Failure of plastic surgical clinical trials to document compliance with international ethical guidelines: A systematic review

2013 ◽  
Vol 66 (1) ◽  
pp. 3-8 ◽  
Author(s):  
M. Felix Freshwater ◽  
D.E. Garcia-Zalisnak ◽  
N.E. González-Ortiz
2020 ◽  
Vol 21 (1) ◽  
pp. 124
Author(s):  
Elinaldo Da Conceição Dos Santos ◽  
Ana Carolina Pereira Nunes Pinto ◽  
Juliana Ribeiro Fonseca Franco De Macedo ◽  
Adriana Claudia Lunardi

Introduction: Patients receiving cardiac surgeries present high risk of developing postoperative complications. Incentive spirometry (IS) is used for the prevention and treatment of postoperative pulmonary complications in patients undergoing cardiac surgeries. Publications have suggested that IS is ineffective. In contrast, some studies have shown that when IS is adequately used, it may lead to beneficial outcomes. Objectives: To assess the effect of IS in patients undergoing cardiac surgeries. Methods/design: Systematic Reviews with randomised and quasi-randomised trials with adult patients undergoing cardiac surgeries, evaluating the effect of flow or volume-oriented IS. Outcome measures: postoperative pulmonary complications; adverse events; mortality; length of hospital stay; length of intensive care unit stay; reintubation rate; pulmonary function; antibiotic use; oxygenation; and respiratory muscle strength. Search: MEDLINE, EMBASE, CENTRAL, PEDro, CINAHL, LILACS, SCIELO, Allied, AMED, Scopus, Open Grey database, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, clinicaltrialsregister.eu, and ReBec. Two authors will independently extract data. PEDro scale will be used to evaluate the methodological quality of the studies. Meta-analysis will be performed using the inverse variance method and the random effects model in RevMan 5.3. We will use the I2 statistic to estimate the amount of heterogeneity across studies in each meta-analysis. Ethics and dissemination: The approval of an ethical committee is not required. Only clinical trials that have complied with ethical guidelines and followed the Declaration of Helsinki, will be included in this systematic review. The findings of this study will help clarify uncertainties about the effects of incentive spirometry in the postoperative period of cardiac surgery and may be disseminated to clinicians, assisting in decision making and including the best evidence in the treatment of their patients. Discussion: This review will clarify the uncertainty over whether IS is a useful technique for patients undergoing cardiac surgeries. While good quality studies have shown IS is an effective prophylactic technique, other studies have suggested that there is no evidence to support IS utilization.Keywords: incentive spirometry, cardiac surgery, postoperative.


2016 ◽  
Vol 22 ◽  
pp. 69
Author(s):  
Hemant Thacker ◽  
Rajeev Chawla ◽  
Navneet Agrawal ◽  
Rohit Kapoor ◽  
Noel Somasundaram ◽  
...  

Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.


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