations, including: limited follow up (e.g. 3 years); lack of statistical power to examine important secondary outcomes (e.g., reoperations and revisions); exclusion of important patient subgroups (e.g., older, disabled); and a lack of consideration of economic outcomes (e.g., health care use and expenditures). Because insurance coverage for sleeve gastrectomy proceeded in a staggered, regional approach, there is a unique opportunity to use these policy changes as an instrumental variable in comparing sleeve gastrectomy vs. laparoscopic gastric bypass, the gold-standard bariatric procedure. We have the following Specific Aims: Aim 1. To compare the long-term safety of sleeve gastrectomy vs. gastric bypass. We will use two complementary claims datasets, including a large, commercially insured population from MarketScan and the national fee-for-service Medicare population, to evaluate the long-term safety of the sleeve gastrectomy compared to laparoscopic gastric bypass surgery up to 7 years after their procedure. Aim 2. To evaluate long-term health care use and expenditures of sleeve gastrectomy vs. gastric bypass. Using data from MarketScan and Medicare, we will evaluate the use of health care services (hospital days, emergency department visits, and outpatient visits) and health care expenditures for sleeve gastrectomy (vs. gastric bypass) for up to 7 years after their procedure. Aim 3. To evaluate heterogeneity in safety, health care use, and expenditures for sleeve gastrectomy vs. gastric bypass. We will evaluate safety, health care use, and expenditures, for important patient subgroups, including older and disabled populations (e.g., Medicare beneficiaries), those with poor baseline health status (e.g., high comorbid disease burdens and high baseline expenditures), and select comorbid diseases (e.g., patients with type 2 diabetes) and for providers with different characteristics (e.g., surgeons with more vs. less volume). A better understanding of the long-term outcomes of sleeve gastrectomy (vs. gastric bypass) will allow patients to make more informed decisions regarding long-term outcomes and need for additional surgery. These data will also be invaluable for informing private insurers and the Center for Medicare and Medicaid Services (CMS) as they reassess their coverage decisions for bariatric surgery.

抽象的：在过去的几年中，袖胃切除术已迅速成为最常见的体重减轻美国的程序，取代胃旁路程序。但是，很少有该程序的长期结果的证据。人们对长期安全和程序的耐用性。袖胃切除术的现有最佳证据是来自小型随机试验有几个限制，包括：限制后续行动（例如3年）；缺乏检查统计能力重要的次要结果（例如，重新操作和修订）；排除重要的患者子组（例如，较旧，残疾）;缺乏对经济成果的考虑（例如，医疗保健使用和支出）。因为袖胃切除术的保险覆盖范围是交错的区域性方法，有一个独特的机会将这些政策更改用作比较的工具变量袖胃切除术与腹腔镜胃旁路，金标准的减肥手术。我们有以下具体目标：目标1。比较袖子胃切除术的长期安全性与。胃旁路。我们将使用两个补充索赔数据集，包括一个大型，商业保险的从市场范围和国家费用为服务的医疗保险人口的人口，以评估长期与腹腔镜胃旁路手术相比，袖胃切除术的安全性长达7年程序。目标2。评估袖子胃切除术与袖子的长期保健使用和支出。胃旁路。使用MarketScan和Medicare的数据，我们将评估医疗服务的使用（医院日，急诊室就诊和门诊就诊）和袖子的医疗保健支出胃切除术（与胃搭桥术）在其手术后长达7年。目标3。评估异质性安全性，医疗保健使用和袖子胃切除术与胃旁路的支出。我们将评估安全，医疗保健使用和支出，包括重要的患者子组，包括较老和残疾人口（例如，医疗保险受益人），基线健康状况差的人（例如，合并症高的疾病负担和高基线支出）和选择合并症（例如2型糖尿病患者）对于具有不同特征的提供者（例如，具有更多数量的外科医生）。更好了解袖胃切除术（与胃旁路）的长期结局将使患者能够做出关于长期结局和需要进行额外手术的更明智的决定。这些数据也将对于通知私人保险公司和医疗保险和医疗补助服务中心（CMS）是无价的重新评估其减肥手术的覆盖范围。