A Simple Blinding Index for Randomized Controlled Trials

Overview

Journal Contemp Clin Trials Commun

Date 2024 Dec 17

PMID 39686958

Authors

David Petroff

Miroslav Bacak

Nikolaos Dagres

Patrick Dilk

Rolf Wachter

Affiliations

Soon will be listed here.

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.

References

Takakura N, Yajima H . A double-blind placebo needle for acupuncture research. BMC Complement Altern Med. 2007; 7:31. PMC: 2176062. DOI: 10.1186/1472-6882-7-31. View

Zaslawski C, Rogers C, Garvey M, Ryan D, Yang C, Zhang S . Strategies to maintain the credibility of sham acupuncture used as a control treatment in clinical trials. J Altern Complement Med. 1998; 3(3):257-66. DOI: 10.1089/acm.1997.3.257. View

Shin M, Kim J, Lee M, Kim K, Choi J, Kang K . Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010; 88(8):e328-33. DOI: 10.1111/j.1755-3768.2010.02027.x. View

Hemila H . Assessment of blinding may be inappropriate after the trial. Contemp Clin Trials. 2005; 26(4):512-4. DOI: 10.1016/j.cct.2005.04.002. View

Al-Lamee R, Thompson D, Dehbi H, Sen S, Tang K, Davies J . Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2017; 391(10115):31-40. DOI: 10.1016/S0140-6736(17)32714-9. View

Lee S, Liong M, Yuen K, Leong W, Chee C, Cheah P . Acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain. Am J Med. 2008; 121(1):79.e1-7. PMC: 4497585. DOI: 10.1016/j.amjmed.2007.07.033. View

Moroz A, Freed B, Tiedemann L, Bang H, Howell M, Park J . Blinding measured: a systematic review of randomized controlled trials of acupuncture. Evid Based Complement Alternat Med. 2013; 2013:708251. PMC: 3603669. DOI: 10.1155/2013/708251. View

Lin Y, Sahker E, Shinohara K, Horinouchi N, Ito M, Lelliott M . Assessment of blinding in randomized controlled trials of antidepressants for depressive disorders 2000-2020: A systematic review and meta-analysis. EClinicalMedicine. 2022; 50:101505. PMC: 9257339. DOI: 10.1016/j.eclinm.2022.101505. View

Streitberger K, Kleinhenz J . Introducing a placebo needle into acupuncture research. Lancet. 1998; 352(9125):364-5. DOI: 10.1016/S0140-6736(97)10471-8. View

10.

Tong Y, Guo H, Han B . Fifteen-day acupuncture treatment relieves diabetic peripheral neuropathy. J Acupunct Meridian Stud. 2010; 3(2):95-103. DOI: 10.1016/S2005-2901(10)60018-0. View

11.

Kolahi J, Bang H, Park J . Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol. 2009; 37(6):477-84. PMC: 3044082. DOI: 10.1111/j.1600-0528.2009.00494.x. View

12.

Bang H, Ni L, Davis C . Assessment of blinding in clinical trials. Control Clin Trials. 2004; 25(2):143-56. DOI: 10.1016/j.cct.2003.10.016. View

13.

Newcombe R . Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998; 17(8):873-90. DOI: 10.1002/(sici)1097-0258(19980430)17:8<873::aid-sim779>3.0.co;2-i. View

14.

James K, Bloch D, Lee K, Kraemer H, Fuller R . An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation--a VA cooperative study. Stat Med. 1996; 15(13):1421-34. DOI: 10.1002/(SICI)1097-0258(19960715)15:13<1421::AID-SIM266>3.0.CO;2-H. View

15.

Henneicke-von Zepelin H . Assessment of blinding in clinical trials. Contemp Clin Trials. 2005; 26(4):512. DOI: 10.1016/j.cct.2005.04.004. View

16.

Chae Y, Um S, Yi S, Lee H, Chang D, Yin C . Comparison of biomechanical properties between acupuncture and non-penetrating sham needle. Complement Ther Med. 2011; 19 Suppl 1:S8-S12. DOI: 10.1016/j.ctim.2010.09.002. View