Some Restricted randomization rules in sequential designs

Soares, José Francisco; Wu, Changbao

doi:10.1080/03610928308828586

Cited by 138 publications

(135 citation statements)

References 8 publications

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“…Randomization was performed centrally, in 1:1:1:1 allocation between arms, stratified by the presence of cavitation on baseline chest radiograph and by enrollment site, and restricted to limit imbalance between arms to no more than two subjects (22).…”

Section: Setting Population and Designmentioning

confidence: 99%

Daily Rifapentine for Treatment of Pulmonary Tuberculosis. A Randomized, Dose-Ranging Trial

Dorman

Savic

Goldberg

et al. 2015

Am J Respir Crit Care Med

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Rationale: Rifapentine has potent activity in mouse models of tuberculosis chemotherapy but its optimal dose and exposure in humans are unknown.Objectives: We conducted a randomized, partially blinded dose-ranging study to determine tolerability, safety, and antimicrobial activity of daily rifapentine for pulmonary tuberculosis treatment.Methods: Adults with sputum smear-positive pulmonary tuberculosis were assigned rifapentine 10, 15, or 20 mg/kg or rifampin 10 mg/kg daily for 8 weeks (intensive phase), with isoniazid, pyrazinamide, and ethambutol. The primary tolerability end point was treatment discontinuation. The primary efficacy end point was negative sputum cultures at completion of intensive phase. Measurements and Main Results:A total of 334 participants were enrolled. At completion of intensive phase, cultures on solid media were negative in 81.3% of participants in the rifampin group versus 92.5% (P = 0.097), 89.4% (P = 0.29), and 94.7% (P = 0.049) in the rifapentine 10, 15, and 20 mg/kg groups. Liquid cultures were negative in 56.3% (rifampin group) versus 74.6% (P = 0.042), 69.7% (P = 0.16), and 82.5% (P = 0.004), respectively. Compared with the rifampin group, the proportion negative at the end of intensive phase was higher among rifapentine recipients who had high rifapentine areas under the concentration-time curve. Percentages of participants discontinuing assigned treatment for reasons other than microbiologic ineligibility were similar across groups (rifampin, 8.2%; rifapentine 10, 15, or 20 mg/kg, 3.4, 2.5, and 7.4%, respectively).Conclusions: Daily rifapentine was well-tolerated and safe. High rifapentine exposures were associated with high levels of sputum sterilization at completion of intensive phase. Further studies are warranted to determine if regimens that deliver high rifapentine exposures can shorten treatment duration to less than 6 months. Clinical trial registered with www.clinicaltrials.gov (NCT 00694629).

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Section: Setting Population and Designmentioning

confidence: 99%

Daily Rifapentine for Treatment of Pulmonary Tuberculosis. A Randomized, Dose-Ranging Trial

Dorman

Savic

Goldberg

et al. 2015

Am J Respir Crit Care Med

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“…13 This procedure concealed the randomization from individuals who were directly involved with the participants in Memphis. The randomization was conducted within strata from a model with 5 classification factors: maternal race (black versus nonblack), maternal age (<17, 17-18, and ≥19 years), gestational age at enrollment (<20 vs ≥20 weeks), employment status of head of household (employed versus unemployed), and geographic region of residence (4 regions).…”

Section: Randomizationmentioning

confidence: 99%

Effects of Nurse Home Visiting on Maternal and Child Functioning: Age-9 Follow-up of a Randomized Trial

et al. 2007

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OBJECTIVE-Our goal was to test the effect of prenatal and infancy home visits by nurses on mothers' fertility and children's functioning 7 years after the program ended at child age 2.METHODS-We conducted a randomized, controlled trial in a public system of obstetric and pediatric care. A total of 743 primarily black women <29 weeks' gestation, with previous live births and at least 2 sociodemographic risk characteristics (unmarried, <12 years of education, unemployed), were randomly assigned to receive nurse home visits or comparison services. Primary outcomes consisted of intervals between births of first and second children and number of children born per year; mothers' stability of relationships with partners and relationships with the biological father of the child; mothers' use of welfare, food stamps, and Medicaid; mothers' use of substances; mothers' arrests and incarcerations; and children's academic achievement, school conduct, and mental disorders. Secondary outcomes were the sequelae of subsequent pregnancies, women's employment, experience of domestic violence, and children's mortality.RESULTS-Nurse-visited women had longer intervals between births of first and second children, fewer cumulative subsequent births per year, and longer relationships with current partners. From birth through child age 9, nurse-visited women used welfare and food stamps for fewer months. Nurse-visited children born to mothers with low psychological resources, compared with controlgroup counterparts, had better grade-point averages and achievement test scores in math and reading in grades 1 through 3. Nurse-visited children, as a trend, were less likely to die from birth through age 9, an effect accounted for by deaths that were attributable to potentially preventable causes.CONCLUSIONS-By child age 9, the program reduced women's rates of subsequent births, increased the intervals between the births of first and second children, increased the stability of their relationships with partners, facilitated children's academic adjustment to elementary school, and seems to have reduced childhood mortality from preventable causes.Address correspondence to David L. Olds, PhD, University of Colorado at Denver and Health Sciences Center, 1825 Marion St, Suite 200, Denver, CO 80218. olds.david@tchden.org. The authors have indicated they have no financial relationships relevant to this article to disclose. NIH Public Access Author ManuscriptPediatrics. Author manuscript; available in PMC 2010 March 16. Published in final edited form as:Pediatrics. Home visiting by nurses for low-income, at-risk families has been promoted as a promising strategy for preventing child abuse and neglect, children's mental health problems, 1-3 and infant mortality. 4 Recent evidence suggests that the benefits hoped for from such programs do not hold for all types of home-visiting programs. 5 A program of home visiting by nurses known as the Nurse-Family Partnership (NFP) has produced consistent effects on several aspects of maternal and child heal...

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“…The big stick design (BSD) introduced by Soares and Wu (1983) consists of tossing a fair coin until the imbalance |D i | reaches a maximum tolerated imbalance mti ∈ N.…”

Section: Randomization Proceduresmentioning

confidence: 99%

randomizeR: An R Package for the Assessment and Implementation of Randomization in Clinical Trials

Uschner¹,

Schindler²,

Hilgers³

et al. 2018

J. Stat. Soft.

100

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Randomization in clinical trials is the key design technique to ensure the comparability of treatment groups. Although there exist a large number of software products which assist the researcher to implement randomization, no tool which would cover a wide range of procedures and allow the comparative evaluation of the procedures under practical restrictions has been proposed in the literature so far.The R package randomizeR addresses this need. The paper includes a detailed description of the randomizeR package that serves as a tutorial for the generation of randomization sequences and the assessment of randomization procedures.

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Some Restricted randomization rules in sequential designs

Cited by 138 publications

References 8 publications

Daily Rifapentine for Treatment of Pulmonary Tuberculosis. A Randomized, Dose-Ranging Trial

Daily Rifapentine for Treatment of Pulmonary Tuberculosis. A Randomized, Dose-Ranging Trial

Effects of Nurse Home Visiting on Maternal and Child Functioning: Age-9 Follow-up of a Randomized Trial

randomizeR: An R Package for the Assessment and Implementation of Randomization in Clinical Trials

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