Evidence map›Paper›PMID 25043719›Full record

ArticleStatistics in medicine2014

A better alternative to stratified permuted block design for subject randomization in clinical trials.

Wenle Zhao

Abstract read
In one paragraph

Article in Statistics in medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 citing papers in PubMed.

  1. Trial
  2. A roadmap to using randomization in clinical trials.BMC medical research methodology · 2021
    Trial
  3. Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study.Movement disorders : official journal of the Movement Disorder Society · 2020
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
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  12. Review
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  16. Small samples and increased variability - discussing the need for restricted types of randomization in exercise interventions in old age.European review of aging and physical activity : official journal of the European Group for Research into Elderly and Physical Activity · 2019
    Article
  17. Characterizing permuted block randomization as a big stick procedure.Contemporary clinical trials communications · 2016
    Article
  18. Review
  19. Article
  20. Article
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

1 author.

Wenle ZhaoDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC 29425, U.S.A.

Funding

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
The ALIAS StudyU01NS054630 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI PALESCH, YUKO Y · 2005 to 2010
$6.9M
NINDS NIH HHS U01NS0059041NINDS NIH HHS U01 NS054630NINDS NIH HHS U01NS054630NINDS NIH HHS U01 NS059041NINDS NIH HHS U01 NS087748NINDS NIH HHS U01NS087748
6 · The paper itself

Abstract

Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization.

Indexed as

Random AllocationResearch DesignAlgorithmsBiasClinical Trials as TopicComputer SimulationHumansProbabilityProbability TheoryRandomized Controlled Trials as Topicbiased-coin minimization methodbig stick designblock urn designclinical trialpermuted blockrandomization

Identifiers

PMID25043719
PMCPMC4262630

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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.