Evidence map›Paper›PMID 31215122›Full record

ArticleTropical medicine & international health : TM & IH2019

Clinical trials in low-resource settings: the perspectives of caregivers of paediatric participants from Uganda, Tanzania and Kenya.

Machteld van den Berg, Bernhards Ogutu, Nelson K Sewankambo, Sonja Merten, Nikola Biller-Andorno, Marcel Tanner

Abstract read
In one paragraph

Article in Tropical medicine & international health : TM & IH, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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

6 authors.

Machteld van den BergInstitute of Biomedical Ethics and History of Medicine, University of Zurich, Zurich, Switzerland.
Bernhards OgutuKenya Medical Research Institute, Nairobi, Kenya.
Nelson K SewankamboCollege of Health Sciences, Makerere University, Kampala, Uganda.
Sonja MertenSwiss Tropical and Public Health Institute, Basel, Switzerland.
Nikola Biller-AndornoInstitute of Biomedical Ethics and History of Medicine, University of Zurich, Zurich, Switzerland.
Marcel TannerSwiss Tropical and Public Health Institute, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesVaccine clinical trials in low-resource settings have unique challenges due to structural and financial inequities. Specifically, protecting participant and caregiver autonomy to participate in the research study can be a major challenge, so understanding the setting and contextual factors which influence the decision process is necessary. This study investigates the experience of caregivers consenting on behalf of paediatric participants in a malaria vaccine clinical trial where participation enables access to free, high-quality medical care.

methodsWe interviewed a total of 78 caregivers of paediatric participants previously enrolled in a phase II or III malaria vaccine clinical trial in Uganda, Tanzania and Kenya. Interviews were qualitative and analysed using a thematic framework analysis focusing on the embodied caregiver in the political, economic and social reality.

resultsCaregivers of participants in this study made the decision to enrol their child based on economic, social and political factors that extended beyond the trial into the community and the home. The provision of health care was the dominant reason for participation. Respondents reported how social networks, rumours, hierarchal structures, financial constraints and family dynamics affected their experience with research.

conclusionsThe provision of medical care was a powerful motivator for participation. Caregiver choice was limited by structural constraints and scarce financial resources. The decision to participate in research extended beyond individual consent and was embedded in community and domestic hierarchies. Future research should assess other contexts to determine how the choice to participate in research is affected when free medical care is offered.

Indexed as

Malaria VaccinesAdultCaregiversChildClinical Trials as TopicDeveloping CountriesHealth Services AccessibilityHumansInterviews as TopicKenyaParentsPatient Acceptance of Health CarePovertyTanzaniaUgandaMalaria Vaccinescaregiversclinical trialscomplexity theorydéveloppement de vaccinsessais cliniqueslow-resource settingsqualitative researchrecherche qualitativerégions à faibles ressourcessoignantsthéorie de la complexitévaccine development

Identifiers

PMID31215122
PMCPMC6852514

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.