A generic minimization random allocation and blinding system on web

Cai, Hong; Xia, Jielai; Xu, Dan; Dong-huai, Gao; Yan, Yizhong

doi:10.1016/j.jbi.2006.02.015

Cited by 18 publications

(14 citation statements)

References 19 publications

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“…The same RA enrolled and assigned participants to the interventions. Covariate adaptive randomization is recommended for small trials to balance important factors between groups [33]. Missing data were addressed at the participant level to minimize attrition and incomplete data.…”

Section: Methodsmentioning

confidence: 99%

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

Wahbeh

Oken²

2016

JMIR Ment Health

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BackgroundMindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated.ObjectivesThe primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes.MethodsPotential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance, perceived stress, and mindfulness were completed before and after the intervention period via Web-based surveys.ResultsWe enrolled 44 adults were enrolled and 31 adults completed all study activities. There were no group differences on demographics or important variables at baseline. Participants rated the IMMI arm higher than the Access to Guided Meditation arm on Client Satisfaction Questionnaire. IMMI was able to increase home practice behavior significantly compared to the Access to Guided Meditation arm: days practiced (P=.05), total minutes (P=.01), and average minutes (P=.05). As expected, there were no significant differences on health outcomes.ConclusionsIn conclusion, IMMI was found to be feasible and acceptable. The IMMI arm had increased daily meditation practice compared with the Access to Guided Meditation control group. More interaction through staff and/or through built-in email or text reminders may increase daily practice even more. Future studies will examine IMMI’s efficacy at improving health outcomes in the general population and also compare...

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Section: Methodsmentioning

confidence: 99%

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

Wahbeh

Oken²

2016

JMIR Ment Health

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“…Randomization procedures were conducted by a web‐based minimization random allocation system (http://rct.fmmu.edu.cn) [20]. Trial name, participating centers, and all involved parameters were set (e.g., treatment‐numbers = 4, block‐length = 8, bias‐assignment‐probability = 1).…”

Section: Methodsmentioning

confidence: 99%

Ginsenoside‐Rd improves outcome of acute ischaemic stroke – a randomized, double‐blind, placebo‐controlled, multicenter trial

Liu

Wang

Wen

et al. 2012

Euro J of Neurology

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“…However, details describing the system are limited. Cai et al developed a generic minimization random allocation and blinding system coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages [11, 12]. System details, usage, and a portion of the code are available, but the design of the database is complex, resulting in difficulties associated with programming and maintenance.…”

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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A generic minimization random allocation and blinding system on web

Abstract: Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

Cited by 18 publications

References 19 publications

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

Ginsenoside‐Rd improves outcome of acute ischaemic stroke – a randomized, double‐blind, placebo‐controlled, multicenter trial

MACT: A Manageable Minimization Allocation System

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