How well are patient-reported outcomes reported in third molar randomized clinical trials? A meta-epidemiological evaluation of adherence to the CONSORT-PRO extension

This meta-epidemiological cross-sectional study assessed the adherence of randomized controlled trials (RCTs) on third molar surgery to the CONSORT-PRO extension and evaluated their risk of bias. A comprehensive search was performed across Medline via PubMed, EMBASE, CINAHL, PsycINFO, Cochrane Library, LILACS, Web of Science, Scopus, Epistemonikos, and Google Scholar. Parallel, crossover, and split-mouth RCTs that reported patient-reported outcomes (PROs) as primary or secondary endpoints were included. The primary outcome was the proportion of CONSORT-PRO items reported. Screening, data extraction, and assessments were independently performed by two reviewers. Of the 4220 records identified, 23 RCTs met the eligibility criteria. Overall adherence to CONSORT-PRO was low (mean = 45.6 %; SD = 8.9), with higher compliance among trials using PROs as primary outcomes (mean = 50.5 %; SD = 6.2) and lower when PROs were secondary (mean = 43.5 %; SD = 9.1). Approximately 43.5 % of trials presented some concerns regarding overall risk of bias. Adherence to CONSORT-PRO in RCTs on lower third molar surgery remains suboptimal, particularly when PROs are secondary outcomes. Strengthening methodological rigor and integrating CONSORT-PRO guidelines from trial design through reporting are essential to improve the quality, transparency, and reproducibility of patient-reported outcome data in this field.