Inappropriate Evaluation of Effect Modifications Based on Categorical Outcomes: A Systematic Review of Randomized Controlled Trials
Bibliographic record
Abstract
Our meta-epidemiological study aimed to describe the prevalence of reporting effect modification only on relative scale outcomes and inappropriate interpretations of the coefficient of interaction terms in nonlinear models on categorical outcomes. Our study targeted articles published in the top 10 high-impact-factor journals between 1 January and 31 December 2021. We included two-arm, parallel-group, interventional superiority randomized controlled trials to evaluate the effects of modifications on categorical outcomes. The primary outcomes were the prevalence of reporting effect modifications only on relative scale outcomes and that of inappropriately interpreting the coefficient of interaction terms in nonlinear models on categorical outcomes. We included 52 articles, of which 41 (79%) used nonlinear regression to evaluate effect modifications. At least 45/52 articles (87%) reported effect modifications based only on relative scale outcomes, and at least 39/41 (95%) articles inappropriately interpreted the coefficient of interaction terms merely as indices of effect modifications. The quality of the evaluations of effect modifications in nonlinear models on categorical outcomes was relatively low, even in randomized controlled trials published in medical journals with high impact factors. Researchers should report effect modifications of both absolute and relative scale outcomes and avoid interpreting the coefficient of interaction terms in nonlinear regression analyses.
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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 | 0.232 | 0.548 |
| Meta-epidemiology (narrow) | 0.003 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.024 |
| Bibliometrics | 0.015 | 0.014 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.008 | 0.007 |
| Open science | 0.003 | 0.004 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.002 | 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".