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

Background: Systematic reviews and RCTs represent the pinnacle of clinical evidence and are considered level-1 evidence in the formation of ophthalmology clinical practice guidelines. Objectives: Here we aim to investigate the editorial policies and their enforcement of reporting guidelines and clinical trial registration. Additionally, we seek to determine whether RCTs published in journals requiring the previously mentioned guidelines and registries are more compliant than their counterparts in journals not requiring such guidelines.

Methods: This study used a cross-sectional design to select RCTs published in the top 20 ophthalmology journals from June 8th 2019 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 ophthalmology journals, 14 (70%) did not “require” the use of a single guideline within their “Instructions to Authors” section. The remaining 6 (30%) “required” the use of at least one guideline. Additionally, 8 (40%) of the journals did not require clinical trial registration prior to publication among RCTs. Among the journals requiring CONSORT guidelines, only 89 (62%) of the 144 RCTs included a CONSORT flow diagram within the study. Among the journals recommending CONSORT guidelines, only 34 (38%) of the 89 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] = 2.62, 95% confidence interval [CI] = 1.52 to 4.51)

Conclusions: Our study found that there is room for improvement in top ophthalmology journals in the requirement of reporting guidelines, with limited RCTs following CONSORT in their studies. Also, a limited number of ophthalmology journals require trial registration in their study. We propose that ophthalmology journals augment their requirements for publication to include these two steps, and we believe that this will allow for better adherence to higher methodological quality in ophthalmologic research.