Implementation of prospective trial registration in the field of otolarynchology

Article type
Authors
Stegeman I1, Leeflang M2, Hooft L3
1Department of Otorhinolaryngology – Head and Neck Surgery, The Netherlands
2Department of Clinical Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center, The Netherlands
3Dutch Cochrane Centre, The Netherlands
Abstract
Background:
In an effort to make research more transparent and to diminish publication bias, the International Committee of Medical Journal Editors (ICMJE) requires all randomized controlled trials (RCTs) to be registered in a public database before enrolment of the first patient. All registered trials receive an unique trial number, if this number is also reported in the article, registered trial information is easily accessible.

Objectives:
In this study we assessed the trial registration and the reporting of trial registration number in otolarynchologic studies.

Methods:
We examined RCTs published in the top-ten journals in otolarynchology. We assessed whether the articles reported a trial registration number, if not, we assessed whether those RCTs were registered in a trial register linked to the World Health Organization Search Portal (including ClinicalTrials.gov).

Results:
Seventy-nine publications of RCTs were identified, seven of which reported trial registration numbers in the manuscript. Additionally, five trials were found to be registered that did not report a trial number in their manuscript. In total 6.3% (11/79) of the RCTs were registered.

Conclusions:
In conclusion, clinical trial registration is not yet adopted in otolarynchology. That makes it impossible to check for selective reporting or publication for most of the trials. Further promotion of trial registration should be implemented by otolarynchologic journals.