Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.

Studies using real-world data (RWD) can complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This review presents the experience resulting from the European Medicines Agency (EMA) pilot to generate RWE to support evaluations by EU regulators and down-stream decision makers from September 2021 to February 2023. A total of 61 research topics were identified for RWE generation during this period, covering a wide range of research questions, primarily generating evidence on medicines safety (22, 36%), followed by questions on the design and feasibility of clinical trials (11, 18%), drug utilization (10, 16%), clinical management (10, 16%), and disease epidemiology.

Preeclampsia prediction with blood pressure measurements: A global external validation of the ALSPAC models.

Objective: The prediction of preeclampsia in pregnancy has resulted in a plethora of prognostic models. Yet, very few make it past the development stage and most fail to influence clinical practice. The timely identification of high-risk pregnant women could deliver a tailored antenatal care regimen, particularly in low-resource settings.

The role of individual, household, and area of residence factors on self-rated health in Colombian adults: A multilevel study.

Introduction: Self-rated health is strongly associated with morbidity and mortality. It is largely influenced by individual factors but also by individuals' social surroundings and environment.

Objective: To investigate individual, household, and locality factors associated with self-rated ealth in Colombian adults.

Trends in socioeconomic inequalities in stunting prevalence in Latin America and the Caribbean countries: differences between quintiles and deciles.

Background: With the adoption of the Sustainable Development Goals (SDGs), there is a renewed commitment of tackling the varied challenges of undernutrition, particularly stunting (SDG 2.2). Health equity is also a priority in the SDG agenda and there is an urgent need for disaggregated analyses to identify disadvantaged subgroups.

Ethnic group inequalities in coverage with reproductive, maternal and child health interventions: cross-sectional analyses of national surveys in 16 Latin American and Caribbean countries.

Background: Latin American and Caribbean populations include three main ethnic groups: indigenous people, people of African descent, and people of European descent. We investigated ethnic inequalities among these groups in population coverage with reproductive, maternal, newborn, and child health interventions.

Methods: We analysed 16 standardised, nationally representative surveys carried out from 2004 to 2015 in Latin America and the Caribbean that provided information on ethnicity or a proxy indicator (household language or skin colour) and on coverage of reproductive, maternal, newborn, and child health interventions.

Measurement of social inequalities in health: concepts and methodological approaches in the Brazilian context.

This study aims to describe methodological approaches to measure and monitor health inequalities and to illustrate their applicability. The measures most frequently used in the literature were reviewed. Data on coverage and quality of pre-natal care in Brazil, from the Demographic and Maternal and Child Health Survey (PNDS-2006) and the National Health Survey (PNS-2013) were used to illustrate their applicability.

Growth across life course and cardiovascular risk markers in 18-year-old adolescents: the 1993 Pelotas birth cohort.

Objective: To evaluate the association between growth trajectories from birth to adolescence and cardiovascular risk marker levels at age 18 years in a population-based cohort. In order to disentangle the effect of weight gain from that of height gain, growth was analysed using conditional weight relative to linear growth (CWh) and conditional length/height (CH).

Design: Prospective study.

Prevalence of erectile dysfunction oral drugs use in a city of southern Brazil.

The last decade has seen a breakthrough in the treatment of erectile dysfunction (ED) with the advent of phosphodiesterase-5 inhibitors. There are few population-based observational studies on the prevalence of use of these drugs. We conducted a cross-sectional population-based study in the city of Pelotas (Brazil).

Socioeconomic inequalities in skilled birth attendance and child stunting in selected low and middle income countries: Wealth quintiles or deciles?

Background: Wealth quintiles derived from household asset indices are routinely used for measuring socioeconomic inequalities in the health of women and children in low and middle-income countries. We explore whether the use of wealth deciles rather than quintiles may be advantageous.

Methods: We selected 46 countries with available national surveys carried out between 2003 and 2013 and with a sample size of at least 3000 children.

Summary indices for monitoring universal coverage in maternal and child health care.

Objective: To compare two summary indicators for monitoring universal coverage of reproductive, maternal, newborn and child health care.

Methods: Using our experience of the Countdown to 2015 initiative, we describe the characteristics of the composite coverage index (a weighted average of eight preventive and curative interventions along the continuum of care) and co-coverage index (a cumulative count of eight preventive interventions that should be received by all mothers and children). For in-depth analysis and comparisons, we extracted data from 49 demographic and health surveys.

Coverage and equity in reproductive and maternal health interventions in Brazil: impressive progress following the implementation of the Unified Health System.

Background: The Brazilian SUS (Unified Health System) was created in 1988 within the new constitution, based on the premises of being universal, comprehensive, and equitable. The SUS offers free health care, independent of contribution or affiliation. Since then, great efforts and increasing investments have been made for the system to achieve its goals.

Maternal mortality in Brazil from 2001 to 2012: time trends and regional differences.

Objective:: To assess time trends in maternal mortality in Brazil and its five geographical regions from 2001 to 2012, as well as to describe its main causes.

Methods:: This is a time series analysis, from data obtained in the Mortality Information System (SIM) and in the Live Births Information System (SINASC). Maternal mortality ratio (MMR) and causes of maternal death were described according to the categories of the Tenth Revision of the International Classification of Diseases, in the years 2001, 2006, and 2011.

Inequalities in full immunization coverage: trends in low- and middle-income countries.

Objective: To investigate disparities in full immunization coverage across and within 86 low- and middle-income countries.

Methods: In May 2015, using data from the most recent Demographic and Health Surveys and Multiple Indicator Cluster Surveys, we investigated inequalities in full immunization coverage - i.e.

[Trends and inequalities in risk behaviors among adolescents: a comparison of birth cohorts in Pelotas, Rio Grande do Sul State, Brazil].

This study focuses on trends and inequalities in health risk behaviors among adolescents. A cross-sectional study compared two birth cohorts in the city of Pelotas, Rio Grande do Sul State, Brazil. The sample included 1,281 adolescents from the 1982 cohort and 4,106 from the 1993 cohort, followed in 2001 and 2011, respectively.

Remaining missed opportunities of child survival in Peru: modelling mortality impact of universal and equitable coverage of proven interventions.

Background: Peru has made great improvements in reducing stunting and child mortality in the past decade, and has reached the Millennium Development Goals 1 and 4. The remaining challenges or missed opportunities for child survival needs to be identified and quantified, in order to guide the next steps to further improve child survival in Peru.

Methods: We used the Lives Saved Tool (LiST) to project the mortality impact of proven interventions reaching every women and child in need, and the mortality impact of eliminating inequalities in coverage distribution between wealth quintiles and urban-rural residence.

Distribution of Glycated Haemoglobin According to Early-Life and Contemporary Characteristics in Adolescents and Adults without Diabetes: The 1982 and 1993 Pelotas Birth Cohorts.

Aim: Glycated haemoglobin (HbA1c), a marker of glucose control in individuals with diabetes mellitus, is also related with the incidence of cardiometabolic risk in populations free of disease. The aim of this study was to describe the distribution of HbA1c levels according to early-life and contemporary factors in adolescents and adults without diabetes mellitus.

Methods: HbA1c was measured in adults aged 30 years and adolescents aged 18 years who are participants in the 1982 and 1993 Pelotas Birth Cohorts, respectively.

Who Delivers without Water? A Multi Country Analysis of Water and Sanitation in the Childbirth Environment.

Background And Objectives: Hygiene during childbirth is essential to the health of mothers and newborns, irrespective of where birth takes place. This paper investigates the status of water and sanitation in both the home and facility childbirth environments, and for whom and where this is a more significant problem.

Methods: We used three datasets: a global dataset, with information on the home environment from 58 countries, and two datasets for each of four countries in Eastern Africa: a healthcare facility dataset, and a dataset that incorporated information on facilities and the home environment to create a comprehensive description of birth environments in those countries.

Patterns and determinants of antenatal care utilization: analysis of national survey data in seven countdown countries.

Background: Antenatal care (ANC) is critical for improving maternal and newborn health. WHO recommends that pregnant women complete at least four ANC visits. Countdown and other global monitoring efforts track the proportions of women who receive one or more visits by a skilled provider (ANC1+) and four or more visits by any provider (ANC4+).

Child health and nutrition in Peru within an antipoverty political agenda: a Countdown to 2015 country case study.

Background: Peru is an upper-middle-income country with wide social and regional disparities. In recent years, sustained multisectoral antipoverty programmes involving governments, political parties, and civil society have included explicit health and nutrition goals and spending increased sharply. We did a country case study with the aim of documenting Peru's progress in reproductive, maternal, neonatal, and child health from 2000-13, and explored the potential determinants.

Missed opportunities in full immunization coverage: findings from low- and lower-middle-income countries.

Background: An estimated 23 million infants are still not being benefitted from routine immunization services. We assessed how many children failed to be fully immunized even though they or their mothers were in contact with health services to receive other interventions.

Design: Fourteen countries with Demographic and Health Surveys and Multiple Indicator Cluster Surveys carried out after 2000 and with coverage for DPT (Diphtheria-tetanus-pertussis) vaccine below 70% were selected.

Progress in reducing inequalities in reproductive, maternal, newborn,' and child health in Latin America and the Caribbean: an unfinished agenda.

Objective: To expand the "Countdown to 2015" analyses of health inequalities beyond the 75 countries being monitored worldwide to include all countries in Latin America and the Caribbean (LAC) that have adequate data available.

Methods: Demographic and Health Surveys and Multiple Indicator Cluster Surveys were used to monitor progress in health intervention coverage and inequalities in 13 LAC countries, five of which are included in the Countdown (Bolivia, Brazil, Guatemala, Haiti, and Peru) and eight that are not (Belize, Colombia, Costa Rica, Dominican Republic, Guyana, Honduras, Nicaragua, and Suriname). The outcomes included neonatal and under-5 year mortality rates, child stunting prevalence, and the composite coverage index-a weighted average of eight indicators of coverage in reproductive, maternal, newborn, and child health.