A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes
A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes
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DOI：
10.1016/j.soard.2013.05.006
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发表时间：
2013-11-01
影响因子：
3.1
通讯作者：
Cummings, David E.
中科院分区：
文献类型：
--
作者：
Arterburn, David;Flum, David R.;Cummings, David E.
背景：减肥手术与生活方式治疗的随机试验可能会招募积极性很高的患者，这可能会限制研究结果的解释和推广。这项研究的目的是评估基于人群的共享决策(SDM)方法在一项比较腹腔镜Roux-en-Y胃旁路手术和强化生活方式干预的试验中招募轻中度肥胖症和2型糖尿病成年人的可行性。方法：在电子数据库中确定体重指数(BMI)在30到45 kg/m(2)之间的成年成员，并进行多阶段筛查。除了标准的办公室同意外，候选人还接受了电话调查，使用决策辅助工具进行肥胖和糖尿病治疗选择的教育，并与护士从业者进行SDM电话交谈。结果：我们确定了1808名成员，其中828名(45.7%)的BMI为30-34.9 kg/m(2)。在这些人中，1063人(59%)同意电话调查，416人(23%)表示对治疗方案的教育感兴趣，277人(15%)完成了SDM过程。首选的治疗方案是手术(21[8%])、饮食和锻炼(149[53.8%])、药物治疗(5[2%])、不进行上述治疗(8[3%])和不确定(94[34%])。最终，43名参与者被随机分配到试验中。在同意和不同意参与我们的试验的人中，观察到显著的差异，主要与性别、疾病严重程度和降糖药物的使用有关。结论：这种基于人群、基于SDM的招募策略成功地识别、招募并随机分配了对手术和生活方式管理有平衡看法的患者。即使采用这种方法，选择偏向可能仍然存在，这突显了在未来的所有研究中仔细描述非参与者的必要性。(Surg OBES Relat Dis 2013；9：837-844。)(C)2013年美国新陈代谢和减肥外科学会。版权所有。
Background: Randomized trials of bariatric surgery versus lifestyle treatment likely enroll highly motivated patients, which may limit the interpretation and generalizability of study findings. The objective of this study was to assess the feasibility of a population-based shared decision-making (SDM) approach to recruitment for a trial comparing laparoscopic Roux-en-Y gastric bypass surgery with intensive lifestyle intervention among adults with mild to moderate obesity and type 2 diabetes.Methods: Adult members with a body mass index (BMI) between 30 and 45 kg/m(2) taking diabetes medications were identified in electronic databases and underwent a multiphase screening process. Candidates were given a telephone survey, education about treatment options for obesity and diabetes using decision aids, and an SDM phone call with a nurse practitioner, in addition to standard office-based consent.Results: We identified 1808 members, and 828 (45.7%) had a BMI of 30-34.9 kg/m(2). Among these, 1063 (59%) agreed to the telephone survey, 416 (23%) expressed interest in education about treatment options, and 277 (15%) completed the SDM process. The preferred treatment options were surgery (21 [8%]), diet and exercise (149 [53.8%]), pharmacotherapy (5 [2%]), none of the above (8 [3%]), and unsure (94 [34%]). Ultimately, 43 participants were randomly assigned to the trial. Significant differences, mainly related to sex, disease severity, and hypoglycemic medication use, were observed among people who did and did not agree to participate in our trial.Conclusion: This population-based, SDM-based recruitment strategy successfully identified, enrolled, and randomly assigned patients who had balanced views of surgery and lifestyle management. Even with this approach, selection biases may remain, highlighting the need for careful characterization of nonparticipants in all future studies. (Surg Obes Relat Dis 2013;9:837-844.) (c) 2013 American Society for Metabolic and Bariatric Surgery. All rights reserved.