Proposals for sample size calculation programs

Methods of Information in Medicine

Volumn 46, Issue 6, 2007, Pages 655-661

  Heinzl, H ^a   Benner, A ^b   Ittrich, C ^b   Mittlböck, Martina ^a  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

Author keywords

Auxiliary alternative hypothesis; Directional two sided hypothesis test; Irresponsibly underpowered study; Sample size calculation; Type III error

Indexed keywords

ARTICLE; CALCULATION; ERROR; FISHER EXACT TEST; MATHEMATICAL ANALYSIS; MEDICAL RESEARCH; PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL ANALYSIS;

CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; HUMANS; MODELS, STATISTICAL; MODELS, THEORETICAL; SAMPLE SIZE; SOFTWARE;

EID: 37349052323     PISSN: 00261270     EISSN: None     Source Type: Journal    
DOI: 10.3414/ME0295     Document Type: Article

References (28)

1. Bock J. Bestimmung des Stichprobenumfangs für biologische Experimente und kontrollierte klinische Studien. München: R. Oldenbourg Verlag; 1998.
2. Brown BW, Brauner C, Chan A, Gutierrez D, Herson J, Lovato J, Polsley J, Venier J. DSTPLAN Version 4.2: Calculations for Sample Sizes and Related Problems. The University of Texas MD Anderson Cancer Center: Houston, TX, 2000.
3. Chow SC, Liu JP. Design and analysis of clinical trials. Concepts and methodologies. Second edition. Hoboken, New Jersey: Wiley; 2004.
4. Chow SC, Shao J, Wang H. Sample size calculations in clinical research. Boca Raton, Florida: CRC Press - Taylor & Francis Group; 2003.
5. Dahmen G, Rochon J, König IR, Ziegler A. Sample size calculations for controlled clinical trials using generalized estimating equations (GEE). Methods Inf Med 2004; 43 (5): 451-456.
6. Dahmen G, Ziegler A. Independence estimating equations for controlled clinical trials with small sample sizes - interval estimation. Methods Inf Med 2006; 45 (4): 430-434.
7. Draxler W, Mittlböck M. Basic principles in the planning of clinical trials in surgical oncology. European Surgery 2006; 38 (1): 27-32.
8. Emerson JD, Tritchler D. The three-decision problem in medical decision making. Statistics in Medicine 1987; 6 (2): 101-112.
9. Finner H. Stepwise multiple test procedures and control of directional errors. The Annals of Statistics 1999; 27 (1): 274-289.
10. Hasselblad V, Allen AS. Power calculations for large multi-arm placebo-controlled studies of dichotomous outcomes. Statistics in Medicine 2003; 22 (12): 1943-1954.
11. Hauschke D, Steinijans VW. Directional decision for a two-tailed alternative. Letter to the editor. Journal of Biopharmaceutical Statistics 1996; 6 (2): 211-213.
12. Hintze J. NCSS and PASS. Number Cruncher Statistical Systems. Kaysville, Utah, 2001.
13. ICH. Guideline E9 on Statistical Principles for Clinical Trials. International Conference on Harmonisation, 1998. (http://www.ich.org)
14. Julious SA. Sample sizes for clinical trials with normal data. Tutorial in biostatistics. Statistics in Medicine 2004; 23 (12): 1921-1986.
15. Len T, Krebs CJ. A review of statistical power analysis software. Bulletin of the Ecological Society of America 1997; 78 (2): 126-139. (http://www.zoology.ubc.ca/~krebs/power.html)
16. Leventhal L, Huynh C-L. Directional decisions for two-tailed tests: power, error rates, and sample size. Psychological Methods 1996; 1 (3): 278-292.
17. Mace AE. Sample-Size Determination. Hunting-ton, New York: Robert E. Drieger Publishing Company; 1974.
18. Machin D, Campbell MJ, Fayers PM, Pinol APY. Sample Size Tables for Clinical Studies. Second Edition. Blackwell Science Ltd.: Oxford; 1997.
19. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. The Lancet 2001; 357 (9263): 1191-1194.
20. Neuhauser M. The Choice of [alpha] for One-sided Tests. Drug Information Journal 2004; 38: 57-60.
21. Parker RA, Berman NG. Sample size: more than calculations. The American Statistician 2003; 57 (3): 166-170.
22. Piantadosi S. Clinical Trials: A Methodologic Perspective. Second Edition. John Wiley & Sons Ltd.: New York; 2005.
23. Rippin G. Design issues and sample size when exposure measurement is inaccurate. Methods Inf Med 2001; 40 (2): 137-140.
24. Schwartz D, Flamant R, Lellouch J. Clinical Trials. Translated by MJR Healy. London: Academic Press; 1980.
25. Senn S. Statistical Issues in Drug Development. Chichester: John Wiley & Sons Ltd.; 1997.
26. Sonnemann E. Allgemeine Lösungen multipler Testprobleme. EDV in Medizin und Biologie 1982; 13 (4): 120-128.
27. Stürmer T, Gefeller O, Brenner H. A computer program to estimate power and relative efficiency of flexibly matched case-control studies. Methods Inf Med 2005; 44 (5): 693-696.
28. Victor N. On clinically relevant differences and shifted nullhypotheses. Methods Inf Med 1987; 26 (3): 109-116.