Abstract
Background: Publishing protocols of randomized controlled trials (RCT) facilitates a detailed description of study rationale, design, and related ethical and safety issues. 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 RCT protocols. Methods: PubMed and EMBASE were searched, identifying 596 protocols published over a decade. Data were extracted on quality characteristics. Methodological quality was stated as high if adequate generation of allocation, concealment of allocation and intention-to-treat analysis were used. A comparison was made by publication period, geographical region and medical specialty. Results: The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common topics. Whereas most protocols in the first period originated from North America (n=30, 44%), in the second and third this was Europe (respectively, n=65, 47% and n=190, 48%) (p=0.02). Quality of protocols was higher in Europe compared to North America. Surgical protocols had the highest quality among the three specialty topics used in this study (OR=1.94, CI=1.09-3.45, p=0.02). Conclusion: A five-fold increase in RCT protocol publication was observed. Although quality of protocols improved, it varied between geographical regions and across medical specialties. Improving training in RCT methodology is therefore important.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.