Evidence map›Paper›PMID 36949623›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Factors Associated With Discontinuation of Tuberculosis Preventive Treatment: Post Hoc Analysis of 2 Randomized, Controlled Trials.

Alex Allard-Gray, Isaac Boakye, Alioune Camara, Lisa Eisenbeis, Eleny Guimarães-Teixeira, Oumou Sow, David Zielinski, Jonathon R Campbell, Dick Menzies

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT00170209 phase3completednot on this map

A Randomized Trial to Compare Effectiveness of 4 Months Rifampin (4 RIF) With 9 Months Isoniazid (9 INH) in the Prevention of Active TB in Children: The P4v9 Trial

TypeinterventionalSponsorMcGill UniversityRan2011 to 2015Enrolled844ConditionsLatent Tuberculosis InfectionArmsIsoniazid, Rifampin
NCT00931736 phase3completednot on this map

A Randomized Clinical Trial of 4 Months of Rifampin vs. 9 Months of Isoniazid for Latent Tuberculosis Infection. Part 3 - Effectiveness

TypeinterventionalSponsorMcGill UniversityRan2009 to 2017Enrolled6,031ConditionsLatent Tuberculosis InfectionArmsIsoniazid, Rifampin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. 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

9 authors.

Alex Allard-GrayIndigenous Health Professions Program, McGill University, Montreal, Quebec, Canada.
Isaac BoakyeResearch & Development Unit, Komfo Anokye Teaching Hospital, Kumasi, Ghana.
Alioune CamaraDepartment of Medical Sciences, Faculty of Health Sciences and Techniques, Gamal Abdel Nasser University of Conakry, Conakry, Guinea.
Lisa EisenbeisMinistry of Health, Government of Alberta, Edmonton, Alberta, Canada.
Eleny Guimarães-TeixeiraDepartment of Internal Medicine, Faculdade de Medicina do IDOMED/Estacio, Rio de Janeiro, Brazil.
Oumou SowDepartment of Medical Sciences, Faculty of Health Sciences and Techniques, Gamal Abdel Nasser University of Conakry, Conakry, Guinea.
David ZielinskiPediatric Respirology, Montreal Children's Hospital, McGill University Health Center Research Institute, Montreal, Quebec, Canada.
Jonathon R CampbellDepartments of Medicine & Global and Public Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada.ORCID 0000-0003-2341-2166
Dick MenziesMcGill International TB Centre, Research Institute of the McGill University Health Center, Montreal, Quebec, Canada.

Funding

CIHR MCT-44154CIHR MCT-94831
6 · The paper itself

Abstract

backgroundAdherence to tuberculosis preventive treatment (TPT) is an important determinant of clinical benefit. We assessed the association of participant behaviors early in TPT with subsequent discontinuation.

methodsWe used data from a phase 3 randomized trial and the preceding phase 2 trial to compare 4 months of rifampin to 9 months of isoniazid for TPT. We excluded participants whose providers discontinued TPT due to adverse events or tuberculosis disease. We analyzed 4 outcomes: discontinuing TPT within the first month of treatment, discontinuing TPT between the first and second month, discontinuing TPT after the second month, and completing treatment but not per protocol. We analyzed the association of outcomes with regimen and participant characteristics and 4 behavioral predictors of discontinuation recorded at the month 1 and month 2 follow-up visits: reporting symptoms of intolerance, missing >20% of doses, rescheduling appointments, and not bringing their medication bottle.

resultsOverall, 6656 participants were included (phase 3, 5848; phase 2, 808), of whom 4318 (64.9%) completed treatment per protocol. Participant characteristics were inconsistently associated with discontinuation. Phase 3 trial participants with 1, 2, or 3-4 behavioral predictors at the month 1 follow-up had 5.0 (95% confidence interval, 3.6-6.7), 18.6 (13.3-26.1), and 79.4 (38.2-165.0), respectively, higher odds of discontinuing before the second month. The corresponding number of predictors at the month 2 follow-up had 1.8 (1.4-2.2), 4.7 (3.6-6.2), and 7.4 (4.6-11.9) higher odds of discontinuing before completing treatment; phase 2 findings were similar.

conclusionsFour behavioral predictors recorded early in therapy were more strongly associated with subsequent discontinuation than participant characteristics, particularly when more than 1 behavioral predictor was recorded. Clinical Trials Registration. NCT00170209; NCT00931736.

Indexed as

TuberculosisAntitubercular AgentsClinical ProtocolsDrug Administration ScheduleHumansIsoniazidRifampinAntitubercular AgentsIsoniazidRifampinadherencepreventive therapytuberculosis

Identifiers

PMID36949623
PMCPMC10320123

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.