作者回复:关于“压力管理与体外受精:一项随机对照试验”。

Q3 Medicine
Maria Koumparou, P. Bakas, K. Pantos, M. Economou, G. Chrousos
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引用次数: 0

摘要

Komiya等人最近给编辑写了一封信,提出了我们的研究“压力管理和体外受精(IVF):一项随机对照试验”的可靠性和有效性问题他们的评论集中在注册的默认,没有任何提及病例退出,试管婴儿治疗细节的模糊以及缺乏参与者背景的具体数字。然而,CONSORT 2010的原则不能应用于先导随机试验和可行性试验,只能应用于随机试验(RTs)或随机对照试验(rct)。同样,2016年CONSORT延期也提出了一些试点和可行性试验的原则,但它并不直接适用于内部试点研究、非随机试点和可行性研究或II期研究。3,4许多国际期刊不要求对试点和可行性试验进行注册,而只要求对RTs或rct进行注册,5认为临床试验注册不是低偏倚风险的指标感谢Komiya等人的有用评论,我们的文章2现在包含了在线“补充材料”,我们在其中逐一澄清了他们的所有观点。具体来说,补充材料的材料和方法部分包括注册,流程图和试管婴儿治疗的详细信息,结果部分包括参与者背景的详细信息。因此,我们认为现在可以检查和确保研究的可靠性和有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Authors Reply: Regarding "Stress Management and in Vitro Fertilization (IVF): A Pilot Randomized Controlled Trial".
Komiya et al recently sent a letter to the editor1 raising issues of reliability and validity of our study "Stress Management and in Vitro Fertilization (IVF): A Pilot Randomized Controlled Trial".2 Their comments focused on the default of the registration, the absence of any mention of case dropout, the ambiguity in the details of IVF treatment and the lack of specific figures on the background of the participants. However, the principles of CONSORT 2010 cannot be applied to Pilot Randomized and Feasibility Trials, only to Randomized Trials (RTs) or Randomized Controlled Trials (RCTs). Similarly, the CONSORT Extension 2016 suggested some principles for Pilot and Feasibility Trials, but again it does not directly apply to internal pilot studies, non-randomized pilot and feasibility studies, or phase II studies.3,4 Many international journals do not require registration for Pilot and Feasibility Trials, but only for RTs or RCTs,5 granted that clinical trial registration is not an indicator of low risk of bias.6 Thanks to the useful comments by Komiya et al, our article2 now includes online "Supplementary Materials" in which we clarify all their points one by one. Specifically, the Material and Method section of Supplementary Materials includes details for the Registration, the Flow Chart and the IVF Treatment, and the Results section includes details for the Background of the Participants. Thus, we believe that the level of reliability and validity of the study can be now examined and ensured.
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来源期刊
Psychiatrike = Psychiatriki
Psychiatrike = Psychiatriki Medicine-Medicine (all)
CiteScore
2.60
自引率
0.00%
发文量
37
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