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Biomedical subjects

Edgardo Abalos

Publications and source records attributed to Edgardo Abalos.

11 recordsLinked to original sources
PubMed2006

The Trial Protocol Tool: The PRACTIHC software tool that supported the writing of protocols for pragmatic randomized controlled trials.

OBJECTIVE: To develop a tool that would make it easier for researchers, especially those in low- and middle-income countries, to write research protocols for pragmatic randomized controlled trials. STUDY DESIGN AND SETTING: A series of focus groups was held at the inaugural meeting of the Pragmatic RAndomized Controlled Trials in Health Care (PRACTIHC) project in 2001 to develop a desired specification for the Trial Protocol Tool. A working group of five individuals from the PRACTIHC group was formed to develop content for the tool. RESULTS: The Trial Protocol Tool was developed in English and Spanish as a Microsoft Windows HTML help system. A Web-based version is also available. This main body of the tool provides information, advice, and resources about the major headings that should be part of every research protocol. Illustrative examples are used throughout and are taken directly from the tool's protocol library. Additional resources include checklists, programs (e.g., a sample size calculator), and example documents (e.g., patient information leaflets). CONCLUSION: The Trial Protocol Tool packages all the key requirements for the development of a research protocol into one resource. We believe that the use of the tool will help researchers to design effective trials and to write high-quality protocols.

Clinical Protocols↗
PubMed2006

Perinatal research in developing countries--is it possible?

Maternal mortality remains the health statistic for which there is the greatest disparity between developing and developed countries. The risk of stillbirth or neonatal death is also high in developing countries. The inequality of research funding between rich and poor countries is dramatic, with only 10% of research funding directed towards diseases which contribute 90% of the global burden of disease. The need for high-quality, relevant perinatal research in developing countries is compelling. There are many examples of good perinatal research in developing countries. Nevertheless, significant challenges remain and are being tackled. We need better information about maternal and perinatal health, and about performance of the health services, we need more evaluation of what helps and what harms within the existing health services, and we need improved strategies for implementation of research findings.

Biomedical Research↗
PubMed2006

Preeclampsia, gestational hypertension and intrauterine growth restriction, related or independent conditions?

OBJECTIVE: Preeclampsia, gestational hypertension, and unexplained intrauterine growth restriction may have similar determinants and consequences. In this study, we compared determinants and perinatal outcomes associated with these obstetric conditions. STUDY DESIGN: We analyzed 39,615 pregnancies (data from the WHO Antenatal Care Trial), of which 2.2% were complicated by preeclampsia, 7.0% by gestational hypertension, and 8.1% by unexplained intrauterine growth restriction (ie, not associated with maternal smoking, maternal undernutrition, preeclampsia, gestational hypertension, or congenital malformations). We compared the risk factors associated with these groups. Fetal death, preterm delivery, and severe neonatal morbidity and mortality were the primary outcomes. Logistic regression analyses were adjusted for study site, socioeconomic status, and (if appropriate) birth weight and gestational age. RESULTS: Diabetes, renal or cardiac disease, previous preeclampsia, urinary tract infection, high maternal age, twin pregnancy, and obesity increased the risk of both hypertensive conditions. Previous large-for-age birth, reproductive tract surgery, antepartum hemorrhage and reproductive tract infection increased the risk for gestational hypertension only. Independent of maternal age, primiparity was a risk factor only for preeclampsia. Both preeclampsia and gestational hypertension were associated with increased risk for fetal death and severe neonatal morbidity and mortality. Mothers with preeclampsia compared with those with unexplained intrauterine growth restriction were more likely to have a history of diabetes, renal or cardiac disease, chronic hypertension, previous preeclampsia, body mass index more than 30 kg/cm2, urinary tract infection and extremes of maternal age. Conversely, unexplained intrauterine growth restriction was associated with higher risk of low birth weight in previous pregnancies, but not with previous preeclampsia. Both conditions increased the risk for perinatal outcomes independently but preeclampsia was associated with considerable higher risk. CONCLUSION: Preeclampsia and gestational hypertension shared many risk factors, although there are differences that need further evaluation. Both conditions significantly increased morbidity and mortality. Conversely, preeclampsia and unexplained intrauterine growth restriction, often assumed to be related to placental insufficiency, seem to be independent biologic entities.

Female↗
PubMed2004

The tools and techniques of evidence-based medicine.

Evidence-based medicine is the conscientious, explicit and judicious use of the current best evidence in making decisions about the care of individual patients. Along with individual clinical expertise, it is a required core skill for clinical problem solving and it is considered to be a comprehensive component of the medical curricula. This chapter is a general overview of the steps to be followed by clinicians to search, identify and appraise the best-available evidence that could help them to resolve a particular clinical problem. It includes the principles for the identification of a clinical problem and its translation into a question, and the main sources for searching and locating the best-available evidence. References for guidelines designed for appraisal of the methods used in the original papers and for the interpretation of its results are also provided.

Databases, Factual↗
PubMed2004

Strategies to prevent and treat preeclampsia: evidence from randomized controlled trials.

Preeclampsia-eclampsia is a major cause of morbidity and mortality in mothers, fetuses, and neonates worldwide, most devastating in developing nations. Its cause is still uncertain, and many controversies exist concerning its management. The World Health Organization is aware of this and is coordinating a series of systematic reviews that focus on the etiology and the best strategies for the screening, prevention, and treatment of preeclampsia. This article summarizes results from systematic reviews of randomized trials to prevent and manage preeclampsia. There is a prophylactic role of modest magnitude for low-dose aspirin but the number to treat (90 women) to avoid one case of preeclampsia still is considered high. Antioxidant and calcium supplement trials remain to be completed before firm conclusions can be rendered on their efficacy for prevention. Magnesium sulfate is effective in preventing and treating eclampsia, while severe hypertension (with or without proteinuria) requires drug therapy, but there appears to be no benefits to treating mild to moderate hypertension without proteinuria in pregnancy. Finally, our review focuses on the quality of data reviewed, suggesting the need for better evidence, and discusses the use of systematic reviews as a strategy to focus future research on this important area of reproductive medicine.

Female↗
PubMed2004

Heterogeneity of perinatal outcomes in the preterm delivery syndrome.

OBJECTIVE: Our aim was to document the differential neonatal morbidity and intrapartum and neonatal mortality of subgroups of preterm delivery. METHODS: This analysis included 38,319 singleton pregnancies, of which 3,304 (8.6%) were preterm deliveries (less than 37 completed weeks) enrolled in the World Health Organization randomized trial of a new antenatal care model. We classified them as preterm deliveries after spontaneous initiation of labor, either with or without maternal obstetric and medical complications; preterm deliveries after prelabor spontaneous rupture of amniotic membranes (PROM), either with or without obstetric and medical complications; and medically indicated preterm deliveries with maternal obstetric and medical complications. Severe neonatal morbidity and neonatal mortality were the primary outcomes. RESULTS: Fifty-six percent of all preterm deliveries were spontaneous, without maternal complications. Small for gestational age was increased only among the medically indicated preterm delivery group (22.3%). Very early preterm delivery (less than 32 weeks of gestation) was highest among PROM with complications (37%). For intrapartum fetal death and neonatal death, after adjusting by gestational age and other confounding variables, we found that the obstetric and medical complications preceding preterm delivery predicted the different risk levels. Conversely, for severe neonatal morbidity the clinical presentation, ie, PROM or medically indicated, predicted the increased risk. CONCLUSION: There are differential neonatal outcomes among preterm deliveries according to clinical presentation, pregnancy complications, gestational age at delivery, and its association with small for gestational age. This syndromic nature of the condition should be considered if preterm delivery is to be fully understood and thus reduced.

Adolescent↗
PubMed2003

Nutritional interventions during pregnancy for the prevention or treatment of maternal morbidity and preterm delivery: an overview of randomized controlled trials.

This overview assesses the effectiveness of nutritional interventions to prevent or treat maternal morbidity, mortality and preterm delivery. Cochrane systematic reviews and other up-to-date systematic reviews and individual randomized controlled trials were sought. Searches were carried out up to July 2002. Iron and folate supplements reduce anemia and should be included in antenatal care programs. Calcium supplementation to women at high risk of hypertension during pregnancy or low calcium intake reduced the incidence of both preeclampsia and hypertension. Fish oil and vitamins E and C are promising for preventing preeclampsia and preterm delivery and need further testing. Vitamin A and beta-carotene reduced maternal mortality in a large trial; ongoing trials should provide further evaluation. No specific nutrient supplementation was identified for reducing preterm delivery. Nutritional advice, magnesium, fish oil and zinc supplementation appear promising and should be tested alone or together in methodologically sound randomized controlled trials. Anema in pregnancy can be prevented and treated effectively. Considering the multifactorial etiology of the other conditions evaluated, it is unlikely that any specific nutrient on its own, blanket interventions or magic bullets will prevent or treat preeclampsia, hemorrhage, obstructed labor, infections, preterm delivery or death during pregnancy. The few promising interventions for specific outcomes should be tested or reconsidered when results of ongoing trials become available. Until then, women and their families should receive support to improve their diets as a general health rule, which is a basic human right.

Clinical Trials as Topic↗
PubMed2003

Nutritional interventions during pregnancy for the prevention or treatment of impaired fetal growth: an overview of randomized controlled trials.

This paper reviews the efficacy of nutrition interventions to prevent or treat impaired fetal growth. Searches were made for Cochrane systematic reviews and randomized controlled trials published before October 2002. Balanced protein energy supplementation reduced the risk of small for gestational age (SGA) by 30% (95%CI: 20% to 43%) while one trial conducted in New York, U.S., reported a negative effect of high protein supplementation on SGA (RR 1.58; 95%CI: 1.03-2.41). Calcium supplementation protected against low birth weight (RR 0.83; 95%CI: 0.71-0.98). Micronutrient supplements did not affect birth weight, except for magnesium supplementation, which reduced the risk of SGA by 30%. This finding, however, needs or be interpreted with caution because of methodological issues in the data analysis. Programmatic recommendations can be made only for intervening with balanced protein energy supplements, especially in population with a high prevalence of undernutrition. Research is needed to determine the efficacy of multiple micronutrient supplementation and the effect of single micronutrients supplementation on specific growth outcomes such as fetal organ and bone growth. In addition, the public health relevance of these outcomes and their relation to morbidity need to be evaluated.

Dietary Supplements↗
PubMed2002

The cost-effectiveness of routine versus restrictive episiotomy in Argentina.

OBJECTIVE: This article provides the estimates of the cost implications of switching from routine to restrictive episiotomy in 2 provinces in Argentina (Santa Fe and Salta) from the viewpoint of the health provider. STUDY DESIGN: A decision-tree model was constructed that used the probabilities and patient outcomes (the results of a trial in Argentina), resource use, cost, and local epidemiologic data from interviews with obstetricians in the selected provinces and from literature reviews. Probabilistic sensitivity analysis was conducted, which provided 90% confidence ranges for the cost data. RESULTS: For each low-risk vaginal delivery, there is a potential reduction in provider cost of $20.21 (range, $19.36-$21.09) with a restrictive policy of episiotomy in Santa Fe province and a reduction of $11.63 (range, $10.89-$12.42) in Salta province. CONCLUSION: The more effective policy of restrictive episiotomy is also less costly than that of routine episiotomy. The results are robust and consistent in both provinces. Further research is required to confirm the appropriate indications for episiotomy and the impact on outcomes of variations in episiotomy cost rates.

Argentina↗