Abstract 3740: Using Standardized Web-based Tests in Clinical Trials to Improve Investigator and Coordinator Protocol Familiarity: Experience from Antihypertensive Treatment of Acute Cerebral Hemorrhage II trial
Bibliographic record
Abstract
Background: Prior to site initiations, the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-II) trial steering committee require that all investigators and coordinators participating in the trial pass a multiple choice web based test that assesses the individual’s knowledge of the trial protocol and manual of procedures. Requiring a test of this nature was expected to increase the probability that key individuals participating in the trial at various clinical sites had acquired protocol familiarity that would enable them to conduct the trial properly. This benefit was weighed against the additional burden imposed on the site initiation process. Methods: The steering committee developed a bank of 38 multiple choice questions based on the ATACH-II protocol and manual of procedures (MoP). These questions were identified as appropriate for an investigator, a coordinator, or both. The test was programmed by the ATACH-II Data Coordination Unit and hosted on a web page linked to the ATACH-II Clinical Trial Management System (CTMS). Each time a user registers to take the test a random selection of 14 questions appropriate for that user type (investigator or coordinator) is generated. When a user passes the test, the test certification document is automatically created and uploaded into the ATACH-II CTMS. Results: In the first year of the trial the test has been taken 418 times. Users are required to answer 12 questions correctly in order to pass. Users registered as investigators have taken the test 263 times with a 55.9% pass rate. Users registered as coordinators or other study team members have taken the test 155 times with a 56.1% pass rate. The pass ratio has increased from 49.5% at the end of the first quarter to 56.0% at the end of the last quarter of the first year. The mean score is 10/14 and the median score is 12/14 among all participants taking the test. Conclusion: Requiring each investigator and coordinator to become certified by passing this test adds substantial burden to the site initiation process. However, the 56% pass rate observed provides evidence that such efforts may be required to promote the necessary familiarity with the protocol and MoP for this trial.
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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 | 0.393 | 0.460 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.003 | 0.004 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.003 |
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".