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      Clinical trials in Brazilian journals of ophthalmology: where we are Translated title: Ensaios clínicos em periódicos brasileiros de oftalmologia: onde estamos

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          Abstract

          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®.

          Translated abstract

          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.

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          Most cited references77

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          Systematic reviews in health care: Assessing the quality of controlled clinical trials.

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            A Phase IIIb study to evaluate the safety of ranibizumab in subjects with neovascular age-related macular degeneration.

            To evaluate the safety and efficacy of intravitreal ranibizumab in a large population of subjects with neovascular age-related macular degeneration (AMD). Twelve-month randomized (cohort 1) or open-label (cohort 2) multicenter clinical trial. A total of 4300 subjects with angiographically determined subfoveal choroidal neovascularization (CNV) secondary to AMD. Cohort 1 subjects were randomized 1:1 to receive 0.3 mg (n = 1169) or 0.5 mg (n = 1209) intravitreal ranibizumab for 3 monthly loading doses. Dose groups were stratified by AMD treatment history (treatment-naïve vs. previously treated). Cohort 1 subjects were retreated on the basis of optical coherence tomography (OCT) or visual acuity (VA) criteria. Cohort 2 subjects (n = 1922) received an initial intravitreal dose of 0.5 mg ranibizumab and were retreated at physician discretion. Safety was evaluated at all visits. Safety outcomes included the incidence of ocular and nonocular adverse events (AEs) and serious adverse events (SAEs). Efficacy outcomes included changes in best-corrected VA over time. Some 81.7% of cohort 1 subjects and 49.9% of cohort 2 subjects completed the 12-month study. The average total number of ranibizumab injections was 4.9 for cohort 1 and 3.6 for cohort 2. The incidence of vascular and nonvascular deaths during the 12-month study was 0.9% and 0.7% in the cohort 1 0.3 mg group, 0.8% and 1.5% in the cohort 1 0.5 mg group, and 0.7% and 0.9% in cohort 2, respectively. The incidence of death due to unknown cause was 0.1% in both cohort 1 dose groups and cohort 2. The number of vascular deaths and deaths due to unknown cause did not differ across cohorts or dose groups. Stroke rates were 0.7%, 1.2%, and 0.6% in the 0.3 mg and 0.5 mg groups and cohort 2, respectively. At month 12, cohort 1 treatment-naïve subjects had gained an average of 0.5 (0.3 mg) and 2.3 (0.5 mg) VA letters and previously treated subjects had gained 1.7 (0.3 mg) and 2.3 (0.5 mg) VA letters. Intravitreal ranibizumab was safe and well tolerated in a large population of subjects with neovascular AMD. Ranibizumab had a beneficial effect on VA. Future investigations will seek to establish optimal dosing regimens for persons with neovascular AMD. Proprietary or commercial disclosure may be found after the references.
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              Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2.

              To evaluate efficacy and safety of quarterly (and then monthly) ranibizumab during the 2-year Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of ranibizumab in subjects with subfoveal CNV with or without classic CNV secondary to AMD (PIER) study. Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Patients were randomized 1:1:1 to sham injection (n = 63) or 0.3 mg (n = 60) or 0.5 mg (n = 61) intravitreal ranibizumab monthly for 3 months and then quarterly. During study year 2, eligible sham-group patients crossed over to 0.5 mg ranibizumab quarterly. Later in year 2, all eligible randomized patients rolled over to 0.5 mg ranibizumab monthly. Key efficacy and safety outcomes of the 2-year trial are reported. At month 24, visual acuity (VA) had decreased an average of 21.4, 2.2, and 2.3 letters from baseline in the sham, 0.3 mg, and 0.5 mg groups (P 14 months of sham injections. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                abo
                Arquivos Brasileiros de Oftalmologia
                Arq. Bras. Oftalmol.
                Conselho Brasileiro de Oftalmologia (São Paulo, SP, Brazil )
                0004-2749
                1678-2925
                February 2013
                : 76
                : 1
                : 21-25
                Affiliations
                [02] Recife PE orgnameUniversidade Federal de Pernambuco - UFPE orgdiv1Department of Ophthalmology Brazil
                [01] Campinas SP orgnameUniversidade Estadual de Campinas - UNICAMP orgdiv1Department of Ophthalmology Brazil
                Article
                S0004-27492013000100007
                10.1590/S0004-27492013000100007
                1d81422d-b0f1-4660-8172-7835499db056

                This work is licensed under a Creative Commons Attribution 4.0 International License.

                History
                : 05 October 2012
                : 14 November 2012
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 55, Pages: 5
                Product

                SciELO Brazil


                Oftalmologia,Ensaio clínico,Quality control,Journal Impact factor,Citation databases,Ophthalmology,Clinical trial,Controle de qualidade,Fator de impacto de revistas,Bases de dados de citações

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