Blinding Assessment in Randomized Controlled Clinical Trials_Chinese Journal of Evidence-Based Medicine

Authors：

 YANShi-yan ¹ , HELi-yun ¹ ,  LIUBao-yan ²

1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
2. China Academy of Chinese Medical Sciences, Beijing 100700, China;

Corresponding author：

LIUBao-yan, Email: liuby@mail.cintcm.ac.cn

Keywords：

Blinding; Blinding quality assessment; Randomized controlled trial

DOI：

10.7507/1672-2531.20140104

Video：

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Abstract Full text Figures/Tables Video References Cited by

Blinding is an effective measure to control and reduce the bias caused by the subjective factors of participants in a study. However, the failure of blinding results in more bias. Therefore, it is necessary to assess blinding quality in clinical trials involving blinding. The relevant international articles and methods of blinding assessment were summarized in this study. According to the present situation of blinding assessment, researchers don't pay enough attention to the assessment of blinding quality, relevant studies lack, comprehensive methods and tools for blinding quality, and researchers have discrepancy with time points in blinding quality. Therefore, it is necessary to conduct further studies in all aspects, and it is suggested that comprehensive blinding quality scales should be developed according to the key influencing factors of the implementation of blinding. Through the assessment of the implementation of key factors, the risk and degree of blinding should be confirmed in order to better interpret and assess researcher results.

Citation： YANShi-yan, HELi-yun, LIUBao-yan. Blinding Assessment in Randomized Controlled Clinical Trials. Chinese Journal of Evidence-Based Medicine, 2014, 14(5): 631-632. doi: 10.7507/1672-2531.20140104 Copy

1.	Sackett DL. Commentary:Measuring the success of blinding in RCTs:don't, must, can't or needn't?. Int J Epidemiol, 2007, 36(3): 664-665.
2.	钟丽丹, 郑颂华, 吴泰相, 等.提高临床研究方案设计水平是改善临床研究总体水平的基石.中国循证医学杂志, 2013, 13(12):1500.
3.	Piaggio G, Elbourne DR, Altman DG, et al. Reporting of noninferiority and equivalence randomized trials:an extension of the CONSORT statement. JAMA, 2006, 295(10):1152-1160.
4.	Fergusson D, Glass KC, Waring D, et al. Turning a blind eye:the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ, 2004, 328(7437):432.
5.	Hrobjartsson A, Forfang E, Haahr MT, et al. Blinded trials taken to the test:an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol, 2007, 36(3):654-663.
6.	Boutron I, Estellat C, Ravaud P. A review of blinding in randomized controlled trials found results inconsistent and questionable. J Clin Epidemiol, 2005, 58(12):1220-1226.
7.	王云飞, 阮新民, 吴焕林, 等.大型双盲临床试验中药安慰剂制备方法及效果评价研究.中药新药与临床药理, 2011, 22(3):255-257.
8.	温泽淮, 王奇, 梁伟雄, 等.生脉胶囊治疗慢性心衰双盲随机对照试验中盲法的实施.广州中医药大学学报, 2004, 21(4):315-322.
9.	Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials, 2004, 25(2):143-156.
10.	James K, Bloch D, Lee K, et al. An index for assessing blindness in a multi-centre clinical trial:disulfiram for alcohol cessation-a VA cooperative study. Stat Med, 1996, 15(13):1421-1434.
11.	Lao L, Bergman S, Hamilton GR, et al. Evaluation of acupuncture for pain control after oral surgery:a placebo-controlled trial. Arch Otolaryngol Head Neck Surg, 1999, 125(5):567-572.
12.	Larosa JC, Applegate W, Crouse JR 3rd, et al. Cholesterol lowering in the elderly. Results of the cholesterol reduction ini seniors program(crisp) pilot study. Arch Intern Med, 1994, 154(5):529-539.
13.	Rees J, Wade T, Levy D, et al. Changes in beliefs identify unblinding in randomized controlled trials:a method to meet consort guidelines. Contemp Clin Trials, 2005, 26(1):25-37.
14.	Kolahi J, Abrishami M. Multiple-blind:towards a new blinding protocol for future generations of clinical trials. Med Hypotheses, 2009, 73(5):843-845.
15.	Arandjelovic O. A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials. PLoS One, 2012, 7(12): e48984.
16.	Boodhwani M, Hamilton A, De Varennes B, et al. A multicenter randomized controlled trial to assess the feasibility of testing modified ultrafiltration as a blood conservation technology in cardiac surgery. J Thorac Cardiovasc Surg, 2010, 139(3):701-706.
17.	Colford JM., Rees JR, Wade TJ, et al. Participant blinding and gastrointestinal illness in a randomized, controlled trial of an in-home drinking water intervention. Emerg Infect Dis, 2002, 8(1):29-36.
18.	Enblom A, Hammar M, Steineck G, et al. Can individuals identify if needling was performed with an acupuncture needle or a nonpenetrating sham needle?. Complement Ther Med, 2008, 16(5):288-294.
19.	Enblom A, Johnsson A, Hammar M, et al. The nonpenetrating telescopic sham needle may blind patients with different characteristics and experiences when treated by several therapists. Evid Based Complement Alternat Med, 2011, 2011:185034.
20.	Iafrati MD, Hallett JW, Geils G, et al. Early results and lessons learned from a multicenter, randomized, double-blind trial of bone marrow aspirate concentrate in critical limb ischemia. J Vasc Surg, 2011, 54(6):1650-1658.
21.	[21 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):477-484.
22.	Lee H, Bang H, Kim Y, et al. Non-penetrating sham needle, is it an adequate sham control in acupuncture research?. Complement Ther Med, 2011, 19(Suppl 1):S41-48.
23.	Moroz A, Freed B, Tiedemann L, et al. Blinding measured:a systematic review of randomized controlled trials of acupuncture. Evid Based Complement Alternat Med, 2013, 2013:708251.
24.	Hopton AK, Macpherson H. Assessing blinding in Randomised Controlled Trials of Acupancture:Challenges and Recommandations. Chin J Integr Med, 2011, 17(3):173-176.
25.	White AR, Filshie J, Cummings TM. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med, 2001, 9(4):237-245.
26.	Park J, Bang H, Canette I. Blinding in clinical trials, time to do it better. Complement Ther Med, 2008, 16(1):121-123.
27.	Desbiens N. In randomizaiton controlled trials, should subjects in both placebo and drug groups be expected to guess that they are taking drug 50% of the time? Med Hypotheses, 2002, 59(3):227-232.
28.	Sackett DL. Why we don't test for blindness at the end of our trials. BMJ, 2004, 328(7448):1136.

1. Sackett DL. Commentary:Measuring the success of blinding in RCTs:don't, must, can't or needn't?. Int J Epidemiol, 2007, 36(3): 664-665.
2. 钟丽丹, 郑颂华, 吴泰相, 等.提高临床研究方案设计水平是改善临床研究总体水平的基石.中国循证医学杂志, 2013, 13(12):1500.
3. Piaggio G, Elbourne DR, Altman DG, et al. Reporting of noninferiority and equivalence randomized trials:an extension of the CONSORT statement. JAMA, 2006, 295(10):1152-1160.
4. Fergusson D, Glass KC, Waring D, et al. Turning a blind eye:the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ, 2004, 328(7437):432.
5. Hrobjartsson A, Forfang E, Haahr MT, et al. Blinded trials taken to the test:an analysis of randomized clinical trials that report tests for the success of blinding. Int J Epidemiol, 2007, 36(3):654-663.
6. Boutron I, Estellat C, Ravaud P. A review of blinding in randomized controlled trials found results inconsistent and questionable. J Clin Epidemiol, 2005, 58(12):1220-1226.
7. 王云飞, 阮新民, 吴焕林, 等.大型双盲临床试验中药安慰剂制备方法及效果评价研究.中药新药与临床药理, 2011, 22(3):255-257.
8. 温泽淮, 王奇, 梁伟雄, 等.生脉胶囊治疗慢性心衰双盲随机对照试验中盲法的实施.广州中医药大学学报, 2004, 21(4):315-322.
9. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials, 2004, 25(2):143-156.
10. James K, Bloch D, Lee K, et al. An index for assessing blindness in a multi-centre clinical trial:disulfiram for alcohol cessation-a VA cooperative study. Stat Med, 1996, 15(13):1421-1434.
11. Lao L, Bergman S, Hamilton GR, et al. Evaluation of acupuncture for pain control after oral surgery:a placebo-controlled trial. Arch Otolaryngol Head Neck Surg, 1999, 125(5):567-572.
12. Larosa JC, Applegate W, Crouse JR 3rd, et al. Cholesterol lowering in the elderly. Results of the cholesterol reduction ini seniors program(crisp) pilot study. Arch Intern Med, 1994, 154(5):529-539.
13. Rees J, Wade T, Levy D, et al. Changes in beliefs identify unblinding in randomized controlled trials:a method to meet consort guidelines. Contemp Clin Trials, 2005, 26(1):25-37.
14. Kolahi J, Abrishami M. Multiple-blind:towards a new blinding protocol for future generations of clinical trials. Med Hypotheses, 2009, 73(5):843-845.
15. Arandjelovic O. A new framework for interpreting the outcomes of imperfectly blinded controlled clinical trials. PLoS One, 2012, 7(12): e48984.
16. Boodhwani M, Hamilton A, De Varennes B, et al. A multicenter randomized controlled trial to assess the feasibility of testing modified ultrafiltration as a blood conservation technology in cardiac surgery. J Thorac Cardiovasc Surg, 2010, 139(3):701-706.
17. Colford JM., Rees JR, Wade TJ, et al. Participant blinding and gastrointestinal illness in a randomized, controlled trial of an in-home drinking water intervention. Emerg Infect Dis, 2002, 8(1):29-36.
18. Enblom A, Hammar M, Steineck G, et al. Can individuals identify if needling was performed with an acupuncture needle or a nonpenetrating sham needle?. Complement Ther Med, 2008, 16(5):288-294.
19. Enblom A, Johnsson A, Hammar M, et al. The nonpenetrating telescopic sham needle may blind patients with different characteristics and experiences when treated by several therapists. Evid Based Complement Alternat Med, 2011, 2011:185034.
20. Iafrati MD, Hallett JW, Geils G, et al. Early results and lessons learned from a multicenter, randomized, double-blind trial of bone marrow aspirate concentrate in critical limb ischemia. J Vasc Surg, 2011, 54(6):1650-1658.
21. [21 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):477-484.
22. Lee H, Bang H, Kim Y, et al. Non-penetrating sham needle, is it an adequate sham control in acupuncture research?. Complement Ther Med, 2011, 19(Suppl 1):S41-48.
23. Moroz A, Freed B, Tiedemann L, et al. Blinding measured:a systematic review of randomized controlled trials of acupuncture. Evid Based Complement Alternat Med, 2013, 2013:708251.
24. Hopton AK, Macpherson H. Assessing blinding in Randomised Controlled Trials of Acupancture:Challenges and Recommandations. Chin J Integr Med, 2011, 17(3):173-176.
25. White AR, Filshie J, Cummings TM. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med, 2001, 9(4):237-245.
26. Park J, Bang H, Canette I. Blinding in clinical trials, time to do it better. Complement Ther Med, 2008, 16(1):121-123.
27. Desbiens N. In randomizaiton controlled trials, should subjects in both placebo and drug groups be expected to guess that they are taking drug 50% of the time? Med Hypotheses, 2002, 59(3):227-232.
28. Sackett DL. Why we don't test for blindness at the end of our trials. BMJ, 2004, 328(7448):1136.

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