Quantification methods were developed for selection bias by predictability of allocations with unequal block randomization

Journal of Clinical Epidemiology

Volumn 58, Issue 12, 2005, Pages 1269.e1-1269.e2

  Dupin Spriet, Thérèse ^a   Fermanian, Jacques ^b   Spriet, Alain ^c  

^a UNIV LILLE   (France)

^b HÔPITAL NECKER ENFANTS MALADES   (France)

^c Alain Spriet   (France)

Author keywords

Blocks; Clinical trials; Predictability; Randomization; Selection bias

Indexed keywords

ARTICLE; CALCULATION; METHODOLOGY; PATIENT; PATIENT SELECTION; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RANDOMIZATION; RISK ASSESSMENT;

EID: 27744443669     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2005.04.008     Document Type: Article

References (29)

1. L. Hansson, T. Hedner, and B. Dahlöf Prospective Randomized Open Blinded End-Point. Prospective Randomized Open Blinded End-point (PROBE) Study: a novel design for intervention trials Blood Press 1 1992 113 119
2. T. Dupin-Spriet, A. Spriet, and F. Mareschi Jury of resemblance Drug Inf J 27 1993 135 143
3. D.G. Altman, and C.J. Doré Randomisation and baseline comparisons in clinical trials Lancet 335 1990 149 153
4. D.H. Williams, and C.E. Davis Reporting of assignment methods in clinical trials Control Clin Trials 15 1994 294 298
5. J.M. Lachin Statistical properties of randomization in clinical trials Control Clin Trials 9 1988 289 311
6. K.F. Schulz Subverting randomization in controlled trials JAMA 274 1995 1456 1458
7. H.C. Kraemer, and K.H. Fendt Random assignment in clinical trials: issues in planning (Infant Health and Development Program) J Clin Epidemiol 43 1990 1157 1167
8. S. Senn Allocating treatments to patients in clinical trials Statistical issues in drug development 1997 John Wiley Chichester, UK 69-94
9. R. Peto Failure of randomisation by "sealed" envelope [Letter] Lancet 354 1999 73
10. L. Hansson, L.H. Lindholm, L. Niskanen, J. Lanke, T. Hedner, A. Niklason, K. Luomanmäki, B. Dahlhöf, U. de Faire, C. Mörlin, B.E. Karlberg, P.O. Wester, and J.E. Björck Effect of angiotensin-converting- enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPP) randomised trial Lancet 353 1999 611 616
11. E.M. Balk, P.A. Bonis, H. Moskowitz, C.H. Schmid, J.P. Ioannidis, and J. Lau Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials JAMA 287 2002 2973 2982
12. P. Juni, and M. Egger Allocation concealment in clinical trials JAMA 288 2002 2406 2407
13. J.P. Matts, and J.M. Lachin Properties of permuted-block randomisation in clinical trials Control Clin Trials 9 1988 327 344
14. T. Dupin-Spriet, J. Fermanian, and A. Spriet Quantification of predictability in block randomization Drug Inf J 38 2004 135 141
15. International Conference on Harmonisation on technical requirements for registration of pharmaceuticals for human use. ICH topic E9. Note for guidance on statistical principles for clinical trials. February 1998 [Available at: http://www.ich.org/cache/compo/276-254-1.html ].
16. D.G. Altman, and J.M. Bland How to randomise BMJ 319 1999 703 704
17. S.J. Kunselman, T.J. Armstrong, T.B. Britton, and P.E. Forand Asthma Clinical Research Network. Implementing randomization procedures in the asthma clinical research network Control Clin Trials 22 6 Suppl 2001 181S 195S
18. V.W. Berger, A. Ivanova, and M.D. Knoll Minimizing predictability while retaining balance through the use of less restrictive randomization procedures Stat Med 22 2003 3017 3028
19. W. Rosenberger, and J.M. Lachin Randomization in clinical trials: theory and practice 2002 John Wiley New York
20. UKPDS group UK prospective diabetes study VIII: study design, progress and performance Diabetologia 34 1991 877 890
21. J. Wils The establishment of a large collaborative trial programme in the adjuvant treatment of colon cancer Br J Cancer 77 Suppl 2 1998 23 28
22. The GUSTO V investigators Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial Lancet 357 2001 1905 1914
23. V.W. Berger, and S. Weinstein Ensuring the comparability of comparison groups: is randomization enough? Control Clin Trials 25 2004 515 524
24. B. Efron Forcing a sequential experiment to be balanced Biometrika 58 1971 403 417
25. M. Zelen The randomisation and stratification of patients to clinical trials J Chron Dis 27 1974 365 375
26. J.H. Klotz Maximum entropy constrained balance randomization for clinical trials Biometrics 34 1978 283 287
27. D.M. Titterington On constrained balance randomization for clinical trials Biometrics 39 1983 1083 1086
28. K.F. Schulz, and D.A. Grimes Unequal group sizes in randomised trials: guarding against guessing Lancet 359 2002 966 970
29. V.W. Berger, and D.V. Exner Detecting selection bias in randomised clinical trials Control Clin Trials 20 1999 319 327