title: Reconstructing communities in cluster trials?
abstract: BACKGROUND
  There 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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Residents' 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.
  
  
  CONCLUSIONS
  We 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.
  
  
  BACKGROUND
  ISRCTN Register: ISRCTN56183183 Clinical Trials Registry of India: CTRI/2012/09/003004 .
authors.affiliation: University College London, London, UK.
authors.forename: Sapfo
authors.initials: S
authors.lastname: Lignou
authors.affiliation: Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, 400017, Maharashtra, India.
authors.forename: Sushmita
authors.initials: S
authors.lastname: Das
authors.affiliation: Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, 400017, Maharashtra, India.
authors.forename: Jigna
authors.initials: J
authors.lastname: Mistry
authors.affiliation: Institute for Global Health, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
authors.forename: Glyn
authors.initials: G
authors.lastname: Alcock
authors.affiliation: Society for Nutrition, Education and Health Action (SNEHA), Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, 400017, Maharashtra, India.
authors.forename: Neena Shah
authors.initials: NS
authors.lastname: More
authors.affiliation: Institute for Global Health, Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
authors.forename: David
authors.initials: D
authors.lastname: Osrin
authors.affiliation: University College London, London, UK. sarah.edwards@ucl.ac.uk.
authors.forename: Sarah J L
authors.initials: SJ
authors.lastname: Edwards
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002662:Child Health Services; D016000:Cluster Analysis; D003153:Community Health Services; D003159:Community-Institutional Relations; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007194:India; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D044623:Nutrition Therapy; D010358:Patient Participation; D010465:Perception; D011204:Poverty Areas; D012107:Research Design; D035842:Research Subjects / Q000523:psychology*; D014932:Women's Health Services; D055815:Young Adult
keywords: CRTs; Clusters; Community; Community engagement; India; Mumbai