Evidence map›Paper›PMID 35007306›Full record

ArticlePloS one2022

Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study).

Rachael M Burke, Saulos Nyirenda, Hussein H Twabi, Marriott Nliwasa, Elizabeth Joekes, Naomi Walker, Rose Nyirenda, Ankur Gupta-Wright, Katherine Fielding, Peter MacPherson and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04545164 (Computer Aided Screening for Tuberculosis in Low Resource Environments), which is not on this 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 52% 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.

NCT04545164 nacompletednot on this map

Computer Aided Screening for Tuberculosis in Low Resource Environments

TypeinterventionalSponsorLondon School of Hygiene and Tropical MedicineRan2020 to 2022Enrolled498ConditionsTuberculosis Infection, HIV InfectionsArmsCAD4TB, FujiLAM
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

11 authors at 6 institutions in 2 countries.

Rachael M BurkeFaculty of Infectious and Tropical Disease, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom.ORCID 0000-0002-2156-5030
Saulos NyirendaZomba Central Hospital, Malawi Ministry of Health, Zomba, Malawi.
Hussein H TwabiHelse Nord TB Initiative, Kamuzu University of Health Sciences, Blantyre, Malawi.ORCID 0000-0003-4473-296X
Marriott NliwasaHelse Nord TB Initiative, Kamuzu University of Health Sciences, Blantyre, Malawi.
Elizabeth JoekesDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Naomi WalkerDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Rose NyirendaDepartment of HIV AIDS, Malawi Ministry of Health, Lilongwe, Malawi.
Ankur Gupta-WrightFaculty of Infectious and Tropical Disease, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Katherine FieldingFaculty of Epidemiology and Population Health, Infectious Disease Epidemiology Department, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Peter MacPhersonFaculty of Infectious and Tropical Disease, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom.ORCID 0000-0002-0329-9613
Elizabeth L CorbettFaculty of Infectious and Tropical Disease, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, United Kingdom.
University of Liverpool · GBKamuzu Central Hospital · MWLiverpool School of Tropical Medicine · GBLondon School of Hygiene & Tropical Medicine · GBMinistry of Health · MWPublic Health Institute of Malawi · MW

Funding

Medical Research Council MR/M007375/1Medical Research Council MR/R010161/1Wellcome Trust 200901/Z/16/ZWellcome Trust 206575/Z/17/Z
6 · The paper itself

Abstract

backgroundPeople living with HIV (PLHIV) have a high risk of death if hospitalised in low-income countries. Tuberculosis has long been the leading cause of admission and death, in part due to suboptimal diagnostics. Two promising new diagnostic tools are digital chest Xray with computer-aided diagnosis (DCXR-CAD) and urine testing with Fujifilm SILVAMP LAM (FujiLAM). Neither test has been rigorously evaluated among inpatients. Test characteristics may be complementary, with FujiLAM especially sensitive for disseminated tuberculosis and DCXR-CAD especially sensitive for pulmonary tuberculosis, making combined interventions of interest. DESIGN AND

methodsAn exploratory unblinded, single site, two-arm cluster randomised controlled trial, with day of admission as the unit of randomisation. A third, smaller, integrated cohort arm (4:4:1 random allocation) contributes to understanding case-mix, but not trial outcomes. Participants are adults living with HIV not currently on TB treatment. The intervention (DCXR-CAD plus urine FujiLAM plus usual care) is compared to usual care alone. The primary outcome is proportion of participants started on tuberculosis treatment by day 56, with secondary outcomes of mortality (time to event) measured to to 56 days from enrolment, proportions with undiagnosed tuberculosis at death or hospital discharge and comparing proportions with enrolment-day tuberculosis treatment initiation. DISCUSSION: Both DCXR-CAD and FujiLAM have potential clinical utility and may have complementary diagnostic performance. To our knowledge, this is the first randomised trial to evaluate these tests among hospitalised PLHIV.

Indexed as

HIV-1HIV InfectionsMycobacterium tuberculosisTuberculosis, PulmonaryAdultFemaleHospitalsHumansMalawiMaleRandomized Controlled Trials as Topic

Identifiers

PMID35007306
PMCPMC8746787
OpenAlexW4206048524

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.