Inconsistent Methodology as a Barrier to Meaningful Research Outputs From Studies of Atrial Fibrillation After Cardiac Surgery.
Inconsistent Methodology as a Barrier to Meaningful Research Outputs From Studies of Atrial Fibrillation After Cardiac Surgery.
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DOI：
10.1053/j.jvca.2021.10.009
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发表时间：
2022-03
影响因子：
2.8
通讯作者：
中科院分区：
文献类型：
--
作者：
心脏手术后心房颤动（AFACS）是一种重要的术后并发症。有显着的研究兴趣，在这一领域，但也有相关的异质性报告AFACS的定义和方法用于识别。在临床研究中，关于这种变化程度的数据很少。我们回顾了自2001年以来的文献，包括报告成人AFACS结局的手稿。我们排除了较小的研究和患者未接受胸骨切开术的研究。根据六个不同的类别对每份手稿中记录的方案进行分析，以确定AFACS的定义，用于识别它的技术以及纳入/排除标准。我们还注意到，当一个类别没有在记录的方案中描述。我们确定了302项研究，其中92项被纳入。62%的研究是随机对照试验。手稿中存在显著异质性，包括排除术前AF患者、满足主要终点所需的AF定义和持续时间、筛选方法的类型（连续、间歇或机会性）、研究期间的监测持续时间（天）、使用预定义ECG标准进行诊断以及要求研究者进行独立确认。此外，这些标准的定义也往往没有说明。AFACS研究需要一致的报告标准，以推动该领域的科学进步。我们提出了试验设计和报告标准的实用标准。这些措施包括充分的样本量估计，AFACS终点的明确定义和AFACS检测方案。
Atrial fibrillation after cardiac surgery (AFACS) is an important postoperative complication. There is significant research interest in this field but also relevant heterogeneity in reported AFACS definitions and approaches used for its identification. Few data exist on the extent of this variation in clinical studies. We reviewed the literature since 2001 and included manuscripts reporting outcomes of AFACS in adults. We excluded smaller studies and studies where patient did not undergo a sternotomy. The documented protocol in each manuscript was analyzed according to six different categories to determine how AFACS was defined, which techniques were used to identify it and inclusion / exclusion criteria. We also noted when a category was not described in the documented protocol. We identified 302 studies, of which 92 were included. 62% of studies were randomised controlled trials. There was significant heterogeneity in the manuscripts, including the exclusion of patients with AF pre-surgery, the definition and duration of AF needed to meet the primary endpoint, the type of screening approach ( continuous, episodic or opportunistic), the duration of monitoring during the study period in days, the diagnosis with pre-defined ECG criteria, and the requirement for independent confirmation by study investigators. Furthermore, the definitions of these criteria were also frequently not described. Consistent reporting standards for AFACS research are needed to advance scientific progress in the field. We propose pragmatic standards for trial design and reporting standards. These include adequate sample size estimation, clear definition of the AFACS endpoints and a protocol for AFACS detection.
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影响因子：
7.2
作者：
Sanders, Julie;Keogh, Bruce E.;Montgomery, Hugh E.
通讯作者：
Montgomery, Hugh E.
影响因子：
37.8
作者：
Benedetto U;Gaudino MF;Dimagli A;Gerry S;Gray A;Lees B;Flather M;Taggart DP;ART Investigators*
通讯作者：
ART Investigators*
DOI：
10.1016/j.jtcvs.2014.11.032
发表时间：
2015-03-01
影响因子：
6
作者：
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通讯作者：
Kirklin, James K.
影响因子：
24
作者：
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通讯作者：
Massumi, A
影响因子：
1.3
作者：
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通讯作者：
O'Brien，Ben