title: Home-based management of severely acute malnutrition: feasibility of ethically designed, community-based randomised clinical trials.
abstract: The Indian Council of Medical Research had, on May 31, 2011, called for research proposals on severely acute malnourished (SAM) children to generate evidence for the development of practical and scalable regimens to medically rehabilitate children suffering from SAM, without serious complications, at the home/community level and/or peripheral inpatient facilities. The primary outcomes of the proposed research study are recovery from SAM in the short term, as well as sustenance of recovery (for at least six months after the initiation of treatment). The secondary outcomes are the acceptability, feasibility and safety of the regimes being tested. It was suggested that the studies be designed as individual or cluster randomised or quasi randomised controlled trials (RCTs). This paper analyses the methodological, operational, and most importantly, ethical challenges and implications of conducting community-based RCTs involving SAM children. The paper dwells in detail on why and how the RCT design is inappropriate and unsuitable for studying the effectiveness of home-based management of SAM children in the community.
authors.affiliation: School of Public Health, SRM University, Potheri-Kattankulathur, Chennai 603 203, India,. rajanpatil@yahoo.com.
authors.forename: Rajan R
authors.initials: RR
authors.lastname: Patil
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D015362:Child Nutrition Disorders / Q000628:therapy*; D055812:Community-Based Participatory Research; D019468:Disease Management; D032984:Ethics, Research; D005240:Feasibility Studies; D006268:Health Facilities; D006699:Home Care Services; D006801:Humans; D007194:India; D044342:Malnutrition / Q000628:therapy*; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012111:Residence Characteristics