Use of modified intention-to-treat analysis in studies of direct oral anticoagulants and risk of selection bias: a systematic review
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
BACKGROUND: Following their evaluation in randomised controlled trials (RCTs), direct oral anticoagulants (DOACs) have replaced warfarin for stroke prevention in atrial fibrillation (AF), and treatment and prevention of venous thromboembolism (VTE). To avoid selection bias, it is recommended that RCTs use an intention-to-treat (ITT) analysis strategy. OBJECTIVE: The objective of this study was to systematically review and compare reported analytical strategies, the proportion of randomised patients included in analyses and the reasons for participant exclusions. STUDY SELECTION: A systematic search of PubMed, EMBASE and the Cochrane library for phase III trials of DOACs was conducted. Titles and abstracts were screened for relevance by two independent reviewers. Patient population, intervention studied, number of patients included in randomisation and analysis, reasons for exclusions from analysis and trial conclusions were extracted from each article. FINDINGS: Twenty-nine studies were included, five were about stroke prevention in AF, 10 about VTE treatment and 14 about thromboprophylaxis. Trials of AF and VTE treatment had low proportions of postrandomisation exclusions (around 1%). In contrast, surgical and medical thromboprophylaxis trials excluded almost 30% of participants postrandomisation. This was in spite of authors' claims of using an ITT or modified ITT approach. Higher exclusion proportions in these trials were associated with non-clinically defined primary outcomes and incomplete outcome assessments. CONCLUSIONS: Clinicians should be aware that the level of evidence in favour of DOAC use for thromboprophylaxis is weak due to high rates of postrandomisation exclusions and risks of selection bias.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Review About the Canadian research system: no · About a Canadian topic: no | Systematic review | low |
| gpt | Meta-epidemiology (narrow)Meta-epidemiology (broad)Metaresearch Domain: Methods · Genre: Review About the Canadian research system: no · About a Canadian topic: no | Systematic review | high |
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.027 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.012 | 0.001 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it