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Record W4390443395 · doi:10.1093/ibd/izad314

The Clinical Interpretation of Noninferiority Trials

2023· review· en· W4390443395 on OpenAlexaff
Pavel S Roshanov, Reena Khanna

Bibliographic record

VenueInflammatory Bowel Diseases · 2023
Typereview
Languageen
FieldMathematics
TopicStatistical Methods in Clinical Trials
Canadian institutionsPopulation Health Research InstituteLawson Health Research InstituteWestern University
Fundersnot available
KeywordsInterpretation (philosophy)MedicineClinical trialIntensive care medicineMedical physicsComputer scienceInternal medicine

Abstract

fetched live from OpenAlex

Noninferiority trials are designed to demonstrate that a new treatment is not unacceptably worse than a standard treatment, considering an allowable difference termed the noninferiority margin. We highlight that selection of noninferiority margins at the time of study design can be biased toward wider margins that favor noninferiority claims. We discuss a clinically oriented approach to interpretation of results with a focus on confidence intervals and recommend that readers base their judgments regarding noninferiority on margins reflecting patient values and preferences rather than those set by investigators. We provide examples from trials in inflammatory bowel diseases.

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.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.027
metaresearch head score (Gemma)0.648
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.936
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0270.648
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0070.004
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0000.000

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.

Opus teacher head0.684
GPT teacher head0.637
Teacher spread0.047 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designOther design
Domainnot available
GenreReview

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".

Quick stats

Citations1
Published2023
Admission routes1
Has abstractyes

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