Test selection, adaptation, and evaluation: a systematic approach to assess nutritional influences on child development in developing countries.

BACKGROUND: Evaluating the impact of nutrition interventions on developmental outcomes in developing countries can be challenging since most assessment tests have been produced in and for developed country settings. Such tests may not be valid measures of children's abilities when used in a new context. AIMS: We present several principles for the selection, adaptation, and evaluation of tests assessing the developmental outcomes of nutrition interventions in developing countries where standard assessment tests do not exist. We then report the application of these principles for a nutrition trial on the Indonesian island of Lombok. SAMPLE: Three hundred children age 22-55 months in Lombok participated in a series of pilot tests for the purpose of test adaptation and evaluation. Four hundred and eighty-seven 42-month-old children in Lombok were tested on the finalized test battery. METHODS: The developmental assessment tests were adapted to the local context and evaluated for a number of psychometric properties, including convergent and discriminant validity, which were measured based on multiple regression models with maternal education, depression, and age predicting each test score. RESULTS: The adapted tests demonstrated satisfactory psychometric properties and the expected pattern of relationships with the three maternal variables. Maternal education significantly predicted all scores but one, maternal depression predicted socio-emotional competence, socio-emotional problems, and vocabulary, while maternal age predicted socio-emotional competence only. CONCLUSION: Following the methodological principles we present resulted in tests that were appropriate for children in Lombok and informative for evaluating the developmental outcomes of nutritional supplementation in the research context. Following this approach in future studies will help to determine which interventions most effectively improve child development in developing countries.

Programmatic effects of a large-scale multiple-micronutrient supplementation trial in Indonesia: using community facilitators as intermediaries for behavior change.

BACKGROUND: Clinical trials can serve as an opportunity gateway for enhanced health benefits to the target population, above and beyond the specific intervention being tested. OBJECTIVE: The Supplementation with Multiple Micronutrients Intervention Trial (SUMMIT), a randomized, controlled clinical trial in Lombok, Indonesia, found that supplementation during pregnancy with multiple micronutrients reduced 90-day infant mortality by nearly 20% as compared with iron-folic acid. This trial was designed as both a program and research trial and used community facilitators to serve as liaisons between the study and the pregnant women. This analysis documents the programmatic impacts of SUMMIT on health-seeking and early infant mortality resulting from community facilitators' field activities. METHODS: Data on compliance, human resource practices, health-seeking, and health outcomes from the 31,290 SUMMIT enrollees were analyzed. RESULTS: Overall compliance with either iron-folic acid or multiple micronutrients was high in the program, at 85.0%. Early prenatal care visits increased significantly. Sixty-three percent of primiparous women used a skilled birth attendant (SBA); among multiparous women, the rate of use of a SBA rose from 35% for the last birth to 53%. Use of a SBA resulted in a 30% reduction in early infant mortality (RR, 0.70; 95% CI, 0.59 to 0.83; p < .0001), independently of any reductions due to multiple micronutrients. The community facilitators played a central role in improving health-seeking; however, the quality of the community facilitators' performance was associated with the impact of the micronutrient supplement on infant health. In a subsample of community facilitators, better-performing facilitators were found to markedly improve the overall impact of the multiple micronutrients on early infant mortality (RR, 0.67; 95% CI, 0.49 to 0.92; p = .0117). In contrast, infants of women with poorly performing community facilitators were found to derive no additional benefit from the multiple micronutrients (RR, 1.04; 95% CI, 0.64 to 1.72; p = .8568). CONCLUSIONS: Systematic enhancements to the quality of implementation of SUMMIT led to significant increases in use of SBAs at delivery, resulting in a 30% reduction in early infant mortality independent of the impact of micronutrient supplementation. Therefore, if women were to consume multiple micronutrients on a regular basis and were to use a SBA at delivery, the risk of early infant mortality could be reduced by nearly 50%. The impacts of community facilitators in effecting changes in women's health behaviors are notable and are applicable to other health programs. Enhancements to program implementation should be driven by evidence, be accountable to the communities the program serves, and be evaluated on the basis of measurable gains in health for women and children.

Assessing the effect of the Expanding Maternal and Neonatal Survival program on improving stabilization and referral for maternal and newborn complications in Indonesia.

OBJECTIVE: To determine if the Expanding Maternal and Neonatal Survival (EMAS) program was associated with improved effectiveness of the referral system in Indonesia to facilitate timely and effective management of complications experienced by women and newborns. METHODS: Poisson regression using longitudinal monitoring data was used to assess the impact of the EMAS program on stabilization practices prior to referral. Data from a nonrandomized quasi-experimental pre-post evaluation study were used to assess the impact of the EMAS program along the referral pathway using χ2 analysis. RESULTS: Monitoring data demonstrated improvements in intervention areas for stabilization of pre-eclampsia/eclampsia (24% vs 61%, incidence rate ratio [IRR] 2.4; 95% confidence interval [CI], 2.3-2.6) and treatment of newborns with suspected severe infection (30% vs 54%, IRR 2.0; 95% CI, 1.6-2.4) prior to referral. The EMAS program was associated with significantly higher levels of communication, advanced notification, back referral, and hospital emergency readiness and staff preparedness compared with the comparison arm. CONCLUSION: The EMAS program contributed to improvements in the management of obstetric and newborn complications, including communication, transportation, and preparation of pregnant mothers in need of referral and hospital emergency readiness and staff preparedness.

The effect of Expanding Maternal and Neonatal Survival interventions on improving the coverage of labor monitoring and complication prevention practices in hospitals in Indonesia: A difference-in-difference analysis.

OBJECTIVE: To assess whether the Expanding Maternal and Neonatal Survival (EMAS) program was associated with improved care provided during hospital-based childbirth. METHODS: A quasi-experimental study with two rounds of data collection examined whether EMAS interventions improved facility-based labor and childbirth care. Direct clinical observations were conducted for 1208 deliveries across 13 hospitals in 12 districts. Primary outcome measures included implementation of standard practices to reduce the risk of complications during labor and childbirth for both women and newborns. RESULTS: Adjusted difference-in-difference analysis compared the mean difference in quality scores between EMAS intervention hospitals and comparison sites and consistently found significantly better performance in EMAS sites: 14 points higher for labor monitoring (ß-coefficient 14.1; 95% confidence interval [CI], 7.1-21.0); 38 points higher for newborn resuscitation readiness (ß-coefficient 38.1; 95% CI, 31.1-45.2); and 33 points higher for infection prevention practices (ß-coefficient 32.6; 95% CI, 28.5-36.8). CONCLUSION: EMAS approaches emphasizing facility readiness and adherence to performance standards significantly improved labor monitoring and complication prevention practices during childbirth.

Maternal multiple micronutrient supplementation and other biomedical and socioenvironmental influences on children's cognition at age 9-12 years in Indonesia: follow-up of the SUMMIT randomised trial.

BACKGROUND: Brain and cognitive development during the first 1000 days from conception are affected by multiple biomedical and socioenvironmental determinants including nutrition, health, nurturing, and stimulation. An improved understanding of the long-term influence of these factors is needed to prioritise public health investments to optimise human development. METHODS: We did a follow-up study of the Supplementation with Multiple Micronutrients Intervention Trial (SUMMIT), a double-blind, cluster-randomised trial of maternal supplementation with multiple micronutrients (MMN) or iron and folic acid (IFA) in Indonesia. Of 27 356 live infants from birth to 3 months of age in 2001-04, we re-enrolled 19 274 (70%) children at age 9-12 years, and randomly selected 2879 from the 18 230 who were attending school at a known location. Of these, 574 children were oversampled from mothers who were anaemic or malnourished at SUMMIT enrolment. We assessed the effects of MMN and associations of biomedical (ie, maternal and child anthropometry and haemoglobin and preterm birth) and socioenvironmental determinants (ie, parental education, socioeconomic status, home environment, and maternal depression) on general intellectual ability, declarative memory, procedural memory, executive function, academic achievement, fine motor dexterity, and socioemotional health. The SUMMIT trial was registered, number ISRCTN34151616. FINDINGS: Children of mothers given MMN had a mean score of 0·11 SD (95% CI 0·01-0·20, p=0·0319) higher in procedural memory than those given IFA, equivalent to the increase in scores with half a year of schooling. Children of anaemic mothers in the MMN group scored 0·18 SD (0·06-0·31, p=0·0047) higher in general intellectual ability, similar to the increase with 1 year of schooling. Overall, 18 of 21 tests showed a positive coefficient of MMN versus IFA (p=0·0431) with effect sizes from 0·00-0·18 SD. In multiple regression models, socioenvironmental determinants had coefficients of 0·00-0·43 SD and 22 of 35 tests were significant at the 95% CI level, whereas biomedical coefficients were 0·00-0·10 SD and eight of 56 tests were significant, indicating larger and more consistent impact of socioenvironmental factors (p<0·0001). INTERPRETATION: Maternal MMN had long-term benefits for child cognitive development at 9-12 years of age, thereby supporting its role in early childhood development, and policy change toward MMN. The stronger association of socioenvironmental determinants with improved cognition suggests present reproductive, maternal, neonatal, and child health programmes focused on biomedical determinants might not sufficiently enhance child cognition, and that programmes addressing socioenvironmental determinants are essential to achieve thriving populations. FUNDING: Grand Challenges Canada Saving Brains Program.