Related Experiment Video
Updated: Apr 12, 2026
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Home-based management of severely acute malnutrition: feasibility of ethically designed, community-based randomised
1School of Public Health, SRM University, Potheri-Kattankulathur, Chennai 603 203, India,. rajanpatil@yahoo.com.
Insights
Randomized controlled trials (RCTs) are unsuitable for studying home-based management of severely acute malnourished (SAM) children. This paper highlights the ethical and methodological challenges of using RCTs in community-based research for SAM children.
Area of Science:
- Pediatrics
- Public Health
- Clinical Trials
Background:
- The Indian Council of Medical Research sought evidence for home-based rehabilitation of severely acute malnourished (SAM) children.
- Research proposals focused on practical, scalable regimens for SAM children without serious complications.
Purpose of the Study:
- To analyze the methodological, operational, and ethical challenges of community-based randomized controlled trials (RCTs) involving SAM children.
- To critically evaluate the suitability of RCT designs for home-based management of SAM.
Main Methods:
- Analysis of methodological, operational, and ethical implications.
- Critique of the randomized controlled trial (RCT) design for community-based research.
Main Results:
- The paper argues that RCTs are inappropriate and unsuitable for studying the effectiveness of home-based management of SAM children in the community.
- Significant ethical and operational challenges exist in applying RCTs to this population.
Conclusions:
- The randomized controlled trial (RCT) design presents substantial challenges for ethically and effectively evaluating home-based interventions for severely acute malnourished (SAM) children.
- Alternative research designs may be more appropriate for community-based SAM management studies.
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.
Related Concept Videos
01:30Community Based Intervention
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...