Do we value the safety of our treatments? An empirical assessment of reporting of Harms in Randomized Controlled Trials in Orthodontics
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.659 | 0.943 |
| Meta-epidemiology (narrow) | 0.001 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.007 |
| Bibliometrics | 0.013 | 0.018 |
| Science and technology studies | 0.002 | 0.013 |
| Scholarly communication | 0.010 | 0.016 |
| Open science | 0.004 | 0.007 |
| Research integrity | 0.005 | 0.004 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".