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评估针灸随机对照试验中的盲法:挑战与建议。

Assessing blinding in randomised controlled trials of acupuncture: challenges and recommendations.

机构信息

Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.

出版信息

Chin J Integr Med. 2011 Mar;17(3):173-6. doi: 10.1007/s11655-011-0663-9. Epub 2011 Feb 27.

DOI:10.1007/s11655-011-0663-9
PMID:21359917
Abstract

The revision of CONSORT guidelines for reporting blinding in randomised controlled trials is the subject of controversy and criticism. To determine whether the criticism is justified, in this short communication paper we discuss the problems encountered in the methodology of the assessment of blinding, and the reporting of blinding in randomised controlled trials and the standards of reporting on blinding with reference to their usage in clinical trials of acupuncture for chronic pain. To conclude we recommend two simple guidelines: the development of sound clinical protocols that anticipate potential difficulties and reinforce overall internal validity, and secondly. the accurate reporting of the methodologies used to ensure a clear view of blinding procedures.

摘要

CONSORT 指南中关于随机对照试验中盲法报告的修订备受争议和批评。为了确定这些批评是否有道理,在这篇简短的交流论文中,我们将讨论在评估盲法的方法学以及随机对照试验中盲法报告以及参照针刺治疗慢性疼痛临床试验中的使用情况报告盲法标准方面遇到的问题。最后,我们建议两条简单的准则:制定合理的临床方案,预见潜在的困难,增强整体内部有效性;其次,准确报告所使用的方法学,以确保对盲法程序有清晰的了解。

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2
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本文引用的文献

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Contemp Clin Trials. 2011 Mar;32(2):240-3. doi: 10.1016/j.cct.2010.11.004. Epub 2010 Nov 9.
2
[Integrated traditional Chinese and Western medicine versus Western medicine in treatment of arteriosclerosis obliterans: a systematic review of randomized controlled trials].中西医结合与西医治疗闭塞性动脉硬化症的对比:随机对照试验的系统评价
Zhong Xi Yi Jie He Xue Bao. 2010 Oct;8(10):917-27. doi: 10.3736/jcim20101003.
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Towards better reporting of interventions in clinical trials of acupuncture.
盲法评估:向前迈进的一步。
Dent Hypotheses. 2021 Oct-Dec;12(4):169-173. doi: 10.4103/denthyp.denthyp_99_21. Epub 2021 Dec 21.
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Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000-2019: A review and meta-analytic approach.2000-2019 年腰痛随机对照试验中的盲法、假手术和治疗效果:综述和荟萃分析方法。
Clin Trials. 2021 Jun;18(3):361-370. doi: 10.1177/1740774520984870. Epub 2021 Jan 21.
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A pre-trial evaluation of blinding for a Chinese herbal medicine trial.一项中药试验设盲的预试验评估。
Contemp Clin Trials Commun. 2020 Aug 5;19:100632. doi: 10.1016/j.conctc.2020.100632. eCollection 2020 Sep.
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Do acupuncture trials have lower risk of bias over the last five decades? A methodological study of 4 715 randomized controlled trials.过去五十年间,针灸试验的偏倚风险是否更低?4715 项随机对照试验的方法学研究。
PLoS One. 2020 Jun 10;15(6):e0234491. doi: 10.1371/journal.pone.0234491. eCollection 2020.
7
Sample size calculations for blinding assessment.用于盲法评估的样本量计算。
J Biopharm Stat. 2018;28(5):857-869. doi: 10.1080/10543406.2017.1399898. Epub 2017 Nov 20.
8
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Eur J Pain. 2013 Sep;17(8):1109-25. doi: 10.1002/j.1532-2149.2013.00297.x. Epub 2013 Mar 7.
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