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BMC Pregnancy and Childbirth | 2012

Gestational diabetes and pregnancy outcomes - a systematic review of the World Health Organization (WHO) and the International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria

Eliana Marcia da Ros Wendland; Maria Regina Torloni; Maicon Falavigna; Janet Trujillo; Maria Alice Dode; Maria Amélia Alves de Campos; Bruce Bartholow Duncan; Maria Inês Schmidt

BackgroundTwo criteria based on a 2 h 75 g OGTT are being used for the diagnosis of gestational diabetes (GDM), those recommended over the years by the World Health Organization (WHO), and those recently recommended by the International Association for Diabetes in Pregnancy Study Group (IADPSG), the latter generated in the HAPO study and based on pregnancy outcomes. Our aim is to systematically review the evidence for the associations between GDM (according to these criteria) and adverse outcomes.MethodsWe searched relevant studies in MEDLINE, EMBASE, LILACS, the Cochrane Library, CINHAL, WHO-Afro library, IMSEAR, EMCAT, IMEMR and WPRIM. We included cohort studies permitting the evaluation of GDM diagnosed by WHO and or IADPSG criteria against adverse maternal and perinatal outcomes in untreated women. Only studies with universal application of a 75 g OGTT were included. Relative risks (RRs) and their 95% confidence intervals (CI) were obtained for each study. We combined study results using a random-effects model. Inconsistency across studies was defined by an inconsistency index (I2) > 50%.ResultsData were extracted from eight studies, totaling 44,829 women. Greater risk of adverse outcomes was observed for both diagnostic criteria. When using the WHO criteria, consistent associations were seen for macrosomia (RR = 1.81; 95%CI 1.47-2.22; p < 0.001); large for gestational age (RR = 1.53; 95%CI 1.39-1.69; p < 0.001); perinatal mortality (RR = 1.55; 95% CI 0.88-2.73; p = 0.13); preeclampsia (RR = 1.69; 95%CI 1.31-2.18; p < 0.001); and cesarean delivery (RR = 1.37;95%CI 1.24-1.51; p < 0.001). Less data were available for the IADPSG criteria, and associations were inconsistent across studies (I2 ≥ 73%). Magnitudes of RRs and their 95%CIs were 1.73 (1.28-2.35; p = 0.001) for large for gestational age; 1.71 (1.38-2.13; p < 0.001) for preeclampsia; and 1.23 (1.01-1.51; p = 0.04) for cesarean delivery. Excluding either the HAPO or the EBDG studies minimally altered these associations, but the RRs seen for the IADPSG criteria were reduced after excluding HAPO.ConclusionsThe WHO and the IADPSG criteria for GDM identified women at a small increased risk for adverse pregnancy outcomes. Associations were of similar magnitude for both criteria. However, high inconsistency was seen for those with the IADPSG criteria. Full evaluation of the latter in settings other than HAPO requires additional studies.


Canadian Medical Association Journal | 2014

Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise

Holger J. Schünemann; Wojtek Wiercioch; Itziar Etxeandia; Maicon Falavigna; Nancy Santesso; Reem A. Mustafa; Matthew Ventresca; Romina Brignardello-Petersen; Kaja-Triin Laisaar; Sergio Kowalski; Tejan Baldeh; Yuan Zhang; Ulla Raid; Ignacio Neumann; Susan L. Norris; Judith Thornton; Robin Harbour; Shaun Treweek; Gordon H. Guyatt; Pablo Alonso-Coello; Marge Reinap; Jan Brozek; Andrew D Oxman; Elie A. Akl

Background: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. Methods: We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. Results: We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. Interpretation: The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.


Diabetes Research and Clinical Practice | 2012

Effectiveness of gestational diabetes treatment: a systematic review with quality of evidence assessment.

Maicon Falavigna; Maria Inês Schmidt; Janet Trujillo; Luísia F. Alves; Eliana Wendland; Maria Regina Torloni; Stephen Colagiuri; Bruce Bartholow Duncan

AIMS To evaluate the effectiveness of gestational diabetes (GDM) treatment compared to usual antenatal care, in the prevention of adverse pregnancy outcomes. Additionally, to assess the quality of the evidence to support GDM treatment according to GRADE guidelines. METHODS Fourteen electronic databases and reference lists of relevant literature were searched for articles published from inception to February, 2012. Controlled clinical trials comparing GDM treatment to usual antenatal care were included. Independent extraction of articles was done by two authors using predefined data fields. RESULTS Seven trials involving 3157 women were included. We found high quality evidence that treatment of GDM reduces macrosomia (RR=0.47; 95% CI, 0.34-0.65; NNT=11.4) and large for gestational age birth (RR=0.57; 95% CI, 0.47-0.71; NNT=12.2); moderate quality evidence that treatment reduces preeclampsia (RR=0.61; 95% CI, 0.46-0.81; NNT=21.0) and hypertensive disorders in pregnancy (RR=0.64; 95% CI, 0.51-0.81; NNT=18.1); and low quality evidence that treatment reduces shoulder dystocia (RR=0.41; 95% CI, 0.22-0.76; NNT=48.8). No statistically significant reduction was seen for caesarean section. No increase in small for gestational age or preterm birth was found. CONCLUSIONS Treatment of GDM is effective in reducing macrosomia (high quality evidence), preeclampsia and shoulder dystocia.


The Journal of Clinical Endocrinology and Metabolism | 2014

Efficacy of vitamin D supplementation in depression in adults: a systematic review.

Guowei Li; Lawrence Mbuagbaw; Zainab Samaan; Maicon Falavigna; Shiyuan Zhang; Jonathan D. Adachi; Alexandra Papaioannou; Lehana Thabane

CONTEXT Randomized controlled trials (RCTs) investigating the efficacy of vitamin D (Vit D) in depression provided inconsistent results. OBJECTIVE We aim to summarize the evidence of RCTs to assess the efficacy of oral Vit D supplementation in depression compared to placebo. DATA SOURCES We searched electronic databases, two conference proceedings, and gray literature by contacting authors of included studies. STUDY SELECTION We selected parallel RCTs investigating the effect of oral Vit D supplementation compared with placebo on depression in adults at risk of depression, with depression symptoms or a primary diagnosis of depression. DATA EXTRACTION Two reviewers independently extracted data from relevant literature. DATA SYNTHESIS Classical and Bayesian random-effects meta-analyses were used to pool relative risk, odds ratio, and standardized mean difference. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. RESULTS Six RCTs were identified with 1203 participants (72% females) including 71 depressed patients; five of the studies involved adults at risk of depression, and one trial used depressed patients. Results of the classical meta-analysis showed no significant effect of Vit D supplementation on postintervention depression scores (standardized mean difference = -0.14, 95% confidence interval = -0.41 to 0.13, P = .32; odds ratio = 0.93, 95% confidence interval = 0.54 to 1.59, P = .79). The quality of evidence was low. No significant differences were demonstrated in subgroup or sensitivity analyses. Similar results were found when Bayesian meta-analyses were applied. CONCLUSIONS There is insufficient evidence to support the efficacy of Vit D supplementation in depression symptoms, and more RCTs using depressed patients are warranted.


BMJ | 2015

Use of GRADE for assessment of evidence about prognosis: Rating confidence in estimates of event rates in broad categories of patients

Alfonso Iorio; Frederick A. Spencer; Maicon Falavigna; Carolina Alba; Eddie Lang; Bernard Burnand; Tom McGinn; Jill Hayden; Katrina Williams; Beverly Shea; Robert Wolff; Ton Kujpers; Pablo Perel; Per Olav Vandvik; Paul Glasziou; Holger J. Schünemann; Gordon H. Guyatt

Introduction The term prognosis refers to the likelihood of future health outcomes in people with a given disease or health condition or with particular characteristics such as age, sex, or genetic profile. Patients and healthcare providers may be interested in prognosis for several reasons, so prognostic studies may have a variety of purposes,1–4 including establishing typical prognosis in a broad population, establishing the effect of patients’ characteristics on prognosis, and developing a prognostic model (often referred to as a clinical prediction rule) (Table 1). Considerations in determining the trustworthiness of estimates of prognosis arising from these types of studies differ. This article covers studies answering questions about the prognosis of a typical patient from a broadly defined population; we will consider prognostic studies assessing risk factors and clinical prediction guides in subsequent papers. Knowing the likely course of their disease may help patients to come to terms with, and plan for, the future. Knowledge of the risk of adverse outcomes or the likelihood of spontaneous resolution of symptoms is critical in predicting the likely effect of treatment and planning diagnostic investigations.5 If the probability of facing an adverse outcome is very low or the spontaneous remission of the disease is high (“good prognosis”), the possible absolute benefits of treatment will inevitably be low and serious adverse effects related to treatment or invasive diagnostic tests, even if rare, will loom large in any decision. If instead the probability of an adverse outcome is high (“bad prognosis”), the impact of new diagnostic information or of effective treatment may be large and patients may be ready to accept higher risks of diagnostic investigation and treatment related adverse effects. Inquiry into the credibility or trustworthiness of prognostic estimates has, to date, largely focused on individual studies of prognosis. Systematic reviews of the highest quality evidence including all the prognostic studies assessing a particular clinical situation are, however, gaining increasing attention, including the Cochrane Collaboration’s work (in progress) to define a template for reviews of prognostic studies (http://prognosismethods.cochrane.org/scope-ourwork). Trustworthy systematic reviews will not only ensure comprehensive collection, summarization, and critique of the primary studies but will also conduct optimal analyses. Matters that warrant consideration in such analyses include the method used to pool rates and whether analyses account for all the relevant covariates; the literature provides guidance on both questions.6 7 In this article, we consider how to establish degree of confidence in estimates from such bodies of evidence. The guidance in this article is directed primarily at researchers conducting systematic reviews of prognostic studies. It will also be useful to anyone interested in prognostic estimates and their associated confidence (including guideline developers) when evaluating a body of evidence (for example, a guideline panel using baseline risk estimates to estimate the absolute effect of Summary poIntS


Diabetes Research and Clinical Practice | 2014

Strategies for implementing the WHO diagnostic criteria and classification of hyperglycaemia first detected in pregnancy

Stephen Colagiuri; Maicon Falavigna; Mukesh M. Agarwal; Michel Boulvain; Edward J. Coetzee; Moshe Hod; Sara Meltzer; Boyd E. Metzger; Yasue Omori; Ingvars Rasa; Maria Inês Schmidt; Veerasamy Seshiah; David Simmons; Eugene Sobngwi; Maria Regina Torloni; Hui xia Yang

The World Health Organization (WHO) has recently released updated recommendations on Diagnostic Criteria and Classification of Hyperglycaemia First Detected in Pregnancy which are likely to increase the prevalence of gestational diabetes mellitus (GDM). Any increase in the number of women with GDM has implications for health services since these women will require treatment and regular surveillance during the pregnancy. Some health services throughout the world may have difficulty meeting these demands since country resources for addressing the diabetes burden are finite and resource allocation must be prioritised by balancing the need to improve care of people with diabetes and finding those with undiagnosed diabetes, including GDM. Consequently each health service will need to assess their burden of hyperglycaemia in pregnancy and decide if and how it will implement programmes to test for and treat such women. This paper discusses some considerations and options to assist countries, health services and health professionals in these deliberations.


Revista Do Instituto De Medicina Tropical De Sao Paulo | 2008

Candida esophagitis: species distribution and risk factors for infection

Dimas Alexandre Kliemann; Alessandro C. Pasqualotto; Maicon Falavigna; Thiane Giaretta; Luiz Carlos Severo

Although Candida albicans is the main cause of fungal esophagitis, other species such as C. tropicalis, C. krusei and C. stellatoidea have also been implicated. Several studies have identified risk factors for C. albicans esophagitis. However, data for non-C. albicans species is still sparse. The aim of this study was to determine the etiology of Candida esophagitis in our medical centre over an 18-month period. Additionally, we aimed to investigate predisposing conditions for esophageal candidosis caused by different Candida species. A total of 21,248 upper gastroscopies were performed in Santa Casa Complexo Hospitalar between January 2005 and July 2006. The prevalence of Candida esophagitis was 0.74% (n = 158). C. albicans caused the vast majority of infections (96.2%), followed by C. tropicalis (2.5%), C. lusitaniae (0.6%) and C. glabrata (0.6%). There were 81 women (51.3%) and 77 men (48.7%). No case of mixed infection occurred. Concomitant oral candidosis was documented for 10.8% (n = 17). Most of cases (55.1%) involved outpatients. Around one fifth of patients in our cohort had no identifiable risk factors for esophageal candidosis (20.8%). Since nearly all infections were caused by C. albicans we were not able to determine risk factors for esophagitis caused by other Candida species.


Diabetes Research and Clinical Practice | 2015

Impact of the International Association of Diabetes and Pregnancy Study Groups criteria for gestational diabetes

Janet Trujillo; Álvaro Vigo; Bruce Bartholow Duncan; Maicon Falavigna; Eliana Marcia da Ros Wendland; Maria Amélia Alves de Campos; Maria Inês Schmidt

AIMS To evaluate the diagnostic criteria of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and alternative criteria in terms of resultant prevalence of gestational diabetes mellitus (GDM) and measures of diagnostic impact. METHODS The Brazilian Gestational Diabetes Study (EBDG) is a cohort of pregnant women enrolled consecutively in prenatal care clinics of the Brazilian National Health Service from 1991 to 1995, a time and setting in which those with lesser than diabetes hyperglycemia rarely received drug treatment. Eligibility criteria were age ≥20 years, gestational age 20-28 weeks and no history of diabetes outside pregnancy. After interview and anthropometric measurements, a standardized 2h 75g OGTT was scheduled. Women were followed through early postpartum. RESULTS Prevalence of GDM defined by IADPSG criteria was 18.0% (95% CI 16.9-19.0), ranging from 2.7 to 17.0% with the alternative criteria. Relative risks for large for gestational age (LGA) and preeclampsia were generally small. The diagnostic impact assessed by pre- to post-test gain in the probability of an outcome was also small (3.6% for LGA and 0.5% for preeclampsia). Alternative criteria reached maximum gains of 9.7% and 5.3%, respectively. The fractions of LGA births and preeclampsia attributable to GDM by the IADPSG criteria were small, 6.7% and 3.5%, respectively. CONCLUSIONS The IADPSG criteria identify more women as having GDM but their diagnostic and population impacts with respect to adverse outcomes are small. Alternative definitions, although also presenting small diagnostic and population impacts, showed advantages which may be useful in specific settings.


Diabetes Research and Clinical Practice | 2013

Impact of gestational diabetes mellitus screening strategies on perinatal outcomes: A simulation study

Maicon Falavigna; Isaías Valente Prestes; Maria Inês Schmidt; Bruce Bartholow Duncan; Stephen Colagiuri; Gojka Roglic

AIMS To evaluate the impact on perinatal outcomes of universal gestational diabetes (GDM) screening based on 1999 WHO and IADPSG diagnostic criteria; to assess the quality of the evidence (GRADE) to support GDM screening. METHODS Simulation of a hypothetical cohort of community-based pregnant women with 10% GDM prevalence (1999 WHO). Most parameters were obtained from recent systematic reviews. RESULTS Compared to no screening, screening based on 1999 WHO criteria (followed by treatment) reduced the incidence of large for gestational age (LGA) neonates by 0.53% (95% CI 0.37-0.74%; NNS=189) and of preeclampsia by 0.27% (0.10-0.45%; NNS=376). Screening based on IADPSG criteria reduced incidences by 0.85% (0.54-1.29%; NNS=117) and by 0.39% (0.15-0.65%; NNS=257), respectively. Compared to screening based on 1999 WHO criteria, screening with IADPSG criteria reduced the incidence of LGA by 0.32% (0.09-0.63%; NNS=309) and of preeclampsia by 0.12% (0.01-0.25; NNS=808). The quality of evidence for both screening approaches is very low. CONCLUSIONS Universal screening for GDM has only a modest impact on pregnancy outcomes. The impact of screening based on IADPSG (vs. WHO, 1999) criteria is slightly larger. However, costs and resources should also be considered in local selection of a screening approach.


PLOS ONE | 2010

Co-infection by hepatitis C virus in HIV-infected patients in southern Brazil: genotype distribution and clinical correlates.

Fernando Herz Wolff; S C Fuchs; Nêmora N. T. Barcellos; Paulo Ricardo de Alencastro; Maria Letícia R. Ikeda; Ajácio B. M. Brandão; Maicon Falavigna; Flávio Danni Fuchs

Background Prevalence rates of Hepatitis C Virus (HCV) co-infection, the distribution of HCV genotypes, and the frequency of spontaneous resolution of hepatitis C in patients infected with the Human Immunodeficiency Virus (HIV) have a worldwide disparity. The purpose of this study is to investigate the prevalence of HCV antibodies (anti-HCV) in patients with HIV, the proportion and correlates of infection by different HCV genotypes, and rates of spontaneous resolution of HCV infection. Methods A cross-sectional study was conducted among 1143 HIV patients under follow-up in a HIV/AIDS outpatient reference center of the Brazilian public health system. From 357 anti-HCV positive patients, a consecutive sample of 227 individuals HCV treatment-naïve was interviewed and 207 was tested for HCV-RNA and genotypes. Results Anti-HCV was detected in 357 patients (31.2%). HCV-RNA was undetectable in 16.4% of 207 anti-HCV positive individuals. Genotype 1 was diagnosed in 81.5% of the sample, genotype 2 in 1.7% and genotype 3 in 16.2%. Male gender was the unique characteristic associated with higher prevalence of genotype 1 HCV. Conclusions Co-infection by HCV is frequent among patients with HIV in our State, and it is particularly high the infection by HCV genotype 1. Further investigation is necessary to explain the important regional variation in the proportion of infection by the different HCV genotypes and to better understand rates of spontaneous HCV clearance.

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Maria Inês Schmidt

Universidade Federal do Rio Grande do Sul

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Elie A. Akl

American University of Beirut

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Bruce Bartholow Duncan

Universidade Federal do Rio Grande do Sul

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Cinara Stein

Universidade Federal de Ciências da Saúde de Porto Alegre

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Maria Regina Torloni

Federal University of São Paulo

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