Quality of Reporting Nutritional Randomized Controlled Trials in Patients with Cystic Fibrosis.

Background: Randomized controlled trials (RCTs) have a major role in the making of evidence-based guidelines. We aimed to critically appraise the RCTs that addressed nutritional interventions in Cystic Fibrosis (CF) patients. Materials and Methods: Embase, PubMed and the Cochrane Library were systematically searched until July 2015. Methodology and reporting of nutritional RCTs were evaluated by the CONSORT checklist and additional dimensions relevant to CF patients. Results: 51 RCTs were included. Full details on methods were provided in a minority of studies. The mean duration of intervention was under 6 months. 56.9% of the RCTs did not define a primary outcome; 70.6% of studies did not provide details on sample size calculation; and only 31.4% reported on the subgroup or separated between important subgroups. Conclusions: The examined RCTs were characterized by a weak methodology, a small number of patients with no sample size calculations, a relatively short intervention, and many times did not examined outcomes that are important to the patient. Improvement over the years has been minor. (C) 2016 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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