The creation of The 100 Million Brazilian Cohort was motivated by the availability of high quality but dispersed social and health databases in Brazil and the need to integrate data and evaluate the impact of policies aiming to improve the social determinants of health (e.g. social protection policies) on health outcomes, overall and in subgroups of interest in a dynamic cohort. The baseline of The 100 Million Brazilian Cohort comprises 131 697 800 low-income individuals in 35 358 415 families from 2011 to 2018. The Cohort population is mostly composed of children and young adults, with a higher proportion of females than the general Brazilian population, who identify themselves as Brown and live in the urban area of the country. Exposure to social protection and the follow-up of individuals are obtained through: (i) deterministic linkage using the Social Identification Number (NIS) to link the Cohort baseline to social protection programmes and to periodically renewed socioeconomic information in Cadatro Único datasets; and/or (ii) non-deterministic linkage using the CIDACS-RL non-deterministic linkage tool, to link the Cohort baseline to administrative health care datasets such as mortality (Mortality Information System, SIM), disease notification (Information System for Notifiable Diseases, SINAN), birth information (Live Birth Information System, SINASC) and nutrition status (Food and Nutrition Surveillance System, SISVAN). So far, studies have used The 100 Million Brazilian Cohort to investigate the socioeconomic and demographic determinants of leprosy, leprosy treatment outcomes and low birthweight and to evaluate the impact of the Bolsa Familia Programme (BFP) on leprosy and child mortality. Other studies are now being conducted that are of utmost relevance to the health inequalities of Brazil and many low- and middle-income countries, and many research opportunities are being opened up with the linkage of a range of health outcomes. Large social inequalities and poverty are major historical characteristics of Latin America in general and Brazil in particular. In the past two decades, Brazil has experienced substantial social and health changes, including significant reductions in poverty and inequalities. Although social protection has been one of the major contributors to improved living conditions in this country, the benefits may be facing a reversal with recent political changes in several countries with governments prone to privilege ‘austerity’ over ‘social protection’ policies.1–3 Among the programmes implemented to expand social protection, the most prominent one is the Conditional Cash Transfer Programme, the ‘Bolsa Família Programme’ (BFP), that transfers cash directly to poor households. Additional social protection programmes include the Housing Programme(‘Minha Casa Minha Vida’), the Access to Water Programme (‘Cisternas’) and the Light for All Programme (‘Luz Para Todos’) to improve access to electricity in rural communities, among others. The social determinants of health, the conditions in which people are born, grow, work, live and age, are important causes of health inequities and influence the onset and evolution of many different aspects of illness and health.4–7 Whereas there is substantial evidence on the effect of different social and economic factors on health, little is known about the health impact of policies targeted to modify these socioeconomic determinants.8–10 Evaluation of the effects of societal, economic and environmental policies and interventions on health outcomes is complex and requires approaches different from the traditional methods such as randomixed control trials (RCTs) and observational studies. The development of several complex analytical approaches in impact evaluation, in addition to other contemporary developments and new challenges in various disciplines, is opening up new opportunities for exploring large databases originally collected for different purposes and is expanding its use for conducting research. In 2001, the Brazilian government created the unified registry for social programmes ‘Cadastro Único’. The registry was greatly expanded and, by 2003, it became the main registry for the implementation and management of new and existing social programmes.11 As of 2018, the electronic database of the Cadastro Único comprised individual records of over 130 million people who had applied at any time for social benefits, of whom 74 million individuals were active in the database in that year.12 The extensive coverage of this social registry, the availability of individual data and the possibility of linkage to other health care data made it possible to design a cohort to evaluate the impact of the BFP and other social protection programmes on health and other outcomes. The creation of the 100 Million Brazilian Cohort by the Center for Data and Knowledge Integration for Health (CIDACS) was motivated by the availability of high-quality but dispersed social and health databases in Brazil and the need to integrate data and evaluate the impact of policies aiming to improve the social determinants of health (e.g. social protection policies) on health outcomes, overall and in subgroups in a dynamic Brazilian cohort in a middle-income country with high inequalities. This study was done under the Declaration of Helsinki and the Brazilian research regulation agency and was approved by the Ethics Committee of Instituto Gonçalo Muniz from Oswaldo Cruz Foundation (Fiocruz) (1.612.302). The National Unified Register for Social Programmes (Cadastro Único para Pro- gramas Sociais or Cadastro Único) identifies low-income families who have applied for social assistance in Brazil. Since 2003, Cadastro Único has become the main instrument used by the Brazilian government to assess the family's eligibility for social programmes. To be enrolled in Cadastro Único, families have to have an income of up to half minimum wage per capita (approximately USD125 in 2020) or a total family income of three minimum wages (approximately USD750). Demographic and socioeconomic information on all family members is provided by a designated representative of the family, who must be at least 16 years old and should preferably be a woman. The baseline of the 100 Million Brazilian Cohort comprises individuals registered in Cadastro Único for the first time. It includes individuals who have applied to receive any social benefit since 2001, although not all individuals have necessarily been successful in this application. Information on receipt of the largest social benefit in Brazil, the Bolsa Familia programme, is only available from 2004 onwards.11 It is important to note that there was is a permanent effort to actively enrol extreme poor and poor families in Cadastro Único.12 Applicants answer a detailed form that collects demographic, economic and social information of each member of the family and on family and household characteristics. The baseline dataset includes a total of 131 697 800 individuals, about 62% of the Brazilian population, who entered at different periods from 2001 to 2018 (Figure 1). Once enrolled in the Cohort, individuals will remain in the Cohort even if they improve their socioeconomic conditions and are not longer eligible for social support. Nevertheless, individuals will be followed up to 31 December 2018, until they die (i.e. by linking individuals with death registry) or until they present an specific outcome of interest to be defined using linked data. There is an ongoing arrangement with the Ministry of Citizenship to get this baseline regularly updated, as the register at Cadastro Único is continuous. Number of individuals in the 100 Million Brazilian Cohort by entry calendar year Number of individuals in the 100 Million Brazilian Cohort by entry calendar year The Cohort comprises approximately 11 million individuals enrolled in 2001 and 2002 for social benefits (i.e. prior to the official launch of Cadastro Único in 2003); 22 million people registered in the first 3 years (2003–05); 27.4 million people registered in 2006; over 9 million individuals enrolled in 2007; and an average of 5 to 6 million new applicants per year enrolled from 2008 to 2018. When comparing the sex and age distribution of the 100 Million Brazilian Cohort at baseline (i.e. at the moment individuals were first enrolled—any time over 2011–2018) with that of Brazilian 2010 Census population, the Cohort population is over-representative of children and young people and under-representative of older adults and males (Figure 2). This is mostly the case because a large proportion of the Cohort are enrolled with the objective to apply to the Bolsa Familia Programme which targets pregnant/breastfeeding woman and children. Most of the population that were ever enrolled in the 100 Million Brazilian Cohort identified themselves for race/ethnicity as Brown (55.8%), 30.7% were self-identified as White, 6.6% as Black, 0.4% as from Asian ancestry and 0.6% as Indigenous (Table 1). By analysing children aged 6 to 15 years of age at baseline, it was found that 86.7% were attending school (84.1% attending government school), 2.4 % were not attending (but had already attended) and 3.4% had never attended. Similarly, 52.2% of the individuals aged 16 years or older had completed elementary or middle school, 19.2% had completed high school and 12.2% had never attended school (Table 1). Comparison of the age and sex structure of the 100 Million Brazilian Cohort population (N = 131 697 800) and the Brazilian population for 2010 (N = 190 732 694) Comparison of the age and sex structure of the 100 Million Brazilian Cohort population (N = 131 697 800) and the Brazilian population for 2010 (N = 190 732 694) Social and demographic characteristics of individuals ever enrolled in the 100 Million Brazilian Cohort (N = 131 697 800) Social and demographic characteristics of individuals ever enrolled in the 100 Million Brazilian Cohort (N = 131 697 800) At baseline, the majority of the population was living in urban area (73.5%), in private permanent housing (n = 120 814 360, 91.7%) and in buildings that were predominantly made of bricks (73.0%) (Table 1). Furthermore, 67.9% of the baseline population were served by the public water supply, 42.3% by the public sewage and 71.4% by the public waste collection system. Individuals’ follow-up is determined by the baseline registry up to the assessment of health outcomes obtained through linkage with health databases which has been continued by transfer to CIDACS upon agreements with the Brazilian Government (Table 2, Figure 3). At the first registration in Cadastro Único, each individual is allocated a unique Social Information Number (NIS). Social protection programmes databases (e.g. BFP, Minha Casa Minha Vida) also contain the NIS number for each beneficiary. Hence, individual records from Cadastro Único and social protection programmes databases can be linked deterministically using exact matching. Individuals registered in Cadastro Único also have a household identifier; hence, once the family member responsible for receiving BFP benefit in the baseline data is identified, it is also possible to assign the benefit to all members of a household. This linkage is performed for each year of BFP benefit, to take into account changes in the household structure. According to Cadastro Único regulations, each participant is required to update their socioeconomic information every 2 years as long as they are a candidate for receiving one of the government's social protection programmes. The registry update is mandatory for those who are receiving a benefit and for those who had their benefits turned down but want to reapply. Main data sources linked to build the 100 Million Brazilian Cohort. MCMV—Minha Casa Minha Vida housing programme, SINASC—Sistema de Informação sobre Nascidos Vivos (Live Birth Information System), SIH—Sistema de Informações Hospitalares (Hospital Information System), SISVAN—Sistema de Vigilância Nutricional (Food and Nutrition Surveillance System), SINAN—Sistema de Informação de Agravos de Notificação (Information System for Notifiable Diseases), SIM—Sistema de Informação sobre Mortalidade (Mortality Information System) Main data sources linked to build the 100 Million Brazilian Cohort. MCMV—Minha Casa Minha Vida housing programme, SINASC—Sistema de Informação sobre Nascidos Vivos (Live Birth Information System), SIH—Sistema de Informações Hospitalares (Hospital Information System), SISVAN—Sistema de Vigilância Nutricional (Food and Nutrition Surveillance System), SINAN—Sistema de Informação de Agravos de Notificação (Information System for Notifiable Diseases), SIM—Sistema de Informação sobre Mortalidade (Mortality Information System) Structure and main components of the 100 Million Cohort, sources of data and relevant variables to be linked MCMV—Minha Casa Minha Vida housing programme. SIM—Sistema de Informação sobre Mortalidade (Mortality Information System). SINASC—Sistema de Informação sobre Nascidos Vivos (Live Birth Information System). SINAN—Sistema de Informação de Agravos de Notificação (Information System for Notifiable Diseases). SIH—Sistema de Informações Hospitalares (Hospital Information System). SISVAN—Sistema de Vigilância Nutricional (Food and Nutrition Surveillance System). Structure and main components of the 100 Million Cohort, sources of data and relevant variables to be linked MCMV—Minha Casa Minha Vida housing programme. SIM—Sistema de Informação sobre Mortalidade (Mortality Information System). SINASC—Sistema de Informação sobre Nascidos Vivos (Live Birth Information System). SINAN—Sistema de Informação de Agravos de Notificação (Information System for Notifiable Diseases). SIH—Sistema de Informações Hospitalares (Hospital Information System). SISVAN—Sistema de Vigilância Nutricional (Food and Nutrition Surveillance System). A non-deterministic linkage is performed using CIDACS-RL13 to link administrative health care datasets, such as mortality (SIM), disease notification (SINAN), birth information (SINASC) and nutrition status and measurements (SISVAN). CIDACS-RL is a record linkage tool designed to link large administrative data from Brazil using an individual's name, maternal name, gender, municipality of residency and date of birth or age records.13 It enables the integration of outcomes (mortality, hospitalization, diseases and child and maternal outcomes) into the Cohort baseline.14–17 Individuals registered with the baseline of the 100 Million Brazilian Cohort have a range of socioeconomic and demographic characteristics measured at individual and family levels (Table 1), which serve as exposures for studying the socioeconomic determinants of health. Also, the fact that families share an identifier allows study of siblings, intrahousehold transmission and intergenerational effects of poverty. In addition, exposures to several social interventions are measured through the linkage of the Cohort baseline with social protection programmes databases. So far, the Cohort baseline has been linked with BFP (receipt and conditionalities) and Minha Casa Minha Vida programmes receipt, but will be further linked with Cisternas receipt and have the potential to be linked with many others (Table 2, Figure 3). The BFP, implemented in 2004, originally set the eligibility criteria at a fixed monthly per capita household income of 100 Brazilian reais (BRL) (USD25) for poor families and BRL50 (USD12) for extremely poor families. Since then, there have been several updates in the programme thresholds to account for inflation and increases in the living costs. BFP covers 23% of the Brazilian population with the benefits ranging from BRL41 (USD10) to a maximum of BRL300 (USD75) per month. The mother, when present, must receive the monthly payment on behalf of the whole family.18 The BFP database, when linked with the Cohort baseline, provides information on which low-income families received BFP benefits, the starting and end date of the receipt and the values that each family received over time. Several studies have reported that this programme is associated with improved socioeconomic determinants of health and better health-related outcomes, and have found that municipalities with higher coverage of BFP are associated with lower poverty and reduced inequalities,19 lower crime rates,20,21 lower suicide rates,22 lower leprosy23 and tuberculosis incidence,24 and lower child mortality and hospital admissions.25 BFP receipt is subject to families’ compliance with conditionalities. Conditionalities are commitments made by beneficiary families with the aim of increasing the access by the poorest Brazilians to the social rights of health, education and social assistance, which can further increase the chances of breaking out of the intergenerational poverty cycle. The conditionalities include: (i) enrolment and minimum monthly school attendance of 85% for children aged 6 to 15 years and 75% for adolescents aged 16 and 17 years; (ii) children up to 7 years of age must complete vaccination and growth monitoring; and (iii) beneficiary families with pregnant women and breastfeeding mothers should follow a health and nutrition agenda (pre- and postnatal care, vaccination and health and nutrition surveillance).26 The BFP conditionality database provides the information on educational enrolment or attendance, vaccination history, growth and nutrition monitoring of children and young adults and prenatal and postnatal care of pregnant and lactating mothers. The assessments of health outcomes over time compose the follow-up measurements of the 100 Million Brazilian Cohort (Figure 3). To evaluate individual health outcomes, the Cohort baseline is linked to national health registries (e.g. birth or death registries, disease notification, hospitalisations, and food and nutrition data including assessment of anthropometric measures and food consumption markers). Currently, the Cohort baseline and other relevant databases are being geocoded, allowing a more granular spatial analysis below the municipality level and to to a better of the inequities and that on the poorest The of the Cohort to be will to each research and the outcome The possible of new interventions or outcomes will increase the analytical by allowing of not only the impact of different interventions but also the effect of two or more studies have already used the 100 Million Brazilian Cohort to investigate the social determinants of health and to evaluate the impact of social protection on outcomes (Table and many are being By linking the Cohort baseline with BFP and leprosy registries, studies have that poor socioeconomic characteristics are important determinants of individuals and and are associated with leprosy treatment In addition, it was that BFP is associated with lower leprosy in municipalities in the and that leprosy receiving BFP have higher of to leprosy treatment and by linking the Cohort baseline with birth a study has also the socioeconomic determinants of low and or large for Several other studies are in the social determinants or impact of social protection on child and maternal health, leprosy, and The ongoing linkage of data will the and for studies. In addition, the coverage of long periods and major economic changes and in the past allows study of the impact of those changes on health and on the economic (e.g. access to Bolsa school In the the Cohort will also of the impact of government policies and changes as data become available for using the 100 Million Brazilian Cohort SINASC—Sistema de Informação sobre Nascidos Vivos (Live Birth Information SISVAN—Sistema de Vigilância Nutricional (Food and Nutrition Surveillance SINAN—Sistema de Informação de Agravos de Notificação (Information System for Notifiable Diseases). using the 100 Million Brazilian Cohort SINASC—Sistema de Informação so
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