Worldwide trends in volume and quality of published protocols of randomized controlled trials.

ABSTRACT:

Introduction

Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols.

Methods

A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and

SUBMITTER: van Rosmalen BV 

PROVIDER: S-EPMC5351864 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature