Do baseline participant characteristics impact the effectiveness of a mobile health intervention for depressive symptoms? A post-hoc subgroup analysis of the CONEMO trials.

OBJECTIVE: To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO). METHODS: The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization - suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension - in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models. RESULTS: Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively). CONCLUSION: There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial. CLINICAL TRIAL REGISTRATION: NCT02846662 (São Paulo, Brazil - SP), NCT03026426 (Lima, Peru - LI).

A Mobile Health Intervention for Patients With Depressive Symptoms: Protocol for an Economic Evaluation Alongside Two Randomized Trials in Brazil and Peru.

BACKGROUND: Mobile health interventions provide significant strategies for improving access to health services, offering a potential solution to reduce the mental health treatment gap. Economic evaluation of this intervention is needed to help inform local mental health policy and program development. OBJECTIVE: This paper presents the protocol for an economic evaluation conducted alongside 2 randomized controlled trials (RCTs) to evaluate the cost-effectiveness of a psychological intervention delivered through a technological platform (CONEMO) to treat depressive symptoms in people with diabetes, hypertension, or both. METHODS: The economic evaluation uses a within-trial analysis to evaluate the incremental costs and health outcomes of CONEMO plus enhanced usual care in comparison with enhanced usual care from public health care system and societal perspectives. Participants are patients of the public health care services for hypertension, diabetes, or both conditions in São Paulo, Brazil (n=880) and Lima, Peru (n=432). Clinical effectiveness will be measured by reduction in depressive symptoms and gains in health-related quality of life. We will conduct cost-effectiveness and cost-utility analyses, providing estimates of the cost per at least 50% reduction in 9-item Patient Health Questionnaire scores, and cost per quality-adjusted life year gained. The measurement of clinical effectiveness and resource use will take place over baseline, 3-month follow-up, and 6-month follow-up in the intervention and control groups. We will use a mixed costing methodology (ie, a combination of top-down and bottom-up approaches) considering 4 cost categories: intervention (CONEMO related) costs, health care costs, patient and family costs, and productivity costs. We will collect unit costs from the RCTs and national administrative databases. The multinational economic evaluations will be fully split analyses with a multicountry costing approach. We will calculate incremental cost-effectiveness ratios and present 95% CIs from nonparametric bootstrapping (1000 replicates). We will perform deterministic and probabilistic sensitivity analyses. Finally, we will present cost-effectiveness acceptability curves to compare a range of possible cost-effectiveness thresholds. RESULTS: The economic evaluation project had its project charter in June 2018 and is expected to be completed in September 2021. The final results will be available in the second half of 2021. CONCLUSIONS: We expect to assess whether CONEMO plus enhanced usual care is a cost-effective strategy to improve depressive symptoms in this population compared with enhanced usual care. This study will contribute to the evidence base for health managers and policy makers in allocating additional resources for mental health initiatives. It also will provide a basis for further research on how this emerging technology and enhanced usual care can improve mental health and well-being in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT12345678 (Brazil) and NCT03026426 (Peru); https://clinicaltrials.gov/ct2/show/NCT02846662 and https://clinicaltrials.gov/ct2/show/NCT03026426. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26164.

The relationship between indicators of socioeconomic status and cesarean section in public hospitals.

OBJECTIVE: To assess the relationship between indicators of socioeconomic status and cesarean section in public hospitals that adopt standardized protocols of obstetrical care. METHODS: This was a prospective cohort study conducted between May 2005 and January 2006 with 831 pregnant women recruited from 10 public primary care clinics in São Paulo, Brazil. Demographic and clinical characteristics were collected during pregnancy. The three main exposures were schooling, monthly family income per capita, and residential crowding. The main outcome was cesarean section at three public hospitals located in the area. Crude and adjusted risk ratios (RR), with 95% confidence intervals were calculated using Poisson regression with robust variance. We examined the effects of each exposure variable on cesarean section accounting for potential confounders by using four different models: crude, adjusted by mother's characteristics, by obstetrical complications, and by the other two indicators of socioeconomic status. RESULTS: Among the 757 deliveries performed in the public hospitals, 215 (28.4%) were by cesarean section. In the bivariate analysis, cesarean section was associated with higher family income per capita, higher education, lower residential crowding, pregnancy planning, white skin color, having a partner, and advanced maternal age. In the multivariate analysis, after adjustment for covariates, none of the socioeconomic status variables remained associated with cesarean section. CONCLUSIONS: In this group, the chance of women undergoing cesarean section was not associated with indicators of socioeconomic status only, but was defined in accordance with major obstetric and clinical conditions.

The relationship between indicators of socioeconomic status and cesarean section in public hospitals

ABSTRACT OBJECTIVE To assess the relationship between indicators of socioeconomic status and cesarean section in public hospitals that adopt standardized protocols of obstetrical care. METHODS This was a prospective cohort study conducted between May 2005 and January 2006 with 831 pregnant women recruited from 10 public primary care clinics in São Paulo, Brazil. Demographic and clinical characteristics were collected during pregnancy. The three main exposures were schooling, monthly family income per capita, and residential crowding. The main outcome was cesarean section at three public hospitals located in the area. Crude and adjusted risk ratios (RR), with 95% confidence intervals were calculated using Poisson regression with robust variance. We examined the effects of each exposure variable on cesarean section accounting for potential confounders by using four different models: crude, adjusted by mother’s characteristics, by obstetrical complications, and by the other two indicators of socioeconomic status. RESULTS Among the 757 deliveries performed in the public hospitals, 215 (28.4%) were by cesarean section. In the bivariate analysis, cesarean section was associated with higher family income per capita, higher education, lower residential crowding, pregnancy planning, white skin color, having a partner, and advanced maternal age. In the multivariate analysis, after adjustment for covariates, none of the socioeconomic status variables remained associated with cesarean section. CONCLUSIONS In this group, the chance of women undergoing cesarean section was not associated with indicators of socioeconomic status only, but was defined in accordance with major obstetric and clinical conditions.

The relationship between socioeconomic indicators during pregnancy and gynecological appointment at any time after childbirth.

BACKGROUND: The rates of receipt of postnatal care vary widely between high and low-middle income countries. This study aimed to examine the association between indicators of socioeconomic status during pregnancy and gynecological appointment at any time after childbirth (GA). METHODS: a prospective cohort study with pregnant women recruited from 10 primary care clinics of the public sector in the city of São Paulo, Brazil. Socioeconomic characteristics and obstetric information were obtained through a questionnaire administered during pregnancy and in the postpartum period. Adjusted risk ratios (RR) with 95% confidence intervals (CI) were calculated using Poisson regression. RESULTS: Eight hundred and thirty one pregnant women were included in the study during the antenatal period and 701 were re-assessed during the postnatal period. Among them, 283 (59.6) attended a gynecological consultation. After adjusting for covariates, higher socioeconomic status during pregnancy was associated with greater risk of having a GA (RR:1.23, CI 95%:1.05:1.45 for family per capita monthly income; RR:1.19, CI 95 % 1.01:1.40 for asset score). CONCLUSION: In this sample, the attendance for GA was above average and women with higher socio-economic status were more likely to have receipt of such care. Special efforts should be made to improve the attendance and frequency of gynecological consultations after childbirth among poorer women.

Aconselhamento genético para diagnóstico citogenetico em idade materna avançada: um estudo exploratório / Genetic counseling for invasive diagnostic procedures in advanced maternal age: an exploratory study

O acesso ao diagnóstico pré-natal profilatico de anomalias cromossômicas fetais a partir de procedimentos invasivos em pacientes de instituiçöes publicas brasileiras e fenômeno relativamente recente, e seu impacto ainda é desconhecido em nosso meio. O objetivo deste estudo foi verificar o grau de aceitaçäo do diagnóstico citogenético entre mulheres grávidas com idade superior a 35 anos, em hospital publico de uma universidade em Säo Paulo, e sua associaçäo com o nível sócio-econômico e cultural das pacientes. Método: Entrevistas semidirigidas foram realizadas com 80 pacientes antes e depois das consultas de aconselhamento genético, com o objetivo de avaliar o nível de conhecimento das pacientes e os motivos alegados para a decisäo de submeter-se ou näo ao procedimento invasivo; dados das consultas também foram analisados...