With more vaccines becoming available worldwide, vaccine research is on the rise in developing countries. To gain a better understanding of safety reporting from vaccine clinical research in developing countries, we conducted a systematic review in Medline and Embase (1989-2011) of published randomized clinical trials (RCTs) reporting safety outcomes with ≥50% developing country participation (...

BACKGROUND The pragmatic-explanatory continuum indicator summary version 2 (PRECIS-2) tool has recently been developed to classify randomized clinical trials (RCTs) as pragmatic or explanatory based on their design characteristics. Given that treatment effects in explanatory trials may be greater than those obtained in pragmatic trials, conventional meta-analytic approaches may not accurately a...

BACKGROUND Previous work highlighted a number of methodological constraints when reporting health-related quality of life (HRQOL) outcomes from randomized controlled trials (RCTs). Given this, the objective of this study was to investigate whether the quality of such HRQOL reports has improved over time. MATERIALS AND METHODS On the basis of a predefined set of criteria, 159 RCTs with a HRQOL...

BACKGROUND Intracoronary (IC) abciximab administration remains a promising approach aimed to increase a drug concentration in the target area and possibly improve clinical outcomes in the setting of ST-segment elevation myocardial infarction (STEMI). The goal of this literature review and meta-analysis is to update available knowledge comparing IC and intravenous (IV) abciximab administration i...

Background: Intravenous immunoglobulin (IVIG) is an established treatment of immune mediated demyelinating neuropathy including Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy. Recent trials suggest its efficacy in treating relapsing- remitting multiple sclerosis. IVIG exerts a number of effects, which may be beneficial in treating multiple sclerosis (MS): R...

background: intravenous immunoglobulin (ivig) is an established treatment of immune mediated demyelinating neuropathy including guillain-barré syndrome and chronic inflammatory demyelinating polyneuropathy. recent trials suggest its efficacy in treating relapsing- remitting multiple sclerosis. ivig exerts a number of effects, which may be beneficial in treating multiple sclerosis (ms): reductio...

BACKGROUND In randomized controlled trials (RCTs), the intention-to-treat (ITT) principle, which involves maintaining study participants in the treatment groups to which they were randomized regardless of postrandomization withdrawal, is the recommended analytic approach for preserving the integrity of randomization, yet little is known about the use of ITT in nursing RCTs. OBJECTIVES The pur...

During the days August 22-24, 2013 has been held in Harbin (China) an International Consensus Conference aimed to improve the quality and the reporting of the randomized controlled trials (RCTs) in infertility and subfertility field. I, as Italian scientist with experience in clinical infertility trials, was invited to have a speech on the Italian experience in RCTs, with particular regard for ...