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Record W4412806735 · doi:10.1186/s12874-025-02631-0

Using a large language model (ChatGPT) to assess risk of bias in randomized controlled trials of medical interventions: protocol for a pilot study of interrater agreement with human reviewers

2025· article· en· W4412806735 on OpenAlexaff
Christopher Rose, Julia Bidonde, Martin Ringsten, Julie Glanville, Rigmor C. Berg, Chris Cooper, Ashley Elizabeth Muller, Hans Bugge Bergsund, José F. Meneses-Echávez, Thomas Potrebny

Bibliographic record

VenueBMC Medical Research Methodology · 2025
Typearticle
Languageen
FieldMedicine
TopicArtificial Intelligence in Healthcare and Education
Canadian institutionsUniversity of Saskatchewan
FundersNorwegian Institute of Public Health
KeywordsInter-rater reliabilityPsychological interventionRandomized controlled trialSystematic reviewProtocol (science)MEDLINEMedicineClinical trialPsychologyMedical physicsFamily medicinePhysical therapyRating scaleNursingAlternative medicinePathology

Abstract

fetched live from OpenAlex

BACKGROUND: Risk of bias (RoB) assessment is an essential part of systematic reviews that requires reading and understanding each eligible trial and RoB tools. RoB assessment is subject to human error and is time-consuming. Machine learning-based tools have been developed to automate RoB assessment using simple models trained on limited corpuses. ChatGPT is a conversational agent based on a large language model (LLM) that was trained on an internet-scale corpus and has demonstrated human-like abilities in multiple areas including healthcare. LLMs might be able to support systematic reviewing tasks such as assessing RoB. We aim to assess interrater agreement in overall (rather than domain-level) RoB assessment between human reviewers and ChatGPT, in randomized controlled trials of interventions within medical interventions. METHODS: We will randomly select 100 individually- or cluster-randomized, parallel, two-arm trials of medical interventions from recent Cochrane systematic reviews that have been assessed using the RoB1 or RoB2 family of tools. We will exclude reviews and trials that were performed under emergency conditions (e.g., COVID-19), as well as public health and welfare interventions. We will use 25 of the trials and human RoB assessments to engineer a ChatGPT prompt for assessing overall RoB, based on trial methods text. We will obtain ChatGPT assessments of RoB for the remaining 75 trials and human assessments. We will then estimate interrater agreement using Cohen's κ. RESULTS: The primary outcome for this study is overall human-ChatGPT interrater agreement. We will report observed agreement with an exact 95% confidence interval, expected agreement under random assessment, Cohen's κ, and a p-value testing the null hypothesis of no difference in agreement. Several other analyses are also planned. CONCLUSIONS: This study is likely to provide the first evidence on interrater agreement between human RoB assessments and those provided by LLMs and will inform subsequent research in this area.

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)0.328
metaresearch head score (Gemma)0.588
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.418
Threshold uncertainty score0.993

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.3280.588
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0050.000
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.000

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 head0.957
GPT teacher head0.773
Teacher spread0.184 · 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; both teacher heads agree on what is shown here.

Study designRandomized trial
Domainnot available
GenreEmpirical

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

Citations2
Published2025
Admission routes1
Has abstractyes

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