Navegando por Palavras-chave "Randomised clinical trials"

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    Evolution of reports of randomised clinical trials in plastic surgery
    (Elsevier B.V., 2011-06-01) Veiga, Daniela Francescato [UNIFESP]; Veiga Filho, Joel [UNIFESP]; Pellizzon, Rosely de Fátima [UNIFESP]; Juliano, Yara [UNIFESP]; Ferreira, Lydia Masako [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Univ Vale Sapucai
    Well-designed, well-conducted and well-reported randomised clinical trials (RCTs) can significantly impact medical care, by contributing to a strong evidence base from which clinical guidelines can be derived. in a previous study, we assessed the quality of reports of RCTs in plastic surgery published from 1966 to 2003. the aim of the present study was to verify what have changed over the last years. RCTs in plastic surgery published from 2004 to 2008 were identified through electronic searches, and classified according to their allocation concealment. Trials with allocation concealment appropriately described were evaluated as to their quality. Two independent reviewers performed the evaluations, using two tools: the Delphi List and the Jadad's quality scale. From 3840 identified studies, 96 were selected for classification according to allocation concealment; 28 (29%) of them appropriately described allocation concealment. From 1966 to 2003, 34 (17%) RCTs appropriately described allocation concealment (chi(2) = 22.98, p < 0.000). in the evaluation of the 28 RCTs by the Delphi List, the agreement coefficient between raters (kw) was 0.46 (z = 7.24, p < 0.000). Groups were similar at baseline in 96.4% of these trials, and this was the only item of the Delphi List, which significantly improved when compared with the period from 1966 to 2003 (chi(2) = 18.53, p < 0.000). When evaluated by Jadad's criteria, 14% of the RCTs were scored two points or less and thus considered of low quality (kw = 0.72, z = 8.57, p < 0.001). From 1966 to 2003, 59% of RCTs were scored two points or less (chi(2) = 17.07, p < 0.004). We concluded that the quality of reports of RCTs in plastic surgery (as measured by the Jadad's criteria and only one component of the nine components of the Delphi List) significantly increased over the last years. (C) 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier B.V. All rights reserved.
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    Suplementação com ácidos graxos poliinsaturados (ômega 3 - EPA e DHA) para o tratamento de pacientes com epilepsia refratária : revisão sistemática e metanálise
    (Universidade Federal de São Paulo (UNIFESP), 2017-06-29) Vasconcelos, Vivian Sarmento de [UNIFESP]; Torloni, Maria Regina [UNIFESP]; http://lattes.cnpq.br/5661395483781554; http://lattes.cnpq.br/6022583540773749; Universidade Federal de São Paulo (UNIFESP)
    Objectives: To assess the effectiveness and safety of omega-3 polyunsaturated fatty acids (PUFA) in the control of seizures in patients with refractory epilepsy. Methods: Cochrane systematic review. We searched the following eletronic databases, without language restrictions: Cochrane Epilepsy Group Specialised Register, CENTRAL, MEDLINE, EMBASE, SCOPUS, LILACS and clinical trials registers. We included all randomised and quasi-randomised studies using PUFAs (in association with convential treatment) versus conventional treatment or other treatments for patients of any age with drug-resistant epilepsy. The following outcomes were assessed: seizure freedom, seizure reduction, improvement in quality of life, adverse effects and changes in plasma lipid profile. Two independent review authors were involved in study selection, data extraction and quality assessment of the included trials. Results: The search retrieved 71 citations, 8 studies were selected for full-text reading and 3 studies fulfilled the selection criteria and were included in the review. Two placebo controlled trials involving adults were conducted in developed countries, while one placebo controlled trial involving children was conducted in a developing country (Egypt). The three studies recruited a total of 155 subjects (85 adults and 70 children); 78 (43 adults and 35 children) were randomised to PUFAs and 77 (42 adults and 35 children) to placebo. All participants were followed for up to 12 weeks. Seizure freedom was reported by only one study, with a high risk of bias, involving exclusively children. The relative risk (RR) for this outcome was significantly higher in the children receiving PUFA compared to the control group: RR 20.00, 95% confidence interval (CI) 2.84 to 140.99, 1 study, 70 children. Similarly, PUFA supplementation was associated with a significant difference in the proportion of children with at least 50% reduction in seizure frequency: RR 33.00 95% CI 4.77 to 228.15, 1 study with a high risk of bias, 70 children. However, this effect was not observed when the data from two studies with adults were pooled: RR 0.57, 95% CI 0.19 to 1.75, I² 0%, 2 studies, 78 participants, low-quality evidence. None of the studies assessed bleeding as a potential adverse effect. There were no significant differences between the PUFA and control groups in relation to gastrointestinal effects: RR 0.78, 95% CI 0.32 to 1.89, 2 studies, 85 participants, low-quality evidence. Supplementation with PUFA did not produce significant differences in mean frequency of seizures, quality of life or other side effects. Conclusions: In view of the limited number of studies and small sample sizes, there is not enough evidence to support the use of PUFA supplementation in patients with refractory epilepsy. More trials are needed to assess the benefits of PUFA supplementation in the treatment of drug resistant epilepsy.