Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of ­ and responsibility for ­ group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

Feasibility of kangaroo mother care in Mumbai.

OBJECTIVE: The purpose of this study was to determine the feasibility and acceptability of kangaroo care in a tertiary care hospital in India. METHODS: A randomized controlled trial was performed over one year period in which 89 neonates were randomized into two groups kangaroo mother care (KMC) and conventional method of care (CMC). RESULTS: Forty-four babies were randomized into KMC group and 45 to CMC. There was significant reduction in KMC vs CMC group of hypothermia (10/44 vs 21/45, p-value < 0.01), higher oxygen saturations (95.7 vs 94.8%, p-value < 0.01) and decrease in respiratory rates (36.2 vs 40.7, p-value < 0.01). There were no statistically significant differences in the incidence of hyperthermia, sepsis, apnea, onset of breastfeeding and hospital stay in two groups. 79% of mothers felt comfortable during the KMC and 73% felt they would be able to give KMC at home. KMC is feasible, as mothers are already admitted in hospitals and are involved in the care of newborn. CONCLUSION: KMC is a simple and feasible intervention; acceptable to most mothers admitted in hospitals. There may be benefits in terms of reducing the incidence of hypothermia with no adverse effects of KMC demonstrated in the study. The present study has important implications in the care of LBW infants in the developing countries, where expensive facilities for conventional care may not be available at all place.

Urban slum-specific issues in neonatal survival.

Urbanization is rapidly spreading throughout the developing world. An urban slum poses special health problems due to poverty, overcrowding, unhygienic surroundings and lack of an organized health Infrastructure. The primary causes of neonatal mortality are sepsis, perinatal asphyxia and prematurity. Home deliveries, late recognition of neonatal illness, delay in seeking medical help and inappropriate treatment contribute to neonatal mortality. Measures to reduce neonatal mortality in urban slums should focus on health education, improvement of antenatal practices, institutional deliveries, and ensuring quality perinatal care. Success of a comprehensive health strategy would require planned health infrastructure, strengthening and unification of existing health care program and facilities; forming a system of referral and developing a program with active participation of the community.