The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials: A methodological systematic review

BMC Medical Research Methodology

Volumn 16, Issue 1, 2016, Pages

  Bello, Segun ^a,b   Wei, Maoling ^c   Hilden, Jørgen ^d   Hróbjartsson, Asbjørn ^a,e  

^a Rigshospitalet   (Denmark)

^b UNIVERSITY OF IBADAN   (Nigeria)

^c SICHUAN UNIVERSITY   (China)

^d UNIVERSITY OF COPENHAGEN   (Denmark)

^e UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

BIBLIOGRAPHIC DATABASE; DOUBLE BLIND PROCEDURE; DRUG THERAPY; HUMAN; METHODOLOGY; OUTCOME ASSESSMENT; PROCEDURES; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; SINGLE BLIND PROCEDURE; STANDARDS; STATISTICS AND NUMERICAL DATA;

DATABASES, BIBLIOGRAPHIC; DOUBLE-BLIND METHOD; DRUG THERAPY; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY CONTROL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SINGLE-BLIND METHOD;

EID: 84957661586     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/s12874-016-0111-9     Document Type: Article

References (32)

1. Schulz KF, Chalmers I, Altman DG. The landscape and lexicon of blinding in randomised trials. Ann Intern Med. 2002;136:254-9.
2. Hróbjartsson A, Boutron I. Blinding in randomized clinical trials: imposed impartiality. Clin Pharmacol Ther. 2011;90(5):732-6.
3. Savović J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med. 2012;157(6):429-38.
4. Hróbjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Hilden J, Boutron I, et al. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ. 2012;344:e1119.
5. Hróbjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Hilden J, Boutron I, et al. Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors. CMAJ. 2013. doi: 10.1503/cmaj.120744.
6. Hróbjartsson A, Thomsen ASS, Emanuelsson F, et al. Observer bias in randomized clinical trials with time-to-event outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. Int J Epidemiol. 2014. doi: 10.1093/ije/dyt270.
7. Hróbjartsson A, Emanuelsson F, Thomsen ASS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol 2014; doi: 10.1093/ije/dyu115.
8. Chan AW, Altman DG. Epidemiology and reporting of randomized trials published in PubMed journals. Lancet. 2005;365(9465):1159-62.
9. Boutron I, Estellat C, Guittet L, Dechartres A, Sackett DL, Hróbjartsson A, et al. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review. PLoS Med. 2006;3(10):e425.
10. Moncrieff J, Wessely S, Hardy R. Active placebos versus antidepressants for depression. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD003012. doi: 10.1002/14651858.CD003012.pub2.
11. Hien TT, Dung NT, Truong NT, Van NTT, Chau TNB, Hoang NVM, et al. A randomised trial evaluating the safety and immunogenicity of the novel single oral dose typhoid vaccine M01ZH09 in healthy Vietnamese children. PLoS One. 2010;5(7):e11778.
12. Eby GA, Davis DR, Halcomb WW. Reduction in duration of common cold by zinc gluconate lozenges in a double-blind study. Antimicrob Agents Chemother. 1984;25:20-4.
13. Farr BM, Gwaltney Jr JM. The problems of taste in placebo matching: an evaluation of zinc gluconate for the common cold. J Chronic Dis. 1987;40(9):875-9.
14. Fai CK, Qi GD, Wei DA, Chung LP. Placebo preparation for the proper clinical trials of herbal medicine-requirements, verification and quality control. Recent Patents Inflamm Allergy Drug Discov. 2011;5:169-74.
15. Walter SD, Awasthi S, Jeyaseelan L. Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example. Contemporary Clinical Trials. 2005;26:459-68.
16. Hill LE, Ninn AJ. Matching quality of agents employed in "double-blind" controlled clinical trials. Lancet. 1976;1:352-6.
17. Blumenthal DS, Burke R, Shapiro AK. The validity of "identical matching placebos". JAMA Psychiatry. 1974;31(2):214.
18. Dupin-Spriet T, Spriet A. Jury of resemblance. Drug Information Journal. 1993;27:135-43.
19. Wen Z, Wang Q, Liang W, Lai S. Application of blind method in double-blind randomized controlled trial of Shengmai capsule for chronic heart failure. J Guangzhou Uni Tradit Chi Med. 2004;21(4):315-22.
20. Argawal G, Awasthi S, Kabra SK, Kaul A, Singhi S, Walter SD, et al. Three day versus five day treatment weith amoxicillin for non-severe pneumonia in young children: a multicenter randomized controlled trial. BMJ. 2004;328:791.
21. Sieveking DP, Woo KS, Fung KP, Lundman P, Nakhla S, Celermajer DS. Chinese herbs Danshen and Gegen modulate key early atherogenic events in vitro. Int J Cardiol. 2005;105:40-5.
22. Farr BM, Conner EM, Betts RF, Oleske J, Minnefor A, Gwaltney Jr JM. Two randomized controlled trials of zinc gluconate lozenge therapy of experimentally induced rhinovirus colds. Antimicrob Agents Chemother. 1987;31(8):1183-7.
23. Chan AW, Hróbjartsson A, Haarh MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trial: comparison of protocols to published articles. JAMA. 2004;291(20):2457-65.
24. Tsukayama H, Yamashita H, Kimura T, Otsuki K. Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Clin J Pain. 2006;22(4):346-9.
25. White P, Lewith G, Hopwood V, Prescott P. The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trials. Pain. 2003;106(3):401-9.
26. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352(9125):364-5.
27. Takakura N, Yajima H. A placebo acupuncture needle with potential for double blinding-a validation study. Acupunct Med. 2008;26(4):224-30.
28. Bello S, Moustgaard H, Hróbjartsson A. The risk of unblinding was infrequently and incompletely reported in 300 randomised clinical trial publications. J Clin Epidemiol. 2014. doi: 10.1016/j.jclinepi.2014.05.007.
29. World Health Organization. Good manufacturing practices for pharmaceutical products: main principles. WHO Technical Report. 2003;908(4):36-89.
30. World Health Organization. Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans. WHO Technical Report. 1996;863(7):97-108.
31. Food and Drug Administration. Guideline on the preparation of investigational new drug products (human and animal). 1991.
32. Health Canada. Good manufacturing practices guidelines drugs used in clinical trials. Annex 13. 2009.