Original article The difference between study recommendations, stated policy, and actual practice in a clinical trial
Bibliographic record
Abstract
Background: We determined whether physicians involved in a clinical trial adhere to the study rec-ommendations or the stated policy of their treatment centre with respect to the administration of boost radiation after breast conserving surgery. Patients and methods: Boost radiation treatment policy was determined by survey at 25 oncology centres involved in a randomised trial of breast or breast plus nodal radiation in Canada. Actual practice was compared with stated policy and study recommendations. Results: Among 248 subjects, 201 (81%) were treated according to stated policy [k = 0.40, 95% confidence intervals (CI) 0.27–0.52; P<0.0001], indicating only a fair to moderate agreement between stated and actual practice, while 232 (94%) were treated according to study recommen-dations (k = 0.59, 95 % CI 0.40–0.77; P<0.0001), indicating moderate to near substantial agreement between study recommendations and actual practice (P = 0.88 for z-test of difference). In a multivari-ate analysis, subjects who had invasive disease at a resection margin were more likely to get a boost than those with margins clear of invasive tumour by 2 mm [odds ratio (OR) 49, 95 % CI 7.6–322; P<0.0001]. Conclusions: Physicians appear compliant with study recommendations for a non-randomised manoeuvre in a clinical trial, possibly at the expense of compliance with stated local policy. Clinical trial protocols should incorporate standard practice. Key words: clinical trials, data collection, radiotherapy
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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 | 0.722 | 0.911 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.002 | 0.006 |
| Science and technology studies | 0.002 | 0.009 |
| Scholarly communication | 0.008 | 0.006 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.006 | 0.005 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".