Reporting Quality of Adverse Events in Temporomandibular Disorders Treatment: A Systematic Review.

OBJECTIVE

To evaluate the quality of adverse event (AE) reporting and identify factors associated with reporting quality in randomized controlled trials (RCTs) of temporomandibular disorders (TMDs) treatment.

METHODS

We searched MEDLINE, Cochrane Library (CENTRAL), and EMBASE for RCTs on TMD treatment. Trial characteristics and AE data were extracted, with specific AEs classified using System Organ Class (SOC) terminology. We assessed the reporting quality with the 16-item CONSORT Harms 2022 checklist. Factors influencing reporting quality were analyzed using multiple linear regression and an artificial neural network (ANN) with SHapley Additive exPlanations (SHAP) interpretation.

RESULTS

Of 79 RCTs analyzed, neurological symptoms (e.g., headache, dizziness) were the primary AEs. Only three checklist items were reported in over 50% of studies. The median reporting score percentage was 18.8% (IQR 26.7%). No significant differences in score percentages were observed across treatment modalities (p = 0.565). We finally screened out five key factors linked to higher reporting quality, including non-profit funding, combined efficacy-safety endpoints, absence of international collaboration, European country location, and registration status.

CONCLUSIONS

AE reporting quality in TMDs treatment RCTs remains suboptimal. Adherence to the most current CONSORT Harms guidelines is recommended to improve transparency and consistency in harms reporting.