基于人群的、共享决策的方法招募 2 型糖尿病患者参加减肥手术与生活方式的随机试验。
A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes.
机构信息
Group Health Research Institute, Seattle, Washington.
出版信息
Surg Obes Relat Dis. 2013 Nov-Dec;9(6):837-44. doi: 10.1016/j.soard.2013.05.006. Epub 2013 Jun 4.
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.
背景
减肥手术与生活方式治疗的随机试验可能招募了高度积极的患者，这可能限制了研究结果的解释和推广。本研究的目的是评估基于人群的共享决策（SDM）方法在招募肥胖和 2 型糖尿病成人中的可行性，该方法将比较腹腔镜 Roux-en-Y 胃旁路手术与强化生活方式干预。
方法
电子数据库中确定了身体质量指数（BMI）在 30 至 45kg/m2 之间且正在服用糖尿病药物的成年成员，并对其进行了多阶段筛选过程。除了标准的办公室同意程序外，还对候选人进行了电话调查、使用决策辅助工具进行肥胖和糖尿病治疗选择的教育，以及与执业护士进行 SDM 电话通话。
结果
我们确定了 1808 名成员，其中 828 名（45.7%）的 BMI 为 30-34.9kg/m2。在这些人中，1063 名（59%）同意进行电话调查，416 名（23%）对治疗选择的教育表示感兴趣，277 名（15%）完成了 SDM 过程。首选的治疗选择是手术（21 名[8%]）、饮食和运动（149 名[53.8%]）、药物治疗（5 名[2%]）、以上均无（8 名[3%]）和不确定（94 名[34%]）。最终，43 名参与者被随机分配到试验中。在同意参加我们试验的人和不同意参加的人之间观察到显著差异，主要与性别、疾病严重程度和低血糖药物使用有关。
结论
这种基于人群的、基于 SDM 的招募策略成功地确定、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，选择偏倚可能仍然存在，这突出表明在所有未来的研究中都需要仔细描述非参与者。
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