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针对年幼自闭症儿童的干预研究中的不良事件报告

Adverse event reporting in intervention research for young autistic children.

作者信息

Bottema-Beutel Kristen, Crowley Shannon, Sandbank Micheal, Woynaroski Tiffany G

机构信息

Boston College, USA.

University of Texas at Austin, USA.

出版信息

Autism. 2021 Feb;25(2):322-335. doi: 10.1177/1362361320965331. Epub 2020 Oct 19.

Abstract

In this study, we looked at published research on interventions for young autistic children that did not involve administering medication. We were interested in determining how often studies reported on whether adverse events (i.e. physical or psychological distress to the participants) or adverse effects (i.e. adverse events that are thought to be caused by the intervention) had occurred. We found that of the 150 reports we examined, only 11 mentioned adverse events. One of these studies reported adverse events occurred, and three reported that adverse effects occurred. We also reviewed the studies to examine the reasons that were given to explain why any participants dropped out of the intervention (termed "withdrawal"), to determine if any of these reasons could be considered adverse events or adverse effects. Fifty-four studies described reasons for withdrawal, and 10 of these studies had reasons that could be categorized as an adverse event, 8 studies had reasons that could be categorized as an adverse effect, and an additional 12 studies had reasons that were too vaguely described to determine whether they were adverse events or not. We recommend that autism intervention researchers develop more systematic methods of looking for and reporting adverse events and effects, so that professionals and families can be better informed when choosing to enroll their autistic children in interventions.

摘要

在本研究中,我们查阅了已发表的关于针对年幼自闭症儿童的非药物干预措施的研究。我们感兴趣的是确定研究报告不良事件(即参与者的身体或心理困扰)或不良反应(即被认为由干预措施导致的不良事件)发生频率的情况。我们发现,在我们审查的150份报告中,只有11份提到了不良事件。其中一项研究报告不良事件发生,三项研究报告不良反应发生。我们还审查了这些研究,以考察所给出的用以解释参与者退出干预措施(称为“退出”)的原因,从而确定这些原因中是否有任何可被视为不良事件或不良反应。54项研究描述了退出的原因,其中10项研究的原因可归类为不良事件,8项研究的原因可归类为不良反应,另有12项研究的原因描述过于模糊,无法确定是否为不良事件。我们建议自闭症干预研究人员开发更系统的方法来查找和报告不良事件及反应,以便专业人员和家庭在选择让自闭症儿童参与干预措施时能有更充分的了解。

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