Publication of Study Exit Procedures in Clinical Trials of Deep Brain Stimulation: A Focused Literature Review.
Publication of Study Exit Procedures in Clinical Trials of Deep Brain Stimulation: A Focused Literature Review.
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研究退出程序在深脑刺激的临床试验中发表：重点文献综述。
DOI：
10.3389/fnhum.2020.581090
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发表时间：
2020
影响因子：
2.9
通讯作者：
Ford PJ
中科院分区：
文献类型：
--
作者：
Sankary LR;Nallapan AM;Hogue O;Machado AG;Ford PJ
与临床试验的入组和参与者退出相关的临床研究程序的发表存在相当大的可变性。尽管最近努力鼓励研究数据共享和提高研究成果的透明度，但研究程序的报告仍然不一致。研究程序的透明度对于研究结果的解释以及临床试验设计和实施中最佳实践的一致实施具有重要意义。本文使用MEDLINE数据库对脑深部电刺激（DBS）临床试验的出版物进行了回顾，检查了与退出DBS研究相关的研究程序和数据发表的频率和一致性。相关的考虑，如设备外植或继续使用，电池和其他设备硬件更换，以及试验后的后续护理也进行了审查。本综述发现研究退出程序的发表和报告存在显著差异。在本综述纳入的47项临床试验中，19%(9)披露了退出研究的相关程序。本综述检查的其他退出相关数据和研究程序的报告在不到一半的纳入临床试验中被发现。参与者的保留率和随访时间比本综述中任何其他类别的数据都要多。结果为提高DBS和相关临床研究领域的研究设计、实施和临床试验结果发表的一致性提供了信息。
Considerable variability exists in the publication of clinical research study procedures related to study enrollment and participant exit from clinical trials. Despite recent efforts to encourage research data sharing and greater transparency regarding research outcomes, reporting of research procedures remains inconsistent. Transparency about study procedures has important implications for the interpretation of study outcomes and the consistent implementation of best practices in clinical trial design and conduct. This review of publications from clinical trials of deep brain stimulation (DBS) using the MEDLINE database examines the frequency and consistency of publication of research procedures and data related to exit from DBS research. Related considerations, such as device explant or continued use, battery and other device hardware replacements, and post-trial follow-up care are also reviewed. This review finds significant variability in the publication and reporting of study exit procedures. Of the 47 clinical trials included in this review, 19% (9) disclosed procedures related to exit from research. Reporting of other exit-related data and study procedures examined in this review was identified in fewer than half of the included clinical trials. The rate of participant retention and duration of follow-up was reported more than any other category of data included in this review. Results inform efforts to improve consistency in research design, conduct, and publication of results from clinical trials in DBS and related areas of clinical research.
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影响因子：
168.9
作者：
DeVito, Nicholas J.;Bacon, Seb;Goldacre, Ben
通讯作者：
Goldacre, Ben
影响因子：
7.7
作者：
Lee, Darrin J.;Dallapiazza, Robert F.;Lozano, Andres M.
通讯作者：
Lozano, Andres M.
影响因子：
4.7
作者：
Park RJ;Scaife JC;Aziz TZ
通讯作者：
Aziz TZ
影响因子：
2.5
作者：
Plow EB;Malone DA Jr;Machado A
通讯作者：
Machado A
影响因子：
105.7
作者：
Zorzela, Liliane;Loke, Yoon K.;Vohra, Sunita
通讯作者：
Vohra, Sunita