Evidence map›Paper›PMID 26688534›Full record

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

Understanding NIH clinical case definitions for pediatric intrathoracic TB by applying them to a clinical trial.

C A Beneri, L Aaron, S Kim, P Jean-Philippe, S Madhi, A Violari, M F Cotton, C Mitchell, S Nachman, P1041 team

Open access · greenAbstract read
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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 41% 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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children: An Update.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    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

10 authors at 3 institutions in 2 countries.

C A BeneriDepartment of Pediatrics, Stony Brook School of Medicine, Stony Brook, New York, New York, USA.
L AaronHarvard School of Public Heath, Boston, Massachusetts, USA.
S KimRutgers New Jersey Medical School, The State University of New Jersey, Newark, New Jersey, USA.
P Jean-PhilippeDivision of AIDS, Henry M. Jackson Foundation for the Advancement of Military Medicine Inc, Bethesda, Maryland, USA.
S MadhiRespiratory and Meningeal Pathogens Research Unit, Medical Research Council, Faculty of Health Sciences, USA; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.
A ViolariPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
M F CottonDepartment of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.
C MitchellUniversity of Miami Miller School of Medicine, Miami, Florida, USA.
S NachmanDepartment of Pediatrics, Stony Brook School of Medicine, Stony Brook, New York, New York, USA.
P1041 team
Perinatal HIV Research Unit · ZAStellenbosch University · ZAUniversity of Miami · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
USE OF OXANDROLONE TO IMPROVE FUNCTION IN CHRONIC SCIM01RR016587 · NCRR · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FLOREZ, HERMES · 2002 to 2005
$6.8M
NCRR NIH HHS M01 RR016587NIAID NIH HHS HHSN272200800014CNIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI106716NIAID NIH HHS UM1AI106716
6 · The paper itself

Abstract

settingStandardized clinical case definitions represent the best option for pediatric tuberculosis (TB) disease diagnosis and classification.

objectiveTo apply published guidelines for intrathoracic TB classification for use in reporting diagnostic studies with passive case finding to presumed TB patients from International Maternal Pediatric Adolescent AIDS Clinical Trials P1041, a trial of isoniazid prophylaxis in healthy human immunodeficiency virus exposed, bacille Calmette-Guérin vaccinated infants which employed active surveillance to assess a novel application of these guidelines in this setting.

methodsP1041 presumed TB patients were retrospectively cross-classified by protocol-defined and National Institutes of Health (NIH) classifications, and agreement was assessed.

resultsOf 219 TB suspects, 166 had signs/symptoms, with 158 considered TB (21 confirmed, 92 probable, 45 possible) and 8 not TB (6 TB unlikely, 2 alternative diagnoses). Weight loss and failure to thrive represented the majority of the observed signs/symptoms. Among those with signs/symptoms, agreement between definitions was poor. Furthermore, 53 TB presumptives were without signs/symptoms, including 33 classified by the P1041 protocol as TB.

conclusionPoor agreement between P1041 and NIH classifications reflects cases identified through active vs. passive surveillance, the latter reflecting the intended use of NIH definitions. Given the interest in standardized definitions for broader application, future efforts could focus on expanding TB disease classification to presumed TB patients identified through active surveillance.

Indexed as

Clinical Trials as TopicBenchmarkingChildChild Health ServicesChild, PreschoolFemaleHumansInfantInfant, NewbornMaleNational Institutes of Health (U.S.)Practice Guidelines as TopicRetrospective StudiesTuberculosis, PulmonaryUnited States

Identifiers

PMID26688534
PMCPMC4928853
OpenAlexW2411262985

What OpenQuestion holds

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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.