Evidence map›Paper›PMID 23758662›Full record

Trial reportTrials2013

Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial.

Richard J Lessells, Graham S Cooke, Nuala McGrath, Mark P Nicol, Marie-Louise Newell, Peter Godfrey-Faussett

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Spatial clustering of drug-resistant tuberculosis in Hlabisa subdistrict, KwaZulu-Natal, 2011-2015.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018
    Article
  4. Impact and cost-effectiveness of current and future tuberculosis diagnostics: the contribution of modelling.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2014
    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

6 authors.

Richard J LessellsDepartment of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK. richard.lessells@lshtm.ac.uk
Graham S Cooke
Nuala McGrath
Mark P Nicol
Marie-Louise Newell
Peter Godfrey-Faussett

Funding

Medical Research Council MR/K007688/1Wellcome Trust 083495MAWellcome Trust 085251Wellcome Trust 090999Wellcome Trust 090999/Z/09/ZWellcome Trust 097410
6 · The paper itself

Abstract

backgroundTuberculosis control in sub-Saharan Africa has long been hampered by poor diagnostics and weak health systems. New molecular diagnostics, such as the Xpert® MTB/RIF assay, have the potential to improve patient outcomes. We present a cluster randomised trial designed to evaluate whether the positioning of this diagnostic system within the health system has an impact on important patient-level outcomes. METHODS/

designThis pragmatic cluster randomised clinical trial compared two positioning strategies for the Xpert MTB/RIF system: centralised laboratory versus primary health care clinic. The cluster (unit of randomisation) is a 2-week time block at the trial clinic. Adult pulmonary tuberculosis suspects with confirmed human immunodeficiency virus infection and/or at high risk of multidrug-resistant tuberculosis are enrolled from the primary health care clinic. The primary outcome measure is the proportion of culture-confirmed pulmonary tuberculosis cases initiated on appropriate treatment within 30 days of initial clinic visit. Univariate logistic regression will be performed as the primary analysis using generalised estimating equations with a binomial distribution function and a logit link.

conclusionDiagnostic research tends to focus only on performance of diagnostic tests rather than on patient-important outcomes. This trial has been designed to improve the quality of evidence around diagnostic strategies and to inform the scale-up of new tuberculosis diagnostics within public health systems in high-burden settings.

trial registrationCurrent Controlled Trials ISRCTN18642314; South African National Clinical Trials Registry DOH-27-0711-3568.

Indexed as

Bacteriological TechniquesMolecular Diagnostic TechniquesResearch DesignRural Health ServicesAmbulatory Care FacilitiesAntitubercular AgentsClinical ProtocolsCoinfectionHIV InfectionsHumansLaboratoriesLogistic ModelsMycobacterium tuberculosisPoint-of-Care SystemsPredictive Value of TestsPrimary Health CareAntitubercular Agents

Identifiers

PMID23758662
PMCPMC3686680

What OpenQuestion holds

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LicenceCC BY
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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.