A Note on Hypothesis Test in Binary Data under the Single-Consent Randomized Design
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A Note on Hypothesis Test in Binary Data Under the Single-Consent Randomized Design
Kung-long Lui, PhD Professor of S ta tis tics, Department of Mathematics and Statistics, San Diego State University, San Diego, California
Key Words Prerandomized design; Power; v p e I error; Efficiency; Simple compliance study; Efficiency Correspondence Address Kung-long Lui, PhD. Professor of S ta tis tics, Department of Mathematics and Statistics, San Diego State Universib, San Diego, CA 92182-7720 (email: [email protected]).
When we compare an experimental treatment with the best standard therapy, Zelen first proposed use of the single-consent randomized design to increase the accrual rate of patients into trials. Under the single-consent randomized design, 1 developed Go other simple test procedures to improve the power of the commonly used procedurefor the intention-to-treat analysis in testing whether there is a difference in treatment effects in this article. Based on
INTRODUCTION Conventional randomized trials (CRTs) are the most commonly used study design to compare therapies for the treatment of human disease. As noted by Zelen (1,2),however, CRTs may sometimes present difficulties in their execution in countries where it is necessary to require informing the patient (or hidher parents or guardians) that the treatment he or she will receive will be chosen by a chance mechanism. To avoid the awkward situations in which a physician appears to be unaware of what he or she is doing as if a coin was being tossed to decide treatment, some physicians may have reluctance to enter their patients into a CRT (1,2). To improve the accrual rate of patients into trials, Zelen first proposed the single-consent randomized design (SCRD), in which patients are randomly assigned to receive either the experimental or the standard treatment (1,2). Patients assigned to the experimental treatment are allowed to switch to the standard treatment if they are not willing to accept the assigned therapy. On the other hand, patients assigned to the standard treatment will automatically receive this treatment, which is assumed to be the best standard therapy available. For example, consider the two extracorporeal membrane oxygenation (ECMO) studies evaluated on newborn infants with a diagnosis of persistent pulmonary
Monte Carlo simulation, 1 evaluated and compared these three test procedures with respect to type 1 error and powex 1 demonstrated that the two test procedures developed here outperformed the commonly employed test procedure in a variety of situations. Finally, I employed an example by stu+ng the effect of vitamin A supplementation on reducing mortality in preschool children to illustrate the use of these test procedures.
hypertension (2,3). The control group was the conventional therapy, which had a fatality rate as high as 80%. If a CRT was employed, the informed consent process would require that the parents of an infant near death be approached to give consent for an invasive surgical procedure (ECMO) that might not even b
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