Assessment of the Reporting Quality of Randomized, Controlled Trials of Percutaneous Patent Foramen Ovale Closure for the Treatment of Migraine Based on the CONSORT Statement.

Abstract

The presence of patent foramen ovale (PFO) has been associated with migraine. Several retrospective, nonrandomized studies support reduction of migraine frequency and severity after PFO closure. However, three randomized, controlled trials (RCTs) have not met their primary efficacy endpoints, and their reporting quality has not been assessed. The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist. Systematic searches of two databases (MEDLINE/PubMed and Cochrane Library) were conducted. The primary objective was to establish the mean CONSORT adherence of RCTs of PFO closure for the migraine treatment, and secondary objectives were the calculation of adherence per CONSORT item and the effect of CONSORT statement in high-ranked medical journals. A 37-item questionnaire based on the CONSORT 2010 checklist was used to assess the reporting quality. Adequate adherence to the CONSORT statement was defined as reporting over 70 percent of the items. The search identified three eligible articles for analysis. The mean adherence was 69.66±4.49 percent. Only one of the studies achieved a good reporting quality (≥75%). Twenty-six of the 37 items of the CONSORT checklist (70.3%) were reported in more than half of the studies. Quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains unsatisfactory. Further improvement of reporting quality is essential to assess the validity of clinical research.