“Every Newborn-INDEPTH” (EN-INDEPTH) study protocol for a randomised comparison of household survey modules for measuring stillbirths and neonatal deaths in five Health and Demographic Surveillance sites

Background: Under-five and maternal mortality were halved in the Millennium Development Goals (MDG) era, with slower reductions for 2.6 million neonatal deaths and 2.6 million stillbirths. The Every Newborn Action Plan aims to accelerate progress towards national targets, and includes an ambitious Measurement Improvement Roadmap. Population-based household surveys, notably Demographic and Health Surveys (DHS) and Multiple Indicator Cluster Surveys, are major sources of population-level data on child mortality in countries with weaker civil registration and vital statistics systems, where over two-thirds of global child deaths occur. To estimate neonatal/child mortality and pregnancy outcomes (stillbirths, miscarriages, birthweight, gestational age) the most common direct methods are: (1) the standard DHS-7 with Full Birth History with additional questions on pregnancy losses in the past 5 years (FBH+) or (2) a Full Pregnancy History (FPH). No direct comparison of these two methods has been undertaken, although descriptive analyses suggest that the FBH+ may underestimate mortality rates particularly for stillbirths. Methods: This is the protocol paper for the Every Newborn-INDEPTH study (INDEPTH Network, International Network for the Demographic Evaluation of Populations and their Health Every Newborn, Every Newborn Action Plan), aiming to undertake a randomised comparison of FBH+ and FPH to measure pregnancy outcomes in a household survey in five selected INDEPTH Network sites in Africa and South Asia (Bandim in urban and rural Guinea-Bissau; Dabat in Ethiopia; IgangaMayuge in Uganda; Kintampo in Ghana; Matlab in Bangladesh). The survey will reach >68 000 pregnancies to assess if there is ≥15% difference in stillbirth rates. Additional questions will capture birthweight, gestational age, birth/death certification, termination of pregnancy and fertility intentions. The World Bank's Survey Solutions platform will be tailored for data collection, including recording paradata to evaluate timing. A mixed methods assessment of barriers and enablers to reporting of pregnancy and adverse pregnancy outcomes will be undertaken. Conclusions: This large-scale study is the first randomised comparison of these two methods to capture pregnancy outcomes. Results are expected to inform the evidence base for survey methodology, especially in DHS, regarding capture of stillbirths and other outcomes, notably neonatal deaths, abortions (spontaneous and induced), birthweight and gestational age. In addition, this study will inform strategies to improve health and demographic surveillance capture of neonatal/child mortality and pregnancy outcomes.Children’s Investment Fund Foundation (CIFF

Community engagement in biomedical research in an African setting: the Kintampo Health Research Centre experience.

BACKGROUND: Community engagement (CE) is becoming relevant in health research activities; however, models for CE in health research are limited in developing countries. The Kintampo Health Research Centre (KHRC) conducts research to influence health policy locally and also internationally. Since its establishment in 1994 with the mandate of conducting relevant public health studies in the middle part of Ghana, KHRC has embarked on a series of clinical and operational studies involving community members. In these studies, community members have been engaged through community durbars before, during and also after all study implementations. Lessons learnt from these activities suggested the need to embark on further CE processes that could serve as a model for emerging research institutions based in African communities. METHODS: Interactive community durbars, workshops, in-depth discussions, focus group discussions and radio interactions were used as the main methods in the CE process. RESULTS: Community members outlined areas of research that they perceived as being of interest to them. Though community members expressed continual interest in our traditional areas of research in communicable, maternal, neonatal and child health, they were interested in new areas such as non- communicable diseases such as diabetes and hypertension. Misconceptions about KHRC and its research activities were identified and clarified. This research provided KHRC the opportunity to improve communication guidelines with the community and these are being used in engaging the community at various stages of our research, thus improving on the design and implementation of research. CONCLUSION: KHRC has developed a culturally appropriate CE model based on mutual understanding with community members. The experience obtained in the CE process has contributed to building CE capacity in KHRC. Other health research institutions in developing countries could consider the experiences gained

Randomised comparison of two household survey modules for measuring stillbirths and neonatal deaths in five countries: the Every Newborn-INDEPTH study.

BACKGROUND: An estimated 5·1 million stillbirths and neonatal deaths occur annually. Household surveys, most notably the Demographic and Health Survey (DHS), run in more than 90 countries and are the main data source from the highest burden regions, but data-quality concerns remain. We aimed to compare two questionnaires: a full birth history module with additional questions on pregnancy losses (FBH+; the current DHS standard) and a full pregnancy history module (FPH), which collects information on all livebirths, stillbirths, miscarriages, and neonatal deaths. METHODS: Women residing in five Health and Demographic Surveillance System sites within the INDEPTH Network (Bandim in Guinea-Bissau, Dabat in Ethiopia, IgangaMayuge in Uganda, Matlab in Bangladesh, and Kintampo in Ghana) were randomly assigned (individually) to be interviewed using either FBH+ or FPH between July 28, 2017, and Aug 13, 2018. The primary outcomes were stillbirths and neonatal deaths in the 5 years before the survey interview (measured by stillbirth rate [SBR] and neonatal mortality rate [NMR]) and mean time taken to complete the maternity history section of the questionnaire. We also assessed between-site heterogeneity. This study is registered with the Research Registry, 4720. FINDINGS: 69 176 women were allocated to be interviewed by either FBH+ (n=34 805) or FPH (n=34 371). The mean time taken to complete FPH (10·5 min) was longer than for FBH+ (9·1 min; p<0·0001). Using FPH, the estimated SBR was 17·4 per 1000 total births, 21% (95% CI -10 to 62) higher than with FBH+ (15·2 per 1000 total births; p=0·20) in the 5 years preceding the survey interview. There was strong evidence of between-site heterogeneity (I2=80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites. The estimated NMR did not differ between modules (FPH 25·1 per 1000 livebirths vs FBH+ 25·4 per 1000 livebirths), with no evidence of between-site heterogeneity (I2=0·7%; p=0·40). INTERPRETATION: FPH takes an average of 1·4 min longer to complete than does FBH+, but has the potential to increase reporting of stillbirths in high burden contexts. The between-site heterogeneity we found might reflect variations in interviewer training and survey implementation, emphasising the importance of interviewer skills, training, and consistent implementation in data quality. FUNDING: Children's Investment Fund Foundation

Status of birth and pregnancy outcome capture in Health Demographic Surveillance Sites in 13 countries

Objectives: We compared pregnancy identification methods and outcome capture across 31 Health Demographic Surveillance System (HDSS) sites in 14 countries in sub-Saharan Africa and Asia. Methods: From 2009 to 2014, details on the sites and surveillance systems including frequency of update rounds, characteristics of enumerators and interviewers, acceptable respondents were collected and compared across sites. Results: The 31 HDSS had a combined population of over 2,905,602 with 165,820 births for the period. Stillbirth rate ranged from 1.9 to 42.6 deaths per 1000 total births and the neonatal mortality rate from 2.6 to 41.6 per 1000 live births. Three quarters (75.3%) of recorded neonatal deaths occurred in the first week of life. The proportion of infant deaths that occurred in the neonatal period ranged from 8 to 83%, with a median of 53%. Sites that registered pregnancies upon locating a live baby in the routine household surveillance round had lower recorded mortality rates. Conclusions: Increased attention and standardization of pregnancy surveillance and the time of birth will improve data collection and provide platforms for evaluations and availability of data for decision-making with implications for national planning.</p

Status of birth and pregnancy outcome capture in Health Demographic Surveillance Sites in 13 countries

Objectives: We compared pregnancy identification methods and outcome capture across 31 Health Demographic Surveillance System (HDSS) sites in 14 countries in sub-Saharan Africa and Asia. Methods: From 2009 to 2014, details on the sites and surveillance systems including frequency of update rounds, characteristics of enumerators and interviewers, acceptable respondents were collected and compared across sites. Results: The 31 HDSS had a combined population of over 2,905,602 with 165,820 births for the period. Stillbirth rate ranged from 1.9 to 42.6 deaths per 1000 total births and the neonatal mortality rate from 2.6 to 41.6 per 1000 live births. Three quarters (75.3%) of recorded neonatal deaths occurred in the first week of life. The proportion of infant deaths that occurred in the neonatal period ranged from 8 to 83%, with a median of 53%. Sites that registered pregnancies upon locating a live baby in the routine household surveillance round had lower recorded mortality rates. Conclusions: Increased attention and standardization of pregnancy surveillance and the time of birth will improve data collection and provide platforms for evaluations and availability of data for decision-making with implications for national planning.</p