Properties of permuted-block randomization in clinical trials

Matts, John P.; Lachin, John M.

doi:10.1016/0197-2456(88)90047-5

Cited by 266 publications

(213 citation statements)

References 8 publications

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“…A random permuted block design was used for randomization of participants in a 4‐to‐3 ratio with randomly varying block size [Matts and Lachin, 1988]. Children and parents were blinded to group allocation; for practical reasons, this was not possible for researchers.…”

Section: Methodsmentioning

confidence: 99%

Real‐time fMRI neurofeedback in adolescents with attention deficit hyperactivity disorder

Alegría

Wulff

Brinson

et al. 2017

Human Brain Mapping

117

103

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Attention Deficit Hyperactivity Disorder (ADHD) is associated with poor self‐control, underpinned by inferior fronto‐striatal deficits. Real‐time functional magnetic resonance neurofeedback (rtfMRI‐NF) allows participants to gain self‐control over dysregulated brain regions. Despite evidence for beneficial effects of electrophysiological‐NF on ADHD symptoms, no study has applied the spatially superior rtfMRI‐NF neurotherapy to ADHD. A randomized controlled trial tested the efficacy of rtfMRI‐NF of right inferior prefrontal cortex (rIFG), a key region that is compromised in ADHD and upregulated with psychostimulants, on improvement of ADHD symptoms, cognition, and inhibitory fMRI activation. To control for region‐specificity, an active control group received rtfMRI‐NF of the left parahippocampal gyrus (lPHG). Thirty‐one ADHD boys were randomly allocated and had to learn to upregulate their target brain region in an average of 11 rtfMRI‐NF runs over 2 weeks. Feedback was provided through a video‐clip of a rocket that had to be moved up into space. A transfer session without feedback tested learning retention as a proximal measure of transfer to everyday life. Both NF groups showed significant linear activation increases with increasing number of runs in their respective target regions and significant reduction in ADHD symptoms after neurotherapy and at 11‐month follow‐up. Only the group targeting rIFG, however, showed a transfer effect, which correlated with ADHD symptom reductions, improved at trend level in sustained attention, and showed increased IFG activation during an inhibitory fMRI task. This proof‐of‐concept study demonstrates for the first time feasibility, safety, and shorter‐ and longer‐term efficacy of rtfMRI‐NF of rIFG in adolescents with ADHD. Hum Brain Mapp 38:3190–3209, 2017. © 2017 The Authors Human Brain Mapping Published by Wiley Periodicals, Inc.

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Section: Methodsmentioning

confidence: 99%

Real‐time fMRI neurofeedback in adolescents with attention deficit hyperactivity disorder

Alegría

Wulff

Brinson

et al. 2017

Human Brain Mapping

117

103

View full text Add to dashboard Cite

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“…Prospectively generated permuted block randomization 12 using four blocks of size four each and an allocation ratio of 3:1 within each block (treatment:no treatment) was used to create three dose cohorts of five to six patients each. In each dose cohort, four patients were randomized to IDDD implantation plus administration of idursulfase-IT once monthly (every 28 ± 7 days) for 6 months, and in each dose cohort one or two patients were randomized to no treatment.…”

Section: Methodsmentioning

confidence: 99%

A phase I/II study of intrathecal idursulfase-IT in children with severe mucopolysaccharidosis II

Muenzer

Hendriksz

Fan

et al. 2016

Genetics in Medicine

148

116

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Purpose: Approximately two-thirds of patients with the lysosomal storage disease mucopolysaccharidosis II have progressive cognitive impairment. Intravenous (i.v.) enzyme replacement therapy does not affect cognitive impairment because recombinant iduronate-2-sulfatase (idursulfase) does not penetrate the blood-brain barrier at therapeutic concentrations. We examined the safety of idursulfase formulated for intrathecal administration (idursulfase-IT) via intrathecal drug delivery device (IDDD). A secondary endpoint was change in concentration of glycosaminoglycans in cerebrospinal fluid. Methods:Sixteen cognitively impaired males with mucopolysaccharidosis II who were previously treated with weekly i.v. idursulfase 0.5 mg/ kg for ≥6 months were enrolled. Patients were randomized to no treatment or 10-mg, 30-mg, or 1-mg idursulfase-IT monthly for 6 months (four patients per group) while continuing i.v. idursulfase weekly. Results:No serious adverse events related to idursulfase-IT were observed. Surgical revision/removal of the IDDD was required in 6 of 12 patients. Twelve total doses were administrated by lumbar puncture. Mean cerebrospinal fluid glycosaminoglycan concentration was reduced by approximately 90% in the 10-mg and 30-mg groups and approximately 80% in the 1-mg group after 6 months. Conclusions:These preliminary data support further development of investigational idursulfase-IT in MPS II patients with the severe phenotype who have progressed only to a mild-to-moderate level of cognitive impairment.

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“…With a permuted-block algorithm and random block [ 30 ] , fifty-two participants were randomly assigned to two groups. Twenty-five participants were allocated into the control group and twenty-seven into the treatment group.…”

Section: Experimental Designmentioning

confidence: 99%

Leveraging user's performance in reporting patient safety events by utilizing text prediction in narrative data entry

Gong

Hua

Wang

2016

Computer Methods and Programs in Biomedicine

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Background-Narrative data entry pervades computerized health information systems and serves as a key component in collecting patient-related information in electronic health records and patient safety event reporting systems. The quality and efficiency of clinical data entry are criticalin arriving at an optimal diagnosis and treatment. The application of text prediction holds potential for enhancing human performance of data entry in reporting patient safety events.Objective-This study examined two functions of text prediction intended for increasing efficiency and data quality of text data entry reporting patient safety events.Methods-The study employed a two-group randomized design with 52 nurses. The nurses were randomly assigned into a treatment group or a control group with a task of reporting five patient fall cases in Chinese using a web-based test system, with or without the prediction functions. Ttest, Chi-square and linear regression model were applied to evaluating the outcome differences in free-text data entry between the groups.Results-While both groups of participants exhibited a good capacity for accomplishing the assigned task of reporting patient falls, the results from the treatment group showed an overall increase of 70.5% in text generation rate, an increase of 34.1% in reporting comprehensiveness score and a reduction of 14.5% in the non-adherence of the comment fields. The treatment group also showed an increasing text generation rate over time, whereas no such an effect was observed in the control group.Corresponding Author: Yang Gong, MD, PhD, Yang.Gong@uth.tmc.edu, 713-500-3547, 7000 Fannin St. Suite 165, Houston, TX 77030. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Authors' ContributionsYang Gong: Responsible for study design, data collection and analysis, and co-author with review and revision responsibilities Lei Hua: Responsible for the conceptualization, study design, prototype development, testing session observation, data collection and analysis, co-authored the manuscript. Shen Wang: Organized and coordinated with the study participants, assisted in preparing testing cases, data analysis and had review responsibilities. Conflicts of InterestWe declare there are no conflicts of interest involved in the research. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptConclusion-As an attempt investigating the effectiveness of text prediction functions in reporting patient safety events, the study findings proved an effective strategy for assisting reporters in generating complementary free tex...

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Properties of permuted-block randomization in clinical trials

Cited by 266 publications

References 8 publications

Real‐time fMRI neurofeedback in adolescents with attention deficit hyperactivity disorder

Real‐time fMRI neurofeedback in adolescents with attention deficit hyperactivity disorder

A phase I/II study of intrathecal idursulfase-IT in children with severe mucopolysaccharidosis II

Leveraging user's performance in reporting patient safety events by utilizing text prediction in narrative data entry

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