PDF(Pubmed)
Abstract：
UNASSIGNED: To assess the external validity of randomized controlled trials (RCTs) of bariatric surgical treatment on diabetes control.
UNASSIGNED: Multisite RCTs provide the strongest evidence supporting clinical treatments and have the greatest internal validity. However, characteristics of trial participants may not be representative of patients receiving treatment in the real world. There is a need to assess how the results of RCTs generalize to all contemporary patient populations undergoing treatments.
UNASSIGNED: All patients undergoing sleeve gastrectomy at University of California Los Angeles (UCLA) between January 8, 2018 and May 19, 2023 had their baseline characteristics, weight change, and diabetes control compared with those enrolled in the surgical treatment and medications potentially eradicate diabetes efficiently (STAMPEDE) and diabetes surgery study (DSS) RCTs of bariatric surgery\'s effect on diabetes control. Weight loss and diabetes control were compared between UCLA patients who did and did not fit the entry criteria for these RCTs.
UNASSIGNED: Only 65 (17%) of 387 patients with diabetes fulfilled the eligibility criteria for STAMPEDE, and 29 (7.5%) fulfilled the criteria for DSS due to being older, having higher body mass index, and lower HbA1c. UCLA patients experienced slightly less weight loss than patients in the RCTs but had similar diabetes control. The 313 (81%) patients not eligible for study entry into either RCT had similar long-term diabetes control as those who were eligible for the RCTs.
UNASSIGNED: Even though only a very small proportion of patients undergoing bariatric surgery met the eligibility criteria for the 2 major RCTs, most patients in this contemporary cohort had similar outcomes. Diabetes outcomes from STAMPEDE and DSS generalize to most patients undergoing bariatric surgery for diabetes control.
UNASSIGNED: Multisite RCTs provide the strongest evidence supporting clinical treatments and have the greatest internal validity. However, characteristics of trial participants may not be representative of patients receiving treatment in the real world. There is a need to assess how the results of RCTs generalize to all contemporary patient populations undergoing treatments.
UNASSIGNED: All patients undergoing sleeve gastrectomy at University of California Los Angeles (UCLA) between January 8, 2018 and May 19, 2023 had their baseline characteristics, weight change, and diabetes control compared with those enrolled in the surgical treatment and medications potentially eradicate diabetes efficiently (STAMPEDE) and diabetes surgery study (DSS) RCTs of bariatric surgery\'s effect on diabetes control. Weight loss and diabetes control were compared between UCLA patients who did and did not fit the entry criteria for these RCTs.
UNASSIGNED: Only 65 (17%) of 387 patients with diabetes fulfilled the eligibility criteria for STAMPEDE, and 29 (7.5%) fulfilled the criteria for DSS due to being older, having higher body mass index, and lower HbA1c. UCLA patients experienced slightly less weight loss than patients in the RCTs but had similar diabetes control. The 313 (81%) patients not eligible for study entry into either RCT had similar long-term diabetes control as those who were eligible for the RCTs.
UNASSIGNED: Even though only a very small proportion of patients undergoing bariatric surgery met the eligibility criteria for the 2 major RCTs, most patients in this contemporary cohort had similar outcomes. Diabetes outcomes from STAMPEDE and DSS generalize to most patients undergoing bariatric surgery for diabetes control.
摘要：
■评估减肥手术治疗对糖尿病控制的随机对照试验（RCT）的外部有效性。
■多位点随机对照试验提供了最有力的证据支持临床治疗，并具有最大的内部有效性。然而,试验参与者的特征可能不能代表现实世界中接受治疗的患者.需要评估RCT的结果如何推广到正在接受治疗的所有当代患者群体。
■2018年1月8日至2023年5月19日在加州大学洛杉矶分校（UCLA）接受袖状胃切除术的所有患者均具有基线特征，体重变化,与参加手术治疗和药物可能有效根除糖尿病（STAMPEDE）和糖尿病手术研究（DSS）减重手术对糖尿病控制的影响的RCTs相比。比较了符合和不符合这些随机对照试验进入标准的UCLA患者的体重减轻和糖尿病控制。
■387例糖尿病患者中只有65例（17%）符合STAMPEDE的资格标准，29人(7.5%)因年龄较大而符合DSS标准，具有较高的体重指数，降低HbA1c。UCLA患者的体重减轻比RCT患者略少，但糖尿病控制相似。313名(81%)不符合进入任一RCT研究条件的患者与符合RCT条件的患者具有相似的长期糖尿病控制。
尽管接受减肥手术的患者中只有很小一部分符合两项主要随机对照试验的资格标准，这一当代队列中的大多数患者具有相似的结局.来自STAMPEDE和DSS的糖尿病结果普遍适用于大多数接受减肥手术以控制糖尿病的患者。
■多位点随机对照试验提供了最有力的证据支持临床治疗，并具有最大的内部有效性。然而,试验参与者的特征可能不能代表现实世界中接受治疗的患者.需要评估RCT的结果如何推广到正在接受治疗的所有当代患者群体。
■2018年1月8日至2023年5月19日在加州大学洛杉矶分校（UCLA）接受袖状胃切除术的所有患者均具有基线特征，体重变化,与参加手术治疗和药物可能有效根除糖尿病（STAMPEDE）和糖尿病手术研究（DSS）减重手术对糖尿病控制的影响的RCTs相比。比较了符合和不符合这些随机对照试验进入标准的UCLA患者的体重减轻和糖尿病控制。
■387例糖尿病患者中只有65例（17%）符合STAMPEDE的资格标准，29人(7.5%)因年龄较大而符合DSS标准，具有较高的体重指数，降低HbA1c。UCLA患者的体重减轻比RCT患者略少，但糖尿病控制相似。313名(81%)不符合进入任一RCT研究条件的患者与符合RCT条件的患者具有相似的长期糖尿病控制。
尽管接受减肥手术的患者中只有很小一部分符合两项主要随机对照试验的资格标准，这一当代队列中的大多数患者具有相似的结局.来自STAMPEDE和DSS的糖尿病结果普遍适用于大多数接受减肥手术以控制糖尿病的患者。
