Risk of selection bias in randomised trials

Trials

Volumn 16, Issue 1, 2015, Pages

  Kahan, Brennan C ^a   Rehal, Sunita ^b   Cro, Suzie ^b  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b MRC CLINICAL TRIALS UNIT   (United Kingdom)

Author keywords

Clinical trial; Randomisation procedure; Randomised controlled trial; Selection bias

Indexed keywords

ARTICLE; CLINICAL STUDY; HUMAN; MEDICAL LITERATURE; PROGNOSIS; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK; SELECTION BIAS; STRATIFIED SAMPLE; TREATMENT PLANNING; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL (TOPIC); PROCEDURES; SAMPLE SIZE;

CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE; SELECTION BIAS;

EID: 84941212847     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0920-x     Document Type: Article

References (29)

1. Berger VW. Quantifying the magnitude of baseline covariate imbalances resulting from selection bias in randomized clinical trials. Biom J. 2005;47(2):119-27. discussion 28-39.
2. Berger VW, Exner DV. Detecting selection bias in randomized clinical trials. Control Clin Trials. 1999;20(4):319-27.
3. Follmann D, Proschan M. The effect of estimation and biasing strategies on selection bias in clinical trials with permuted blocks. J Stat Plann Inference. 1994;39(1):1-17.
4. Kennes LN, Cramer E, Hilgers RD, Heussen N. The impact of selection bias on test decisions in randomized clinical trials. Stat Med. 2011;30(21):2573-81.
5. Odgaard-Jensen J, Vist GE, Timmer A, Kunz R, Akl EA, Schunemann H, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev. 2011;4:MR000012.
6. Rosenberger WF, Lachin JM. Randomization in clinical trials. Chichester: Wiley; 2005.
7. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408-12.
8. Schulz KF, Grimes DA. Unequal group sizes in randomised trials: guarding against guessing. Lancet. 2002;359(9310):966-70.
9. Tamm M, Cramer E, Kennes LN, Heussen N. Influence of selection bias on the test decision. A simulation study. Methods Inf Med. 2012;51(2):138-43.
10. Kunz R, Oxman AD. The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. BMJ. 1998;317(7167):1185-90.
11. Nuesch E, Reichenbach S, Trelle S, Rutjes AW, Liewald K, Sterchi R, et al. The importance of allocation concealment and patient blinding in osteoarthritis trials: a meta-epidemiologic study. Arthritis Rheum. 2009;61(12):1633-41.
12. Brown S, Thorpe H, Hawkins K, Brown J. Minimization - reducing predictability for multi-centre trials whilst retaining balance within centre. Stat Med. 2005;24(24):3715-27.
13. Schulz KF. Subverting randomization in controlled trials. JAMA. 1995;274(18):1456-8.
14. Berger VW. Selection bias and covariate imbalances in randomized clinical trials. Chichester: Wiley; 2005.
15. Berger VW, Weinstein S. Ensuring the comparability of comparison groups: is randomization enough? Control Clin Trials. 2004;25(5):515-24.
16. Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ. 2012;345:e5840.
17. Hewitt CE, Torgerson DJ. Is restricted randomisation necessary? BMJ. 2006;332(7556):1506-8.
18. Hewitt CE, Torgerson DJ, Berger VW. Potential for technical errors and subverted allocation can be reduced if certain guidelines are followed: examples from a web-based survey. J Clin Epidemiol. 2009;62(3):261-9.
19. Parzen M, Lipsitz S, Dear K. Does clustering affect the usual test statistics of no treatment effect in a randomized clinical trial? Biom J. 1998;40(4):385-402.
20. Reitsma A, Chu R, Thorpe J, McDonald S, Thabane L, Hutton E. Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes. Trials. 2014;15:377.
21. Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC Med Res Methodol. 2014;14:20.
22. Kahan BC, Morris TP. Analysis of multicentre trials with continuous outcomes: when and how should we account for centre effects? Stat Med. 2013;32(7):1136-49.
23. Berger VW. Varying the block size does not conceal the allocation. J Critical Care. 2006;21(2):229. author reply -30.
24. Kahan BC. Rank minimization with a two-step analysis should not replace randomization in clinical trials. J Clin Epidemiol. 2012;65(7):808-9.
25. Wei LJ, Lachin JM. Properties of the urn randomization in clinical trials. Control Clin Trials. 1988;9(4):345-64.
26. Kahan BC, Jairath V, Dore CJ, Morris TP. The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies. Trials. 2014;15:139.
27. Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med. 2012;31(4):328-40.
28. Eldridge S, Kerry S, Torgerson DJ. Bias in identifying and recruiting participants in cluster randomised trials: what can be done? BMJ. 2009;339:b4006.
29. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.