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Background Globally, nearly 250 million children (43% of all children under 5 years of age) are at risk of compromised neurodevelopment due to poverty, stunting, and lack of stimulation. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved infant and young child feeding (IYCF) on early child development (ECD) among children enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe. Methods and findings SHINE was a cluster-randomized community-based 2×2 factorial trial. A total of 5,280 pregnant women were enrolled from 211 clusters (defined as the catchment area of 1–4 village health workers [VHWs] employed by the Zimbabwean Ministry of Health and Child Care). Clusters were randomly allocated to standard of care, IYCF (20 g of small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counseling), WASH (ventilated improved pit latrine, handwashing stations, chlorine, liquid soap, and play yard), and WASH + IYCF. Primary outcomes were child length-for-age Z-score and hemoglobin concentration at 18 months of age. Children who completed the 18-month visit and turned 2 years (102–112 weeks) between March 1, 2016, and April 30, 2017, were eligible for the ECD substudy. We prespecified that primary inferences would be drawn from findings of children born to HIV-negative mothers; these results are presented in this paper. A total of 1,655 HIV-unexposed children (64% of those eligible) were recruited into the ECD substudy from 206 clusters and evaluated for ECD at 2 years of age using the Malawi Developmental Assessment Tool (MDAT) to assess gross motor, fine motor, language, and social skills; the MacArthur–Bates Communicative Development Inventories (CDI) to assess vocabulary and grammar; the A-not-B test to assess object permanence; and a self-control task. Outcomes were analyzed in the intention-to-treat population. For all ECD outcomes, there was not a statistical interaction between the IYCF and WASH interventions, so we estimated the effects of the interventions by comparing the 2 IYCF groups with the 2 non-IYCF groups and the 2 WASH groups with the 2 non-WASH groups. The mean (95% CI) total MDAT score was modestly higher in the IYCF groups compared to the non-IYCF groups in unadjusted analysis: 1.35 (0.24, 2.46; p = 0.017); this difference did not persist in adjusted analysis: 0.79 (−0.22, 1.68; p = 0.057). There was no evidence of impact of the IYCF intervention on the CDI, A-not-B, or self-control tests. Among children in the WASH groups compared to those in the non-WASH groups, mean scores were not different for the MDAT, A-not-B, or self-control tests; mean CDI score was not different in unadjusted analysis (0.99 [95% CI −1.18, 3.17]) but was higher in children in the WASH groups in adjusted analysis (1.81 [0.01, 3.61]). The main limitation of the study was the specific time window for substudy recruitment, meaning not all children from the main trial were enrolled. Conclusions We found little evidence that the IYCF and WASH interventions implemented in SHINE caused clinically important improvements in child development at 2 years of age. Interventions that directly target neurodevelopment (e.g., early stimulation) or that more comprehensively address the multifactorial nature of neurodevelopment may be required to support healthy development of vulnerable children. Trial registration ClinicalTrials.gov NCT01824940, In this substudy from a 2x2 factorial cluster-randomized trial, Melissa Gladstone and colleagues assess whether improved WASH and/or feeding provide a benefit to early child development., Author summary Why was this study done? Some 43% of children globally fail to reach their full developmental potential due to stunting and poverty. Current evidence shows that improved nutrition has a modest effect on early child development. Improving water, sanitation, and hygiene (WASH) may plausibly benefit neurodevelopment through reduced illness and improved gut health (through improving nutrient absorption and optimizing gut–brain communication). What did the researchers do and find? The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial tested the individual and combined effects of improved complementary feeding (provision of a small quantity of lipid-based nutrient supplement from 6 to 18 months of age, with complementary feeding counseling) and improved household WASH (provision of a pit latrine, handwashing stations, soap, chlorine, and hygiene counseling) on early child development at 24 months. In all, 1,655 children born to HIV-negative women were assessed for gross motor, fine motor, language, cognitive, and social development using tools that were designed and adapted for rural Zimbabwe. We found little evidence that the complementary feeding or WASH interventions tested improved child neurodevelopment at 2 years of age. What do these findings mean? Complementary feeding and WASH interventions (as described above) may not have a clinically significant impact on child neurodevelopment. More holistic approaches and interventions that explicitly target early child development may be needed to substantially impact child neurodevelopment.

Introduction Inequalities in maternal and newborn health persist in many high-income countries, including for women of refugee background. The Bridging the Gap partnership programme in Victoria, Australia, was designed to find new ways to improve the responsiveness of universal maternity and early child health services for women and families of refugee background with the codesign and implementation of iterative quality improvement and demonstration initiatives. One goal of this ‘whole-of-system’ approach was to improve access to antenatal care. The objective of this paper is to report refugee women’s access to hospital-based antenatal care over the period of health system reforms. Methods and findings The study was designed using an interrupted time series analysis using routinely collected data from two hospital networks (four maternity hospitals) at 6-month intervals during reform activity (January 2014 to December 2016). The sample included women of refugee background and a comparison group of Australian-born women giving birth over the 3 years. We describe the proportions of women of refugee background (1) attending seven or more antenatal visits and (2) attending their first hospital visit at less than 16 weeks’ gestation compared over time and to Australian-born women using logistic regression analyses. In total, 10% of births at participating hospitals were to women of refugee background. Refugee women were born in over 35 countries, and at one participating hospital, 40% required an interpreter. Compared with Australian-born women, women of refugee background were of similar age at the time of birth and were more likely to be having their second or subsequent baby and have four or more children. At baseline, 60% of refugee-background women and Australian-born women attended seven or more antenatal visits. Similar trends of improvement over the 6-month time intervals were observed for both populations, increasing to 80% of women at one hospital network having seven or more visits at the final data collection period and 73% at the other network. In contrast, there was a steady decrease in the proportion of women having their first hospital visit at less than 16 weeks’ gestation, which was most marked for women of refugee background. Using an interrupted time series of observational data over the period of improvement is limited compared with using a randomisation design, which was not feasible in this setting. Conclusions Accurate ascertainment of ‘harder-to-reach’ populations and ongoing monitoring of quality improvement initiatives are essential to understand the impact of system reforms. Our findings suggest that improvement in total antenatal visits may have been at the expense of recommended access to public hospital antenatal care within 16 weeks of gestation., Jane Yelland and colleagues report refugee women's access to antenatal services in Australia during a period of health systems reform., Author summary Why was the study done? Women of refugee background have rates of stillbirth and perinatal mortality two to three times higher than Australian-born women. Antenatal care is a key preventive strategy for the optimal health of pregnant women and newborn babies and is critical to addressing modifiable factors for poor health outcomes. Refugee women experience barriers in accessing and engaging in antenatal care, and healthcare providers report challenges in responding to the social context and needs of refugee families. What did the researchers do and find? We codesigned and implemented multiple quality improvement and demonstration initiatives in universal health services, including four maternity hospitals. We used an interrupted time series design to assess the timing and number of antenatal clinical visits for refugee women compared with Australian-born women over 3 years of reform. Applying a method devised by the partnership, we identified from routinely collected data that 10% of all women giving birth at the participating hospitals were of refugee background. There was an increase over time in the proportion of refugee and Australian-born women attending the standard number of visits, with women of refugee background commencing hospital antenatal care well past the recommended gestation. What do these findings mean? For women of refugee background, delayed access to hospital-based care increases the likelihood of missing out on critical elements of pregnancy care vital to optimising maternal and child outcomes. Accurate ascertainment of this ‘harder-to-reach’ population is essential to evaluating the impact of quality improvement initiatives on refugee families’ access to healthcare. An interrupted time series design with a comparison group is suited to measuring change in number and timing of antenatal visits, although data quality, contextual influences, and qualitative insights into system change are important for interpreting outcomes. Ongoing monitoring of quality improvement initiatives on populations vulnerable to poor health outcomes is essential to understand the impact of system reforms and efforts to reduce inequalities.

Summary Two views exist of medical science: one emphasises discovery and explanation, the other emphasises evaluation of interventions. This essay analyses in what respects these views differ, and how they lead to opposite research hierarchies, with randomisation on top for evaluation and at bottom for discovery and explanation. The two views also differ strongly in their thinking about the role of prior specification of a research hypothesis. Hence, the essay explores the controversies surrounding subgroup analyses and multiplicity of analyses in observational research. This exploration leads to a rethinking of the universally accepted hierarchy of strength of study designs, which has the randomised trial on top: this hierarchy may be confounded by the prior odds of the research hypothesis. Finally, the strong opinions that are sometimes displayed in pitting the two types of medical science against each other may be explained by a difference in “loss function”: the difference in penalty for being wrong. A longer, more detailed version of this paper is found in supplementary Text S1.