Evidence map›Paper›PMID 39986684›Full record

ArticleBMJ health & care informatics2025

Potential role of ChatGPT in simplifying and improving informed consent forms for vaccination: a pilot study conducted in Italy.

Claudia Cosma, Alessio Radi, Rachele Cattano, Patrizio Zanobini, Guglielmo Bonaccorsi, Chiara Lorini, Marco Del Riccio

Abstract read
In one paragraph

Article in BMJ health & care informatics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Claudia CosmaDepartment of Health Sciences, University of Florence, Florence, Italy claudia.cosma@unifi.it.ORCID http://orcid.org/0009-0000-6958-0275
Alessio RadiDepartment of Health Sciences, University of Florence, Florence, Italy.ORCID http://orcid.org/0000-0001-9637-3458
Rachele CattanoCentral Tuscany Local Health Unit, 50142 Florence, Italy.
Patrizio ZanobiniDepartment of Health Sciences, University of Florence, Florence, Italy.
Guglielmo BonaccorsiDepartment of Health Sciences, University of Florence, Florence, Italy.
Chiara Lorini *Department of Health Sciences, University of Florence, Florence, Italy.
Marco Del Riccio *Department of Health Sciences, University of Florence, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesInformed consent forms are important for assisting patients in making informed choices regarding medical procedures. Because of their lengthy nature, complexity and specialised terminology, consent forms usually prove challenging for the general public to comprehend. This pilot study aims to use Chat Generative Pretrained Transformer (ChatGPT), a large language model (LLM), to improve the readability and understandability of a consent form for vaccination.

methodsThe study was conducted in Italy, within the Central Tuscany Local Health Unit. Three different consent forms were selected and approved: the standard consent form currently in use (A), a new form totally generated by ChatGPT (B) and a modified version of the standard form created by ChatGPT (C). Healthcare professionals in the vaccination unit were asked to evaluate the consent forms regarding adequacy, comprehensibility and completeness and to give an overall judgement. The Kruskal-Wallis test and Dunn's test were used to evaluate the median scores of the consent forms across these variables.

resultsConsent forms A and C achieved the top scores in every category; consent form B obtained the lowest score. The median scores were 4.0 for adequacy on consent forms A and C and 3.0 on consent form B. Consent forms A and C received high overall judgement ratings with median scores of 4.0, whereas consent form B received a median score of 3.0.

conclusionsThe findings indicate that LLM tools such as ChatGPT could enhance healthcare communication by improving the clarity and accessibility of consent forms, but the best results are seen when these tools are combined with human knowledge and supervision.

Indexed as

ComprehensionConsent FormsInformed ConsentVaccinationGenerative Artificial IntelligenceHumansItalyPilot ProjectsArtificial intelligenceBMJ Health InformaticsHealth Information ManagementPublic Health

Identifiers

PMID39986684
PMCPMC11848659

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.