SMART use of medications for the treatment of adolescent severe obesity: A sequential multiple assignment randomized trial protocol.
SMART use of medications for the treatment of adolescent severe obesity: A sequential multiple assignment randomized trial protocol.
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明智地使用药物治疗青少年严重肥胖：一项序贯多重分配随机试验方案。
DOI：
10.1016/j.cct.2024.107444
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发表时间：
2024
影响因子：
2.2
通讯作者：
Kelly,AaronS
中科院分区：
文献类型：
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作者：
Fox,ClaudiaK;Vock,DavidM;Sherwood,NancyE;Gross,AmyC;Ryder,JustinR;Bensignor,MeganO;Bomberg,EricM;Sunni,Muna;Bramante,CarolynT;Jacobs,Nina;Raatz,SarahJ;Kelly,AaronS
背景严重肥胖是一种复杂的慢性疾病，影响着美国近 9% 的青少年。尽管目前的主要治疗方法是生活方式疗法，但儿科临床实践指南建议添加辅助抗肥胖药物 (AOM)，例如芬特明和托吡酯。然而，关于何时开始辅助 AOM 以及如何使用 AOM 的指导尚不清楚。此外，当前治疗指南的一个固有局限性是其“一刀切”的方法，它没有考虑到肥胖的异质性以及患者对所有干预措施反应的高度变异性。方法本文描述了序贯多重分配随机试验（SMART）的研究设计和方法，“SMART 使用药物治疗青少年严重肥胖”。该试验将研究 1) 对生活方式治疗无反应的青少年何时开始 AOM（特别是芬特明），以及 2) 当对初始药物干预反应欠佳时如何修改 AOM（特别是，对于芬特明无反应者，在芬特明中添加托吡酯或改用托吡酯单药治疗是更好）。至关重要的是，可能对治疗反应产生不同影响的参与者特征将被评估，并被评估为干预效果的潜在调节因素。 结论 这项研究的数据将用于为治疗青少年严重肥胖症的适应性干预措施的开发提供信息，其中包括关于何时以及如何使用 AOM 的经验得出的决策规则。未来的研究将针对标准的“一刀切”治疗来测试这种适应性干预。
BackgroundSevere obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti-obesity medication (AOM), such as phentermine and topiramate. However, guidance regardingwhenadjunct AOM should be started andhowAOM should be used is unclear. Furthermore, an inherent limitation of current treatment guidelines is their “one-size-fits-all” approach, which does not account for the heterogeneous nature of obesity and high degree of patient variability in response to all interventions.MethodsThis paper describes the study design and methods of a sequential multiple assignment randomized trial (SMART), “SMART Use of Medications for the Treatment of Adolescent Severe Obesity.” The trial will examine 1)whento start AOM (specifically phentermine) in adolescents who are not responding to lifestyle therapy and 2)howto modify AOM when there is a sub-optimal response to the initial pharmacological intervention (specifically, for phentermine non-responders, is it better to add topiramate to phentermine or switch to topiramate monotherapy). Critically, participant characteristics that may differentially affect response to treatment will be assessed and evaluated as potential moderators of intervention efficacy.ConclusionData from this study will be used to inform the development of an adaptive intervention for the treatment of adolescent severe obesity that includes empirically-derived decision rules regarding when and how to use AOM. Future research will test this adaptive intervention against standard “one-size-fits-all” treatments.