Irritable bowel syndrome in celiac disease - relationships to celiac disease antibodies and levels of pro-inflammatory cytokines.

BACKGROUND: Evidence indicates that low-grade inflammation can alter gastrointestinal motor and sensory function and might contribute to the genesis of symptoms in IBS. OBJECTIVE: To examine relationships between IBS, disease antibodies and cytokine titers in celiac patients and a control group. MATERIALS AND METHODS: IBS, CD activity and serum levels of IL-6, IL-8 and IL12/23p40 were determined in celiac patients and controls. RESULTS: 123 celiac patients were included, 89% were female. 59% demonstrated disease activity and 32% met IBS criteria. Prevalence of IBS was not different between patients who adhered or did not adhere to GFD as well as between patients with or without positive antibodies. Celiac patients had increased levels of IL-6, IL-8 and IL12/23p40 as compared to controls. Higher levels of cytokines were found in celiac patients with IBS than in those without IBS. No difference in levels of cytokines was found between patients with and without CD positive antibodies. A significant negative correlation between the mental component of QoL and IL-6 and IL12/23p40 levels was found, but not with IL-8. CONCLUSION: Higher levels of inflammatory cytokines were found in CD patients with IBS than in either those without IBS or controls, indicating that IBS symptoms are associated with an increase in the inflammatory response and a decrease in quality of life of CD patients. These differences in cytokine levels were not related to CD antibodies status suggesting that IBS, in CD, is related to a different inflammatory process than that which is relevant to CD.

Prevalence of invehicle smoking and secondhand smoke exposure in Uruguay.

INTRODUCTION: Protection from secondhand smoke (SHS) is one of the fundamental principles of the WHO Framework Convention for Tobacco Control. Objective data on SHS exposure in vehicles in South America is scarce. This study aimed to estimate prevalence of smoking inside vehicles. METHODS: The point prevalence of smoking in vehicles was observed, and a method for estimating smoking prevalence was piloted. RESULTS: We observed 10 011 vehicles. In 219 (2.2%; 95% CI 1.91 to 2.49) of them, smoking was observed, and in 29.2% of these, another person was exposed to SHS. According to the 'expansion factor' we constructed, direct observation detected one of six to one to nine vehicles in which smoking occurred. The observed prevalence of smoking in vehicles (2.2%) could reflect a real prevalence between 12% and 19%. In 29.2% (95% CI 23.6 to 35.5) and 4.6% (95% CI 2.2 to 8.3) of vehicles in which smoking was observed, another adult or a child, respectively, was exposed to SHS. CONCLUSIONS: Smoking was estimated to occur in 12%-19% of vehicles, with involuntary exposure in one of three of vehicles observed. These data underscore a need for new public policies to eliminate SHS in vehicles to protect public health.

IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN LITIGATION CONCERNING ACCESS TO HIGH-COST DRUGS.

OBJECTIVES: The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process. METHODS: The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants. RESULTS: Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health. CONCLUSIONS: Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

Supply kits for antenatal and childbirth care during antenatal care and delivery: a mixed-methods systematic review, the qualitative approach.

Antenatal care reduces maternal and perinatal mortality and morbidity through the detection and treatment of some conditions, but its coverage is less than optimal within certain populations. Supply kits for maternal health were designed to overcome barriers present when providing care during pregnancy and childbirth particularly to women from underserved population.We conducted a mixed-methods systematic review on the use of supply kits. This manuscript presents the findings from qualitative studies that reported barriers, facilitators, and user's recommendation in the adoption and implementation of any type of kit designed to be used during pregnancy or childbirth.This review included eight studies, and seven were implemented in developing countries. Most studies assessed the implementation of clean delivery kits to be used during labour and delivery, and contributed to gain insights into factors that may hinder or foster the use of kits.Clean delivery kits were conceived to cope with barriers related mainly to access. The most important barrier identified were those related to the socio-cultural and the lack of knowledge dimension such as who held the decision-making authority in the household, as well as popular beliefs behind the idea that birth preparation could bring bad luck, may prevent clients from adhering to their use. In addition, financial constraints and limited understanding of the instructions of use were accessibility barriers found. On the other hand, once used, clean delivery kits for maternal health were accepted by women and health workers. Convenience, hygienic components, and avoidance of delays in receiving care were viewed as satisfactory features.Supply kits are mostly affordable and easily deployable. Increasing awareness among the population about the offered kits and providing information on their benefits emerges as a critical step to foster use in settings where kits are available. Implementation of this strategy requires low complexity resources and could make the use of kits an accepted alternative to increase the use of evidence-based interventions and thus improve quality of care during pregnancy, childbirth and neonatal period mainly at the community level in low income countries and remote areas with low access.

Supply kits for antenatal and childbirth care: a systematic review.

INTRODUCTION: It is critical to increase the uptake of interventions proven to be effective to improve maternal and perinatal outcomes. Supply kits have been suggested to be a feasible strategy designed to ensure timely availability and effective follow-up of care. OBJECTIVE: We conducted a systematic review to summarize the evidence on the uptake, effectiveness and safety of supply kits for maternal care. SEARCH STRATEGY: MEDLINE, the Cochrane Pregnancy and Childbirth Group's Trials Register, Campbell Collaboration, Lilacs, Embase and unpublished studies were searched. SELECTION CRITERIA: Studies that reported the efficacy, safety and use of supply kits for maternal healthcare were eligible. Participants were pregnant women or in childbirth. Supply kits were defined as a collection of medicines, supplies or instruments packaged together with the aim of conducting a healthcare task. DATA COLLECTION AND ANALYSIS: Two reviewers independently performed the screening, data extraction, and methodological and quality assessment. MAIN RESULTS: 24 studies were included: 4 of them were systematic reviews and 20 primary studies. Eighteen studies evaluated a so-called "clean delivery kit". In all but two studies, the kits were used by more than half of the participants. A meta-analysis was deemed inappropriate due to the heterogeneity in study design, in the components of the interventions implemented, in the content of the kits, and in outcomes. Nine studies assessed neonatal outcomes and found statistically significant reductions in cord infection, sepsis and tetanus-related mortality in the intervention group. Three studies showed evidence of reduced neonatal mortality (OR 0.52, 0.60 and 0.71) with statistically significant confidence intervals in all cases. Four studies reported odd ratios for maternal mortality, but only one showed evidence of a statistically significant decrease in this outcome but it was ascribed to hand washing prior to childbirth and not with the use of kits. CONCLUSION: This review suggests potential benefits in the use of supply kits to improve maternal and neonatal health. However, the observational nature of the studies, the heterogeneity and the use of kits incorporated within complex interventions limit the interpretation of the findings.

Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013.

BACKGROUND: The Global Burden of Disease, Injuries, and Risk Factor study 2013 (GBD 2013) is the first of a series of annual updates of the GBD. Risk factor quantification, particularly of modifiable risk factors, can help to identify emerging threats to population health and opportunities for prevention. The GBD 2013 provides a timely opportunity to update the comparative risk assessment with new data for exposure, relative risks, and evidence on the appropriate counterfactual risk distribution. METHODS: Attributable deaths, years of life lost, years lived with disability, and disability-adjusted life-years (DALYs) have been estimated for 79 risks or clusters of risks using the GBD 2010 methods. Risk-outcome pairs meeting explicit evidence criteria were assessed for 188 countries for the period 1990-2013 by age and sex using three inputs: risk exposure, relative risks, and the theoretical minimum risk exposure level (TMREL). Risks are organised into a hierarchy with blocks of behavioural, environmental and occupational, and metabolic risks at the first level of the hierarchy. The next level in the hierarchy includes nine clusters of related risks and two individual risks, with more detail provided at levels 3 and 4 of the hierarchy. Compared with GBD 2010, six new risk factors have been added: handwashing practices, occupational exposure to trichloroethylene, childhood wasting, childhood stunting, unsafe sex, and low glomerular filtration rate. For most risks, data for exposure were synthesised with a Bayesian meta-regression method, DisMod-MR 2.0, or spatial-temporal Gaussian process regression. Relative risks were based on meta-regressions of published cohort and intervention studies. Attributable burden for clusters of risks and all risks combined took into account evidence on the mediation of some risks such as high body-mass index (BMI) through other risks such as high systolic blood pressure and high cholesterol. FINDINGS: All risks combined account for 57·2% (95% uncertainty interval [UI] 55·8-58·5) of deaths and 41·6% (40·1-43·0) of DALYs. Risks quantified account for 87·9% (86·5-89·3) of cardiovascular disease DALYs, ranging to a low of 0% for neonatal disorders and neglected tropical diseases and malaria. In terms of global DALYs in 2013, six risks or clusters of risks each caused more than 5% of DALYs: dietary risks accounting for 11·3 million deaths and 241·4 million DALYs, high systolic blood pressure for 10·4 million deaths and 208·1 million DALYs, child and maternal malnutrition for 1·7 million deaths and 176·9 million DALYs, tobacco smoke for 6·1 million deaths and 143·5 million DALYs, air pollution for 5·5 million deaths and 141·5 million DALYs, and high BMI for 4·4 million deaths and 134·0 million DALYs. Risk factor patterns vary across regions and countries and with time. In sub-Saharan Africa, the leading risk factors are child and maternal malnutrition, unsafe sex, and unsafe water, sanitation, and handwashing. In women, in nearly all countries in the Americas, north Africa, and the Middle East, and in many other high-income countries, high BMI is the leading risk factor, with high systolic blood pressure as the leading risk in most of Central and Eastern Europe and south and east Asia. For men, high systolic blood pressure or tobacco use are the leading risks in nearly all high-income countries, in north Africa and the Middle East, Europe, and Asia. For men and women, unsafe sex is the leading risk in a corridor from Kenya to South Africa. INTERPRETATION: Behavioural, environmental and occupational, and metabolic risks can explain half of global mortality and more than one-third of global DALYs providing many opportunities for prevention. Of the larger risks, the attributable burden of high BMI has increased in the past 23 years. In view of the prominence of behavioural risk factors, behavioural and social science research on interventions for these risks should be strengthened. Many prevention and primary care policy options are available now to act on key risks. FUNDING: Bill & Melinda Gates Foundation.

A Multifaceted Strategy to Implement Brief Smoking Cessation Counseling During Antenatal Care in Argentina and Uruguay: A Cluster Randomized Trial.

INTRODUCTION: Argentina and Uruguay have a high prevalence of smoking during pregnancy. However, and despite national recommendations, pregnant women are not routinely receiving cessation counseling during antenatal care (ANC). We evaluated a multifaceted strategy designed to increase the frequency of pregnant women who received a brief smoking cessation counseling based on the 5As (Ask, Advise, Assess, Assist, and Arrange). METHODS: We randomly assigned (1:1) 20 ANC clusters in Buenos Aires, Argentina and Montevideo, Uruguay to receive a multifaceted intervention to implement brief smoking cessation counseling into routine ANC, or to receive no intervention. The primary outcome was the frequency of women who recalled receiving the 5As during ANC at more than one visit. Frequency of women who smoked until the end of pregnancy, and attitudes and readiness of ANC providers towards providing counseling were secondary outcomes. Women's outcomes were measured at baseline and at the end of the 14- to 18-month intervention, by administering questionnaires at the postpartum hospital stay. Self-reported cessation was verified with saliva cotinine. The trial took place between October 03, 2011 and November 29, 2013. RESULTS: The rate of women who recalled receiving the 5As increased from 14.0% to 33.6% in the intervention group (median rate change, 22.1%), and from 10.8% to 17.0% in the control group (median rate change, 4.6%; P = .001 for the difference in change between groups). The effect of the intervention was larger in Argentina than in Uruguay. The proportion of women who continued smoking during pregnancy was unchanged at follow-up in both groups and the relative difference between groups was not statistically significant (ratio of odds ratios 1.16, 95% CI: 0.98-1.37; P = .086). No significant changes were observed in knowledge, attitudes, and self-confidence of ANC providers. CONCLUSIONS: The intervention showed a moderate effect in increasing the proportion of women who recalled receiving the 5As, with a third of women receiving counseling in more than one visit. However, the frequency of women who smoked until the end of the pregnancy was not significantly reduced by the intervention. IMPLICATIONS: No implementation trials of smoking cessation interventions for pregnant women have been carried out in Latin American or in middle-income countries where health care systems or capacities may differ. We evaluated a multifaceted strategy designed to increase the frequency of pregnant women who receive brief smoking cessation counseling based on the 5As in Argentina and Uruguay. We found that the intervention showed a moderate effect in increasing the proportion of women receiving the 5As, with a third of women receiving counseling in more than one visit. However, the frequency of women who smoked until the end of the pregnancy was not significantly reduced by the intervention.

Smoking Patterns and Receipt of Cessation Services Among Pregnant Women in Argentina and Uruguay.

INTRODUCTION: The 5A's (Ask, Advise, Assess, Assist, and Arrange) strategy, a best-practice approach for cessation counseling, has been widely implemented in high-income countries for pregnant women; however, no studies have evaluated implementation in middle-income countries. The study objectives were to assess smoking patterns and receipt of 5A's among pregnant women in Buenos Aires, Argentina and Montevideo, Uruguay. METHODS: Data were collected through administered questionnaires to women at delivery hospitalizations during October 2011-May 2012. Eligible women attended one of 12 maternity hospitals or 21 associated prenatal care clinics. The questionnaire included demographic data, tobacco use/cessation behaviors, and receipt of the 5A's. Self-reported cessation was verified with saliva cotinine. RESULTS: Overall, of 3400 pregnant women, 32.8% smoked at the beginning of pregnancy; 11.9% quit upon learning they were pregnant or later during pregnancy, and 20.9% smoked throughout pregnancy. Smoking prevalence varied by country with 16.1% and 26.7% who smoked throughout pregnancy in Argentina and Uruguay, respectively. Among pregnant smokers in Argentina, 23.8% reported that a provider asked them about smoking at more than one prenatal care visit; 18.5% were advised to quit; 5.3% were assessed for readiness to quit, 4.7% were provided assistance, and 0.7% reported follow-up was arranged. In Uruguay, those percentages were 36.3%, 27.9%, 5.4%, 5.6%, and 0.2%, respectively. CONCLUSIONS: Approximately, one in six pregnant women smoked throughout pregnancy in Buenos Aires and one in four in Montevideo. However, a low percentage of smokers received any cessation assistance in both countries. Healthcare providers are not fully implementing the recommended 5A's intervention to help pregnant women quit smoking.

INFLUENCE OF HEALTH TECHNOLOGY ASSESSMENT AND ITS MEASUREMENT.

OBJECTIVES: The aim of this study was to obtain information on methods used to measure health technology assessment (HTA) influence, decisions that were influenced, and outcomes linked to HTA. METHODS: Electronic databases were used to locate studies in which HTA influence had been demonstrated. Inclusion criteria were studies that reliably reported consideration by decision makers of HTA findings; comparative studies of technology use before and after HTA; and details of changes in policy, health outcomes, or research that could be credibly linked to an HTA. RESULTS: Fifty-one studies were selected for review. Settings were national (24), regional (12), both national and regional (3) hospitals (9), and multinational (3). The most common approach to appraisal of influence was review of policy or administrative decisions following HTA recommendations (51 percent). Eighteen studies (35 percent) reported interview or survey findings, thirteen (26 percent) reviewed administrative data, and six considered the influence of primary studies. Of 142 decisions informed by HTA, the most common types were on routine clinical practice (67 percent of studies), coverage (63 percent), and program operation (37 percent). The most frequent indications of HTA influence were on decisions related to resource allocation (59 percent), change in practice pattern (31 percent), and incorporation of HTA details in reference material (18 percent). Few publications assessed the contribution of HTA to changing patient outcomes. CONCLUSIONS: The literature on HTA influence remains limited, with little on longer term effects on practice and outcomes. The reviewed publications indicated how HTA is being used in different settings and approaches to measuring its influence that might be more widely applied, such as surveys and monitoring administrative data.

Challenges and opportunities for implementing evidence-based antenatal care in Mozambique: a qualitative study.

BACKGROUND: Maternal mortality remains a daunting problem in Mozambique and many other low-resource countries. High quality antenatal care (ANC) services can improve maternal and newborn health outcomes and increase the likelihood that women will seek skilled delivery care. This study explores the factors influencing provider uptake of the recommended package of ANC interventions in Mozambique. METHODS: This study used qualitative research methods including key informant interviews with stakeholders from the health sector and a total of five focus group discussions with women with experience with ANC or women from the community. Study participants were selected from three health centers located in Maputo city, Tete, and Cabo Delgado provinces in Mozambique. Staff responsible for the medicines/supply chain at national, provincial and district level were interviewed. A check list was implemented to confirm the availability of the supplies required for ANC. Deductive content analysis was conducted. RESULTS: Three main groups of factors were identified that hinder the implementation of the ANC package in the study setting: a) system or organizational: include chronic supply chain deficiencies, failures in the continuing education system, lack of regular audits and supervision, absence of an efficient patient record system and poor environmental conditions at the health center; b) health care provider factors: such as limited awareness of current clinical guidelines and a resistant attitude to adopting new recommendations; and c) Users: challenges with accessing ANC, poor recognition amongst women about the purpose and importance of the specific interventions provided through ANC, and widespread perception of an unfriendly environment at the health center. CONCLUSIONS: The ANC package in Mozambique is not being fully implemented in the three study facilities, and a major barrier is poor functioning of the supply chain system. Recommendations for improving the implementation of antenatal interventions include ensuring clinical protocols based on the ANC model. Increasing the community understanding of the importance of ANC would improve demand for high quality ANC services. The supply chain functioning could be strengthened through the introduction of a kit system with all the necessary supplies for ANC and a simple monitoring system to track the stock levels is recommended.

Accuracy of self-reported smoking cessation during pregnancy.

Evidence of bias of self-reported smoking cessation during pregnancy is reported in high-income countries but not elsewhere. We sought to evaluate self-reported smoking cessation during pregnancy using biochemical verification and to compare characteristics of women with and without biochemically confirmed cessation in Argentina and Uruguay. In a cross-sectional study from October 2011 to May 2012, women who attended one of 21 prenatal clinics and delivered at selected hospitals in Buenos Aires, Argentina and Montevideo, Uruguay, were surveyed about their smoking cessation during pregnancy. We tested saliva collected from women <12 h after delivery for cotinine to evaluate self-reported smoking cessation during pregnancy. Overall, 10.0% (44/441) of women who self-reported smoking cessation during pregnancy had biochemical evidence of continued smoking. Women who reported quitting later in pregnancy had a higher percentage of nondisclosure (17.2%) than women who reported quitting when learning of their pregnancy (6.4%).

Barriers and promoters of an evidenced-based smoking cessation counseling during prenatal care in Argentina and Uruguay.

In Argentina and Uruguay, 10.3 and 18.3 %, respectively, of pregnant women smoked in 2005. Brief cessation counseling, based on the 5A's model, has been effective in different settings. This qualitative study aims to improve the understanding of factors influencing the provision of smoking cessation counseling during pregnancy in Argentina and Uruguay. In 2010, we obtained prenatal care providers', clinic directors', and pregnant smokers' opinions regarding barriers and promoters to brief smoking cessation counseling in publicly-funded prenatal care clinics in Buenos Aires, Argentina and Montevideo, Uruguay. We interviewed six prenatal clinic directors, conducted focus groups with 46 health professionals and 24 pregnant smokers. Themes emerged from three issue areas: health professionals, health system, and patients. Health professional barriers to cessation counseling included inadequate knowledge and motivation, perceived low self-efficacy, and concerns about inadequate time and large workload. They expressed interest in obtaining a counseling script. Health system barriers included low prioritization of smoking cessation and a lack of clinic protocols to implement interventions. Pregnant smokers lacked information on the risks of prenatal smoking and underestimated the difficulty of smoking cessation. Having access to written materials and receiving cessation services during clinic waiting times were mentioned as promoters for the intervention. Women also were receptive to non-physician office staff delivering intervention components. Implementing smoking cessation counseling in publicly-funded prenatal care clinics in Argentina and Uruguay may require integrating counseling into routine prenatal care and educating and training providers on best-practices approaches.

Pregnant women's secondhand smoke exposure and receipt of screening and brief advice by prenatal care providers in Argentina and Uruguay.

Secondhand smoke (SHS) exposure has negative effects on maternal and infant health. SHS exposure among pregnant women in Argentina and Uruguay has not been previously described, nor has the proportion of those who have received screening and advice to avoid SHS during prenatal care. Women who attended one of 21 clusters of publicly-funded prenatal care clinics were interviewed regarding SHS exposure during pregnancy at their delivery hospitalization during 2011-2012. Analyses were conducted using SURVEYFREQ procedure in SAS version 9.3 to account for prenatal clinic clusters. Of 3,427 pregnant women, 43.4 % had a partner who smoked, 52.3 % lived with household members who smoked cigarettes, and 34.4 % had no or partial smoke-free home rule. Of 528 pregnant women who worked outside of the home, 21.6 % reported past month SHS exposure at work and 38.1 % reported no or partial smoke-free work policy. Overall, 35.9 % of women were exposed to SHS at home or work. In at least one prenatal care visit, 67.2 % of women were screened for SHS exposure, and 56.6 % received advice to avoid SHS. Also, 52.6 % of women always avoided SHS for their unborn baby's health. In summary, a third of pregnant women attending publicly-funded prenatal clinics were exposed to SHS, and only half of pregnant women always avoided SHS for their unborn baby's health. Provider screening and advice rates can be improved in these prenatal care settings, as all pregnant women should be screened and advised of the harms of SHS and how to avoid it.

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol.

BACKGROUND: Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. METHODS: This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. DISCUSSION: There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country's health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in 'habits' will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study. TRIAL REGISTRATION: Pan African Clinical Trial Registry database. Identification number: PACTR201306000550192.

Rituximab and tocilizumab for the treatment of rheumatoid arthritis.

OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of rituximab and tocilizumab compared with adalimumab, etanercept, and infliximab, in patients with rheumatoid arthritis not responding to first-line treatment, and to compare the efficacy and safety of rituximab versus tocilizumab in patients not responding to anti-tumor necrosis factor α (anti-TNF) therapy. METHODS: A literature search of randomized controlled trials, controlled clinical trials, and systematic reviews was performed to evaluate efficacy and safety of rituximab and tocilizumab. RESULTS: Twenty-four RCTs were included in this systematic review with 6,357 participants; 3,450 treated with biological DMARD and 2,907 with standard care. In patients not responding to first-line treatment, rituximab shows lower response rate in at least 50 percent improvement in the American College of Rheumatology criteria (ACR50) and ACR70 compared with etanercept, at 6 months of follow-up. Tocilizumab shows higher ACR70 response rate compared with infliximab, at the same follow-up time. Other results showed no significant differences. Indirect comparisons between rituximab and tocilizumab in patients not responding for at least one anti-TNF, shows higher ACR20 response rate for tocilizumab at 6 months of follow-up. Regarding safety, adalimumab and etanercept were associated with significant fewer withdrawals due to adverse events compared with infliximab. CONCLUSIONS: Considering efficacy, safety, and the availability of 3 anti-TNFs in the National Medicines Formulary (adalimumab, etanercept, and infliximab), it seems appropriate to remove infliximab from the coverage, and introduce tocilizumab for patients not responding for at least one anti-TNF.

Mode of childbirth in low-risk pregnancies: Nicaraguan physicians' viewpoints.

To explore attitudes of physicians attending births in the public and private sectors and at the managerial level toward cesarean birth in Nicaragua. A qualitative study was conducted consisting of four focus groups with 17 physicians and nine in-depth interviews with decision-makers. Although study participants listed many advantages of vaginal birth and disadvantages of cesarean birth, they perceived that the increase in the cesarean birth rate in Nicaragua has resulted in a reduction in perinatal morbidity and mortality. They ascribed high cesarean birth rates to a web of interrelated provider, patient, and health system factors. They identified five actions that would facilitate a reduction in the number of unnecessary cesarean operations: establishing standards and protocols; preparing women and their families for labor and childbirth; incorporating cesarean birth rate monitoring and audit systems into quality assurance activities at the facility level; strengthening the movement to humanize birth; and promoting community-based interventions to educate women and families about the benefits of vaginal birth. Study participants believe that by performing cesarean operations they are providing the best quality of care feasible within their context. They do not perceive problems with their current practice. The identified causes of unnecessary cesarean operations in Nicaragua are multifactorial, so it appears that a multi-layered strategy is needed to safely reduce cesarean birth rates. The recent Nicaraguan Ministry of Health guidance to promote parto humanizado ("humanization of childbirth") could serve as the basis for a collaborative effort among health care professionals, government, and consumer advocates to reduce the number of unnecessary cesarean births in Nicaragua.

Use of antenatal corticosteroids for preterm birth in Latin America: providers knowledge, attitudes and practices.

BACKGROUND: Antenatal corticosteroids administered to women at risk of preterm birth is an intervention which has been proved to reduce the risk of respiratory distress syndrome, intraventricular hemorrhage, and neonatal mortality. There is a significant gap in the literature regarding the prevalence of the use of antenatal corticosteroids in Latin American countries and the attitudes and opinions of providers regarding this practice. The aim of this study was to assess the knowledge, attitudes and practices of health care providers regarding the use of antenatal corticosteroids in women at risk of preterm birth in Latin America. METHODS: This was a multicenter, prospective, descriptive study conducted in maternity hospitals in Ecuador, El Salvador, Mexico and Uruguay. Physicians and midwives who provide prenatal care or intrapartum care for women delivering in the selected hospitals were approached using a self-administered questionnaire. Descriptive statistics was used. RESULTS: The percentage of use of ACT in threatened preterm labour (TPL) reported by providers varies from 70% in Mexico to 97% in Ecuador. However, 60% to 20% of the providers mentioned that they would not use this medication in women at risk and would limit its use when there was a threatened preterm labour. In only one country recommended regimens of antenatal corticosteroids are followed by around 90% of providers whereas in the other three countries recommended regimens are followed by only 21%, 61%, 69% of providers. Around 40% of providers mentioned that they would administer a new dose of corticosteroids again, regardless the patient already receiving an entire regimen. Between 11% and 35% of providers, according to the countries, mentioned that they do not have adequate information on the correct use of this medication. CONCLUSIONS: This study shows that the use of this intervention could be improved by increasing the knowledge of Latin American providers on its indications, benefits, and regimens.

Tobacco cessation intervention for pregnant women in Argentina and Uruguay: study protocol.

BACKGROUND: Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and infants. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider. The "5 A's" is considered the standard of care worldwide; however, it is under used in Argentina and Uruguay. METHODS: We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal care settings in Argentina and Uruguay. Prenatal care settings will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwives' facilitators in the 10 intervention prenatal clinics (clusters) will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The 10 clusters in the control group will continue with their standard in-service activities. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at maternity hospitals and acceptable to local pregnant women and health providers. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy in the intervention clinics compared to the control clinics. Our secondary hypotheses are that the intervention will decrease the frequency of women who smoke by the end of pregnancy, and that the intervention will increase the attitudes and readiness of midwives towards providing counseling to women in the intervention clinics compared to the control clinics.

COVID-19 mitigation measures increase preterm birth and low birth weight in the public healthcare system in Uruguay.

OBJECTIVE: To evaluate the impact of the COVID-19 pandemic on preterm birth (PB) and low birth weight (LBW), comparing public and private healthcare systems of the National Integrated Health System in Uruguay, where the mitigation measures for the COVID-19 pandemic generated an immediate socioeconomic and psychological crisis, which caused a sharp widening of existing socioeconomic inequalities. METHODS: A national observational study was conducted comparing perinatal outcomes in the first 6 months of 2020 (period of the pandemic without pregnancy infections), which was the beginning of the pandemic, with the same period of the previous year 2019 (pre-pandemic period with no mitigation measures) among pregnant women from the public and private health systems. Data were retrieved from the national database (Informatic Perinatal System) and analyzed by healthcare system category. RESULTS: A total of 36 559 deliveries were assessed: 18 563 in the 2019 study period and 17 996 in the 2020 study period. In the public system, there was a significant increase in the risk of LBW (adjusted relative risk [aRR] 1.12, 95% confidence interval [CI] 1.05-1.36) and of the composite outcome (PB or LBW) (aRR 1.15, 95% CI 1.04-1.26). In the private system, by contrast, there was a non-statistically significant decrease of LBW and there were no changes in the incidence of PB and the composite outcome in 2020. CONCLUSION: The different evolution of birth outcomes in the public and private systems suggests an unequal impact of mitigation measures on populations of different socioeconomic levels. Given that no COVID-19 infections were identified in pregnant women during the study period, this research offers an opportunity to differentiate the biologic effects of the virus from the psychological and social impacts derived from containment measures. GOV IDENTIFIER: NCT05087160.