A simulation study to improve calcium intake through wheat flour fortification.

OBJECTIVE: to simulate the impact on calcium intake- effectiveness and safety- of fortifying wheat flour with 200, 400 and 500 mg of calcium per 100 g of flour. DESIGN: secondary analysis of cross-sectional data collected through repeated 24-hour dietary recalls using IOWA the Intake Modelling, Assessment and Planning Program. SETTING: urban cities in the National Health and Nutrition Survey of Argentina (ENNyS 2018 - 2019). PARTICIPANTS: 21358 participants, including children, adolescents, and adults. RESULTS: Most individuals in all age groups reported consuming wheat flour. The prevalence of low calcium intake was above 80% in individuals older than 9 years. Simulating the fortification of 500 mg of calcium per 100 g of wheat flour showed that the prevalence of low calcium intake could be reduced by more than 40 percentage points in girls and women aged 19 to less than 51 and boys and men aged 4 to less than 71, while it remained above 65% in older ages. The percentages above the upper intake level remained below 1.5% in all age groups. CONCLUSIONS: Calcium flour fortification could be further explored to improve calcium intake. Subnational simulations could be performed to identify groups that might not be reached by this strategy that could be explored in Argentina. This analysis could be used to advocate for a strategy to fortify wheat flour.

Neonatal jaundice incidence, risk factors and outcomes in 54 referral-level facilities in Nigeria.

OBJECTIVE: To determine the incidence, risk factors and outcomes of babies with neonatal jaundice in a network of referral-level hospitals in Nigeria. DESIGN: A cross-sectional analysis of perinatal data collected over a 1-year period. SETTING: Fifty-four referral-level hospitals (48 public and 6 private) across the six geopolitical zones of Nigeria. POPULATION: A total of 77 026 babies born at or admitted to the participating facilities (67 697 hospital live births; plus 9329 out-born babies), with information on jaundice between 1 September 2019 and 31 August 2020. METHODS: Data were extracted and analysed to calculate incidence and sociodemographic and clinical risk factors for neonatal jaundice. MAIN OUTCOME MEASURES: Incidence and risk factors of neonatal jaundice in the 54-referral hospitals in Nigeria. RESULTS: Of 77 026 babies born in or admitted to the participating facilities, 3228 had jaundice (41.92 per 1000 live births). Of the 67 697 hospital live births, 845 babies had jaundice (12.48 per 1000 live births). The risk factors associated with neonatal jaundice were no formal education (adjusted odds ratio [aOR] 1.68, 95% CI 1.11-2.52) or post-secondary education (aOR 1.17, 95% CI 0.99-1.38), previous caesarean section (aOR 1.68, 95% CI 1.40-2.03), booked antenatal care at <13 weeks or 13-26 weeks of gestation (aOR 1.58, 95% CI 1.20-2.08; aOR 1.15, 95% CI 0.93-1.42, respectively), preterm birth (aOR 1.43, 95% CI 1.14-1.78) and labour more than 18 hours (aOR 2.14, 95% CI 1.74-2.63). CONCLUSIONS: Hospital-level and regional-level strategies are needed to address newborn jaundice, which include a focus on management and discharge counselling on signs of jaundice.

Trypanosoma cruzi Infection in Pregnancies without Congenital Transmission Is Associated with Reduced Fetal Growth: A Cross-Sectional Study in Argentina, Honduras, and Mexico.

We aimed to measure the association between Trypanosoma cruzi infection in pregnancy and reduced fetal growth in the absence of T. cruzi congenital transmission. We conducted a cross-sectional study of secondary data of all singleton live births between 2011 and 2013 in five hospitals from Argentina, Honduras, and Mexico. We excluded newborns with T. cruzi infection. Noninfected pregnant people were those without any positive rapid tests. The main study outcomes were birth weight, head circumference, and length for gestational age and sex. Logistic regression models were adjusted for country, age, education level, and obstetric history. Of the 26,544 deliveries, 459 (1.7%) pregnant people were found by rapid tests to be positive for T. cruzi. Of these, 320 were positive by enzyme-linked immunosorbent assay and 231 had a positive polymerase chain reaction (PCR) test. Uninfected newborns from T. cruzi-infected pregnant people were more likely to have birth weights below the 5th and 10th percentiles and head circumferences below the 3rd and 10th percentiles. Among T. cruzi-infected pregnant people diagnosed by PCR, the odds ratios were 1.58 for birth weight below the 10th percentile (95% CI, 1.12-2.23) and 1.57 for birth weight below the 5th percentile (95% CI, 1.02-2.42). Higher T. cruzi parasitic loads in pregnancy had a stronger association with reduced fetal growth (both in birth weight and head circumference), with an odds ratio of 2.31 (95% CI, 1.36-3.91) for a birth weight below the 5th percentile. The association shows, irrespective of causality, that newborns of pregnancies with T. cruzi have an increased risk of reduced fetal growth. We recommend further studies to assess other potential confounders and the causality of these associations.

Quality improvement collaborative for improving patient care delivery in Argentine public health sector intensive care units.

BACKGROUND: The demand for healthcare services during the COVID-19 pandemic was excessive for less-resourced settings, with intensive care units (ICUs) taking the heaviest toll. OBJECTIVE: The aim was to achieve adequate personal protective equipment (PPE) use in 90% of patient encounters, to reach 90% compliance with objectives of patient flow (OPF) and to provide emotional support tools to 90% of healthcare workers (HCWs). METHODS: We conducted a quasi-experimental study with an interrupted time-series design in 14 ICUs in Argentina. We randomly selected adult critically ill patients admitted from July 2020 to July 2021 and active HCWs in the same period. We implemented a quality improvement collaborative (QIC) with a baseline phase (BP) and an intervention phase (IP). The QIC included learning sessions, periods of action and improvement cycles (plan-do-study-act) virtually coached by experts via platform web-based activities. The main study outcomes encompassed the following elements: proper utilisation of PPE, compliance with nine specific OPF using daily goal sheets through direct observations and utilisation of a web-based tool for tracking emotional well-being among HCWs. RESULTS: We collected 7341 observations of PPE use (977 in BP and 6364 in IP) with an improvement in adequate use from 58.4% to 71.9% (RR 1.2, 95% CI 1.17 to 1.29, p<0.001). We observed 7428 patient encounters to evaluate compliance with 9 OPF (879 in BP and 6549 in IP) with an improvement in compliance from 53.9% to 67% (RR 1.24, 95% CI 1.17 to 1.32, p<0.001). The results showed that HCWs did not use the support tool for self-mental health evaluation as much as expected. CONCLUSION: A QIC was effective in improving healthcare processes and adequate PPE use, even in the context of a pandemic, indicating the possibility of expanding QIC networks nationwide to improve overall healthcare delivery. The limited reception of emotional support tools requires further analyses.

Outcomes and quality of care for women and their babies after caesarean section in Nigeria.

OBJECTIVE: To describe the outcomes and quality of care for women and their babies after caesarean section (CS) in Nigerian referral-level hospitals. DESIGN: Secondary analysis of a nationwide cross-sectional study. SETTING: Fifty-four referral-level hospitals. POPULATION: All women giving birth in the participating facilities between 1 September 2019 and 31 August 2020. METHODS: Data for the women were extracted, including sociodemographic data, clinical information, mode of birth, and maternal and perinatal outcomes. A conceptual hierarchical framework was employed to explore the sociodemographic and clinical factors associated with maternal and perinatal death in women who had an emergency CS. MAIN OUTCOME MEASURES: Overall CS rate, outcomes for women who had CS, and factors associated with maternal and perinatal mortality. RESULTS: The overall CS rate was 33.3% (22 838/68 640). The majority of CS deliveries were emergency cases (62.8%) and 8.1% of CS deliveries had complications after delivery, which were more common after an emergency CS. There were 179 (0.8%) maternal deaths in women who had a CS and 29.6% resulted from complications of hypertensive disorders of pregnancy. The overall maternal mortality rate in women who delivered by CS was 778 per 100 000 live births, whereas the perinatal mortality at birth was 51 per 1000 live births. Factors associated with maternal mortality in women who had an emergency CS were being <20 or >35 years of age, having a lower level of education and being referred from another facility or informal setting. CONCLUSIONS: One-third of births were delivered via CS (mostly emergency), with almost one in ten women experiencing a complication after a CS. To improve outcomes, hospitals should invest in care and remove obstacles to accessible quality CS services.

Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial.

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695 .

Neurodevelopmental assessment of normocephalic children born to Zika virus exposed and unexposed pregnant people.

BACKGROUND: Studies examining the association between in utero Zika virus (ZIKV) exposure and child neurodevelopmental outcomes have produced varied results. METHODS: We aimed to assess neurodevelopmental outcomes among normocephalic children born from pregnant people enrolled in the Zika in Pregnancy in Honduras (ZIPH) cohort study, July-December 2016. Enrollment occurred during the first prenatal visit. Exposure was defined as prenatal ZIKV IgM and/or ZIKV RNA result at enrollment. Normocephalic children, >6 months old, were selected for longitudinal follow-up using the Bayley Scales of Infant and Toddler Development (BSID-III) and the Ages & Stages Questionnaires: Social-Emotional (ASQ:SE-2). RESULTS: One hundred fifty-two children were assessed; after exclusion, 60 were exposed and 72 were unexposed to ZIKV during pregnancy. Twenty children in the exposed group and 21 children in the unexposed group had a composite score <85 in any of the BSID-III domains. Although exposed children had lower cognitive and language scores, differences were not statistically significant. For ASQ:SE-2 assessment, there were not statistically significant differences between groups. CONCLUSIONS: This study found no statistically significant differences in the neurodevelopment of normocephalic children between in utero ZIKV exposed and unexposed. Nevertheless, long-term monitoring of children with in utero ZIKV exposure is warranted. IMPACT: This study found no statistically significant differences in the neurodevelopment in normocephalic children with in utero Zika virus exposure compared to unexposed children, although the exposed group showed lower cognitive and language scores that persisted after adjustment by maternal age and education and after excluding children born preterm and low birth weight from the analysis. Children with prenatal Zika virus exposure, including those normocephalic and have no evidence of abnormalities at birth, should be monitored for neurodevelopmental delays. Follow-up is important to be able to detect developmental abnormalities that might not be detected earlier in life.

"Factors associated with provider unwillingness to perform induced abortion in Argentina: A cross-sectional study in four provinces following the legalization of abortion on request".

BACKGROUND: The 2020 Law on Access to the Voluntary Interruption of Pregnancy is a landmark piece of legislation regarding access to abortion in Argentina. Under the new law, abortion is legal up to 14 weeks and 6 days gestation, with exceptions made to the gestational age limit to save a woman´s life, to preserve a woman´s health, and in case of rape. However, widespread refusal to provide care by authorized health providers (due to conscientious objection or lack of awareness of the new law) could hinder access to legal abortion. This study aimed to assess knowledge of the current legal framework and willingness to perform abortions by authorized professionals in Argentina, to compare perceptions about any requirements necessary to perform abortions on legal grounds between willing and unwilling providers and to explore factors associated with refusal to provide care. METHODS: We conducted a cross-sectional study based on a self-administered, anonymous survey to authorized abortion providers in public health facilities in four provinces of Argentina. FINDINGS: Most authorized providers knew the grounds upon which it is currently legal to perform abortions; however, almost half reported being unwilling to perform abortions, mainly due to conscientious objection. Both willing and unwilling providers believed there were additional requirements not actually stipulated by law. Using logistic regression, we found that province where providers serve, working in a tertiary level facility, and older age were factors associated with unwillingness to provide care. CONCLUSIONS: The results of our study indicate that, even in a favorable legal context, barriers at the provider level may hinder access to abortion in Argentina. They help to demonstrate the need for specific actions that can improve access such as training, further research and public policies that guarantee facilities have sufficient professionals willing to provide abortion care.

Effectiveness of peer mentoring and self-monitoring to improve blood pressure control in a vulnerable population in Argentina: Pragmatic randomized open-label controlled trial.

OBJECTIVE: To evaluate the effectiveness of blood pressure (BP) self-monitoring and peer mentoring to improve the control of hypertension in clinical practice in primary care centers (PCCs) located in low-resource settings in Argentina. METHODS: An individual randomized controlled trial was carried out to test two different approaches based on behavioral interventions in PCCs in Argentina. Hypertensive adults were randomly assigned to one of three arms: BP self-monitoring, peer mentoring, and usual care. The primary outcome was the change in BP values from baseline to the end of follow-up at 3 months. A qualitative approach of participants' experiences of the peer mentoring arm was also conducted. RESULTS: A total of 442 participants with hypertension were included in the study. Self-monitoring and peer mentoring interventions did not show a significant difference in BP control compared to usual care. However, this trial showed an improvement regarding antihypertensive medication adherence among those assigned to the peer mentoring intervention compared to the control at the end of follow-up (p = 0.031). DISCUSSION: Self-monitoring and peer mentoring interventions did not demonstrate to be effective in BP control compared to usual care. Implementing a peer support strategy was demonstrated to be feasible and effective in improving medication adherence in this population.

Comparación de la mortalidad en pacientes en quimioterapia o inmunoterapia durante y antes de la pandemia de COVID-19. Estudio multicéntrico de cohortes emparejadas en Argentina / Comparison of mortality in patients on chemotherapy or immunotherapy during and before COVID-19 pandemic. Multicenter matched cohort study in Argentina

RESUMEN Objetivos. Comparar la mortalidad por todas las causas de pacientes oncológicos no vacunados que recibieron quimioterapia o inmunoterapia durante la pandemia, con aquellos tratados antes de la pandemia. Materiales y métodos. Realizamos un estudio de cohortes en cuatro hospitales terciarios en Argentina. Pacientes ambulatorios con una neoplasia sólida de cualquier estadio en tratamiento citotóxico o inmune intravenoso fueron elegibles. La cohorte pandémica se enroló durante la fase inicial del brote y se comparó con una cohorte de un período anterior a la pandemia utilizando emparejamiento por puntuación de propensión (PSM, por sus siglas en inglés). Los sujetos se emparejaron por edad, sexo, seguro de salud, factores de riesgo para complicaciones graves por COVID-19, estado funcional, tipo de cáncer y tratamiento, línea de tratamiento e índice de masa corporal. La mortalidad por todas las causas se estimó en ambas cohortes después de seis meses de seguimiento. Resultados. 169 pacientes fueron reclutados entre abril y agosto de 2020 para la cohorte pandémica y 377 para la cohorte prepandémica en el mismo período de 2019, 168 pacientes fueron emparejados. Luego de la PSM, la mortalidad por todas las causas fue del 17,9% en la cohorte pandémica y del 18,5% en la cohorte prepandémica, Riesgo Relativo: 0,97 (intervalo de confianza al 95 %: 0,61-1,52; p=0,888). En la cohorte pandémica, 30/168 pacientes fallecieron, ninguno por infección por COVID-19. Conclusiones. No hemos observado un aumento de mortalidad en pacientes ambulatorios no vacunados en tratamiento oncológico endovenoso activo durante la pandemia por COVID-19.

ABSTRACT Objectives. To compare all-cause mortality of unvaccinated oncology patients who received chemotherapy or immunotherapy during the pandemic with those treated before the pandemic. Materials and methods. We conducted a cohort study in four tertiary hospitals in Argentina. Outpatients with a solid neoplasm of any stage under-going cytotoxic or intravenous immunotherapy were eligible. The pandemic cohort was enrolled during the initial phase of the outbreak and compared with a pre-pandemic cohort using propensity score matching (PSM). Subjects were matched for age, sex, health insurance, risk factors for severe COVID-19 complications, performance status, cancer type and treatment, line of treatment, and body mass index. All-cause mortality was estimated for both cohorts after 6 months of follow-up. Results. A total of 169 patients were recruited between April and August 2020 for the pandemic cohort and 377 for the pre-pandemic cohort in the same months of 2019; 168 patients were matched. After PSM, all-cause mortality was 17.9% in the pandemic cohort and 18.5% in the pre-pandemic cohort; the Relative Risk was 0.97 (95 % confidence interval: 0.61-1.52; p=0.888). In the pandemic cohort, 30/168 patients died, but none from COVID-19. Conclusions. Our findings show that the mortality rate of unvaccinated ambulatory patients on active intravenous oncology treatment during the COVID-19 pandemic did not increase.

Blood Pressure Association with the 8-Item Morisky Medication Adherence Scale in Hypertensive Adults from Low-Resource Primary Care Settings: Results from a Prospective Cohort Nested within a Randomised Controlled Trial.

INTRODUCTION: One of the self-report adherence scales most widely used is the 8-item Morisky Medication Adherence Scale (MMAS-8). AIM: To evaluate construct validity and reliability of the MMAS-8 in hypertensive adults from low-resource settings within the public primary care level in Argentina. METHODS: Prospective data from hypertensive adults under antihypertensive pharmacological treatment that participated in the "Hypertension Control Program in Argentina" study was analyzed. Participants were followed at baseline, 6, 12 and 18 months. Based on MMAS-8, adherence was defined as low (score < 6), medium (score 6 to < 8) and high (score of 8). RESULTS: 1214 participants were included in the analysis. In comparison to low adherence, high adherence category was associated with a reduction of - 5.6 mmHg (CI 95%: - 7.2; - 4.0) in systolic blood pressure (BP) and - 3.2 mmHg (CI 95%: - 4.2; - 2.2) in diastolic BP; and with a 56% higher likelihood to have controlled BP (p < .0001). Among those participants with baseline score ≤ 6, two points increase in MMAS-8 along follow-up showed a tendency to reduce BP in almost all-time points and a 34% higher likelihood of having controlled BP at the end of the follow-up (p = 0.0039). Cronbach's alpha total-item values in all time-points were higher than 0.70. CONCLUSIONS: Higher MMAS-8 categories were positively associated with BP reduction and higher likelihood of BP control over time. Internal consistency was acceptable and in line with previous studies.

Vulnerable newborn types: Analysis of population-based registries for 165 million births in 23 countries, 2000-2021.

OBJECTIVE: To examine the prevalence of novel newborn types among 165 million live births in 23 countries from 2000 to 2021. DESIGN: Population-based, multi-country analysis. SETTING: National data systems in 23 middle- and high-income countries. POPULATION: Liveborn infants. METHODS: Country teams with high-quality data were invited to be part of the Vulnerable Newborn Measurement Collaboration. We classified live births by six newborn types based on gestational age information (preterm <37 weeks versus term ≥37 weeks) and size for gestational age defined as small (SGA, <10th centile), appropriate (10th-90th centiles), or large (LGA, >90th centile) for gestational age, according to INTERGROWTH-21st standards. We considered small newborn types of any combination of preterm or SGA, and term + LGA was considered large. Time trends were analysed using 3-year moving averages for small and large types. MAIN OUTCOME MEASURES: Prevalence of six newborn types. RESULTS: We analysed 165 017 419 live births and the median prevalence of small types was 11.7% - highest in Malaysia (26%) and Qatar (15.7%). Overall, 18.1% of newborns were large (term + LGA) and was highest in Estonia 28.8% and Denmark 25.9%. Time trends of small and large infants were relatively stable in most countries. CONCLUSIONS: The distribution of newborn types varies across the 23 middle- and high-income countries. Small newborn types were highest in west Asian countries and large types were highest in Europe. To better understand the global patterns of these novel newborn types, more information is needed, especially from low- and middle-income countries.

Global inequities in cesarean section deliveries and required resources persist.

OBJECTIVE: The purpose of this study was to estimate the global distribution and financial cost associated with the inequities present in the use of cesarean sections (CS) worldwide. STUDY DESIGN: We used the latest estimates on CS rates published by WHO and we adopted 10-15 % as the range of CS rates that are considered optimal for adequate use. We calculated the cost (in USD) to achieve CS rates of 10-15 % for countries that reported rates below 10 %. We also calculated the cost of CS rates in excess (>15 % and > 20 %) by estimating how much it would cost to reduce the rates to 10-15 % for each of those countries. RESULTS: 137 countries are included in this analysis with updated data on CS rates between the years 2010 and 2018. Our analysis found that 36 countries reported CS rates < 10 %, whereas 91 countries reported CS rates > 15 % (a majority of which were > 20 %); only 10 countries reported CS rates between 10 and 15 %. The cost of CS exceeding a rate of 15 % is estimated to be $9,586,952,466 including inflation and exceeding 20 % is $7.169.248.033 (USD). The cost of achieving "needed" CS among countries with CS rates < 10 % is $612,609,418 (USD). The cost of cesarean sections exceeding 15 % has increased by 313 % between 2008 and more recent years, accruing $7 billion (USD) more in surplus since 2008. The reallocation of CS funding would save the global economy $9 billion (USD). CONCLUSION: Global inequities in CS performed and associated costs have increased since 2008, resulting in a disproportionate number of resources allocated.

Calcium concentration of drinking water to improve calcium intake: A simulation study.

The risk of inadequate calcium intake is a worldwide problem. We performed a simulation exercise on the impact, effectiveness, and safety of increasing calcium levels in drinking water using the 2019 Health and Nutrition National Survey of Argentina, which provides water intake and water sources data at the individual level. We simulated the distribution of calcium intake assuming a calcium concentration of 100 mg of calcium per liter of tap water and 400 mg of calcium per liter of bottled water. After the simulation, all population groups had a slightly improved calcium intake. Higher impacts were observed in adults, as reported water intake was higher in adults 19-51 years old. In young adult women, the estimated calcium intake inadequacy decreased from 91.0% to 79.7% when calcium was increased in tap water and to 72.2% when calcium was increased in tap and bottled water. The impact was lower in adolescents and older adults who have higher calcium recommendations and reported lower water intake. Increased calcium concentration of water could improve calcium intake in Argentina, especially in adults as their reported water intake is higher. Combining more than one strategy to improve calcium intake might be required for countries like Argentina with low calcium intake.

Calculation of the contribution of water to calcium intake in low- and middle-income countries.

Dietary calcium intake is low in many countries, particularly in low- and middle-income countries (LMICs). Water is often overlooked as a source of dietary calcium despite it being universally consumed and providing good calcium bioavailability. Our objective was to assess water distribution systems in LMICs and to develop a formula to simulate the contribution of different water sources to calcium availability. We calculated the contribution of drinking water considering different calcium concentration levels to estimate total calcium availability. We consider a country's households' access to drinking water sources and the distribution of the country's population by age and gender. Calcium availability could be increased by an average of 49 mg of calcium per person per day in the 62 countries assessed if calcium in drinking water was considered. In 22 (31%) of the countries studied, 80% of households are supplied by water sources that could increase calcium availability. Improving calcium concentration in water could be considered as a strategy in LMICs to slightly improve calcium availability.

Effectiveness of a diabetes program based on digital health on capacity building and quality of care in type 2 diabetes: a pragmatic quasi-experimental study.

Health systems in Latin America face many challenges in controlling the increasing burden of diabetes. Digital health interventions are a promise for the provision of care, especially in developing countries where mobile technology has a high penetration. This study evaluated the effectiveness of the implementation of a Diabetes Program (DP) that included digital health interventions to improve the quality of care of persons with type 2 Diabetes (T2DM) in a vulnerable population attending the public primary care network. MATERIALS AND METHODS: A quasi-experimental pre-post uncontrolled study was conducted in 19 primary care centers and hospitals in the province of Corrientes, Argentina. We included persons with T2DM, age > = 18 years with access to a mobile phone. The multicomponent intervention included a mobile app with a diabetes registry, a clinical decision support tool for providers and a text messaging intervention for patients. RESULTS AND DISCUSSION: One thousand sixty-five participants were included, 72.8% had less than 12 years of formal education and 53.5% lacked health coverage. Comorbidities were hypertension (60.8%) and overweight/obesity (88.2%). During follow-up there was a significant increase in the proportion of participants who underwent laboratory check-ups (HbA1c 20.3%-64.4%; p < 0.01) and foot exams (62.1%-87.2%; p < 0.01). No changes were observed at 12 and 24 months in the proportion of participants with poor metabolic control. The proportion of participants with uncontrolled blood pressure (≥ 140/90 mmHg) decreased from 47.2% at baseline to 30.8% at 24 months in those with a follow-up visit. CONCLUSION: The DP was innovative by integrating digital health interventions in the public primary care level. The study showed improvements in quality indicators related with diabetes care processes and in blood pressure control.

Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: protocol and statistical analysis plan for a pragmatic, stepped-wedge, cluster-randomized pilot trial.

BACKGROUND: The World Health Organization (WHO) Labour Care Guide (LCG) is a paper-based labour monitoring tool designed to facilitate the implementation of WHO's latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine intrapartum care requires a strategy that improves healthcare provider practices during labour and childbirth. Such a strategy might optimize the use of Caesarean section (CS), along with potential benefits on the use of other obstetric interventions, maternal and perinatal health outcomes, and women's experience of care. However, the effects of a strategy to implement the LCG have not been evaluated in a randomised trial. This study aims to: (1) develop and optimise a strategy for implementing the LCG (formative phase); and (2) To evaluate the implementation of the LCG strategy compared with usual care (trial phase). METHODS: In the formative phase, we will co-design the LCG strategy with key stakeholders informed by facility assessments and provider surveys, which will be field tested in one hospital. The LCG strategy includes a LCG training program, ongoing supportive supervision from senior clinical staff, and audit and feedback using the Robson Classification. We will then conduct a stepped-wedge, cluster-randomized pilot trial in four public hospitals in India, to evaluate the effect of the LCG strategy intervention compared to usual care (simplified WHO partograph). The primary outcome is the CS rate in nulliparous women with singleton, term, cephalic pregnancies in spontaneous labour (Robson Group 1). Secondary outcomes include clinical and process of care outcomes, as well as women's experience of care outcomes. We will also conduct a process evaluation during the trial, using standardized facility assessments, in-depth interviews and surveys with providers, audits of completed LCGs, labour ward observations and document reviews. An economic evaluation will consider implementation costs and cost-effectiveness. DISCUSSION: Findings of this trial will guide clinicians, administrators and policymakers on how to effectively implement the LCG, and what (if any) effects the LCG strategy has on process of care, health and experience outcomes. The trial findings will inform the rollout of LCG internationally. TRIAL REGISTRATION: CTRI/2021/01/030695 (Protocol version 1.4, 25 April 2022).

The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women's and newborn's health outcomes, and women's experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries.

Rotavirus Vaccine Impact since Its Introduction in the National Immunization Program of Argentina.

INTRODUCTION: Rotavirus (RV) is the most common cause of childhood diarrhea. Argentina introduced RV vaccination in the National Immunization Program in January 2015. This study evaluates the impact of RV vaccine implementation on the burden of acute diarrheal disease (ADD) and RV positive cases, and hospitalizations among children in Argentina. METHODS: A counterfactual time-series analysis was performed. Data on ADD (2013-2018) and RV diarrhea (2012-2018) cases in children aged < 5 years were collected from the National Healthcare Surveillance System (clinical and laboratory data). Data on hospital discharges following ADD and RV diarrhea (2011-2017) were retrieved from the Health Statistics and Information Office. All data were classified by the age groups < 1 year, < 2 years, 2-5 years. Vaccine impact was defined as the difference between the predicted time trend (simulated using 2012-2014 data) and the actual post-vaccination data (2015-2018). RESULTS: A significant reduction of 22.1% of notified ADD cases and 15.4% of hospital discharges following ADD among children < 2 years was observed in the 3 years after RV vaccine implementation. Data also showed a significant decline of 54.0% and 59.4% of notified RV cases in children < 2 and < 1 years, respectively, and a reduction of 39.3% and 40.8% in RV hospital discharges for the same age groups. CONCLUSION: This study shows a significant reduction in notified ADD cases and RV cases and hospital discharges following ADD and RV cases in children < 2 years after RV vaccine introduction in Argentina in 2015.

Direct evidence gap on fixed versus adjusted-dose benznidazole for adults with chronic Chagas disease without cardiomyopathy: Systematic review and individual patient data meta-analysis.

OBJECTIVES: To determine the comparative efficacy and safety of a fixed dose of benznidazole (BZN) with an adjusted-dose for Trypanosoma cruzi-seropositive adults without cardiomyopathy. METHODS: We conducted a systematic review and individual participant data (IPD) meta-analysis following Cochrane methods, and the PRISMA-IPD statement for reporting. Randomised controlled trials (RCTs) allocating participants to fixed or adjusted doses of BZN for T. cruzi-seropositive adults without cardiomyopathy were included. We searched (December 2021) Cochrane, MEDLINE, EMBASE, LILACS and trial registries and contacted Chagas experts. Selection, data extraction, risk of bias assessment using the Cochrane tool, and a GRADE summary of finding tables were performed independently by pairs of reviewers. We conducted a random-effects IPD meta-analysis using the one-stage strategy, or, if that was impossible, the two-stage strategy. RESULTS: Five RCTs (1198 patients) were included, none directly comparing fixed with adjusted doses of BZN. Compared to placebo, BZN therapy was strongly associated with negative qPCR and sustainable parasitological clearance regardless of the type of dose and subgroup analysed. For negative qPCR, the fixed/adjusted rate of odds ratios (RORF/A ) was 8.83 (95% CI 1.02-76.48); for sustained parasitological clearance, it was 4.60 (95% CI 0.40-52.51), probably indicating at least non-inferior effect of fixed doses, with no statistically significant interactions by scheme for global and most subgroup estimations. The RORF/A for treatment interruption due to adverse events was 0.44 (95% CI 0.14-1.38), probably indicating no worse tolerance of fixed doses. CONCLUSIONS: We found no direct comparison between fixed and adjusted doses of BZN. However, fixed doses versus placebo are probably not inferior to weight-adjusted doses of BZN versus placebo in terms of parasitological efficacy and safety. Network IPD meta-analysis, through indirect comparisons, may well provide the best possible answers in the near future. REGISTRATION: The study protocol was registered in PROSPERO (CRD42019120905).

Comparison of mortality in patients on chemotherapy or immunotherapy during and before COVID-19 pandemic. Multicenter matched cohort study in Argentina. / Comparación de la mortalidad en pacientes en quimioterapia o inmunoterapia durante y antes de la pandemia de COVID-19. Estudio multicéntrico de cohortes emparejadas en Argentina.

OBJECTIVES.: Motivation for the study. The impact of the COVID-19 pandemic on the risk of death in cancer patients on chemotherapy and immunotherapy is controversial. Published studies mainly compared patients on anti-cancer therapy to those off treatment or COVID-19 positive cancer patients to COVID-19 negative ones. Few studies were conducted in developing countries. Main findings. Mortality didn't increase in unvaccinated outpatients on active intravenous oncology treatment during the COVID-19 pandemic. Implications. This is the first propensity score-matched cohort study evaluating the impact of the COVID-19 pandemic on the population of unvaccinated oncology patients receiving intravenous anticancer therapy. . To compare all-cause mortality of unvaccinated oncology patients who received chemotherapy or immunotherapy during the pandemic with those treated before the pandemic. MATERIALS AND METHODS.: We conducted a cohort study in four tertiary hospitals in Argentina. Outpatients with a solid neoplasm of any stage under-going cytotoxic or intravenous immunotherapy were eligible. The pandemic cohort was enrolled during the initial phase of the outbreak and compared with a pre-pandemic cohort using propensity score matching (PSM). Subjects were matched for age, sex, health insurance, risk factors for severe COVID-19 complications, performance status, cancer type and treatment, line of treatment, and body mass index. All-cause mortality was estimated for both cohorts after 6 months of follow-up. RESULTS.: A total of 169 patients were recruited between April and August 2020 for the pandemic cohort and 377 for the pre-pandemic cohort in the same months of 2019; 168 patients were matched. After PSM, all-cause mortality was 17.9% in the pandemic cohort and 18.5% in the pre-pandemic cohort; the Relative Risk was 0.97 (95 % confidence interval: 0.61-1.52; p=0.888). In the pandemic cohort, 30/168 patients died, but none from COVID-19. CONCLUSIONS.: Our findings show that the mortality rate of unvaccinated ambulatory patients on active intravenous oncology treatment during the COVID-19 pandemic did not increase.

OBJETIVOS.: Comparar la mortalidad por todas las causas de pacientes oncológicos no vacunados que recibieron quimioterapia o inmunoterapia durante la pandemia, con aquellos tratados antes de la pandemia. MATERIALES Y MÉTODOS.: Realizamos un estudio de cohortes en cuatro hospitales terciarios en Argentina. Pacientes ambulatorios con una neoplasia sólida de cualquier estadio en tratamiento citotóxico o inmune intravenoso fueron elegibles. La cohorte pandémica se enroló durante la fase inicial del brote y se comparó con una cohorte de un período anterior a la pandemia utilizando emparejamiento por puntuación de propensión (PSM, por sus siglas en inglés). Los sujetos se emparejaron por edad, sexo, seguro de salud, factores de riesgo para complicaciones graves por COVID-19, estado funcional, tipo de cáncer y tratamiento, línea de tratamiento e índice de masa corporal. La mortalidad por todas las causas se estimó en ambas cohortes después de seis meses de seguimiento. RESULTADOS.: 169 pacientes fueron reclutados entre abril y agosto de 2020 para la cohorte pandémica y 377 para la cohorte prepandémica en el mismo período de 2019, 168 pacientes fueron emparejados. Luego de la PSM, la mortalidad por todas las causas fue del 17,9% en la cohorte pandémica y del 18,5% en la cohorte prepandémica, Riesgo Relativo: 0,97 (intervalo de confianza al 95 %: 0,61-1,52; p=0,888). En la cohorte pandémica, 30/168 pacientes fallecieron, ninguno por infección por COVID-19. CONCLUSIONES.: No hemos observado un aumento de mortalidad en pacientes ambulatorios no vacunados en tratamiento oncológico endovenoso activo durante la pandemia por COVID-19.