Evidence map›Paper›PMID 34778571›Full record

ArticleWellcome open research2021

A statistical analysis plan for the Adjunctive Corticosteroids for Tuberculous meningitis in HIV-positive adults (ACT HIV) clinical trial.

Joseph Donovan, Trinh Dong Huu Khanh, Guy E Thwaites, Ronald B Geskus, ACT HIV investigators

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Wellcome open research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03092817 (A Randomized Double Blind Placebo Controlled Trial of Adjunctive Dexamethasone for the Treatment of HIV-infected Adults With Tuberculous Meningitis), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 44% 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.

NCT03092817 phase3completednot on this map

A Randomized Double Blind Placebo Controlled Trial of Adjunctive Dexamethasone for the Treatment of HIV-infected Adults With Tuberculous Meningitis

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2017 to 2023Enrolled520ConditionsTuberculosis, Tuberculous Meningitis, Drug-Induced Liver Injury, HIVArmsDexamethasone, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
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 2 countries.

Joseph DonovanOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.ORCID https://orcid.org/0000-0002-5893-336X
Trinh Dong Huu KhanhOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Guy E ThwaitesOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.ORCID https://orcid.org/0000-0002-2858-2087
Ronald B GeskusOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.ORCID https://orcid.org/0000-0002-2740-3155
ACT HIV investigators
University of Oxford · GB

Funding

Wellcome Trust 110179/Z/15/Z
6 · The paper itself

Abstract

TBM is the most severe form of tuberculosis. Clinical trial data are required to provide an evidence base for adjunctive dexamethasone in HIV-positive individuals with TBM, and to guide clinical practice. This document details the planned analyses at 12 months post randomisation for the ACT HIV clinical trial (NCT03092817); 'a randomised double-blind placebo-controlled trial of adjunctive dexamethasone for the treatment of HIV co-infected adults with tuberculous meningitis (TBM)'. The primary endpoint of the ACT HIV trial is death (from any cause) over the first 12 months after randomisation. This statistical analysis plan expands upon and updates the analysis plan outlined in the published study protocol.

Indexed as

analysis planclinical trialcorticosteroidshuman immunodeficiency virusTuberculous meningitis

Identifiers

PMID34778571
PMCPMC8561610.2
OpenAlexW3207179132

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.