一种用于随机对照试验的简易盲法指标。
A simple blinding index for randomized controlled trials.
作者信息
Petroff David, Bacak Miroslav, Dagres Nikolaos, Dilk Patrick, Wachter Rolf
机构信息
Clinical Trial Centre, Faculty of Medicine, Leipzig University, Germany.
Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Berlin, Germany.
出版信息
Contemp Clin Trials Commun. 2024 Nov 26;42:101393. doi: 10.1016/j.conctc.2024.101393. eCollection 2024 Dec.
Abstract
Blinding is an essential part of many randomized controlled trials. However, its quality is usually not checked, and when it is, common measures are the James index and/or the Bang index. In the present paper we discuss these two indices, providing examples demonstrating their considerable weaknesses and limitations, and propose an alternative method for measuring blinding. We argue that this new approach has a number of advantages. We also provide an R-package for computing our blinding index.
摘要
盲法是许多随机对照试验的重要组成部分。然而，其质量通常未经检查，即便进行检查，常用的指标是詹姆斯指数和/或邦指数。在本文中，我们讨论这两个指数，给出示例说明它们存在的显著弱点和局限性，并提出一种测量盲法的替代方法。我们认为这种新方法有诸多优点。我们还提供了一个用于计算我们的盲法指数的R包。
相似文献
1
A simple blinding index for randomized controlled trials.一种用于随机对照试验的简易盲法指标。
Contemp Clin Trials Commun. 2024 Nov 26;42:101393. doi: 10.1016/j.conctc.2024.101393. eCollection 2024 Dec.
2
Blinding strategies in the conduct and reporting of a randomized placebo-controlled device trial.随机安慰剂对照器械试验实施与报告中的设盲策略。
Clin Trials. 2014 Oct;11(5):547-52. doi: 10.1177/1740774514535999. Epub 2014 Jun 5.
3
Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support.在接受呼吸支持的早产儿中，对程序性干预进行盲法随机对照试验的成功。
Clin Trials. 2023 Oct;20(5):479-485. doi: 10.1177/17407745231171647. Epub 2023 May 5.
4
Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial.参与者和结果评估者对脊柱手法治疗干预措施实施盲法的可行性：一项盲法可行性试验的方案
Pilot Feasibility Stud. 2024 May 2;10(1):70. doi: 10.1186/s40814-024-01492-6.
5
Blinding assessment in randomised sham-controlled trials of acupuncture:protocol for a systematic survey.针刺随机假对照试验中的盲法评估：一项系统综述方案
BMJ Open. 2025 Jan 22;15(1):e090238. doi: 10.1136/bmjopen-2024-090238.
6
Digital blinding of radiographs to mask allocation in a randomized control trial.在一项随机对照试验中对X光片进行数字遮蔽以掩盖分组情况。
World J Orthop. 2017 Oct 18;8(10):785-789. doi: 10.5312/wjo.v8.i10.785.
7
Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students.手法软组织松解背部按摩的研究中是否可以实施盲法？一项采用瑞士研究生的可行性随机对照试验。
Chiropr Man Therap. 2024 Jan 29;32(1):3. doi: 10.1186/s12998-023-00524-x.
8
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.
9
Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups?在盲法不充分的随机临床试验中，干预组是否报告了增强的安慰剂效应，而安慰剂组是否报告了反安慰剂效应？
Syst Rev. 2014 Feb 21;3:14. doi: 10.1186/2046-4053-3-14.
10
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.在流行地区，服用抗叶酸抗疟药物的人群中，叶酸补充剂与疟疾易感性和严重程度的关系。
Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.
本文引用的文献
1
Assessment of blinding in randomized controlled trials of antidepressants for depressive disorders 2000-2020: A systematic review and meta-analysis.2000 - 2020年抗抑郁药治疗抑郁症随机对照试验中的盲法评估：一项系统评价和荟萃分析
EClinicalMedicine. 2022 Jul 1;50:101505. doi: 10.1016/j.eclinm.2022.101505. eCollection 2022 Aug.
2
Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial.稳定型心绞痛患者的经皮冠状动脉介入治疗（ORBITA）：一项双盲、随机对照试验。
Lancet. 2018 Jan 6;391(10115):31-40. doi: 10.1016/S0140-6736(17)32714-9. Epub 2017 Nov 2.
3
Blinding measured: a systematic review of randomized controlled trials of acupuncture.盲法测量：针灸随机对照试验的系统评价。
Evid Based Complement Alternat Med. 2013;2013:708251. doi: 10.1155/2013/708251. Epub 2013 Mar 3.
4
Comparison of biomechanical properties between acupuncture and non-penetrating sham needle.针刺与非穿透假针刺的生物力学特性比较。
Complement Ther Med. 2011 Jan;19 Suppl 1:S8-S12. doi: 10.1016/j.ctim.2010.09.002. Epub 2010 Oct 14.
5
Acupuncture for treating dry eye: a randomized placebo-controlled trial.针刺治疗干眼症：一项随机安慰剂对照试验。
Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10.
6
Fifteen-day acupuncture treatment relieves diabetic peripheral neuropathy.为期15天的针灸治疗可缓解糖尿病周围神经病变。
J Acupunct Meridian Stud. 2010 Jun;3(2):95-103. doi: 10.1016/S2005-2901(10)60018-0.
7
Towards a proposal for assessment of blinding success in clinical trials: up-to-date review.评估临床试验中盲法成功的建议：最新综述。
Community Dent Oral Epidemiol. 2009 Dec;37(6):477-84. doi: 10.1111/j.1600-0528.2009.00494.x. Epub 2009 Sep 15.
8
Acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain.针刺疗法与假针刺疗法治疗慢性前列腺炎/慢性盆腔疼痛的比较
Am J Med. 2008 Jan;121(1):79.e1-7. doi: 10.1016/j.amjmed.2007.07.033.
9
A double-blind placebo needle for acupuncture research.用于针灸研究的双盲安慰剂针。
BMC Complement Altern Med. 2007 Oct 10;7:31. doi: 10.1186/1472-6882-7-31.
10
Assessment of blinding may be inappropriate after the trial.试验结束后进行盲法评估可能并不合适。
Contemp Clin Trials. 2005 Aug;26(4):512-4; author reply 514-5. doi: 10.1016/j.cct.2005.04.002.
Zotero 插件