The effect of correlation structure on treatment contrasts estimated from incomplete clinical trial data with likelihood-based repeated measures compared with last observation carried forward ANOVA

Clinical Trials

Volumn 1, Issue 6, 2004, Pages 477-489

  Mallinckrodt, Craig h ^a   Kaiser, Christopher j ^a   Watkin, John g ^a   Molenberghs, Geert ^b   Carroll, Raymond j ^c  

^a ELI LILLY AND COMPANY   (United States)

^b HASSELT UNIVERSITY   (Belgium)

^c TEXAS A AND M UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYSIS OF VARIANCE; ARTICLE; CLINICAL TRIAL; HUMAN; METHODOLOGY; STATISTICAL MODEL;

ANALYSIS OF VARIANCE; CLINICAL TRIALS; HUMANS; LIKELIHOOD FUNCTIONS; MODELS, STATISTICAL; RESEARCH DESIGN;

EID: 33644630414     PISSN: 17407745     EISSN: None     Source Type: Journal    
DOI: 10.1191/1740774504cn049oa     Document Type: Article

References (35)

1. Gibbons R.D., Hedeker D., Elkin I. et al. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. Arch Gen Psychiatry 1993; 50: 739-750.
2. Milliken G.A., Johnson D.E. The analysis of messy data. New York, NY: CRC Press, 2002.
3. Laird N.M. Missing data in longitudinal studies. Stat Med 1988; 7: 305-315.
4. Lavori P.W. Clinical trials in psychiatry: should protocol deviation censor patient data? Neuropsychopharmacology 1992; 6: 39-48.
5. Little R.J., Rubin D.B. Statistical analysis with missing data. New York, NY: John Wiley and Sons, 1987.
6. Cnaan A., Laird N.M., Slasor P. Using the general linear mixed model to analyze unbalanced repeated measures and longitudinal data. Stat Med 1997; 16: 2349-2380.
7. Diggle P.J., Liang K.-Y., Zeger S.L. Analysis of longitudinal data. Oxford, UK: Clarendon Press, 1994.
8. Diggle P.J., Kenward M.G. Informative dropout in longitudinal data analysis. Appl Stat 1995; 43: 49-93.
9. Heyting A., Tolboom J.T., Essers J.G. Statistical handling of drop-outs in longitudinal clinical trials. Stat Med 1992; 11: 2043-2061.
10. Lavori P.W., Dawson R., Shera D. A multiple imputation strategy for clinical trials with truncation of patient data. Stat Med 1995; 14: 1913-1925.
11. Littell R.C., Milliken G.A., Stroup W.W., Wolfinger R. The SAS system for mixed models. Cary, NC: SAS Institute Inc., 1996.
12. Little R., Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics 1996; 52: 1324-1333.
13. Mallinckrodt C.H., Clark W.S., David S.R. Accounting for dropout bias using mixed-effects models. J Biopharm Stat 2001; 11: 9-21.
14. Mallinckrodt C.H., Clark W.S., David S.R. Type I error rates from mixed effects model repeated measures versus fixed effects ANOVA with missing values imputed via Last Observation Carried Forward. Drug Information J 2001; 35: 1215-1225.
15. Rubin D., Shenker N. Multiple imputations in health care databases: an overview and some applications. Stat Med 1991; 10: 585-598.
16. Rubin DB, Stern HS, Vehovar V. Handling “don't know” survey responses: the case of the Slovenian plebiscite. J Am Stat Assoc 1995; 90: 822-828.
17. Siddiqui O., Ali M.W. A comparison of the random-effects pattern mixture model with last-observationcarried-forward (LOCF) analysis in longitudinal clinical trials with dropouts. J Biopharm Stat 1998; 8: 545-563.
18. Verbeke G., Molenberghs G. Linear mixed models for longitudinal data. New York, NY: Springer Verlag, 2000.
19. Molenberghs G., Thijs H., Jansen I. et al. Analyzing incomplete longitudinal clinical trial data. Biostatistics 2004; 5: 445-464.
20. Rotnitzky A., Robins J.M., Scharfstein D.O. Semiparametric regression for repeated outcomes with non-ignorable non-response. J Am Stat Assoc 1998; 93: 1321-1339.
21. Laird N.M., Ware J.H. Random-effects models for longitudinal data. Biometrics 1982; 38: 963-974.
22. Robins J.M., Rotnitzky A., Zhao L.P. Analysis of semiparametric regression models for repeated outcomes in the presence of missing data. J Am Stat Assoc 1995; 90: 106-121.
23. Shao J., Zhong B. Last-observation carry-forward and last observation analysis. Stat Med 2003; 22: 2429-2441.
24. Mallinckrodt C.H., Clark S.W., Carroll R.J., Molenberghs G. Assessing response profiles from incomplete longitudinal clinical trial data under regulatory considerations. J Biopharm Stat 2003; 13: 179-190.
25. Mallinckrodt C.H., Sanger T.M., Dube S. et al. Assessing and interpreting treatment effects in longitudinal clinical trials with missing data. Biol Psychiatry 2003; 53: 754-760.
26. Jennrich R.I., Schluchter M.D. Unbalanced repeatedmeasures models with structured covariance matrices. Biometrics 1986; 42: 805-820.
27. Park T., Park J.K., Davis C.S. Effects of covariance model assumptions on hypothesis tests for repeated measurements: analysis of ovarian hormone data and pituitary-pteryomaxillary distance data. Stat Med 2001; 20: 2441-2453.
28. Detke M.J., Lu Y., Goldstein D.J., Hayes J.R., Demitrack M.A. Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. J Clin Psychiatry 2002; 63: 308-315.
29. Detke M.J., Lu Y., Goldstein D.J., McNamara R.K., Demitrack M.A. Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression. J Psychiatr Res 2002; 36: 383-390.
30. Goldstein D.J., Mallinckrodt C., Lu Y., Demitrack M.A. Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. J Clin Psychiatry 2002; 63: 225-231.
31. Van Vleck L.D., Gregory K.E. Multiple-trait restricted maximum likelihood for simulated measures of ovulation rate with underlying multivariate normal distributions. J Anim Sci 1992; 70: 57-61.
32. Mallinckrodt C.H. The effects of animal model approximations and data problems on the reliability of genetic evaluations. PhD Thesis. Colorado State University. 1993.
33. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56-61.
34. DeLoach L.J., Higgins M.S., Caplan A.B., Stiff J.L. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg 1998; 86: 102-106.
35. SAS/Stat Software: Changes and enhancements through release 6.12. Cary, NC: SAS Institute, Inc.; 1997.