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Design Issues and Outcomes in Ibd Clinical Trials

2005· review· en· W1995255265 on OpenAlexaff
Bruce E. Sands, María T. Abreu, George D. Ferry, Anne M. Griffiths, Stephen B. Hanauer, Kim L. Isaacs, James D. Lewis, William J. Sandborn, Hillary Steinhart

Bibliographic record

VenueInflammatory Bowel Diseases · 2005
Typereview
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicInflammatory Bowel Disease
Canadian institutionsMount Sinai HospitalSickKids FoundationHospital for Sick ChildrenUniversity of Toronto
Fundersnot available
KeywordsClinical trialMedicineDiseaseIntensive care medicineInflammatory bowel diseasePsychological interventionClinical study designStandardizationQuality of life (healthcare)Physical therapyMedical physicsInternal medicineComputer science

Abstract

fetched live from OpenAlex

Successful clinical trials in inflammatory bowel disease are based on precise definitions of study populations, standardized and well-defined interventions, reliable indices of disease activity, and clearly stipulated outcome measures. Interpretation of research results is often complicated by the differentiation of goals of therapy (remission induction and maintenance, quality of life) and the multitude of patient subsets. Choosing the correct patient subtype to enroll in a clinical trial is critical to the results of a study, its conclusions, and its applicability to the clinical setting. Validated, easy-to-use disease activity indices allow interpretation of results across trials. The use of biomarkers as surrogate clinical endpoints provides reproducibility, ease of statistical handling as a continuous variable, and consistent measurement of response to treatment. Despite these potential advantages, biomarkers of disease activity lack specificity and will need to be validated against clinically meaningful outcomes. Careful subject selection, standardization of disease activity indices, and precise outcome measurement are the keys to continued improvement of the inflammatory bowel disease research process.

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 machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.280
metaresearch head score (Gemma)0.424
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.720
Threshold uncertainty score0.887

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.2800.424
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0110.004
Bibliometrics0.0050.007
Science and technology studies0.0010.014
Scholarly communication0.0110.010
Open science0.0070.005
Research integrity0.0110.016
Insufficient payload (model declined to judge)0.0060.003

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.

Opus teacher head0.086
GPT teacher head0.413
Teacher spread0.327 · 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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designNot applicable
DomainMethods
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

Citations40
Published2005
Admission routes1
Has abstractyes

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