Evidence map›Paper›PMID 23487389›Full record

SynthesisClinical infectious diseases : an official publication of the Infectious Diseases Society of America2013

A meta-analysis of self-administered vs directly observed therapy effect on microbiologic failure, relapse, and acquired drug resistance in tuberculosis patients.

Jotam G Pasipanodya, Tawanda Gumbo

Erratum issued Registry-linked trialOpen access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04187469 (A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis), which is not on this map. Cited by 64 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 9 pooled it
8.9field-weighted citation impact, top 1% 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.

NCT04187469 naunknown statusnot on this mapstarted 2020, after this paper: background citation

A Prospective, Randomized Controlled Study for the Efficacy and Safety of the Substitution of Pyrazinamide and Ethambutol With Moxifloxacin During the Intensive Phase of Treatment of Pulmonary Tuberculosis

TypeinterventionalSponsorFifth Affiliated Hospital, Sun Yat-Sen UniversityRan2020 to 2024Enrolled286ConditionsPulmonary TuberculosisArmsMoxifloxacin, Isoniazid, Rifampicin, Rifampicin,Isoniazid,Pyrazinamide,Ethambutol
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 9 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Effectiveness of interventions for reducing TB incidence in countries with low TB incidence: a systematic review of reviews.European respiratory review : an official journal of the European Respiratory Society · 2019
    Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Directly observed therapy for treating tuberculosis.The Cochrane database of systematic reviews · 2015
    Pooled it
  9. Pooled it
  10. The impact of the stratification by degree of clinical severity and abandonment risk of tuberculosis treatment.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2021
    Trial
  11. Artificial intelligence-derived 3-Way Concentration-dependent Antagonism of Gatifloxacin, Pyrazinamide, and Rifampicin During Treatment of Pulmonary Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  12. Trial
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Multidrug-resistant tuberculosis.Nature reviews. Disease primers · 2024
    Review
  19. Article
  20. Article

4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Jotam G PasipanodyaOffice of Global Health and Department of Medicine, The University of Texas Southwestern Medical Center, Dallas, TX 75390-8507, USA.
Tawanda Gumbo
The University of Texas Southwestern Medical Center · US

Funding

PK-PD of combination antituberculosis therapy for suppression of drug-resistanceR01AI079497 · NIAID · UT SOUTHWESTERN MEDICAL CENTER · PI GUMBO, TAWANDA · 2008 to 2011
$2.3M
NIAID NIH HHS R01 AI079497NIAID NIH HHS R01AI079497
6 · The paper itself

Abstract

backgroundPreclinical studies and Monte Carlo simulations have suggested that there is a relatively limited role of adherence in acquired drug resistance (ADR) and that very high levels of nonadherence are needed for therapy failure. We evaluated the superiority of directly observed therapy (DOT) for tuberculosis patients vs self-administered therapy (SAT) in decreasing ADR, microbiologic failure, and relapse in meta-analyses.

methodsProspective studies performed between 1965 and 2012 in which adult patients with microbiologically proven pulmonary Mycobacterium tuberculosis were separately assigned to either DOT or SAT as part of short-course chemotherapy were chosen. Endpoints were microbiologic failure, relapse, and ADR in patients on either DOT or SAT.

resultsTen studies, 5 randomized and 5 observational, met selection criteria: 8774 patients were allocated to DOT and 3708 were allocated to SAT. For DOT vs SAT, the pooled risk difference for microbiologic failure was .0 (95% confidence interval [CI], -.01 to .01), for relapse .01 (95% CI, -.03 to .06), and for ADR 0.0 (95% CI, -0.01 to 0.01). The incidence rates for DOT vs SAT were 1.5% (95% CI, 1.3%-1.8%) vs 1.7% (95% CI, 1.2%-2.2%) for microbiologic failure, 3.7% (95% CI, 0.7%-17.6%) vs 2.3% (95% CI, 0.7%-7.2%) for relapse, and 1.5% (95% CI, 0.2%-9.90%) vs 0.9% (95% CI, 0.4%-2.3%) for ADR, respectively. There was no evidence of publication bias.

conclusionsDOT was not significantly better than SAT in preventing microbiologic failure, relapse, or ADR, in evidence-based medicine. Resources should be shifted to identify other causes of poor microbiologic outcomes.

Indexed as

Drug Resistance, BacterialAdultAntitubercular AgentsDirectly Observed TherapyHumansMedication AdherenceMycobacterium tuberculosisRecurrenceSelf AdministrationTreatment FailureTuberculosisAntitubercular Agentsacquired drug resistancedirectly observed therapymicrobiologic failureself-administered therapytuberculosis

Identifiers

PMID23487389
PMCPMC3669525
OpenAlexW2100383609

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.