Evidence map›Paper›PMID 27020947›Full record

Trial reportTrials2016

Reconstructing communities in cluster trials?

Sapfo Lignou, Sushmita Das, Jigna Mistry, Glyn Alcock, Neena Shah More, David Osrin, Sarah J L Edwards

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

7 authors.

Sapfo LignouUniversity College London, London, UK.
Sushmita DasSociety for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, 400017, Maharashtra, India.
Jigna MistrySociety for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, 400017, Maharashtra, India.
Glyn AlcockInstitute for Global Health, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Neena Shah MoreSociety for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, 400017, Maharashtra, India.
David OsrinInstitute for Global Health, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
Sarah J L EdwardsUniversity College London, London, UK. sarah.edwards@ucl.ac.uk.

Funding

Medical Research CouncilWellcome Trust 091561/Z/10/Z
6 · The paper itself

Abstract

backgroundThere is growing interest in the ethics of cluster trials, but no literature on the uncertainties in defining communities in relation to the scientific notion of the cluster in collaborative biomedical research.

methodsThe views of participants in a community-based cluster randomised trial (CRT) in Mumbai, India, were solicited regarding their understanding and views on community. We conducted two focus group discussions with local residents and 20 semi-structured interviews with different respondent groups. On average, ten participants took part in each focus group, most of them women aged 18-55. We conducted semi-structured interviews with ten residents (nine women and one man) lasting approximately an hour each and seven individuals (five men and two women) identified by residents as local leaders or decision-makers. In addition, we interviewed two Municipal Corporators (locally elected government officials involved in urban planning and development) and one representative of a political party located in a slum community.

resultsResidents' sense of community largely matched the scientific notion of the cluster, defined by the investigators as a geographic area, but their perceived needs were not entirely met by the trial.

conclusionWe examined whether the possibility of a conceptual mismatch between 'clusters' and 'communities' is likely to have methodological implications for a study or to lead to potential social disharmony because of the research interventions, arguing that it is important to take social factors into account as well as statistical efficiency when choosing the size and type of clusters and designing a trial. One method of informing such a design would be to use existing forums for community engagement to explore individuals' primary sense of community or social group and, where possible, to fit clusters around them.

trial registrationISRCTN Register: ISRCTN56183183 Clinical Trials Registry of India: CTRI/2012/09/003004 .

Indexed as

Community Health ServicesCommunity-Institutional RelationsHealth Knowledge, Attitudes, PracticePerceptionPoverty AreasResearch DesignAdolescentAdultChildChild Health ServicesCluster AnalysisFemaleFocus GroupsHumansIndiaInterviews as TopicClustersCommunityCommunity engagementCRTsIndiaMumbai

Identifiers

PMID27020947
PMCPMC4809035

What OpenQuestion holds

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Registered trials

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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.