A sample size calculation for spontaneous abortion in observational studies

Reproductive Toxicology

Volumn 32, Issue 4, 2011, Pages 490-493

  Xu, Ronghui ^a   Chambers, Christina ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Left truncation; Right censoring; Sample size; Spontaneous abortion; Survival analysis

Indexed keywords

ARTICLE; FOLLOW UP; GESTATIONAL AGE; LOG RANK TEST; OBSERVATIONAL STUDY; PREGNANCY OUTCOME; PROPORTIONAL HAZARDS MODEL; SAMPLE SIZE; SPONTANEOUS ABORTION; SURVIVAL;

ABORTION, SPONTANEOUS; COHORT STUDIES; FEMALE; HUMANS; PREGNANCY; PREGNANCY OUTCOME; PROSPECTIVE STUDIES; REGISTRIES; RISK FACTORS; SAMPLE SIZE;

EID: 82155162489     PISSN: 08906238     EISSN: 18731708     Source Type: Journal    
DOI: 10.1016/j.reprotox.2011.08.009     Document Type: Article

References (23)

1. Chambers C.D., Braddock S.R., Briggs G.G., Einarson A., Johnson Y.R., Miller R.K., et al. Postmarketing surveillance for human teratogenicity: a model approach. Teratology 2001, 64:252-261.
2. Schaefer C., Hannemann D., Meister R. Post-marketing surveillance system for drugs in pregnancy-15 years experience of ENTIS. Reproductive Toxicology 2005, 20:331-343.
3. Meister R., Schaefer C. Statistical methods for estimating the probability of spontaneous abortion in observational studies-analyzing pregnancies exposed to coumarin derivatives. Reproductive Toxicology 2008, 26:31-35.
4. Wilcox A.J., Weinberg C.R., O'Connor J.F., Baird D.D., Schlatterer J.P., Canfield R.E., et al. Incidence of early loss of pregnancy. New England Journal of Medicine 1988, 319:189-194.
5. Tsai W., Jewell N.P., Wang M.C. A note on the product-limit estimator under right censoring and left truncation. Biometrika 1987, 74:883-886.
6. Struthers C.A., Farewell V.T. A mixture models for time to AIDS data with left truncation and an uncertain origin. Biometrika 1989, 76:814-817.
7. Lawless J.F. Statistical models and methods for lifetime data 2003, Wiley, Hoboken. 2nd ed.
8. Farewell V.T. The use of mixture models for the analysis of survival data with long-term survivors. Biometrics 1982, 38:1041-1046.
9. Hanson T., Bedrick E.J., Johnson W.O., Thurmond M.C. A mixture model for bovine abortion and foetal survival. Statistics in Medicine 2003, 22:1725-1739.
10. Cox D.R. Partial likelihood. Biometrika 1975, 62:269-276.
11. Harrington D.P., Fleming T.R. A class of rank test procedures for censored survival data. Biometrika 1982, 69:553-566.
12. Schoenfeld D.A. The asymptotic properties of nonparametric tests for comparing survival distributions. Biometrika 1981, 68:316-319.
13. Schoenfeld D.A. Sample size formula for the proportional-hazards regression model. Biometrics 1983, 39:499-503.
14. Kim K., Tsiatis A.A. Study duration for clinical trials with survival response and early stopping rule. Biometrics 1990, 46:81-92.
15. Jennison C., Turnbull B.W. Group sequential methods with applications to clinical trials 2000, Chapman & Hall/CRC, Boca Raton, FL.
16. Chambers C.D., Johnson K.A., Dick L.M., Felix R.J., Jones K.L. Birth outcomes in pregnant women taking fluocetine. New England Journal of Medicine 1996, 335:1010-1015.
17. Li D., Liu L., Odouli R. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. British Medical Journal 2003, 327:368. 10.1136/bmj.327.7411.368.
18. Xu R., O'Quigley J. Estimating average regression effect under non-proportional hazards. Biostatistics 2000, 1:423-439.
19. Pepe M.S., Fleming T.R. Weighted Kaplan-Meier statistics: a class of distance tests for censored survival data. Biometrics 1989, 45:497-507.
20. Pepe M.S., Fleming T.R. Weighted Kaplan-Meier statistics: large sample and optimality considerations. Journal of the Royal Statistical Society, Series B 1991, 53:341-352.
21. O'Quigley J., Pessione F. The problem of a covariate-time qualitative interaction in a survival study. Biometrics 1991, 47:101-115.
22. Fine J.P., Gray R.J. A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association 1999, 94:496-509.
23. Latouche A., Porcher R. Sample size calculations in the presence of competing risks. Statistics in Medicine 2007, 26:5370-5380.