An Evaluation of Reporting Guidelines and Clinical Trial Registry Requirements Among Otolaryngology Journals

Background: The field of Otolaryngology is rapidly evolving and thus requires trustworthy clinical evidence to support the most current medical technologies and techniques. Objectives: To evaluate the editorial policies of the top Otolaryngology journals and determine their adherence to reporting guidelines and clinical trial registration. Additionally we aim to evaluate whether RCTs published in journals requiring these guidelines are more compliant with trial registration and reporting guidelines compared to their counterparts not requiring such guidelines.

Methods: This study used a cross-sectional design to select RCTs published in the top 20 Otolaryngology journals from June 8th, 2017 to June 8th, 2021. Individual studies were evaluated for adherence to clinical trial registration as well as the CONSORT guideline for clinical trials by the presence or absence of a CONSORT flow diagram and clinical trial registration number in the published text. Additionally, the top 20 journal’s “instructions for authors” section was evaluated to determine if a journal “required”, “recommended”, or “did not require” the 20 most commonly used study guidelines.

Results: Of the 20 top Otolaryngology journals, 9 (45%) did not “require” the use of a single guideline within their “Instructions to Authors” section. The remaining 11 (65%) “required” the use of at least one guideline. Additionally, 9 (45%) of the journals did not require clinical trial registration prior to publication among RCTs. Among the journals requiring CONSORT guidelines, 119 (59%) of the 199 RCTs included a CONSORT flow diagram within the study. Among the journals recommending CONSORT guidelines, only 92 (39%) of the 235 RCTs included a CONSORT flow diagram within the study. Journals requiring CONSORT guidelines were more likely to include flow diagrams compared to journals recommending CONSORT (odds ratio [OR] = 2.31, 95% confidence interval [CI] = 1.57-3.40)

Conclusions: Our results indicate that there is subpar utilization of reporting guidelines as well as enforcement of these guidelines among the top Otolaryngology journals. Of equal concern is the similar lack of utilization and enforcement of clinical trial registration. Based on the findings of our study this is a problem which can be solved at the journal level as requirement of these editorial policies leads to a 2.3x increased likelihood of adherence. As such we encourage Otolaryngology journals to adapt their policies to require incorporation of reporting guidelines and clinical trial registration in their published RCTs.