Evidence map›Paper›PMID 27084812›Full record

ArticleThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2016

Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements.

M G Johnson, J E Stout, D A Benator, W C Whitworth, D P Holland

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 97% of its field
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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

5 authors at 1 institution in 1 country.

M G JohnsonDivision of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA.
J E StoutDivision of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA.
D A BenatorInfectious Diseases Section, Veterans Affairs Medical Center and the George Washington University Medical Center, Washington DC, USA.
W C WhitworthClinical Research Branch, Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, USA.
D P HollandDivision of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA; Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
Duke Medical Center · US

Funding

Ruth L. Kirschstein National Research Service Award (NRSA)- T32T32AI007392 · NIAID · DUKE UNIVERSITY · PI Amy Lynn Corneli, Guido Ferrari · 1990 to 2026
$9.8M
Intramural CDC HHS CC999999
6 · The paper itself

Abstract

settingTwo-month solid medium culture conversion is a commonly used, if suboptimal, endpoint for phase 2 anti-tuberculosis treatment trials. OBJECTIVE AND

designTo model the effect of the performance characteristics (sensitivity and contamination rate) of solid medium on required sample size for a two-arm clinical trial with 85% true (gold standard) culture conversion in the control and 95% in the experimental arm.

resultsIncreasing sensitivity and decreasing contamination reduced the sample size from 239 subjects/arm (60% sensitivity, 30% contamination) to 138 subjects/arm (95% sensitivity, 1% contamination).

conclusionOptimizing solid medium has significant potential to reduce sample size and increase the efficiency of tuberculosis clinical trials.

Indexed as

Bacteriological TechniquesCulture MediaSample SizeAntitubercular AgentsClinical Trials, Phase II as TopicControlled Clinical Trials as TopicEndpoint DeterminationHumansMycobacterium tuberculosisPredictive Value of TestsReproducibility of ResultsTime FactorsTreatment OutcomeTuberculosisAntitubercular AgentsCulture Media

Identifiers

PMID27084812
PMCPMC4960979
OpenAlexW2338894482

What OpenQuestion holds

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LicenceTDM
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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.