Internal pilots for a class of linear mixed models with Gaussian and compound symmetric data

Statistics in Medicine

Volumn 26, Issue 22, 2007, Pages 4083-4099

  Gurka, Matthew J ^a   Coffey, Christopher S ^b   Muller, Keith E ^c  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

Author keywords

Adaptive designs; Exchangeable correlation; Power; Repeated measures; Sample size re estimation; Univariate approach

Indexed keywords

ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; BRAIN BLOOD VESSEL; BRAIN REGION; CONTROLLED STUDY; CORRELATION ANALYSIS; COVARIANCE; DATA ANALYSIS; FACTORIAL ANALYSIS; FINANCIAL MANAGEMENT; LINEAR SYSTEM; MATHEMATICAL ANALYSIS; METHODOLOGY; NORMAL DISTRIBUTION; NUCLEAR MAGNETIC RESONANCE IMAGING; PILOT STUDY; PLANNING; SAMPLE SIZE; STATISTICAL ANALYSIS; TIME; UNIVARIATE ANALYSIS; VASCULAR RESISTANCE;

CEREBRAL VEINS; CLINICAL TRIALS AS TOPIC; HUMANS; MAGNETIC RESONANCE IMAGING; MODELS, STATISTICAL; NORMAL DISTRIBUTION; RESEARCH DESIGN; SAMPLE SIZE; UNITED STATES;

EID: 34548654418     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2840     Document Type: Article

References (27)

1. National Institute of Biomedical Imaging and Bioengineering Establishment Act. Public Law 106-580, Section 2, 2000. Available at http://www.nibibl.nih.gov/about/PL106-580.pdf
2. Tempany CMC, McNeil BJ. Advances in biomedical engineering. Journal of the American Medical Association 2001; 285:562-567.
3. Bullitt E, Wolthusen PA, Brubaker L, Lin W, Zeng D, Van Dyke T. Malignancy-associated vessel tortuosity: a computer-assisted, MR angiographic study of choroid plexus carcinoma in genetically engineered mice. American Journal of Neuroradiology 2006; 27:612-619.
4. Bullitt E, Zeng D, Gerig G, Aylward S, Joshi S, Smith JK, Lin W, Ewend MG. Vessel tortuosity and brain tumor malignancy: a blinded study. Academic Radiology 2005; 12:1232-1240.
5. Huml RA, Ryan RP, Zarcone D. Surrogate markers vs. biological markers: different roles in drug approval. Regulatory Affairs Focus 2004; June:47-49.
6. Bullitt E, Muller KE, Jung I, Lin W, Aylward S. Analyzing attributes of vessel populations. Medical Image Analysis 2004; 9:39-49.
7. Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Statistics in Medicine 1990; 9:65-72.
8. Vonesh EF, Chinchilli VM. Linear and Nonlinear Models for the Analysis of Repeated Measurements. Marcel Dekker Inc.: New York, 1997.
9. Catellier DJ, Muller KE. Tests for Gaussian repeated measures with missing data in small samples. Statistics in Medicine 2000; 19:1101-1114.
10. Schaalje GB, McBride JB, Fellingham GW. Adequacy of approximations to distributions of test statistics in complex mixed linear models. Journal of Agricultural, Biological, and Environmental Statistics 2003; 7:512-524.
11. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted maximum likelihood. Biometrics 1997; 53:983-997.
12. Muller KE, Barton CN. Approximate power for repeated-measures ANOVA lacking sphericity. Journal of the American Statistical Association 1989; 84:549-555; Corrigenda 1991; 86:255-256.
13. Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials (Chapter 14). Chapman & Hall, CRC Press: London, Boca Raton, FL, 2000.
14. Proschan MA. Two-stage sample size re-estimation based on a nuisance parameter: a review. Journal of Biopharmaceutical Statistics 2005; 15:559-574.
15. Coffey CS, Muller KE. Exact test size and power of a Gaussian error linear model for an internal pilot study. Statistics in Medicine 1999; 18:1199-1214.
16. Coffey CS, Muller KE. Some distributions and their implications for an internal pilot study with a univariate linear model. Communications in Statistics - Theory and Methods 2000; 29:2677-2691.
17. Coffey CS, Muller KE. Controlling test size while gaining the benefits of an internal pilot design. Biometrics 2001; 57:625-631.
18. Kieser M, Friede T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Statistics in Medicine 2000; 19:901-911.
19. Coffey CS, Muller KE. GLUMIP 1.0: Free SAS IML software for internal pilots. 2001 Proceedings of the Joint Statistical Meetings, Biometrics Section, Atlanta, GA, U.S.A. [CD-ROM], 2001.
20. Lake S, Kammann E, Klar N, Betensky R. Sample size re-estimation in cluster randomization trials. Statistics in Medicine 2002; 21:1337-1350.
21. Zucker DM, Denne J. Sample size redetermination for repeated measures studies. Biometrics 2002; 58:548-559.
22. Coffey CS, Muller KE. Properties of internal pilots with the univariate approach to repeated measures. Statistics in Medicine 2003; 22:2469-2485.
23. Schott JR. Matrix Analysis for Statistics. Wiley: New York, 1997.
24. Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data (Section 3.2). Springer: New York, 2000.
25. Muller KE, Fetterman BA. Regression and ANOVA: An Integrated Approach Using SAS Software (Chapters 12-13). SAS Institute Inc.: Cary, NC, 2002.
26. Muller KE, Stewart PW. Linear Model Theory: Univariate, Multivariate and Mixed Models (Chapter 6). Wiley: New York, 2006.
27. Helms RW. Comparisons of parameter and hypothesis definitions in a general linear model. Communications in Statistics: Theory and Methods 1988; 17:2725-2753.