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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07728513
Improving AI-Assisted Medical Diagnosis and Triage by the General Public
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
As large language models (LLMs) become widely accessible, a growing share of the public already turns to AI-powered chatbots for health-related information: surveys suggest that one in six American adults consults AI chatbots for health queries at least once a month. At the same time, diagnostic errors and misplaced triage decisions represent a persistent source of preventable patient harm globally [4]. This has prompted considerable interest in whether LLMs can serve as a reliable "front door" to the healthcare system for patients who lack immediate access to a clinician.
However, incidents involving misguided medical suggestions from LLMs to the general public such as fatal overdose and erroneous diagnosis leading to life-threatening treatment delay have been reported. A recent controlled study shows LLMs perform significantly worse for medical assistance in real-world settings compared to their performance on controlled benchmarks. Bean et al. [1] conducted a large preregistered study with 1,298 UK participants in which laypeople were assigned to receive assistance from one of three popular LLMs (GPT-4o, Llama 3, or Command R+) or to use a source of their choice when assessing ten standardized medical scenarios. Although the LLMs alone correctly identified relevant conditions in up to 94.9% of cases, participants using those same LLMs did so in fewer than 34.5% of cases, significantly worse than the group using their typical home resources (∼60%). Similarly, triage accuracy showed no signifcant difference between LLM users and controls, with an overall correct response rate of 43.0% across all groups. This poor performance can be linked to two main failure modes: users providing incomplete symptom information to the AI, and users failing to correctly interpret or act upon the LLM's output.
To address these failure modes, the study tests a new GPT-4o interface wrapped with a fixed system prompt. Rather than passively responding to whatever the user volunteers, the AI is instructed to ask clarifying questions to gather a proper clinical history before offering any medical suggestions. Once the model judges that enough information is gathered, it provides a structured, easy-to-read response detailing possible conditions, their likelihoods, and a clear triage recommendation.
The trial is structured as a two-arm, single-blind RCT. Both arms retain access to whatever assistance methods participants would normally use at home (e.g., web search), and both arms additionally get a GPT-4o-based LLM interface. The difference lies in which interface: the treatment arm receives the new interface described above, while the control arm receives a standard, unmodified GPT-4o interface with no special prompting. Participants are restricted to using the provided LLM interface (GPT-4o) only, and not other LLMs. AI-overview in web searches will be disabled through an extension. The trial utilizes ten previously validated clinical vignettes covering various medical urgencies, ranging from self-care routines up to ambulance-level emergencies, with each participant randomly assigned two of the ten. To achieve sufficient statistical power (accounting for within-participant clustering across those two responses), the target sample size is calculated at 220 total participants, split evenly with 110 individuals per arm.
The participant pool is drawn from the enrolled students and administrative staff at the Lahore University of Management Sciences (LUMS) in Pakistan. To ensure the sample consists strictly of laypeople, anyone currently enrolled in or who has completed a medical, nursing, or allied health professional degree is explicitly excluded from participating.
The study is driven by two co-primary hypotheses: participants with access to the new LLM interface will identify relevant medical conditions at a higher rate than participants using the standard LLM interface, and they will correctly assess the urgency of the medical scenarios at a higher rate. Accuracy is measured by comparing participant responses to a physician-generated gold-standard list using fuzzy matching, then analyzed via mixed-effects logistic regression with participant-level covariates and a Bonferroni-corrected significance threshold. The study also tracks secondary outcomes - self-reported confidence and time spent per scenario - and several exploratory analyses, including an LLM-alone benchmark, moderation by LLM experience, internet usage patterns, digital literacy, and scenario-level variation in accuracy.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ihsan Ayyub Qazi, PhD
- Número de telefone: +923233333766
- E-mail: ihsan.qazi@lums.edu.pk
Estude backup de contato
- Nome: Ayesha Ali, PhD
- Número de telefone: 04235608368
- E-mail: ayeshaali@lums.edu.pk
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
- Recrutamento
- Lahore University of Management Sciences
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Contato:
- Ihsan Ayyub Qazi, PhD
- Número de telefone: +923233333766
- E-mail: ihsan.qazi@lums.edu.pk
-
Contato:
- Ayesha Ali, PhD
- Número de telefone: 04235608368
- E-mail: ayeshaali@lums.edu.pk
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Enrolled student or employed administrative staff at LUMS.
- 18 years of age or older.
- Able to read and understand English.
Exclusion Criteria:
- Individuals with any formal education or professional training in medicine, nursing, or any other healthcare profession.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Treatment Arm (new GPT-4o Interface)
Participants can access any assistance methods they would typically employ (e.g., web search or health portals) in addition to a new LLM interface (based on GPT-4o) to complete medical scenarios.
The new LLM interface uses a fixed system prompt that (a) instructs the model to ask targeted clarifying questions before providing any diagnostic or triage suggestions, and (b) requires all final responses to follow a structured template listing: possible conditions, approximate likelihood of each, and a recommended triage with brief reasoning.
|
Participants can access any assistance methods they would typically employ (e.g., web search or health portals) in addition to a new LLM (GPT-4o) interface to complete medical scenarios.
The new LLM interface uses a fixed system prompt that (a) instructs the model to ask targeted clarifying questions before providing any diagnostic or triage suggestions, and (b) requires all final responses to follow a structured template listing: possible conditions, approximate likelihood of each, and a recommended triage with brief reasoning.
|
|
Comparador de Placebo: Control
Participants can use any assistance methods they would typically employ (e.g., web search or health portals) in addition to a standard LLM (GPT-4o) to complete medical scenarios.
AI-overview in web searches will be disabled via an extension.
They would not be allowed to access any LLMs other than the standard LLM interface.
|
Participants use any assistance methods they would typically employ at home (e.g., Google or health portals) in addition to a standard LLM (GPT-4o) to complete medical scenarios.
AI-overview in web searches will be disabled via an extension.
They would not be allowed to access any LLMs other than the standard LLM interface.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Urgency Assessment Accuracy
Prazo: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
|
The primary outcome will be the percentage of correct urgency assessments, ranging from 0 to 100%, where higher scores indicate better urgency assessment (or triage) performance.
The rating which participants give for the urgency of each case, will be measured on a five-point scale: Self-care, Routine GP, Urgent Primary Care, Accident & Emergency, and Ambulance.
Responses will be compared against the gold-standard answers to produce an accuracy measure.
The primary outcome will be compared at the case-level between the randomized groups.
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Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
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Condition Identification Accuracy
Prazo: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
|
The co-primary outcome is the Condition Identification Accuracy, which is the percentage of cases in which the condition was correctly identified, ranging from 0 to 100%., where higher scores indicate better medical condition identification performance.
Participants name all medical conditions they considered relevant to their decision.
A response is scored as correct for that scenario if at least one named condition matches the physician-generated gold-standard list of relevant conditions.
The co-primary outcome will be compared at the case-level between the randomized groups.
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Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self-Reported Confidence
Prazo: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
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Participants' self-reported confidence in their urgency assessments, measured using a scale ranging from 0 to 100.
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Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
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Time Spent
Prazo: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
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The amount of time participants spend completing each medical scenario in milliseconds.
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Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayesha Ali, PhD, Lahore University of Management Sciences (LUMS)
- Cadeira de estudo: Ihsan Ayyub Qazi, PhD, Lahore University of Management Sciences (LUMS)
- Investigador principal: Zafar Ayyub Qazi, PhD, Lahore University of Management Sciences (LUMS)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AI-Assisted-Diag-Public789
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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