Clinical Trials In Brazilian Journals Of Ophthalmology: Where We Are.

To compare clinical trials published in Brazilian journals of ophthalmology and in foreign journals of ophthalmology with respect to the number of citations and the quality of reporting [by applying the Consolidated Standards for Reporting Trials (CONSORT) statement writing standards]. The sample of this systematic review comprised the two Brazilian journals of ophthalmology indexed at Science Citation Index Expanded and six of the foreign journals of ophthalmology with highest Impact Factor® according ISI. All clinical trials (CTs) published from January 2009 to December 2010 at the Brazilians journals and a 1:1 randomized sample of the foreign journals were included. The primary outcome was the number of citations through the end of 2011. Subgroup analysis included language. The secondary outcome included likelihood of citation (cited at least once versus no citation), and presence or absence of CONSORT statement indicators. The citation counts were statistically significantly higher (P<0.001) in the Foreign Group (10.50) compared with the Brazilian Group (0.45). The likelihood citation was statistically significantly higher (P<0.001) in the Foreign Group (20/20 - 100%) compared with the Brazilian Group (8/20 - 40%). The subgroup analysis of the language influence in Brazilian articles showed that the citation counts were statistically significantly higher in the papers published in English (P<0.04). Of 37 possible CONSORT items, the mean for the Foreign Group was 20.55 and for the Brazilian Group was 13.65 (P<0.003). The number of citations and the quality of reporting of clinical trials in Brazilian journals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor®.7621-

Ensaios clínicos em periódicos brasileiros de oftalmologia: onde estamos

PURPOSE: To compare clinical trials published in Brazilian journals of ophthalmology and in foreign journals of ophthalmology with respect to the number of citations and the quality of reporting [by applying the Consolidated Standards for Reporting Trials (CONSORT) statement writing standards]. METHODS: The sample of this systematic review comprised the two Brazilian journals of ophthalmology indexed at Science Citation Index Expanded and six of the foreign journals of ophthalmology with highest Impact Factor® according ISI. All clinical trials (CTs) published from January 2009 to December 2010 at the Brazilians journals and a 1:1 randomized sample of the foreign journals were included. The primary outcome was the number of citations through the end of 2011. Subgroup analysis included language. The secondary outcome included likelihood of citation (cited at least once versus no citation), and presence or absence of CONSORT statement indicators. RESULTS: The citation counts were statistically significantly higher (P<0.001) in the Foreign Group (10.50) compared with the Brazilian Group (0.45). The likelihood citation was statistically significantly higher (P<0.001) in the Foreign Group (20/20 - 100%) compared with the Brazilian Group (8/20 - 40%). The subgroup analysis of the language influence in Brazilian articles showed that the citation counts were statistically significantly higher in the papers published in English (P<0.04). Of 37 possible CONSORT items, the mean for the Foreign Group was 20.55 and for the Brazilian Group was 13.65 (P<0.003). CONCLUSION: The number of citations and the quality of reporting of clinical trials in Brazilian journals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor®.OBJETIVO: Comparar ensaios clínicos publicados em periódicos brasileiros de oftalmologia e em periódicos estrangeiros de oftalmologia em relação ao número de citações e à qualidade da informação [através da aplicação do Consolidated Standards for Reporting Trials (CONSORT) statement]. MÉTODOS: A amostra desta revisão sistemática abrangeu os dois periódicos brasileiras de oftalmologia indexaoas no Science Citation Index Expanded (Grupo Brasileiro) e seis dos periódicos estrangeiros de oftalmologia com maior fator de impacto de acordo com o ISI (Grupo Estrangeiro). Todos os ensaios clínicos, publicados entre janeiro de 2009 a dezembro de 2010, nos dois periódicos brasileiros e numa amostra aleatória 1:1 dos periódicos estrangeiros foram incluídos. O desfecho primário foi o número de citações até o final de 2011. A análise de subgrupos incluiu o idioma. O desfecho secundário incluiu a probabilidade de citação (citado ao menos uma vez versus não citado), e a presença ou ausência de indicadores da declaração CONSORT. RESULTADOS: O número de citações foi significativamente maior (P<0,001) no Grupo Estrangeiro (10,50) em comparação com o Grupo Brasileiro (0,45). A probabilidade de citação foi estatisticamente superior (P<0,001) no Grupo Estrangeiro (20/20-100%) comparado com o Grupo Brasileiro (8/20-41%). A análise de subgrupo sobre a influência da língua em artigos Brasileiros mostrou que o número de citações foi significativamente maior nos artigos publicados em Inglês (P<0,04). Dos 37 itens do CONSORT possíveis, a média para o Grupo Estrangeiro foi de 20,55 e para o Grupo Brasileiro foi 13,65 (P<0,003). CONCLUSÃO: O número de citações e a qualidade da redação dos ensaios clínicos em periódicos Brasileiros de oftalmologia ainda são baixos quando comparados com os periódicos estrangeiros de oftalmologia com mais alto fator de impacto

Comparison between binocular indirect ophthalmoscopy and digital retinography for diabetic retinopathy screening: the multicenter brazilian type 1 diabetes study

Diabetic retinopathy is the main cause of preventable blindness in the economically active population in western countries. Diabetic retinopathy screening is effective in preventing blindness and can be performed through various diagnostic methods. Our objective is to compare binocular indirect ophthalmoscopy (BIO) to telemedicine protocols of digital retinography for diabetic retinopathy screening in a large and heterogenous type 1 diabetes population in a developing country. Data from 1266 Type 1 Diabetes Mellitus patients from a Brazilian multicenter study were analyzed. Patients underwent BIO and digital retinography, non-mydriatic and mydriatic. Images were sent to a reading center in a telemedicine protocol. Agreement between the different methods was calculated with kappa statistic for diabetic retinopathy and maculopathy classification. Clinical outcome was either observation or referral to specialist. Agreement between BIO and mydriatic retinography was substantial (kappa 0.67-0.74) for diabetic retinopathy observation vs referral classification. Agreement was fair to moderate (kappa 0.24-0.45) between retinography and BIO for maculopathy. Poor mydriasis was the main obstacle to image reading and classification, especially on the non-mydriatic strategy, occurring in 11.9 % of right eyes and 16.9 % of left eyes. Mydriatic retinography showed a substantial agreement to BIO for diabetic retinopathy observation vs referral classification. A significant amount of information was lost on the non-mydriatic technique because of poor mydriasis. We recommend a telemedicine-based diabetic retinopathy screening strategy with digital mydriatic retinography, preferably with 2 fields, and advise against non-mydriatic retinography in developing countries7CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - CNPQ563753/2010-

Current epidemiology of diabetic retinopathy in patients with type 1 diabetes: a national multicenter study in Brazil

Abstract Background Diabetic retinopathy is the leading cause of blindness in economically active populations. The aims of this study were to estimate the prevalence and to identify risk factors for diabetic retinopathy in patients with type 1 diabetes in Brazil. Methods This was a nationwide, cross-sectional study conducted between August 2010 and August 2014. The study included 1760 patients with type 1 diabetes. Patients underwent a standard questionnaire, clinical and laboratory analyses and were screened for diabetic retinopathy. To analyze the risk factors related to diabetic retinopathy, two models of logistic regression models were performed, one considering vision-threatening cases and the other with any diabetic retinopathy cases as dependent variables. The group with vision-threatening included patients with severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy and macular edema. Results In total, 1644 patients (mean age, 30.1± 12.0 years; duration of diabetes, 15.3 ± 9.3 years; female, 55.8%) were studied. 35.7% presented diabetic retinopathy and 12% presented vision-threatening diabetic retinopathy. Three risk factors associated with diabetic retinopathy were in common to both groups: longer diabetes duration (OR 1.07; 95% CI, 1.05–1.09), higher levels of HbA1c (OR 1.24; CI, 1.17–1.32) and higher levels of serum uric acid (OR 1.22; CI, 1.13–1.31) (p < 0.001 for all comparisons). Conclusion The higher rate of vision-threatening retinopathy found in our study highlights the need to improve access to eye care and screening programs for diabetic retinopathy in Brazil. In addition to traditional risk factors, we found an association between serum uric acid levels and diabetic retinopathy. Further studies are needed to address this association

Regional differences in the prevalence of diabetic retinopathy: a multi center study in Brazil

Abstract Background Diabetic retinopathy has a significant impact in every healthcare system. Despite that fact, there are few accurate estimates in the prevalence of DR in Brazil’s different geographic regions, particularly proliferative DR and diabetic macular edema. This study aims to determine the prevalence of diabetic retinopathy in Brazil’s five continental regions and its determinant factors. Methods This multi center, cross-sectional, observational study, conducted between August 2011 and December 2014, included patients with type 1 diabetes from the 5 Brazilian geographic regions (South, Southeast, North, Northeast and Midwest). During a clinical visit, a structured questionnaire was applied, blood sampling was collected and each patient underwent mydriatic binocular indirect ophthalmoscopy evaluation. Results Data was obtained from 1644 patients, aged 30.2 ± 12 years (56.1% female, 54.4% Caucasian), with a diabetes duration of 15.5 ± 9.3 years. The prevalence of diabetic retinopathy was 242 (36.1%) in the Southeast, 102 (42.9%) in the South, 183 (29.9%) in the North and Northeast and 54 (41.7%) in the Midwest. Multinomial regression showed no difference in the prevalence of non-proliferative diabetic retinopathy in each geographic region, although, prevalence of proliferative diabetic retinopathy (p = 0.022), and diabetic macular edema (p = 0.003) was higher in the Midwest. Stepwise analyses reviled duration of diabetes, level of HbA1c and hypertension as independent variables. Conclusions The prevalence of non proliferative diabetic retinopathy in patients with type 1 diabetes was no different between each geographic region of Brazil. The Midwest presented higher prevalence of proliferative diabetic retinopathy and diabetic macular edema. Duration of DM and glycemic control is of central importance to all. Hypertension is another fundamental factor to every region, at special in the South and Southeast. Glycemic control and patients in social and economic vulnerability deserves special attention in the North and Northeast of Brazil

Diabetic retinopathy may indicate an increased risk of cardiovascular disease in patients with Type 1 diabetes—a nested case-control study in Brazil

Cardiovascular disease, the leading cause of death worldwide, and diabetic retinopathy, themain cause of blindness in economically active populations, share clinical risk factors, and pathophysiological features. The aim of this study is to examine the association between diabetic retinopathy, cardiovascular disease, and common risk factors in patients with type 1 diabetes. Design and Methods: This nested case-control study was performed in patients from the Brazilian Type 1 Diabetes Study Group, a nationwide survey that was conducted in Brazil and enrolled 1,760 patients with type 1 diabetes. A total of 342 patients were selected (57 cases with macrovascular disease and 285 controls who were matched for duration of diabetes and gender). Results: In the exploratory analysis, stratified by cardiovascular disease, the following variables were statistically significant: age (p= 0.037), hypertension (p= 0.035), high BMI (p = 0.046), diabetic retinopathy (p = 0.003), and chronic kidney disease (p = 0.026). By multivariate logistic regression, patients with diabetic retinopathy were more likely to develop cardiovascular disease (OR 2.16, 95% CI 1.16-4.02, p = 0.015). Although to a lesser extent than diabetic retinopathy, higher BMI levels were also related to an increase in the risk of cardiovascular disease of 1.08 (95% CI 1.01-1.15, p = 0.024). Conclusion: The presence of diabetic retinopathy indicates a greater risk for cardiovascular disease in Brazilian patients with type 1 diabetes. Further studies are warranted to determine whether a noninvasive exam, such as fundoscopy, could help identify patients who show an increased risk for cardiovascular disease10CONSELHO NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO - CNPQFUNDAÇÃO CARLOS CHAGAS FILHO DE AMPARO À PESQUISA DO ESTADO DO RIO DE JANEIRO - FAPERJ563753/2010-21989.0246.