Melhorar a saúde das gestantes é uma prioridade para as agências de saúde global e para os governos dos países de baixa e média renda. O desafio da erradicação e/ou redução das morbimortalidades materna e perinatal evitáveis vem colocando em destaque a necessidade de expandir as ações para prevenção de agravos para além da abordagem clínica das complicações obstétricas, a partir do fortalecimento dos sistemas de saúde e da valorização da autonomia das mulheres dentro das sociedades, implementando a abordagem de direitos humanos como um dos componentes da qualidade do cuidado à saúde reprodutiva. O objetivo desta pesquisa é determinar se um programa de educação em saúde e apoio às gestantes, adaptado à realidade do Sistema Único de Saúde brasileiro e às especificidades da telefonia celular, é um complemento útil ao acompanhamento pré-natal padrão. A pesquisa foi realizada em duas etapas, tendo início com a condução de uma pesquisa formativa, exploratória, para identificar barreiras e facilitadores da atenção ao pré-natal e parto, avaliar aceitação do uso de mensagens de texto como item complementar ao cuidado pré-natal padrão, e desenvolver e refinar a intervenção do programa PRENACEL. Esta compreende um programa de 148 mensagens de texto no celular com informações essenciais para o acompanhamento do ciclo gravídico-puerperal de mulheres saudáveis, em atendimento na rede pública de saúde. Foi desenvolvida com propósitode melhorar resultados maternos e perinatais. Sua efetividade foi avaliada por meio de um ensaio aleatorizado por conglomerados, realizado em 20 unidades de saúde que provêm assistência pré-natal em uma cidade da região sudeste do Brasil. Gestantes em acompanhamento pré-natal nas unidades de saúde sorteadas para o grupo intervenção foram convidadas a participar do PRENACEL. Em unidades de saúde alocadas ao grupo controle, as gestantes receberam a atenção pré-natal padrão. Os dados analisados foram coletados durante a internação para o parto em quatro maternidades públicas da mesma localidade. Para cada variável de interesse, foram realizadas análise por intenção de tratar e análise por protocolo, pelo cálculo dos riscos relativos, com 95% de intervalo de confiança. Ao final do seguimento da gestação, 1210 mulheres elegíveis à participação no estudo tiveram seus desfechos avaliados nas maternidades selecionadas para a pesquisa, por meio de revisão de prontuários, cartões de pré-natal e entrevista individual estruturada. Das mulheres incluídas nas análises, 770 eram provenientes das unidades de saúde do grupo intervenção e 440 das unidades controle. Receber informações do programa PRENACEL durante a gestação foi associado a um aumento na percepção das mulheres de sentirem-se melhor preparadas para o parto, e na percepção de que o pré-natal colabora para que se sintam mais preparadas. Também foram observados impactos no estabelecimento do contato pele-a-pele e aleitamento materno e no conhecimento sobre intervenções obstétricas. Não foram observadas diferenças nos demais desfechos maternos e perinatais avaliados, incluindo a satisfação das mulheres com o atendimento. Nossa conclusão é de que o PRENACEL pode contribuir para a ampliação do acesso das mulheres a informações que lhes sejam estratégicas para que se sintam melhor preparadas para a experiência do parto. / Improving maternal health is a priority for global health agencies and for governments in low- and middle-income countries. The challenge of reducing preventable maternal and perinatal morbidity and mortality has highlighted the need to expand actions to prevent injuries beyond the clinical approach to obstetric complications, through strengthening health systems and enhancing autonomy of women within societies, by implementing a human rights approach as one of the components of the quality of reproductive health care. The objective of this research is to determine if a program of health education and support to pregnant women, adapted to be used by Brazilian National Health System and delivered by short messages service (SMS) on the cell phone is a useful complement to standard prenatal follow-up. The research was carried out in two stages, starting with the conduction of a formative and exploratory research to identify barriers and facilitators of antenatal and delivery care, to evaluate the acceptance of the use of SMS as a complementary item to antenatal care and to develop and refine the PRENACEL program intervention. It comprises a program of 148 SMS with essential information from pregnancy to puerperium, for healthy pregnant women attending antenatal care. It was developed with the purpose of improving maternal and perinatal outcomes. Its effectiveness was evaluated through a cluster-randomized trial conducted in 20 health units that provide antenatal care in a city in the southeastern region of Brazil. Pregnant women from the health units drawn for the intervention group were invited to participate in PRENACEL. In health unitsallocated to the control group, pregnant women received standard antenatal care. Analyzed data were collected during admission to labor in four public maternity hospitals in the same locality. For each variable of interest, intention-to-treat analysis and analysis by protocol were carried out, as well as the relative risk, with 95% of confidence interval. At the end of the gestation follow-up, 1210 women eligible to participate in the study had their outcomes evaluated in the maternity wards, through their medical records review, antenatal cards review and individual structured interviews. Of the women included in the analyzes, 770 came from the health units of the intervention group and 440 from the control units. Receiving information from the PRENACEL program during pregnancy was associated with an increase in women\'s perception of better preparedness for delivery, and the perception that antenatal care helps them feel more prepared. Enhancement of the timing for early skin-to-skin contact and breastfeeding, and knowledge on obstetric interventions were also observed. No differences were observed in other maternal and perinatal outcomes evaluated, including women\'s satisfaction with care. We concluded that PRENACEL can contribute to increase women\'s access to information that are strategic to the improve their perception of feeling confident and better prepared for the childbirth experience.

Melhorar a saúde das gestantes é uma prioridade para as agências de saúde global e para os governos dos países de baixa e média renda. O desafio da erradicação e/ou redução das morbimortalidades materna e perinatal evitáveis vem colocando em destaque a necessidade de expandir as ações para prevenção de agravos para além da abordagem clínica das complicações obstétricas, a partir do fortalecimento dos sistemas de saúde e da valorização da autonomia das mulheres dentro das sociedades, implementando a abordagem de direitos humanos como um dos componentes da qualidade do cuidado à saúde reprodutiva. O objetivo desta pesquisa é determinar se um programa de educação em saúde e apoio às gestantes, adaptado à realidade do Sistema Único de Saúde brasileiro e às especificidades da telefonia celular, é um complemento útil ao acompanhamento pré-natal padrão. A pesquisa foi realizada em duas etapas, tendo início com a condução de uma pesquisa formativa, exploratória, para identificar barreiras e facilitadores da atenção ao pré-natal e parto, avaliar aceitação do uso de mensagens de texto como item complementar ao cuidado pré-natal padrão, e desenvolver e refinar a intervenção do programa PRENACEL. Esta compreende um programa de 148 mensagens de texto no celular com informações essenciais para o acompanhamento do ciclo gravídico-puerperal de mulheres saudáveis, em atendimento na rede pública de saúde. Foi desenvolvida com propósitode melhorar resultados maternos e perinatais. Sua efetividade foi avaliada por meio de um ensaio aleatorizado por conglomerados, realizado em 20 unidades de saúde que provêm assistência pré-natal em uma cidade da região sudeste do Brasil. Gestantes em acompanhamento pré-natal nas unidades de saúde sorteadas para o grupo intervenção foram convidadas a participar do PRENACEL. Em unidades de saúde alocadas ao grupo controle, as gestantes receberam a atenção pré-natal padrão. Os dados analisados foram coletados durante a internação para o parto em quatro maternidades públicas da mesma localidade. Para cada variável de interesse, foram realizadas análise por intenção de tratar e análise por protocolo, pelo cálculo dos riscos relativos, com 95% de intervalo de confiança. Ao final do seguimento da gestação, 1210 mulheres elegíveis à participação no estudo tiveram seus desfechos avaliados nas maternidades selecionadas para a pesquisa, por meio de revisão de prontuários, cartões de pré-natal e entrevista individual estruturada. Das mulheres incluídas nas análises, 770 eram provenientes das unidades de saúde do grupo intervenção e 440 das unidades controle. Receber informações do programa PRENACEL durante a gestação foi associado a um aumento na percepção das mulheres de sentirem-se melhor preparadas para o parto, e na percepção de que o pré-natal colabora para que se sintam mais preparadas. Também foram observados impactos no estabelecimento do contato pele-a-pele e aleitamento materno e no conhecimento sobre intervenções obstétricas. Não foram observadas diferenças nos demais desfechos maternos e perinatais avaliados, incluindo a satisfação das mulheres com o atendimento. Nossa conclusão é de que o PRENACEL pode contribuir para a ampliação do acesso das mulheres a informações que lhes sejam estratégicas para que se sintam melhor preparadas para a experiência do parto. / Improving maternal health is a priority for global health agencies and for governments in low- and middle-income countries. The challenge of reducing preventable maternal and perinatal morbidity and mortality has highlighted the need to expand actions to prevent injuries beyond the clinical approach to obstetric complications, through strengthening health systems and enhancing autonomy of women within societies, by implementing a human rights approach as one of the components of the quality of reproductive health care. The objective of this research is to determine if a program of health education and support to pregnant women, adapted to be used by Brazilian National Health System and delivered by short messages service (SMS) on the cell phone is a useful complement to standard prenatal follow-up. The research was carried out in two stages, starting with the conduction of a formative and exploratory research to identify barriers and facilitators of antenatal and delivery care, to evaluate the acceptance of the use of SMS as a complementary item to antenatal care and to develop and refine the PRENACEL program intervention. It comprises a program of 148 SMS with essential information from pregnancy to puerperium, for healthy pregnant women attending antenatal care. It was developed with the purpose of improving maternal and perinatal outcomes. Its effectiveness was evaluated through a cluster-randomized trial conducted in 20 health units that provide antenatal care in a city in the southeastern region of Brazil. Pregnant women from the health units drawn for the intervention group were invited to participate in PRENACEL. In health unitsallocated to the control group, pregnant women received standard antenatal care. Analyzed data were collected during admission to labor in four public maternity hospitals in the same locality. For each variable of interest, intention-to-treat analysis and analysis by protocol were carried out, as well as the relative risk, with 95% of confidence interval. At the end of the gestation follow-up, 1210 women eligible to participate in the study had their outcomes evaluated in the maternity wards, through their medical records review, antenatal cards review and individual structured interviews. Of the women included in the analyzes, 770 came from the health units of the intervention group and 440 from the control units. Receiving information from the PRENACEL program during pregnancy was associated with an increase in women\'s perception of better preparedness for delivery, and the perception that antenatal care helps them feel more prepared. Enhancement of the timing for early skin-to-skin contact and breastfeeding, and knowledge on obstetric interventions were also observed. No differences were observed in other maternal and perinatal outcomes evaluated, including women\'s satisfaction with care. We concluded that PRENACEL can contribute to increase women\'s access to information that are strategic to the improve their perception of feeling confident and better prepared for the childbirth experience.

Introduction: Quality improvement (QI) encompasses a wide range of healthcare studies and activities with the common goal of improving patient outcomes, healthcare system performance, and professional development. QI is characterized by a diversity of definitions, stakeholders, clinical fields and study designs, which creates challenges for rigorous reporting and evaluation of these studies. Understanding and addressing the methodological issues that arise from conducting QI studies from multiple clinical disciplines is critical for generating good evidence for healthcare improvement to tackle health system challenges. Objectives: This thesis addressed three independent objectives: (i) Determine the quality of reporting of QI studies in neonatology. (ii) Compare different statistical methods that can be used to analyze data from a cluster randomized controlled trial with repeated measures data and examine how the estimate of intervention effects varies between these approaches. (iii) Determine the cost-effectiveness of providing timely surgery or timely rehabilitation for patients with hip fracture. Methods: Objective 1: We conducted a systematic survey of quality improvement studies in neonatology to examine the extent to which these publications adhered to SQUIRE 2.0, the guidelines for reporting studies that sought to improve the quality, safety, and value of healthcare. Using the same set of articles, we examined how various methodological attributes, such as stakeholder engagement, outcome measures, and statistical process controls, are reported in these studies. Objective 2: To compare the differences in the statistical estimates of intervention effects between linear mixed models and Generalized Estimating Equations, for the CP@Clinic Program cluster randomized RCT, which contains routinely collected monthly outcome data aggregated at the cluster level. Objective 3: We constructed a Markov cohort model to estimate the cost-effectiveness of receiving timely surgery within 24 hours of admission to the emergency department, receiving immediate admission to inpatient rehabilitation following acute care discharge, receiving both, or none. Results: Objective 1: In our assessment of reporting quality, we found that adherence to SQUIRE 2.0 guidelines was inadequate and that journals should endorse the SQUIRE 2.0 guideline for improvement publications to alleviate this issue. We found that process measures was the most frequently reported methodological attribute (89%), while stakeholder engagement with leadership (32%) or caregivers (10%) were infrequently reported or conducted. Objective 2: In comparing statistical methods for analyzing a cluster randomized controlled trial with correlated data, we found that it was critical to apply a correction to the variance estimator of generalized estimating equations to produce robust estimates of the intervention effects. Objective 3: In our economic evaluation, both timely surgery alone and the combination of timely surgery and timely rehabilitation yielded cost-effective improvements in the quality-adjusted life-years of patients with hip fracture. However, the combination of receiving timely surgery and timely rehabilitation requires a high willingness-to-pay threshold, above $128,000 per quality-adjusted life-years, to be considered cost-effective. Conclusions: Overall, understanding the state of reporting and the broad spectrum of methods and methodologic issues for evaluating quality improvement initiatives will advance its rigorous research, evaluation, reporting, and contribution towards informed decision-making for tackling pressing healthcare issues. / Thesis / Doctor of Philosophy (PhD) / Quality improvement (QI) is a field of healthcare research that can be defined in many ways, and research in this field is conducted by researchers from various medical disciplines. Consequently, challenges may arise in reporting and evaluating QI interventions. Thus, it is important to examine how QI interventions are reported in academic literature and the methods used to evaluate their effectiveness in improving health. The current thesis aims to address these issues through three independent objectives: (1) examine the details reported in QI studies in neonatology, (2) compare different statistical methods that can be used to analyze data from a community paramedicine cluster randomized controlled trial, and (3) investigate whether providing timely surgery and timely hospital-based rehabilitation is a cost-effective way to improve the quality of life of patients who have experienced hip fracture. The findings of these studies will provide insights into the challenges of reporting and evaluating QI interventions, and suggest ways to improve them.