Evidence map›Paper›PMID 32334553›Full record

ArticleBMC pulmonary medicine2020

People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial.

Vahe Khachadourian, Nune Truzyan, Arusyak Harutyunyan, Varduhi Petrosyan, Hayk Davtyan, Karapet Davtyan, Martin van den Boom, Michael E Thompson

Registry-linked trialOpen access · goldAbstract readComparative StudyEquivalence TrialMulticenter Study
In one paragraph

Article in BMC pulmonary medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02082340 (Innovative Approach in Tuberculosis Care in Armenia), which is not on this map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
0.5field-weighted citation impact, top 21% 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.

NCT02082340 nacompletednot on this map

Innovative Approach in Tuberculosis Care in Armenia

TypeinterventionalSponsorVarduhi PetrosyanRan2014 to 2015Enrolled392ConditionsTuberculosisArmsTB knowledge and socio-psychological counseling session, SMS text messages, phone calls, Self-administered drug intake strategy, Educational leaflet
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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  4. eHealth in TB clinical management.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022
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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

8 authors at 5 institutions in 3 countries.

Vahe KhachadourianAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of Armenia, Yerevan, Armenia. vahe.khachadourian@gmail.com.ORCID http://orcid.org/0000-0002-9882-8118
Nune TruzyanAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of Armenia, Yerevan, Armenia.
Arusyak HarutyunyanAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of Armenia, Yerevan, Armenia.
Varduhi PetrosyanAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of Armenia, Yerevan, Armenia.
Hayk DavtyanNational Tuberculosis Control Centre, Ministry of Health of the Republic of Armenia, Yerevan, Armenia.
Karapet DavtyanNational Tuberculosis Control Centre, Ministry of Health of the Republic of Armenia, Yerevan, Armenia.
Martin van den BoomJoint Tuberculosis, HIV & Viral Hepatitis Programme, Division of Health Emergencies and Communicable Diseases, WHO/Europe, Copenhagen, Denmark.
Michael E ThompsonDepartment of Public Health Sciences, University of North Carolina at Charlotte, Charlotte, USA.
American University of Armenia · AMNational Statistical Service of the Republic of Armenia · AMLos Angeles County Department of Public Health · USUniversity of North Carolina at Charlotte · USWorld Health Organization Regional Office for Europe · DK

Funding

Grand Challenges Canada S5 0399-01
6 · The paper itself

Abstract

backgroundWHO's directly observed therapy (DOT) strategy for tuberculosis (TB) treatment depends upon a well-organized healthcare system. This study sought to evaluate the effectiveness of self-administered drug intake supported by a family member versus in-clinic DOT.

methodsThis open-label, nationally-representative stratified cluster randomized controlled non-inferiority trial with two parallel equal arms involved drug-susceptible pulmonary TB patients in the continuation treatment phase. We randomly assigned outpatient-TB-centres (52 clusters) to intervention and control arms. The intervention included an educational/counseling session to enhance treatment adherence; weekly visits to outpatient-TB-centres to receive medication, and daily SMS medication reminders and phone calls to track adherence and record side effects. Controls followed clinical DOT at Outpatient-TB-centres. Both groups participated in baseline and 4-5 months follow-up surveys. The trial's non-inferiority comparisons include: treatment success as the clinical (primary) outcome and medication adherence (self-reported), knowledge, depressive symptoms, stigma, quality of life, and social support as non-clinical (secondary) outcomes.

resultsPer-protocol analysis showed that the intervention (n = 187) and control (n = 198) arms achieved successful treatment outcome of 92.0 and 92.9%, respectively, indicating that the treatment success in the intervention group was non-inferior to DOT. Knowledge, depression, stigma, quality of life, and social support also showed non-inferiority, demonstrating substantial improvement over time for knowledge (change in the intervention = 1.05: 95%CL (0.49, 1.60); change in the control = 1.09: 95%CL (0.56, 1.64)), depression score (change in the intervention = - 3.56: 95%CL (- 4.99, - 2.13); change in the control = - 1.88: 95% CL (- 3.26, - 0.49)) and quality of life (change in the intervention = 5.01: 95%CL (- 0.64, 10.66); change in the control = 7.29: 95%CL (1.77, 12.81)). The intervention resulted in improved treatment adherence.

conclusionsThis socially empowering alternative strategy might be a preferable alternative to DOT available to patients in Armenia and in other countries. Further research evaluating cost effectiveness of the intervention and generalizability of the results is warranted.

trial registrationClinicaltrials.gov: NCT02082340, March 10, 2014.

Indexed as

Directly Observed TherapyAdultAntitubercular AgentsArmeniaCounselingFemaleHumansMaleMiddle AgedPatient-Centered CareQuality of LifeSocial SupportTelephoneTreatment OutcomeTuberculosis, PulmonaryAntitubercular AgentsCounsellingPatient-Centreed careTuberculosis

Identifiers

PMID32334553
PMCPMC7183136
OpenAlexW3018411196

What OpenQuestion holds

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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.