Further considerations for placebo controls in surgical trials.

Further considerations for placebo controls in surgical trials.
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DOI:
10.1186/s13063-023-07417-7
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发表时间:
2023-06-10
期刊:
影响因子:
2.5
通讯作者:
--
中科院分区:
医学4区
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--
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在手术试验中使用侵入性安慰剂对照可能具有挑战性。ASPIRE指南于2020年发表在《柳叶刀》上,为设计和进行具有侵入性安慰剂对照的手术试验提供了建议。基于2022年6月举行的国际专家研讨会,我们现在提供有关此主题的进一步见解。这些包括侵入性安慰剂对照的目的和设计,患者信息提供以及如何使用这些试验的结果来为决策提供信息。
The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.
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