ArticlePLoS neglected tropical diseases2016
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment.
Article in PLoS neglected tropical diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Factors related to willingness to participate in biomedical research on neglected tropical diseases: A systematic review.PLoS neglected tropical diseases · 2024Pooled it
- Pooled it
- Enhancing the ethical conduct of a longitudinal cluster-randomized trial of psychosocial stimulation intervention for children with complicated severe acute malnutrition through Rapid Ethical Assessment: a qualitative study.BMC medical ethics · 2021Trial
- Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.The Lancet. Global health · 2018Trial
- Mixing methods: How listening to researchers, healthcare workers, and community members can improve the design of studies testing medical innovations for Neglected Tropical Diseases.PLoS neglected tropical diseases · 2025Article
- Informed consent in cervical cancer screening research in Butajira district, Ethiopia.Global bioethics = Problemi di bioetica · 2025Article
- Article
- Rapid ethical appraisal of stakeholder views on research prior to undertaking immunopathogenesis studies on podoconiosis in northeast Ethiopia during a period of social instability.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2021Article
- Setting up a pragmatic clinical trial in a low-resource setting: A qualitative assessment of GoLBeT, a trial of podoconiosis management in Northern Ethiopia.PLoS neglected tropical diseases · 2021Article
- Cost-effectiveness and social outcomes of a community-based treatment for podoconiosis lymphoedema in the East Gojjam zone, Ethiopia.PLoS neglected tropical diseases · 2019Article
- Ethical Considerations for Movement Mapping to Identify Disease Transmission Hotspots.Emerging infectious diseases · 2019Article
- Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia.BMC medical ethics · 2018Article
- Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia.BMC medical research methodology · 2018Article
- Rapid Ethical Appraisal: A tool to design a contextualized consent process for a genetic study of podoconiosis in Ethiopia.Wellcome open research · 2017Article
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Abstract
backgroundCommunity-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia.
methodsA qualitative study was carried out in Aneded woreda, East Gojjam Zone, Amhara Regional State from August to September, 2013. A total of 14 In-depth Interviews (IDIs) with researchers, experts, and leaders, and 8 Focus Group Discussions (FGDs) involving 80 participants (people of both gender, with and without podoconiosis), were conducted. Interviews were carried out in Amharic. Data analysis was started alongside collection. Final data analysis used a thematic approach based on themes identified a priori and those that emerged during the analysis.
resultsRespondents made a range of specific suggestions, including that sensitisation meetings were called by woreda or kebele leaders or the police; that Health Extension Workers were asked to accompany the research team to patients' houses; that detailed trial information was explained by someone with deep local knowledge; that analogies from agriculture and local social organisations be used to explain randomisation; that participants in the 'delayed' intervention arm be given small incentives to continue in the trial; and that key community members be asked to quell rumours arising in the course of the trial.
conclusionMany of these recommendations were incorporated into the preparatory phases of the trial, or were used during the course of the trial itself. This demonstrates the utility of rapid ethical assessment preceding a complex piece of research in a relatively research-naive setting.
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