Fertility and Sterility
Volume 78, Issue 5 , Pages 951-956 , November 2002

The randomized world is not without its imperfections: reflections on the Women’s Health Initiative Study

  • Paul G McDonough, M.D.

      Affiliations

    • Corresponding Author InformationReprint requests: Paul G. McDonough, M.D., Department of Obstetrics and Gynecology, Medical College of Georgia, 1120 15th Street, Augusta, Georgia 30912, USA (FAX: 706 721-0574).
    • Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta, Georgia, USA

Received 4 September 2002 ,Accepted 4 September 2002.

References 

  1. Writing Group for the Women’s Health Initiative . Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288:321–333
  2. Freedman L, Anderson G, Kipnis V, Prentice R, Wang CY, Rossouw J, et al.  Approaches to monitoring the results of long term disease prevention trials (examples from the Women’s Health Initiative). Control Clin Trials. 1996;17:509–525
  3. Tibshirani R. A plain man’s guide to the proportional hazards model. Clin Invest Med. 1982;5:63–68
  4. The Women’s Health Initiative Study Group . Design paper: design of the Women’s Health Initiative clinical trial and observational study. Control Clin Trials. 1998;19:61–109
  5. Brown BW, Russell K. Methods correcting for multiple testing (operating characteristics). Stat Med. 1997;16:2511–2528
  6. D’Agostino RB. Controlling alpha in a clinical trial (the case for secondary end points). Stat Med. 2000;19:763–766
  7. PEPI Trial Writing Group . Effects of estrogen or estrogen/progestin regimes on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial. JAMA. 1995;273:199–208
  8. Christensen E. Multivariate survival analysis using Cox’s regression model. Hepatology. 1987;7:1346–1358
  9. O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549–556
  10. Poole C. Low P-values or narrow confidence intervals (which are more durable?). Epidemiology. 2001;12:291–294
  11. Aickin M, Gensler H. Adjusting for multiple testing when reporting research results (the Bonferroni vs Holm methods). Am J Public Health. 1996;86:726–728
  12. Pocock SJ, Clayton TC, Altman DG. Survival plots of time to event outcomes in clinical trials (good practice and pitfalls). Lancet. 2002;359:1686–1689
  13. Figueiras A, Domenech-Massons JM, Cadarso C. Regression models (calculating the confidence interval of effects in the presence of interactions). Stat Med. 1998;17:2099–2105
  14. McGuigan KA, Ganz PA, Breant C. Agreement between breast cancer risk estimation methods. J Natl Cancer Inst. 1996;88:1315–1317
  15. Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Schairer C, et al.  Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst. 1989;81:1879–1886
  16. Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of early -onset breast cancer. Implications for risk prediction. Cancer. 1994;73:643–651
  17. Carlin BP, Hodges JS. Hierarchical proportional hazards regression models for highly stratified data. Biometrics. 1999;55:1162–1170
  18. Dupont WD. Converting relative risks to absolute risks (a graphical approach). Stat Med. 1989;8:641–651
  19. Rosner B, Spiegelman D, Willett WC. Correction of logistic regression relative risk estimates and confidence intervals for measurement error (the case of multiple covariates measured with error). Am J Epidemiol. 1990;132:734–745
  20. Armston A, Wood P. Hormone replacement therapy (estradiol-only preparations) (can the laboratory recommend a concentration of plasma estradiol to protect against osteoporosis?). Ann Clin Biochem. 2002;39:184–193
  21. Diver MJ. Monitoring of hormone replacement therapy. Lancet. 1992;340:1470–1471
  22. Klein KO, Baron J, Colli MJ, McDonnell DP, Cutler GB. Estrogen levels in childhood determined by an ultrasensitive recombinant cell bioassay. J Clin Invest. 1994;94:2475–2480
  23. Henderson RA. Chemistry with confidence (should clinical chemistry require confidence intervals for analytical and other data). Clin Chem. 1993;39:929–935
  24. Lacey JV, Mink PJ, Lubin JH, Sherman ME, Troisi R, Hartge P, et al.  Menopausal hormone replacement therapy and risk of ovarian cancer. JAMA. 2002;288:334–341
  25. Kasprzak L, Foulkes WD, Shelling AN. Hereditary ovarian carcinoma. BMJ. 1999;318:786–789
  26. DePasquale SE, Giordano A, Donnenfeld AE. The genetics of ovarian cancer (molecular biology and clinical application). Obstet Gynecol Surv. 1998;53:248–256
  27. Enserink M. Epidemiology (despite safety concerns, U.K. hormone study to proceed). Science. 2002;297:492

 The author has no commercial or corporate conflicts of interest.

PII: S0015-0282(02)04403-5

Fertility and Sterility
Volume 78, Issue 5 , Pages 951-956 , November 2002