P1667: ATTRIBUTES OF RANDOMIZED CONTROLLED TRIALS AND THEIR ASSOCIATIONS WITH FUNDING SOURCE IN VENOUS THROMBOEMBOLISM PROPHYLAXIS FOR PATIENTS WITH CANCER: A BIBLIOGRAPHICAL ANALYSIS
Bibliographic record
Abstract
Topic: 34. Thrombosis and vascular biology - Biology & Translational Research Background: Commercial sponsorship plays a large role in shaping the literature in hematology. Commercial sponsorship has potential to overcome feasibility limitations inherent in randomized controlled trials (RCTs), such as recruitment and duration of follow up, but may attract scrutiny in its robustness or potential for bias. Aims: In RCTs of venous thromboembolism (VTE) prophylaxis in patients with cancer, how do commercially sponsored RCTs compare with non-commercially funded RCTs regarding publication patterns such as reporting bias, robustness, and trial characteristics? Methods: OVID Medline, Embase, and Cochrane CENTRAL, were systematically searched for RCTs that investigated at least one pharmacologic intervention for VTE prophylaxis in adult patients with cancer. Article screening and data extrapolation were conducted in duplicate. Outcomes include a comprehensive set of trial characteristics (e.g. sample size, duration), a favourable outcome, the discrepancy between protocol and manuscript, and appraisal of “spin.” Outcomes were compared using the independent t-test, Mann-Whitney test, Pearson chi-squared test, and Fisher’s exact test where appropriate. Logistic regression was performed to identify factors associated with possible bias. Results: Of the 59 trials analyzed, 34 (63%) reported commercial sponsorship. Commercial sponsorship was not associated with the reporting of favourable outcomes, protocol-manuscript discrepancy, or presence of spin (Chi-squared=0.025, p=0.87; Chi-squared=3.07, p=0.08; Chi-squared=0.20, p=0.65). The commercially sponsored trials had a higher rate of intention-to-treat analysis (Chi-squared=12.2, p=0.0006). In contrast, non-commercially sponsored trials were likelier to report retrospective registration of trial protocol and use of composite primary outcomes (Chi-squared=9.8628, p=0.007; Chi-squared=3.88, p=0.05). Commercial sponsorship was not associated with presence of spin or high levels of spin (Chi-squared=0.20, p=0.65; Chi-squared = 2.52, p=0.11). Spin was most prevalent in the abstract conclusions (9 out of 17 [53.3%]) and manuscript conclusions (8 out of 17 [46.7%]). Summary/Conclusion: There were few significant differences in publication characteristics between commercially sponsored and non-commercially sponsored trials. These results suggest that the evidence from commercially sponsored trials investigating VTE prophylaxis in cancer patients is not likely to be subject to biases attributable to commercial sponsorship.Keywords: Venous thromboembolism, Anticoagulants, Thromboprophylaxis, Cancer
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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 | 0.208 | 0.711 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.017 |
| Bibliometrics | 0.044 | 0.083 |
| Science and technology studies | 0.002 | 0.004 |
| Scholarly communication | 0.009 | 0.007 |
| Open science | 0.003 | 0.004 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.012 | 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".