Sequential multiple assignment randomized trial studies should report all key components: a systematic review.
Sequential multiple assignment randomized trial studies should report all key components: a systematic review.
复制标题
DOI：
10.1016/j.jclinepi.2021.11.007
复制
发表时间：
2022-03
影响因子：
7.2
通讯作者：
Wason J
中科院分区：
文献类型：
--
作者：
Bigirumurame T;Uwimpuhwe G;Wason J
序贯多分配随机试验(SMART)设计允许参与者的多个随机化；这允许评估特定阶段的问题(个体随机化)和适应性干预(即治疗策略)。我们评估了设计智能研究所需信息的报告质量。我们系统地搜索了四个数据库(PubMed、Ovid、Web of Science和Scope us)，查找到2020年6月15日之前提到智能设计的所有试验报告、方案、综述和方法学论文。在157篇入选文献中，临床试验报告12篇(7.64%)，研究方案24篇(15.29%)，方法学论文91篇(58%)，综述论文30篇(19.1%)。所有这些试验都以特定阶段的目标为动力。这些试验中只有4项(33.33%)报告了计算样本量所需的参数。少数试验(16.67%)对确定最佳嵌入式适应性干预措施感兴趣。大多数试验没有报告有关多项测试调整的信息。此外，大多数记录报告的设计主要集中在特定阶段的目标。智能设计的一些特征很少被报道和/或使用。此外，使用这种设计的研究往往不能充分报告关于所有设计参数的信息，从而限制了它们的透明度和可解释性。
Sequential Multiple Assignment Randomized Trial (SMART) designs allow multiple randomizations of participants; this allows assessment of stage-specific questions (individual randomizations) and adaptive interventions (i.e. treatment strategies). We assessed the quality of reporting of the information required to design SMART studies. We systematically searched four databases (PubMed, Ovid, Web of Science and Scopus) for all trial reports, protocols, reviews, and methodological papers which mentioned SMART designs up to June 15, 2020. Of the 157 selected records, 12 (7.64%) were trial reports, 24 (15.29%) were study protocols, 91 (58%) were methodological papers, and 30 (19.1%) were review papers. All these trials were powered using stage-specific aims. Only four (33.33%) of these trials reported parameters required for sample size calculations. A small number of the trials (16.67 %) were interested in determining the best embedded adaptive interventions. Most of the trials did not report information about multiple testing adjustment. Furthermore, most of records reported designs that were mainly focused on stage-specific aims. Some features of SMART designs are seldomly reported and/or used. Furthermore, studies using this design tend to not adequately report information about all the design parameters, limiting their transparency and interpretability.
登录
查看更多内容
DOI：
10.1146/annurev-statistics-022513-115553
发表时间：
2014
影响因子：
7.9
作者：
Chakraborty B;Murphy SA
通讯作者：
Murphy SA
DOI：
10.1016/s0197-2456(98)00037-3
发表时间：
1998-12-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Dupont, WD;Plummer, WD
通讯作者：
Plummer, WD
影响因子：
39.2
作者：
Moher, D;Schulz, KF;Altman, DG
通讯作者：
Altman, DG
DOI：
10.1186/s13012-018-0807-9
发表时间：
2018-08-22
期刊：
Implementation science : IS
影响因子：
--
作者：
Johnson JE;Wiltsey-Stirman S;Sikorskii A;Miller T;King A;Blume JL;Pham X;Moore Simas TA;Poleshuck E;Weinberg R;Zlotnick C
通讯作者：
Zlotnick C
影响因子：
2.8
作者：
Kim, James S.;Asher, Catherine A.;Leyva, Diana
通讯作者：
Leyva, Diana