An easily customized, random allocation system using the minimization method for multi-Institutional clinical trials

Kenjo, Yuko; Antoku, Yasunobu; Akazawa, Kouhei; Hanada, Eisuke; Nosé, Yukihiko

doi:10.1016/s0169-2607(99)00047-4

Cited by 12 publications

(8 citation statements)

References 8 publications

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“…A total of 32 hypogonadal males with the MetS and newly diagnosed T2D (fasting plasma glucose >7.0 at baseline and/or >11.1 after a 2‐hour, 75‐g oral glucose tolerance test, and an elevated level of HbA 1c ) were randomized to either supervised diet and exercise (D&E) alone or in combination with testosterone gel (50 mg once daily; Testogel; Bayer Schering Pharma AG, Berlin, Germany). The procedure of randomization followed recommendations as described in Kenjo et al (2000). The gel was provided by the personnel of the Business Unit Primary Care, Men's Healthcare, Scientific Affairs, Bayer Schering Pharma AG, Berlin, Germany; hospital pharmacy not involved in the study.…”

Section: Methodsmentioning

confidence: 99%

Fifty‐ two—Week Treatment With Diet and Exercise Plus Transdermal Testosterone Reverses the Metabolic Syndrome and Improves Glycemic Control in Men With Newly Diagnosed Type 2 Diabetes and Subnormal Plasma Testosterone

Heufelder¹,

Saad

Bunck³

et al. 2009

Journal of Andrology

283

269

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Men with the metabolic syndrome (MetS) and type 2 diabetes (T2D) often have low testosterone levels. Elevating low testosterone levels may improve features of the MetS and glycemic control. In a single blind, 52-week randomized clinical trial, the effects of supervised diet and exercise (D&E) with or without transdermal testosterone administration on components of the MetS in hypogonadal men with the MetS and newly diagnosed T2D were assessed. A total of 32 hypogonadal men (total testosterone ,12.0 nmol/L) with newly diagnosed T2D and with the MetS as defined by the Adult Treatment Panel III and the International Diabetes Federation received supervised D&E, but 16 received it in combination with testosterone gel (50 mg) once daily (n 5 16). No glucose-lowering agents were administered prior to or during the study period. Outcome measures were components of the MetS as defined by the Adult Treatment Panel III and the International Diabetes Federation. Serum testosterone, glycosylated hemoglobin (HbA 1c ), fasting plasma glucose, high-density lipoprotein cholesterol, triglyceride concentrations, and the waist circumference improved in both treatment groups after 52 weeks of treatment. Addition of testosterone significantly further improved these measures compared with D&E alone. All D&E plus testosterone patients reached the HbA 1c goal of less than 7.0%; 87.5% of them reached an HbA 1c of less than 6.5%. Based on Adult Treatment Panel III guidelines, 81.3% of the patients randomized to D&E plus testosterone no longer matched the criteria of the MetS, whereas 31.3% of the D&E alone participants did. Additionally, testosterone treatment improved insulin sensitivity, adiponectin, and high-sensitivity C-reactive protein. Addition of testosterone to supervised D&E results in greater therapeutic improvements of glycemic control and reverses the MetS after 52 weeks of treatment in hypogonadal patients with the MetS and newly diagnosed T2D.

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Section: Methodsmentioning

confidence: 99%

Fifty‐ two—Week Treatment With Diet and Exercise Plus Transdermal Testosterone Reverses the Metabolic Syndrome and Improves Glycemic Control in Men With Newly Diagnosed Type 2 Diabetes and Subnormal Plasma Testosterone

Heufelder¹,

Saad

Bunck³

et al. 2009

Journal of Andrology

283

269

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“…Random allocation was performed using a web-based minimization program [19] [ Figure 1] in a study involving high-risk mother-baby dyads. The RCT lasted 5 years at three tertiary care centers located in two metropolitan areas where both high-risk pregnant mothers and newborns could be cared for [20].…”

Section: Methodsmentioning

confidence: 99%

“…High-risk newborn babies were enrolled immediately after birth, with informed consents obtained from parents and appropriate guardians prior to delivery or right after delivery when they were accessible. Both a web-based program [19] and a DOS program [9] were used for joint 24-hour accessibility. Subjects were enrolled using the webbased program most of time; the DOS minimization program was used as a supplemental access.…”

Section: Random Allocationmentioning

confidence: 99%

Second-order interactions with the treatment groups in controlled clinical trials

Shiao

Ahn

Akazawa

2007

Computer Methods and Programs in Biomedicine

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SummaryThe occurrence of significant second-order interactions for group characteristics was examined using real data in a randomized controlled trial (RCT). The interactions exist in all RCTs; they could be easily overlooked when using the simple randomization or stratification methods, but could become more obvious when minimization methods are used. Using real data from an RCT, the minimization method enabled balancing the distributions of the four selected stratified factors. Analyses for 3-way second-order interactions including 6 additional potential confounding variables (for a total of 10 variables) presented 8 significant second-order interactions with the treatment groups. Interaction effects need to be evaluated when treatment effects are examined to maximize the power of the treatment effects in any RCTs. A stepwise regression method with piecewise linear functions would be useful to select the significant variables with interaction effects affecting the treatment outcomes in RCTs. Additional ways to handle interaction effects in RCTs are presented in this paper.

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“…Kenjo et al created an easily customized and multi-institutional minimization allocation system [10]. This system is based on the Practical Extraction and Report Language (PERL) for writing common gateway interface (CGI) script.…”

Section: Introductionmentioning

confidence: 99%

MACT: A Manageable Minimization Allocation System

Cui

Wang

et al. 2014

Computational and Mathematical Methods in Medicine

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Background. Minimization is a case allocation method for randomized controlled trials (RCT). Evidence suggests that the minimization method achieves balanced groups with respect to numbers and participant characteristics, and can incorporate more prognostic factors compared to other randomization methods. Although several automatic allocation systems exist (e.g., randoWeb, and MagMin), the minimization method is still difficult to implement, and RCTs seldom employ minimization. Therefore, we developed the minimization allocation controlled trials (MACT) system, a generic manageable minimization allocation system. System Outline. The MACT system implements minimization allocation by Web and email. It has a unified interface that manages trials, participants, and allocation. It simultaneously supports multitrials, multicenters, multigrouping, multiple prognostic factors, and multilevels. Methods. Unlike previous systems, MACT utilizes an optimized database that greatly improves manageability. Simulations and Results. MACT was assessed in a series of experiments and evaluations. Relative to simple randomization, minimization produces better balance among groups and similar unpredictability. Applications. MACT has been employed in two RCTs that lasted three years. During this period, MACT steadily and simultaneously satisfied the requirements of the trial. Conclusions. MACT is a manageable, easy-to-use case allocation system. Its outstanding features are attracting more RCTs to use the minimization allocation method.

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An easily customized, random allocation system using the minimization method for multi-Institutional clinical trials

Cited by 12 publications

References 8 publications

Fifty‐ two—Week Treatment With Diet and Exercise Plus Transdermal Testosterone Reverses the Metabolic Syndrome and Improves Glycemic Control in Men With Newly Diagnosed Type 2 Diabetes and Subnormal Plasma Testosterone

Fifty‐ two—Week Treatment With Diet and Exercise Plus Transdermal Testosterone Reverses the Metabolic Syndrome and Improves Glycemic Control in Men With Newly Diagnosed Type 2 Diabetes and Subnormal Plasma Testosterone

Second-order interactions with the treatment groups in controlled clinical trials

MACT: A Manageable Minimization Allocation System

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