Quality of Reporting Nutritional Randomized Controlled Trials in Patients With Cystic Fibrosis
Vered Daitch1, Tanya Babich, Pierre Singer
1*Infectious Diseases University Research Center, Rabin Medical Center, Beilinson Hospital, Petah Tikva †Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv ‡General Intensive Care Department and Institute of Nutrition Research, Rabin Medical Center, Beilinson Hospital, Petah Tikva §Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.
Objective:
Randomized controlled trials (RCTs) have a major role in the making of evidence-based guidelines. The aim of the present study was to critically appraise the RCTs that addressed nutritional interventions in patients with cystic fibrosis.
Methods:
Embase, PubMed, and the Cochrane Library were systematically searched until July 2015. Methodology and reporting of nutritional RCTs were evaluated by the Consolidated Standards of Reporting Trials (CONSORT) checklist and additional dimensions relevant to patients with CF.
Results:
Fifty-one RCTs were included. Full details on methods were provided in a minority of studies. The mean duration of intervention was <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 examine the outcomes that are important to the patient. Improvement over the years has been minor.
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