Evidence map›Paper›PMID 36647039›Full record

ArticleBMC medical ethics2023

Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.

Yen Hong Thi Nguyen, Thuan Trong Dang, Ngoc Bao Hong Lam, Phuong Thanh Le, Phu Hoan Nguyen, Susan Bull, Evelyne Kestelyn, Jennifer Ilo Van Nuil

Abstract read
In one paragraph

Article in BMC medical ethics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

8 authors.

Yen Hong Thi NguyenOxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam. yen.nth@oucru.org.
Thuan Trong DangOxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam.
Ngoc Bao Hong LamOxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam.
Phuong Thanh LeHospital of Tropical Diseases, Ho Chi Minh City, Vietnam.
Phu Hoan NguyenOxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam.
Susan BullThe Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Evelyne Kestelyn *Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam.
Jennifer Ilo Van Nuil *Oxford University Clinical Research Unit, 764 Vo Van Kiet, Ward 1, District 5, Ho Chi Minh City, Vietnam.

Funding

Wellcome 096527
6 · The paper itself

Abstract

backgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.

objectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.

methodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients' family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.

resultsWe use the concept "fragmented understanding" to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.

conclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants' characteristics and the socio-cultural context in which the trials take place.

Indexed as

Informed ConsentPhysiciansFamilyHumansVietnamClinical trialInequalityInformed consentMotivationsSocio-cultural contextUnderstandingVietnam

Identifiers

PMID36647039
PMCPMC9843952

What OpenQuestion holds

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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.