Evidence map›Paper›PMID 33143714›Full record

ArticleMalaria journal2020

Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting.

Ronald Kiguba, Helen Byomire Ndagije, Victoria Nambasa, Leonard Manirakiza, Elijah Kirabira, Allan Serwanga, Sten Olsson, Niko Speybroeck, Jackson Mukonzo

Abstract read
In one paragraph

Article in Malaria journal, 2020. 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
–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

2 citing papers in PubMed.

  1. Trial
  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

9 authors.

Ronald KigubaDepartment of Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, Uganda. kiguba@gmail.com.ORCID http://orcid.org/0000-0002-2636-4115
Helen Byomire NdagijeNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Victoria NambasaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Leonard ManirakizaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Elijah KirabiraNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Allan SerwangaNational Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Sten OlssonPharmacovigilance Consulting, Uppsala, Sweden.
Niko SpeybroeckInstitute of Health and Society (IRSS), Université catholique de Louvain, Brussels, Belgium.
Jackson MukonzoDepartment of Pharmacology and Therapeutics, Makerere University College of Health Sciences, Kampala, Uganda.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness.

methodsSurvey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness.

resultsOne in five (20%, 137/685; 95% CI 17-23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda's National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI 1.41-4.21), HCPs aged under 25 years (OR = 2.2, 95% CI 1.29-3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI 1.29-3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI 1.62-5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI 0.28-0.93) and western (vs central; OR = 0.4, 95% CI 0.17-0.77) parts of Uganda.

conclusionOne in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.

Indexed as

PharmacovigilanceTreatment OutcomeAntimalarialsArtemisininsDrug CombinationsDrug Therapy, CombinationHumansMalariaUgandaAntimalarialsArtemisininsDrug CombinationsArtemisinin-based combination therapyHealthcare professionalsPharmacovigilanceReporting of artemisinin-based combination therapy failureTherapeutic effectivenessTherapeutic efficacyTherapeutic ineffectivenessTherapeutic inefficacy

Identifiers

PMID33143714
PMCPMC7640656

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Registered trials

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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.