(A1201) An Analysis of Adherence to CONSORT Harms-reporting in Hypoglossal Nerve Stimulator Clinical Trials

Introduction: The aim of this study is to evaluate adherence to the Consolidated Standards for Reporting Trials (CONSORT) harms checklist for randomized and non-randomized trials involving hypoglossal nerve stimulation.

Methods: A cross-sectional design was employed to review randomized-control trials (RCTs), and non-randomized trials related to hypoglossal nerve stimulation published between January 1, 2005, and January 1, 2024. Cochrane Library and PubMed were used to gather clinical trials regarding hypoglossal nerve stimulation. These studies were analyzed for adherence to each of the 10 items found in the CONSORT-Harms checklist. Statistical analysis was performed collectively and separately for both RCTs and non-randomized trials.

Results: Two-hundred sixty-six articles were retrieved from the original literature search, of which, 32 met the inclusion criteria. Six of these articles were excluded due to being behind a paywall. A final total of 26 articles were included in the study. Of the 26 articles, 8 were RCTs and 18 were non-randomized trials. Of the 26 articles, only 1 mentioned CONSORT guidelines (4%). Each article met and average of 4/10 CONSORT guidelines.

Conclusions: Overall adherence to CONSORT-harms reporting guidelines for hypoglossal nerve stimulation was low (4%). With this procedure becoming a more popular treatment option for obstructive sleep apnea, it is imperative that adverse events are reported as they help guide decisions to treat.