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Record W4410629997 · doi:10.1136/bmjopen-2024-096107

Completeness of reporting of simulation studies on responder analysis methods and simulation performance: a methodological survey

2025· review· en· W4410629997 on OpenAlexaff
Xiajing Chu, Derek K. Chu, Junjie Ren, Romina Brignardello‐Petersen, Kehu Yang, Gordon H Guyatt, Lehana Thabane

Bibliographic record

VenueBMJ Open · 2025
Typereview
Languageen
FieldSocial Sciences
TopicSurvey Methodology and Nonresponse
Canadian institutionsSt. Joseph’s Healthcare HamiltonImpactMcMaster UniversityOntario Clinical Oncology Group
Fundersnot available
KeywordsMedicineBinary dataData extractionCovariateStatisticsBayesian probabilityComputer scienceBinary numberMEDLINEMathematics

Abstract

fetched live from OpenAlex

OBJECTIVES: To evaluate the completeness of reporting of simulation studies on responder analysis methods and simulation performance. DESIGN: Systematic methodological survey. DATA SOURCES: We searched Embase, MEDLINE (via Ovid), PubMed and Web of Science Core Collection from inception to 9 October 2023. ELIGIBILITY CRITERIA: We included simulation studies comparing responder analysis methods and assessing simulation performance (bias, accuracy, precision or variance, power, type I and II errors and coverage). DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data and assessed simulation performance. We used descriptive analyses to summarise reporting quality and simulation performance. RESULTS: We identified seven simulation studies exploring augmented binary methods, distributional methods and model-based methods. No studies reported the starting seed, occurrence of failures during simulations, the random number generator used and the number of simulations. No studies reported simulation accuracy. Responder analysis results were not significantly influenced by covariate adjustment. Distributional methods remained adaptable even with skewed data. Compared with standard binary methods, augmented binary methods generated increased power and precision. When the threshold is in the tail of the distribution, a simple asymptotic Bayesian (SAB) distributional approach may not reduce uncertainty but can improve precision. CONCLUSION: Simulation studies comparing responder analysis methods exhibit suboptimal reporting quality. Compared with standard binary methods, augmented binary methods, distributional methods and model-based methods may be better choices, but there is no best one.

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

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 armCategoriesStudy designConfidence
gemmaMetaresearch
Domain: Reporting · Genre: Review
About the Canadian research system: no · About a Canadian topic: no
Observationallow
gptMetaresearch
Domain: Reporting · Genre: Empirical
About the Canadian research system: no · About a Canadian topic: no
Observationalhigh
models agreeAgreement compares identical category sets and study designs across arms.

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)0.631
metaresearch head score (Gemma)0.889
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Reporting · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.369
Threshold uncertainty score0.455

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.6310.889
Meta-epidemiology (narrow)0.0020.004
Meta-epidemiology (broad)0.0100.014
Bibliometrics0.0280.028
Science and technology studies0.0020.006
Scholarly communication0.0100.012
Open science0.0070.008
Research integrity0.0050.003
Insufficient payload (model declined to judge)0.0050.001

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.

Opus teacher head0.939
GPT teacher head0.766
Teacher spread0.173 · 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

Labeled directly by 2 models reading the full record.

Study designObservational
DomainReporting
GenreReview · Empirical

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

Citations0
Published2025
Admission routes1
Has abstractyes

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