Evidence map›Paper›PMID 27885051›Full record

ArticleStatistical methods in medical research2018

Linear-rank testing of a non-binary, responder-analysis, efficacy score to evaluate pharmacotherapies for substance use disorders.

Tyson H Holmes, Shou-Hua Li, David J McCann

Erratum issuedAbstract read
In one paragraph

Article in Statistical methods in medical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors.

Tyson H Holmes1 Human Immune Monitoring Center, Stanford University School of Medicine, Stanford, CA, USA.
Shou-Hua Li2 Division of Therapeutics and Medical Consequences, National Institute on Drug Abuse (NIDA), National Institutes of Health, Bethesda, MD, USA.
David J McCann2 Division of Therapeutics and Medical Consequences, National Institute on Drug Abuse (NIDA), National Institutes of Health, Bethesda, MD, USA.

Funding

Thalamic cortical dysfunction and predictors of relapse in cocaine dependenceK25DA040032 · NIDA · YALE UNIVERSITY · PI ZHANG, SHENG · 2015 to 2019
$834k
NIDA NIH HHS K25 DA040032NIDA NIH HHS Y01 DA040032
6 · The paper itself

Abstract

The design of pharmacological trials for management of substance use disorders is shifting toward outcomes of successful individual-level behavior (abstinence or no heavy use). While binary success/failure analyses are common, McCann and Li (CNS Neurosci Ther 2012; 18: 414-418) introduced "number of beyond-threshold weeks of success" (NOBWOS) scores to avoid dichotomized outcomes. NOBWOS scoring employs an efficacy "hurdle" with values reflecting duration of success. Here, we evaluate NOBWOS scores rigorously. Formal analysis of mathematical structure of NOBWOS scores is followed by simulation studies spanning diverse conditions to assess operating characteristics of five linear-rank tests on NOBWOS scores. Simulations include assessment of Fisher's exact test applied to hurdle component. On average, statistical power was approximately equal for five linear-rank tests. Under none of conditions examined did Fisher's exact test exhibit greater statistical power than any of the linear-rank tests. These linear-rank tests provide good Type I and Type II error control for comparing distributions of NOBWOS scores between groups (e.g. active vs. placebo). All methods were applied to re-analyses of data from four clinical trials of differing lengths and substances of abuse. These linear-rank tests agreed across all trials in rejecting (or not) their null (equality of distributions) at ≤ 0.05.

Indexed as

Drug TherapyLinear ModelsBiasHumansMonte Carlo MethodRandomized Controlled Trials as TopicSubstance-Related DisordersLinear-rank testspharmacotherapy developmentrandomized clinical trialstatistical powersubstance use disordersType I error

Identifiers

PMID27885051
PMCPMC6690342

What OpenQuestion holds

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Registered trials

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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.