Trial reportBulletin of the World Health Organization2009
Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.
Trial report in Bulletin of the World Health Organization, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02895269 (Partnership for Mental Health Development in Sub-Saharan Africa), which is not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Partnership for Mental Health Development in Sub-Saharan Africa: COllaborative Shared Care to IMprove Psychosis Outcome
Who cites it
33 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A Review of the Ring Trial Design for Evaluating Ring Interventions for Infectious Diseases.Epidemiologic reviews · 2022Pooled it
- Neurosurgical Randomized Trials in Low- and Middle-Income Countries.Neurosurgery · 2020Pooled it
- Pooled it
- When communities are really in control: ethical issues surrounding community mobilisation for dengue prevention in Mexico and Nicaragua.BMC public health · 2017Trial
- A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial.PLoS medicine · 2011Trial
- Core Principles and Practices for the Design, Implementation, and Evaluation of Social and Behavior Change for Nutrition in Low- and Middle-Income Contexts with Special Applications for Nutrition-Sensitive Agriculture.Current developments in nutrition · 2024Review
- Stakeholders' experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.Research ethics · 2024Article
- Challenges in conducting population-based seroepidemiology survey of COVID-19 in Lagos State, Nigeria.BMC public health · 2023Article
- Empowering local research ethics review of antibacterial mass administration research.Infectious diseases of poverty · 2022Review
- A Web-Delivered Acceptance and Commitment Therapy Intervention With Email Reminders to Enhance Subjective Well-Being and Encourage Engagement With Lifestyle Behavior Change in Health Care Staff: Randomized Cluster Feasibility Stud.JMIR formative research · 2020Article
- Article
- Public Health's Next Step in Advancing Equity: Re-evaluating Epistemological Assumptions to Move Social Determinants From Theory to Practice.Frontiers in public health · 2020Article
- Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia.BMC medical ethics · 2019Article
- Article
- Ethical issues raised by cluster randomised trials conducted in low-resource settings: identifying gaps in theJournal of medical ethics · 2019Article
- Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies: A systematic review.Medical journal of the Islamic Republic of Iran · 2019Article
- Article
- Article
- Building the evidence base for REDD+: Study design and methods for evaluating the impacts of conservation interventions on local well-being.Global environmental change : human and policy dimensions · 2017Article
- Developing the ethics of implementation research in health.Implementation science : IS · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
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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.