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Ensaios clínicos controlados e randomizados na ortopedia: dificuldades e limitações; Randomized controlled clinical trials in orthopedics: difficulties and limitations

MALAVOLTA, Eduardo Angeli; DEMANGE, Marco Kawamura; GOBBI, Riccardo Gomes; IMAMURA, Marta; FREGNI, Felipe
Fonte: Sociedade Brasileira de Ortopedia e Traumatologia Publicador: Sociedade Brasileira de Ortopedia e Traumatologia
Tipo: Artigo de Revista Científica
POR
Relevância na Pesquisa
95.86%
Os ensaios clínicos controlados e randomizados (ECCR) são considerados o padrão ouro da medicina baseada em evidências na atualidade, sendo importantes para direcionar a conduta médica através de observações científicas consistentes. Passos como seleção dos pacientes, randomização e cegamento são fundamentais na realização de um ECCR e apresentam algumas dificuldades extras nos ensaios que envolvem procedimentos cirúrgicos, como é comum na Ortopedia. O objetivo deste artigo é destacar e discutir algumas dificuldades e eventuais limitações dos ECCR na área cirúrgica.; Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting an RCT, but some additional difficulties are presented in trials that involve surgical procedures, as in common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery.

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

SOUZA, Raphael Freitas de; CHAVES, Carolina de Andrade Lima; NASSER, Mona; FEDOROWICZ, Zbys
Fonte: Faculdade De Odontologia De Bauru - USP Publicador: Faculdade De Odontologia De Bauru - USP
Tipo: Artigo de Revista Científica
ENG
Relevância na Pesquisa
95.94%
INTRODUCTION: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. OBJECTIVE: The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. MATERIAL AND METHODS: Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization...

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

de Souza, Raphael Freitas; Lima Chaves, Carolina de Andrade; Nasser, Mona; Fedorowicz, Zbys
Fonte: Universidade de São Paulo (USP), Faculdade de Odontologia de Bauru Publicador: Universidade de São Paulo (USP), Faculdade de Odontologia de Bauru
Tipo: Artigo de Revista Científica Formato: 104-109
ENG
Relevância na Pesquisa
95.94%
Introduction: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. Objective: The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Material and methods: Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. Criteria to assess methodological quality included: method of randomization...

Systematic review of randomized controlled trials of new anticoagulants for venous thromboembolism prophylaxis in major orthopedic surgeries, compared with enoxaparin

Yoshida, Ricardo de Alvarenga; Yoshida, Winston Bonetti; Maffei, Francisco Humberto de Abreu; El Dib, Regina; Nunes, Rogério; Rollo, Hamilton Almeida
Fonte: Universidade Estadual Paulista Publicador: Universidade Estadual Paulista
Tipo: Artigo de Revista Científica Formato: 355-369
ENG
Relevância na Pesquisa
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Background: In the past 10 years, new anticoagulants (NACs) have been studied for venous thromboembolism (VTE) prophylaxis. Objective: To evaluate the risk/benefit profile of NACs versus enoxaparin for VTE prophylaxis in major orthopedic surgery. Methods: A systematic review of double-blind randomized phase III studies was performed. The search strategy was run from 2000 to 2011 in the main medical electronic databases in any language. Independent extraction of articles was performed by 2 authors using predefined data fields, including study quality indicators. Results: Fifteen published clinical trials evaluating fondaparinux, rivaroxaban, dabigatran, and apixaban were included. Primary efficacy (any deep vein thrombosis [DVT], nonfatal pulmonary embolism, or all-cause mortality) favored fondaparinux (relative risk [RR] 0.50; 95% CI, 0.39, 0.63) and rivaroxaban (RR, 0.50; 95% CI, 0.34, 0.73) over enoxaparin, although significant heterogeneity was observed in both series. The primary efficacy of dabigatran at 220 mg, apixaban, and bemiparin were similar, with RRs of 1.02 (95% CI, 0.86, 1.20), 0.63 (95% CI, 0.39, 1.01), and 0.87 (95% CI, 0.65, 1.17), respectively. The primary efficacy of dabigatran at 150 mg (RR, 1.20; 95% CI, 1.03...

The Effect of Statins on Mortality in Septic Patients: a Meta-Analysis of Randomized Controlled Trials

Pasin, L; Landoni, G; Castro, ML; Cabrini, L; Belletti, A; Feltracco, P; Finco, G; Carozzo, A; Chiesa, R; Zangrillo, A
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em //2013 ENG
Relevância na Pesquisa
115.97%
OBJECTIVE: Statins are among the most prescribed drugs worldwide and their recently discovered anti-inflammatory effect seems to have an important role in inhibiting proinflammatory cytokine production, chemokines expression and counteracting the harmful effects of sepsis on the coagulation system. We decided to perform a meta-analysis of all randomized controlled trials ever published on statin therapy in septic patients to evaluate their effect on survival and length of hospital stay. DATA SOURCES AND STUDY SELECTION: Articles were assessed by four trained investigators, with divergences resolved by consensus. BioMedCentral, PubMed, Embase and the Cochrane Central Register of clinical trials were searched for pertinent studies. Inclusion criteria were random allocation to treatment and comparison of statins versus any comparator in septic patients. DATA EXTRACTION AND SYNTHESIS: Data from 650 patients in 5 randomized controlled studies were analyzed. No difference in mortality between patients receiving statins versus control (44/322 [14%] in the statins group vs 50/328 [15%] in the control arm, RR = 0.90 [95% CI 0.65 to 1.26], p = 0.6) was observed. No differences in hospital stay (p = 0.7) were found. CONCLUSIONS: Published data show that statin therapy has no effect on mortality in the overall population of adult septic patients. Scientific evidence on statins role in septic patients is still limited and larger randomized trials should be performed on this topic.

The Effect of Statins on Mortality in Septic Patients: a Meta-Analysis of Randomized Controlled Trials

Pasin, L; Landoni, G; Castro, ML; Cabrini, L; Belletti, A; Feltracco, P; Finco, G; Carozzo, A; Chiesa, R; Zangrillo, A
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em //2013 ENG
Relevância na Pesquisa
115.97%
OBJECTIVE: Statins are among the most prescribed drugs worldwide and their recently discovered anti-inflammatory effect seems to have an important role in inhibiting proinflammatory cytokine production, chemokines expression and counteracting the harmful effects of sepsis on the coagulation system. We decided to perform a meta-analysis of all randomized controlled trials ever published on statin therapy in septic patients to evaluate their effect on survival and length of hospital stay. DATA SOURCES AND STUDY SELECTION: Articles were assessed by four trained investigators, with divergences resolved by consensus. BioMedCentral, PubMed, Embase and the Cochrane Central Register of clinical trials were searched for pertinent studies. Inclusion criteria were random allocation to treatment and comparison of statins versus any comparator in septic patients. DATA EXTRACTION AND SYNTHESIS: Data from 650 patients in 5 randomized controlled studies were analyzed. No difference in mortality between patients receiving statins versus control (44/322 [14%] in the statins group vs 50/328 [15%] in the control arm, RR = 0.90 [95% CI 0.65 to 1.26], p = 0.6) was observed. No differences in hospital stay (p = 0.7) were found. CONCLUSIONS: Published data show that statin therapy has no effect on mortality in the overall population of adult septic patients. Scientific evidence on statins role in septic patients is still limited and larger randomized trials should be performed on this topic.

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

Souza,Raphael Freitas de; Chaves,Carolina de Andrade Lima; Nasser,Mona; Fedorowicz,Zbys
Fonte: Faculdade De Odontologia De Bauru - USP Publicador: Faculdade De Odontologia De Bauru - USP
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/04/2010 EN
Relevância na Pesquisa
95.94%
INTRODUCTION: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. OBJECTIVE: The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. MATERIAL AND METHODS: Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization...

Effect of long-chain polyunsaturated fatty acid supplementation of preterm infants on disease risk and neurodevelopment: a systematic review of randomized controlled trials

Smithers, L.; Gibson, R.; McPhee, A.; Makrides, M.
Fonte: Amer Soc Clinical Nutrition Publicador: Amer Soc Clinical Nutrition
Tipo: Artigo de Revista Científica
Publicado em //2008 EN
Relevância na Pesquisa
115.86%
Background: Supplementation of preterm formulas with long-chain polyunsaturated fatty acids (LCPUFAs) is based on their effectiveness to increase blood status and improve visual outcomes. Dispute remains over their efficacy on global development. Objective: The objective was to compare the effects of LCPUFA-supplemented with those of control formulas on neurodevelopment and diseases associated with prematurity. Design: We systematically reviewed randomized controlled trials involving preterm infants that tested LCPUFA-supplemented formulas. The weighted mean differences (WMDs) in neurodevelopmental scores and relative risk (RR) of disease were calculated to compare infants fed LCPUFA-supplemented formula with those fed control formula. Results: No clear differences in Bayley Scales of Infant Development (BSID) scores were observed between groups. Mental development of LCPUFA-supplemented infants was 3.4 points higher than that of control infants with BSID version II (WMD: 3.44; 95% CI: 0.56, 6.31; P = 0.02; n = 879), although it was driven by 2 trials with large effect sizes and wide CIs. Psychomotor development was lower in supplemented infants tested with BSID version I (WMD: –7.99; 95% CI: –14.00, –1.99; P = 0.009; n = 87); however...

The importance of high-quality evidence of the long-term impact of nonfatal events used in randomized controlled trials: a case study of Prasugrel

Lu, C.; Karnon, J.; Sorich, M.
Fonte: Mosby Inc Publicador: Mosby Inc
Tipo: Artigo de Revista Científica
Publicado em //2011 EN
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115.92%
Randomized controlled trials (RCTs) are the centerpiece of evidence based medicine. However, because of the limited follow-up, additional evidence on the long-term consequences of the outcomes used in trials is commonly required for clinical and policy decision making. This article provides insights into the importance and challenges of using such evidence through the case study of nonfatal myocardial infarction (MI) and nonfatal bleeding with prasugrel.; C.Y. Lu, J. Karnon and M.J. Sorich

Effects of energy-restricted high-protein, low-fat compared with standard-protein, low-fat diets: a meta-analysis of randomized controlled trials

Wycherley, T.; Moran, L.; Clifton, P.; Noakes, M.; Brinkworth, G.
Fonte: Amer Soc Clinical Nutrition Publicador: Amer Soc Clinical Nutrition
Tipo: Artigo de Revista Científica
Publicado em //2012 EN
Relevância na Pesquisa
105.83%
BACKGROUND: It is currently unclear whether altering the carbohydrate-to-protein ratio of low-fat, energy-restricted diets augments weight loss and cardiometabolic risk markers. OBJECTIVE: The objective was to conduct a systematic review and meta-analysis of studies that compared energy-restricted, isocaloric, high-protein, low-fat (HP) diets with standard-protein, low-fat (SP) diets on weight loss, body composition, resting energy expenditure (REE), satiety and appetite, and cardiometabolic risk factors. DESIGN: Systematic searches were conducted by using MEDLINE, EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials to identify weight-loss trials that compared isocalorically prescribed diets matched for fat intake but that differed in protein and carbohydrate intakes in participants aged ≥18 y. Twenty-four trials that included 1063 individuals satisfied the inclusion criteria. RESULTS: Mean (±SD) diet duration was 12.1 ± 9.3 wk. Compared with an SP diet, an HP diet produced more favorable changes in weighted mean differences for reductions in body weight (-0.79 kg; 95% CI: -1.50, -0.08 kg), fat mass (FM; -0.87 kg; 95% CI: -1.26, -0.48 kg), and triglycerides (-0.23 mmol/L; 95% CI: -0.33, -0.12 mmol/L) and mitigation of reductions in fat-free mass (FFM; 0.43 kg; 95% CI: 0.09...

Statins decrease all-cause mortality only in CKD patients not requiring dialysis therapy - a meta-analysis of 11 randomized controlled trials involving 21,295 participants

Barylski, M.; Nikfar, S.; Mikhailidis, D.; Toth, P.; Salari, P.; Ray, K.; Pencina, M.; Rizzo, M.; Rysz, J.; Abdollahi, M.; Nicholls, S.; Banach, M.
Fonte: Academic Press Ltd Publicador: Academic Press Ltd
Tipo: Artigo de Revista Científica
Publicado em //2013 EN
Relevância na Pesquisa
115.83%
The available studies have reported the benefits of statins on all-cause and cardiovascular mortality in chronic kidney disease (CKD) patients. However studies in end-stage renal disease patients on dialysis yielded conflicting results. Therefore, we performed a meta-analysis and provide the most reliable trial data to date on the impact of statin therapy on cardiovascular events and death from all causes in CKD patients. Data from PubMed, Web of Science, Cochrane Library, and Scopus for the years 1966 to October 2012 were searched. The final meta-analysis included 11 randomized controlled trials involving 21,295 participants with CKD. Among them 6857 were on dialysis. The use of statins in subjects with non-dialysis-dependent CKD resulted in a marked reduction in death from all causes (relative risk [RR]: 0.66; 95% confidence interval [CI]: 0.55-0.79; p<0.0001), cardiac causes (RR: 0.69; 95%CI: 0.55-0.68; p=0.0012), cardiovascular events (RR: 0.55; 95%CI: 0.4-0.75; p=0.0001) and stroke (RR: 0.66; 95%CI: 0.5-0.88; p=0.0022). The use of statins in dialysis-dependent CKD patients resulted in a non-significant effect on death from all causes (RR: 0.99; 95%CI: 0.88-1.11; p=0.85) and stroke (RR: 1.31; 95%CI: 0.9-1.89; p>0.05), but had the effect of reducing death from cardiac causes (RR: 0.79; 95%CI: 0.64-0.98; p<0.05) and cardiovascular events (RR: 0.81; 95%CI: 0.7-0.94; p<0.05). In conclusion...

Effects of statins on lipid profile in chronic kidney disease patients: a meta-analysis of randomized controlled trials

Nikolic, D.; Nikfar, S.; Salari, P.; Rizzo, M.; Ray, K.; Pencina, M.; Mikhailidis, D.; Toth, P.; Nicholls, S.
Fonte: Librapharm Publicador: Librapharm
Tipo: Artigo de Revista Científica
Publicado em //2013 EN
Relevância na Pesquisa
105.85%
OBJECTIVE: The available data on statin effects in chronic kidney disease (CKD) patients are still conflicting. We investigated the impact of short- and long-term statin therapy on lipid profiles in CKD patients requiring or not requiring dialysis. RESEARCH DESIGN AND METHODS: Data from Scopus, PubMed, Web of Science, and the Cochrane Library from 1966 to May 2012 were searched for studies that investigated this effect. We included all randomized controlled clinical trials that investigated the impact of statin therapy on lipids and lipoproteins. RESULTS: The final analysis included 16 trials with 3594 subjects. In CKD patients, statin therapy significantly reduced total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) (p < 0.003 for all comparisons), and the effect insignificantly intensified with duration of statin therapy (56.3 vs 66.8, 22.5 vs 24.1, and 53 vs 56.1 mg/dl, respectively). Comparing statin therapy for ≤ 3 and >3 months in CKD patients on dialysis, the magnitude of TC and LDL-C decreased (26.3 vs 25.9, and 42.2 vs 29.8 mg/dl, respectively, p > 0.05 for both), while TG increased modestly (4.5 vs 13.4 mg/dl). Short-term statin therapy increased high density lipoprotein cholesterol by a mean 0.7 mg/dl (p = 0.04)...

Effect of iodine supplementation in pregnancy on child development and other clinical outcomes: a systematic review of randomized controlled trials

Zhou, S.; Anderson, A.; Gibson, R.; Makrides, M.
Fonte: Amer Soc Clinical Nutrition Publicador: Amer Soc Clinical Nutrition
Tipo: Artigo de Revista Científica
Publicado em //2013 EN
Relevância na Pesquisa
115.88%
BACKGROUND: Routine iodine supplementation during pregnancy is recommended by leading health authorities worldwide, even in countries where the iodine status of the population is sufficient. OBJECTIVES: We evaluated the efficacy and safety of iodine supplementation during pregnancy or the periconceptional period on the development and growth of children. Secondary outcomes included pregnancy outcome and thyroid function. DESIGN: A systematic review of randomized controlled trials (RCTs) was conducted. PUBMED, MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane Central Register of Controlled Trials databases were searched to identify relevant RCTs. RESULTS: Fourteen publications that involved 8 trials met the inclusion criteria. Only 2 included trials reported the growth and development of children and clinical outcomes. Iodine supplementation during pregnancy or the periconceptional period in regions of severe iodine deficiency reduced risk of cretinism, but there were no improvements in childhood intelligence, gross development, growth, or pregnancy outcomes, although there was an improvement in some motor functions. None of the remaining 6 RCTs conducted in regions of mild to moderate iodine deficiency reported childhood development or growth or pregnancy outcomes. Effects of iodine supplementation on the thyroid function of mothers and their children were inconsistent. CONCLUSIONS: In this review...

Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials

Schuit, E.; Stock, S.; Groenwold, R.; Maurel, K.; Combs, C.; Garite, T.; Spong, C.; Thom, E.; Rouse, D.; Caritis, S.; Saade, G.; Zachary, J.; Norman, J.; Rode, L.; Klein, K.; Tabor, A.; Cetingoz, E.; Morrison, J.; Magann, E.; Briery, C.; et al.
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
Publicado em //2012 EN
Relevância na Pesquisa
95.9%
BACKGROUND Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix) or to determine adverse effects for rare outcomes such as intrauterine death. METHODS/DESIGN We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity). Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. DISCUSSION Combining individual patient data from different randomized trials has potential to provide valuable...

The real world mental health needs of heart failure patients are not reflected by the depression randomized controlled trial evidence

Tully, P.J.; Wittert, G.; Selkow, T.; Baumeister, H.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em //2014 EN
Relevância na Pesquisa
105.81%
INTRODUCTION: International depression screening guidelines in heart failure (HF) are partly based on depression treatment efficacy from randomized controlled trials (RCTs). Our aim was to test the external validity of depression RCT criteria in a sample of real-world HF patients. METHODS: HF patients admitted to 3 hospitals in South Australia were referred to a HF psychologist if not already receiving current psychiatric management by psychologist or psychiatrist elsewhere. Screening and referral protocol consisted of the following; (a). Patient Health Questionnaire ≥ 10; (b). Generalized Anxiety Disorder Questionnaire ≥ 7); (c). positive response to 1 item panic attack screener; (d). evidence of suicidality. Patients were evaluated against the most common RCT exclusion criteria personality disorder, high suicide risk, cognitive impairment, psychosis, alcohol or substance abuse or dependency, bi-polar depression. RESULTS: Total 81 HF patients were referred from 404 HF admissions, and 73 were assessed (age 60.6 ± 13.4, 47.9% female). Nearly half (47%) met at least 1 RCT exclusion criterion, most commonly personality disorder (28.5%), alcohol/substance abuse (17.8%) and high suicide risk (11.0%). RCT ineligibility criteria was more frequent among patients with major depression (76.5% vs. 46.2%...

The effect of maternal omega-3 (n-3) LCPUFA supplementation during pregnancy on early childhood cognitive and visual development: a systematic review and meta-analysis of randomized controlled trials

Gould, J.; Smithers, L.; Makrides, M.
Fonte: Amer Soc Clinical Nutrition Publicador: Amer Soc Clinical Nutrition
Tipo: Artigo de Revista Científica
Publicado em //2013 EN
Relevância na Pesquisa
115.87%
BACKGROUND: Maternal fish consumption during pregnancy has been positively associated with cognitive and visual abilities in the offspring, leading to the hypothesis that maternal omega-3 (n-3) long-chain PUFA (LCPUFA) supplementation improves children's neurologic and visual development. OBJECTIVE: The objective was to evaluate the effect of maternal omega-3 LCPUFA supplementation in pregnancy on neurologic and visual development in the offspring. DESIGN: Five electronic databases were searched. Human randomized controlled trials that supplemented the maternal diet with omega-3 LCPUFAs during pregnancy, or pregnancy and lactation, and that assessed either neurologic or visual development of the offspring were included. Trial quality was assessed, and the results of eligible trials were compared in meta-analyses. RESULTS: Eleven RCTs involving 5272 participants were included in the review. Most trials had methodologic limitations. No differences in standardized psychometric test scores for cognitive, language, or motor development were observed between the LCPUFA-supplemented and control groups, except for cognitive scores in 2-5-y-old children, in whom supplementation resulted in higher Developmental Standard Scores (mean difference: 3.92; 95% CI: 0.77...

CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration

Hopewell, S.; Clarke, M.; Moher, D.; Wager, E.; Middleton, P.; Altman, D.; Schulz, K.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em //2008 EN
Relevância na Pesquisa
116.02%
BACKGROUND: Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. METHODS AND FINDINGS: We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g....

Recruitment and implementation strategies in randomised controlled trials of acupuncture and herbal medicine in women's health

Smith, C.; Coyle, M.
Fonte: Churchill Livingstone Publicador: Churchill Livingstone
Tipo: Artigo de Revista Científica
Publicado em //2006 EN
Relevância na Pesquisa
95.87%
INTRODUCTION: Recruitment of subjects to clinical trials is known to be difficult and there is little research describing recruitment and implementation strategies to CAM clinical trials. This paper describes the experiences from recruitment and implementation for five randomised controlled trials in women's health conducted in South Australia. METHODS: Descriptive study reporting on trial documentation and questionnaires completed by women. RESULTS: Recruitment rates varied between trials and a variety of recruitment strategies were used between studies. Promotion of the trials to the wider community were facilitated by issuing press releases and subsequent reporting by the media. Women found the trial acceptable suggesting factors motivating and preventing women from participating were well addressed. CONCLUSION: It is hoped that the experiences described here will give some insight to recruitment and implementation strategies. There is a need for more systematic research and evaluation of these strategies, and dissemination of these findings to assist with successful implementation of trials.

Meta-analysis of two randomized controlled trials to identify long-term symptoms after division of the short gastric vessels during Nissen fundoplication

Engstrom, C.; Jamieson, G.; Devitt, P.; Watson, D.
Fonte: John Wiley & Sons Ltd Publicador: John Wiley & Sons Ltd
Tipo: Artigo de Revista Científica
Publicado em //2011 EN
Relevância na Pesquisa
105.87%
BACKGROUND: Randomized trials suggest that division of the short gastric vessels during Nissen fundoplication is unnecessary. Some trials report an increased risk of gas bloat symptoms following division of the short gastric vessels. In this study long-term follow-up data from the two largest randomized clinical trials of division versus no division of the short gastric vessels during laparoscopic Nissen fundoplication were combined to determine whether there were differences in late outcome. METHODS: Patients with gastro-oesophageal reflux disease who underwent primary laparoscopic antireflux surgery and were included in two previously reported randomized trials were studied. Of 99 patients enrolled in the Swedish study and 102 in the Australian study, the short gastric vessels were divided in 104 and left intact in 97. Data sets were combined and late clinical outcomes analysed. RESULTS: At 10-12 years' follow-up (mean 11.5 years) clinical data were obtained from 170 patients (86 with vessels divided, 84 undivided). Statistical analysis of the combined data set showed no significant differences in symptoms of heartburn or dysphagia, ability to belch or vomit, and use of antisecretory medications. Division of the short gastric vessels was associated with a higher rate of bloating symptoms (72 versus 48 per cent; P = 0.002). CONCLUSION: Division of the short gastric vessels is followed by a slightly poorer clinical outcome at late follow-up after Nissen fundoplication. Surgeons should avoid dividing these vessels when undertaking a laparoscopic Nissen fundoplication.; C. Engström...

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

Souza, Raphael Freitas de; Chaves, Carolina de Andrade Lima; Nasser, Mona; Fedorowicz, Zbys
Fonte: Universidade de São Paulo. Faculdade de Odontologia de Bauru Publicador: Universidade de São Paulo. Faculdade de Odontologia de Bauru
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; Formato: application/pdf
Publicado em 01/04/2010 ENG
Relevância na Pesquisa
95.94%
INTRODUCTION: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. OBJECTIVE: The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. MATERIAL AND METHODS: Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization...