Evidence map›Paper›PMID 32363614›Full record

ArticleStatistics in medicine2020

Statistical properties of minimal sufficient balance and minimization as methods for controlling baseline covariate imbalance at the design stage of sequential clinical trials.

Steven D Lauzon, Viswanathan Ramakrishnan, Paul J Nietert, Jody D Ciolino, Michael D Hill, Wenle Zhao

Abstract read
In one paragraph

Article in Statistics in medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Steven D LauzonDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.ORCID 0000-0002-4911-0636
Viswanathan RamakrishnanDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Paul J NietertDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.ORCID 0000-0002-3933-4986
Jody D CiolinoDepartment of Preventive Medicine, Northwestern University, Chicago, Illinois, USA.
Michael D HillDepartment of Clinical Neuroscience, University of Calgary, Calgary, Alberta, Canada.
Wenle ZhaoDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.

Funding

Subproject Title: Clinical Research Education, Mentoring and Career Development CoreU54GM104941 · NIGMS · UNIVERSITY OF DELAWARE · PI Gregory E Hicks · 2013 to 2026
$60.5M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR001450 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T., FLUME, PATRICK A · 2015 to 2024
$41.1M
Treating Depression and Enhancing Locomotor Recovery Post-strokeP20GM109040 · NIGMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI KAUTZ, STEVEN A. · 2014 to 2024
$23.5M
Workshop to Identify Collaborative Project(s) for the NIH StrokeNet and the Japan NEtwork for Clinical Stroke Trials (NECST)U01NS087748 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Catherine R. Dillon, Jordan J. Elm · 2014 to 2026
$14.1M
Neurological Emergencies Treatment Trials Network Statistical and Data ManagementU01NS059041 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DURKALSKI, VALERIE L, PALESCH, YUKO Y · 2006 to 2015
$9.1M
Proteomics CoreP30DK123704 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DON C. ROCKEY · 2020 to 2026
$8.8M
Resource CoreP30AR072582 · NIAMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI JAMES C OATES · 2017 to 2026
$8.5M
Patient Resource CoreP60AR062755 · NIAMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI GILKESON, GARY S · 2012 to 2016
$5.8M
NCATS NIH HHS UL1 TR001450NIAMS NIH HHS P30 AR072582NIAMS NIH HHS P60 AR062755NIDDK NIH HHS P30 DK123704NIGMS NIH HHS P20 GM109040NIGMS NIH HHS U54 GM104941NINDS NIH HHS U01 NS059041NINDS NIH HHS U01 NS087748
6 · The paper itself

Abstract

When the number of baseline covariates whose imbalance needs to be controlled in a sequential randomized controlled trial is large, minimization is the most commonly used method for randomizing treatment assignments. The lack of allocation randomness associated with the minimization method has been the source of controversy, and the need to reduce even minor imbalances inherent in the minimization method has been challenged. The minimal sufficient balance (MSB) method is an alternative to the minimization method. It prevents serious imbalance from a large number of covariates while maintaining a high level of allocation randomness. In this study, the two treatment allocation methods are compared with regards to the effectiveness of balancing covariates across treatment arms and allocation randomness in equal allocation clinical trials. The MSB method proves to be equal or superior in both respects. In addition, type I error rate is preserved in analyses for both balancing methods, when using a binary endpoint.

Indexed as

Research DesignComputer SimulationRandom AllocationRandomized Controlled Trials as Topicallocation randomnessbaseline covariate imbalanceclinical trialminimal sufficient balanceminimization

Identifiers

PMID32363614
PMCPMC7462097

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.