Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures

Contemporary Clinical Trials

Volumn 28, Issue 2, 2007, Pages 130-137

  Shaffer, Michele L ^a   Chinchilli, Vernon M ^a  

^a PENN STATE COLLEGE OF MEDICINE   (United States)

Author keywords

Emergency medication; Intent to treat; Repeated measures

Indexed keywords

PREDNISONE; SALMETEROL; TRIAMCINOLONE; TRIAMCINOLONE ACETONIDE;

ARTICLE; ASTHMA; CLINICAL TRIAL; CONFIDENCE INTERVAL; DATA ANALYSIS; METHODOLOGY; OBSERVATION; SENSITIVITY ANALYSIS; SUBSTITUTION THERAPY; TREATMENT FAILURE; TREATMENT OUTCOME;

ALGORITHMS; ANTI-INFLAMMATORY AGENTS; ASTHMA; BRONCHODILATOR AGENTS; CLINICAL TRIALS; DRUG THERAPY, COMBINATION; HUMANS; MARKOV CHAINS; MONTE CARLO METHOD; PATIENT DROPOUTS; RANDOMIZED CONTROLLED TRIALS; REGRESSION ANALYSIS; RESEARCH DESIGN; TREATMENT FAILURE;

EID: 33845570296     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2006.06.006     Document Type: Article

References (19)

1. Little R.J.A., and Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics 52 (1996) 1324-1333
2. Beunckens C., Molenberghs G., and Kenward M.G. Direct likelihood analysis versus simple forms of imputation for missing data in randomized clinical trials. Clin Trials 2 (2005) 379-386
3. Shaffer M.L., and Chinchilli V.M. A likelihood-based, counterfactual approach to accounting for treatment failures in clinical trials. J Biopharm Stat 13 (2003) 481-494
4. Shaffer M.L., and Chinchilli V.M. Bayesian inference for randomized clinical trials with treatment failures. Stat Med 23 (2004) 1215-1228
5. Hogan J.W., and Laird N.M. Intention-to-treat analyses for incomplete repeated measures data. Biometrics 52 (1996) 1002-1017
6. Hogan J.W., and Laird N.M. Mixture models for the joint distribution of repeated measures and event times. Stat Med 16 (1997) 239-257
7. White I.R., Bamias C., Hardy P., Pocock S., and Warner J. Randomized clinical trials with added rescue medication: some approaches to their analysis and interpretation. Stat Med 20 (2001) 2995-3008
8. Vonesh E.F., and Chinchilli V.M. Linear and nonlinear models for the analysis of repeated measurements (1997), Marcel Dekker, New York
9. Mazumdar S., Liu K.S., Houck P.R., and Reynolds C.F. Intent-to-treat analysis for longitudinal clinical trials: coping with the challenge of missing values. J Psychiatr Res 33 (1999) 87-95
10. 2-agonist monotherapy vs. continued therapy with inhaled corticosteroids in patients with persistent asthma; a randomized controlled trial. J Am Med Assoc 285 (2001) 2583-2593
11. Lemanske R.F., Sorkness C.A., Mauger E.A., et al. Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol; a randomized controlled trial. J Am Med Assoc 285 (2001) 2594-2603
12. Rubin D.B. Multiple imputation for nonresponse in surveys (1987), Wiley, New York
13. Schafer J.L. Analysis of incomplete multivariate data (1997), Chapman and Hall, New York
14. Little R.J.A., and Rubin D.B. Statistical analysis with missing data. 2nd ed. (2002), Wiley, New York
15. SAS Institute Inc. The MI procedure and the MIANALYZE procedure. SAS/STAT Software: changes and enhancements Release 8.2 (2001), SAS Institute Inc., Cary, North Carolina
16. Schafer J.L. Multiple imputation: a primer. Stat Methods Med Res 8 (1999) 3-15
17. Tanner M.A., and Wong W.H. The calculation of posterior distributions by data augmentation. J Am Stat Assoc 82 (1987) 528-540
18. Laird N.M., and Ware J.H. Random-effects models for longitudinal data. Biometrics 38 (1982) 963-974
19. Schafer J.L., and Yucel R.M. Computational strategies for multivariate linear mixed models with missing values. J Comput Graph Stat 11 (2002) 421-442