Evidence map›Paper›PMID 40370421›Full record

ArticleResearch ethics2024

Stakeholders' experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.

Tiwonge K Mtande, Carl Lombard, Gonasagrie Nair, Stuart Rennie

Abstract read
In one paragraph

Article in Research ethics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

4 authors.

Tiwonge K MtandeStellenbosch University, South Africa, Kamuzu University of Health Sciences, Malawi.ORCID 0000-0003-1706-6615
Carl LombardStellenbosch University, South Africa, South African Medical Research Council, South Africa.
Gonasagrie NairStellenbosch University, South Africa.
Stuart RennieStellenbosch University, South Africa, University of North Carolina at Chapel Hill, USA.

Funding

Advancing Research Ethics Training in Southern Africa (ARESA): Leadership ProgramD43TW010511 · FIC · STELLENBOSCH UNIVERSITY · PI MOODLEY, KEYMANTHRI, RENNIE, STUART · 2017 to 2021
$1.2M
ARESA - Advancing Research Ethics training in Southern AfricaR25TW008981 · FIC · STELLENBOSCH UNIVERSITY · PI MOODLEY, KEYMANTHRI · 2011 to 2015
$1.2M
FIC NIH HHS D43 TW010511FIC NIH HHS R25 TW008981
6 · The paper itself

Abstract

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.

Indexed as

Cluster randomized trialsethical issuesMalawipragmatic trials

Identifiers

PMID40370421
PMCPMC12077595

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.