Journal ArticleDOI
Design and analysis of group sequential tests based on the type I error spending rate function
KyungMann Kim,David L. DeMets +1 more
TLDR
In this paper, the design aspect of this procedure is explored in terms of the maximum sample size needed to achieve a desired level of power and the expected stopping times under both null and alternative hypotheses.Abstract:
SUMMARY Lan & DeMets (1983) devised a method of constructing discrete group sequential boundaries by using the type I error spending rate function. It is extended so as to generate asymmetric as well as symmetric two-sided boundaries for clinical trials. The design aspect of this procedure is explored in terms of the maximum sample size needed to achieve a desired level of power and the expected stopping times under both null and alternative hypotheses. Finally, these properties are employed in search of appropriate type I error spending rate functions for differing situations.read more
Citations
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Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial
Robert C. Bailey,Stephen Moses,Corette B. Parker,Kawango Agot,Ian Maclean,John N. Krieger,Carolyn Williams,Richard T. Campbell,Jeckoniah O. Ndinya-Achola +8 more
TL;DR: In this article, a randomised controlled trial of 2784 men aged 18-24 years in Kisumu, Kenya was conducted to determine whether male circumcision had a protective effect against HIV infection, and to assess safety and changes in sexual behaviour related to this intervention.
Journal ArticleDOI
Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy
Alan H. Kadish,Alan R. Dyer,James P. Daubert,Rebecca Quigg,N.A. Mark Estes,Kelley P. Anderson,Hugh Calkins,David H Hoch,Jeffrey J. Goldberger,Alaa Shalaby,William E. Sanders,Andi Schaechter,Joseph H. Levine +12 more
TL;DR: In patients with severe, nonischemic dilated cardiomyopathy who were treated with ACE inhibitors and beta-blockers, the implantation of a cardioverter-defibrillator significantly reduced the risk of sudden death from arrhythmia and was associated with a nonsignificant reduction in the riskof death from any cause.
Journal Article
Male circumcision for HIV prevention in young men in Kisumu, Kenya : a randomised controlled trial. Commentary
Marie-Louise Newell,Till Bärnighausen,Robert C. Bailey,Stephen Moses,Corette B. Parker,Kawango Agot,Ian Maclean,John N. Krieger,Carolyn Williams,Richard T. Campbell,Jeckoniah O. Ndinya-Achola +10 more
TL;DR: Male circumcision significantly reduces the risk of HIV acquisition in young men in Africa and should be integrated with other HIV preventive interventions and provided as expeditiously as possible.
Journal ArticleDOI
Preoperative Versus Postoperative Chemoradiotherapy for Locally Advanced Rectal Cancer: Results of the German CAO/ARO/AIO-94 Randomized Phase III Trial After a Median Follow-Up of 11 Years
Rolf Sauer,Torsten Liersch,Susanne Merkel,Rainer Fietkau,Werner Hohenberger,Clemens F. Hess,Heinz Becker,Hans-Rudolf Raab,Marie-Therese Villanueva,Helmut Witzigmann,Christian Wittekind,Tim Beissbarth,Claus Rödel +12 more
TL;DR: In this paper, the authors reported long-term results with a median follow-up of 134 months, where they found a difference of 10% in 5-year overall survival as the primary end point.
Journal ArticleDOI
Azithromycin for Prevention of Exacerbations of COPD
Richard K. Albert,Richard K. Albert,John E. Connett,William C. Bailey,Richard Casaburi,J. Allen D. Cooper,Gerard J. Criner,Jeffrey L. Curtis,Mark T. Dransfield,MeiLan K. Han,Stephen C. Lazarus,Barry J. Make,Nathaniel Marchetti,Fernando J. Martinez,Nancy E. Madinger,Charlene McEvoy,Dennis E. Niewoehner,Janos Porsasz,Connie S. Price,Connie S. Price,John J. Reilly,Paul D. Scanlon,Frank C. Sciurba,Steven M. Scharf,George R. Washko,Prescott G. Woodruff,Nicholas R. Anthonisen +26 more
TL;DR: Among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects.
References
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Journal ArticleDOI
A multiple testing procedure for clinical trials.
TL;DR: The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations and the power is found to bevirtually the same.
Journal ArticleDOI
Discrete sequential boundaries for clinical trials
K. K. Gordon Lan,David L. DeMets +1 more
TL;DR: In this article, the authors proposed a more flexible method to construct discrete sequential boundaries based on the choice of a function, a*(t), which characterizes the rate at which the error level ac is spent.
Journal ArticleDOI
Group sequential methods in the design and analysis of clinical trials
TL;DR: In this article, a group sequential design is proposed to divide patient entry into a number of equal-sized groups so that the decision to stop the trial or continue is based on repeated significance tests of the accumulated data after each group is evaluated.
Journal ArticleDOI
Repeated Significance Tests on Accumulating Data
TL;DR: In this article, it was shown that a test criterion which takes the form of a standardized cumulative sum of deviations from expectation divided by its standard error will, with probability one, eventually reach any preassigned value.
Journal ArticleDOI
Two-Sample Repeated Significance Tests Based on the Modified Wilcoxon Statistic
Eric V. Slud,L. J. Wei +1 more
TL;DR: In this paper, the asymptotic distribution theory of sequentially computed modified-Wilcoxon scores is developed for two-sample survival data with random staggered entry and random loss to follow-up.