Trial reportBMC medical ethics2015
"Losing the tombola": a case study describing the use of community consultation in designing the study protocol for a randomised controlled trial of a mental health intervention in two conflict-affected regions.
Trial report in BMC medical ethics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.
- Patient and public involvement in health research in low and middle-income countries: a systematic review.BMJ open · 2019Pooled it
- The willingness to participate in biomedical research involving human beings in low- and middle-income countries: a systematic review.Tropical medicine & international health : TM & IH · 2019Pooled it
- Outcomes of an individual counselling programme in Grozny, Chechnya: a randomised controlled study.BMJ open · 2018Trial
- Ethical Issues Conducting Research During War and Violent Conflict: A Review.Developing world bioethics · 2026Review
- Community-engagement in research in humanitarian settings.Frontiers in public health · 2023Article
- Key issues for participatory research in the design and implementation of humanitarian assistance: a scoping review.Global health action · 2020Article
- A systematic literature review of the ethics of conducting research in the humanitarian setting.Conflict and health · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCommunity consultation is increasingly recommended, and in some cases, required by ethical review boards for research that involves higher levels of ethical risk such as international research and research with vulnerable populations. In designing a randomised control trial of a mental health intervention using a wait list control, we consulted the community where the research would be undertaken prior to finalising the study protocol. The study sites were two conflict-affected locations: Grozny in the Chechen Republic and Kitchanga in eastern Democratic Republic of Congo.
methodsGroup discussions with a range of community members were held in both study sites. Facilitators used a prepared set of questions to guide the discussions and to solicit feedback on the value of the research as well as on the study design. Specific questions were asked about enablers and barriers to participation in the research.
resultsSix groups were held in Grozny and thirteen in Kitchanga. The majority of individuals and groups consulted supported the research, and understood the purpose. In Grozny, the main concern raised was the length of the waiting period. Barriers to both waiting and returning for follow up were identified. In Kitchanga, there was a strong reaction against the wait list control and against randomisation. The consultations provided information on unanticipated harms to the community, allowing changes to the study design to mitigate these harms and increase acceptability of the study. It also served to inform the community of the study, and through engaging with them early, helped promote legitimacy and joint responsibility.
conclusionCommunity consultation prior to finalising the study design for a mental health intervention trial in two humanitarian settings proved feasible. Our experience reinforces the importance of community consultation before the study design is finalised and the importance of broad consultation that includes both community leaders and the potential study participants.
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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.