Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.
Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.
Results A randomised trial can usefully be classified as ‘health equity relevant’ if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as ‘health equity relevant’ may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies.
Conclusion The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.
randomized controlled trials
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Objective To examine gender differences in infant survival on the first day of life, in the first week of life, and in the neonatal and post-neonatal periods by socio-demographic and economic variables.
Design Secondary data analysis was performed on data from a cluster randomised trial on the effect of implementation of the Integrated Management of Neonatal and Childhood Illness programme, India.
Settings The study setting was Palwal and Faridabad, districts of Haryana, a state in North India.
Measures Multiple logistic regression models taking the cluster design into account were used to estimate gender differences in mortality in different periods of infancy.
Results A total of 60 480 infants were included in these analyses. Of 4060 infant deaths, 2054 were female (7.2% of all females born) and 2006 were male (6.3% of all males born). The death rate was significantly higher in females in the post-neonatal period but not during the neonatal period. The odds of death at 29–180 days and at 181–365 days were 1.4 (95% CI 1.3 to 1.6) and 1.7 (95% CI: 1.4 to 2.0) higher in females compared with males, respectively. This increase was seen across all socio-demographic and economic strata.
Conclusion Gender differences during the post-neonatal period are a major threat to the survival and health of female infants in India. Programmes need to identify measures that can specifically reduce female mortality.
BACKGROUND: Around 70% neonatal deaths occur in low birth weight (LBW) babies. Globally, 15% of babies are born with LBW. Kangaroo Mother Care (KMC) appears to be an effective way to reduce mortality and morbidity among LBW babies. KMC comprises of early and continuous skin-to-skin contact between mother and baby as well as exclusive breastfeeding. Evidence derived from hospital-based studies shows that KMC results in a 40% relative reduction in mortality, a 58% relative reduction in the risk of nosocomial infections or sepsis, shorter hospital stay, and a lower risk of lower respiratory tract infections in babies with birth weight <2000 g. There has been considerable interest in KMC initiated outside health facilities for LBW babies born at home or discharged early. Currently, there is insufficient evidence to support initiation of KMC in the community (cKMC). Formative research in our study setting, where 24% of babies are born with LBW, demonstrated that KMC is feasible and acceptable when initiated at home for LBW babies. The aim of this trial is to determine the impact of cKMC on the survival of these babies.
METHODS/DESIGN: This randomized controlled trial is being undertaken in the Palwal and Faridabad districts in the State of Haryana, India. Neonates weighing 1500-2250 g identified within 3 days of birth and their mothers are being enrolled. Other inclusion criteria are that the family is likely to be available in the study area over the next 6 months, that KMC was not initiated in the delivery facility, and that the infant does not have an illness requiring hospitalization. Eligible neonates are randomized into intervention and control groups. The intervention is delivered through home visits during the first month of life by study workers with a background and education similar to that of workers in the government health system. An independent study team collects mortality and morbidity data as well as anthropometric measurements during periodic home visits. The primary outcomes of the study are postenrollment neonatal mortality and mortality between enrollment and 6 months of age. The secondary outcomes are breastfeeding practices; prevalence of illnesses and care-seeking practices for the same; hospitalizations; weight and length gain; and, in a subsample, neurodevelopment.
DISCUSSION: This efficacy trial will answer the question whether the benefits of KMC observed in hospital settings can also be observed when KMC is started in the community. The formative research used for intervention development suggests that the necessary high level of KMC adoption can be reached in the community, addressing a problem that seriously constrained conclusions in the only other trial in which researchers examined the benefits of cKMC.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02653534. Registered on 26 December 2015 (retrospectively registered).
KEYWORDS: Community-initiated Kangaroo Mother Care; Low birth weight babies; Mortality