Do we value the safety of our treatments? An empirical assessment of reporting of Harms in Randomized Controlled Trials in Orthodontics.

AIM: To record reporting of harms by authors of randomized controlled trials (RCTs) in indexed orthodontic journals of the Q1 ranking, and explore associations between published reports and several publication characteristics. MATERIALS AND METHODS: RCTs from six (6) Q1 indexed orthodontic journals, namely the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), the European Journal of Orthodontics (EJO), the Angle Orthodontist (ANGLE), Progress in Orthodontics (PIOR), the Korean Journal of Orthodontics (KJO), and the Journal of the World Federation of Orthodontists (JWFO) from January 2020 to December 2024 were included. Data extraction was conducted for outcome and predictor variables such as reporting of harms or otherwise, and other publication characteristics including year of publication, journal, origin of authorship, number of authors, design of the RCT, registration, funding, reporting of patient reported outcome measures (PROMs). Statistical analyses included descriptive statistics, cross-tabulations, and univariable and multivariable logistic regression. RESULTS: A total of 183 RCTs were included. Twenty four percent of RCTs (44/183) did not report on harms in their publications. A significant association was detected between reporting of harms and journal of publication, with EJO published studies acknowledging pertinent harms almost in their entirety (49/51; 96.1% reported harms; P = .008). RCTs of American affiliated authors were the least likely to report harms (P = .02). Studies reporting on PROMs showed 2.73 higher odds for reporting harms compared with those that did not include PROMs (adjusted odds ratio, OR: 2.73; 95% CI: 1.04, 7.15; P = .04). There was strong evidence that RCTs with registered protocols presented higher odds for reporting harms than nonregistered trials (adjusted OR: 3.68; 95% CI: 1.62, 8.36; P = .002). CONCLUSIONS: Albeit progress has been made, a quarter of orthodontic RCTs still do not include harms in their assessment. Registration, inclusion of PROMs, origin of authorship and journal of publication were significant predictors of harms reporting.