Evidence map›Paper›PMID 35732397›Full record

ArticleBMJ open2022

Harnessing new mHealth technologies to Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART trial): a protocol for a randomised controlled trial.

Kavindhran Velen, Viet Nhung Nguyen, Binh Hoa Nguyen, Tho Dang, Hoang Anh Nguyen, Dinh Hoa Vu, Thu Thuong Do, Cuong Pham Duc, Huu Lan Nguyen, Huu Thuong Pham and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–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.

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

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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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

19 authors.

Kavindhran VelenFaculty of Health and Medicine, The University of Sydney, Sydney, New South Wales, Australia Kavi.velen@sydney.edu.au.ORCID 0000-0001-8577-3915
Viet Nhung NguyenThe National Lung Hospital, Hanoi, Vietnam.
Binh Hoa NguyenThe National Lung Hospital, Hanoi, Vietnam.ORCID 0000-0002-1543-4907
Tho DangWoolcock Institute of Medical Research, Glebe, New South Wales, Australia.
Hoang Anh NguyenNational Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi, Vietnam.
Dinh Hoa VuNational Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi, Vietnam.
Thu Thuong DoThe National Lung Hospital, Hanoi, Vietnam.
Cuong Pham DucWoolcock Institute of Medical Research, Glebe, New South Wales, Australia.
Huu Lan NguyenPham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
Huu Thuong PhamHanoi Lung Hospital, Hanoi, Vietnam.
Ben J MaraisFaculty of Health and Medicine, The University of Sydney, Sydney, New South Wales, Australia.
James JohnstonBCCDC, University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.
Warwick BrittonCentenary Institute of Cancer Medicine and Cell Biology, The University of Sydney, Sydney, New South Wales, Australia.
Justin BeardsleyFaculty of Health and Medicine, The University of Sydney, Sydney, New South Wales, Australia.
Joel NeginSchool of Public Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-2016-311X
Virginia WisemanSchool of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Guy Barrington MarksWoolcock Institute of Medical Research, Camperdown, New South Wales, Australia.
Thu Anh NguyenWoolcock Institute of Medical Research, Hanoi, Vietnam.ORCID 0000-0002-2089-2902
Greg J FoxWoolcock Institute of Medical Research, Glebe, New South Wales, Australia.ORCID 0000-0002-4085-1411

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultidrug-resistant tuberculosis (MDR-TB) remains a major public health problem globally. Long, complex treatment regimens coupled with frequent adverse events have resulted in poor treatment adherence and patient outcomes. Smartphone-based mobile health (mHealth) technologies offer national TB programmes an appealing platform to improve patient care and management; however, clinical trial evidence to support their use is lacking. This trial will test the hypothesis that an mHealth intervention can improve treatment success among patients with MDR-TB and is cost-effective compared with standard practice. METHODS AND ANALYSIS: A community-based, open-label, parallel-group randomised controlled trial will be conducted among patients treated for MDR-TB in seven provinces of Vietnam. Patients commencing therapy for microbiologically confirmed rifampicin-resistant or multidrug-resistant tuberculosis within the past 30 days will be recruited to the study. Participants will be individually randomised to an intervention arm, comprising use of an mHealth application for treatment support, or a 'standard care' arm. In both arms, patients will be managed by the national TB programme according to current national treatment guidelines. The primary outcome measure of effectiveness will be the proportion of patients with treatment success (defined as treatment completion and/or bacteriological cure) after 24 months. A marginal Poisson regression model estimated via a generalised estimating equation will be used to test the effect of the intervention on treatment success. A prospective microcosting of the intervention and within-trial cost-effectiveness analysis will also be undertaken from a societal perspective. Cost-effectiveness will be presented as an incremental cost per patient successfully treated and an incremental cost per quality-adjusted life-year gained. ETHICS: Ethical approval for the study was granted by The University of Sydney Human Research Ethics Committee (2019/676). DISSEMINATION: Study findings will be disseminated to participants and published in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12620000681954.

Indexed as

TelemedicineTuberculosis, Multidrug-ResistantCost-Benefit AnalysisHumansProspective StudiesQuality-Adjusted Life YearsRandomized Controlled Trials as TopicVietnampublic healthrespiratory medicine (see thoracic medicine)tuberculosis

Identifiers

PMID35732397
PMCPMC9226862

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.