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Effects of Expert Arbitration on Clinical Outcomes When Disputes Over Diagnosis Arise Between Physicians and Their Artificial Intelligence Counterparts: a Randomized, Multicenter Trial in Pediatric Outpatients

Effects of Expert Arbitration on Clinical Outcomes When Disputes Over Diagnosis Arise Between Physicians and Their Artificial Intelligence Counterparts: a Randomized, Multicenter Trial in Pediatric Outpatients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04011761
Enrollment
10000
Registered
2019-07-08
Start date
2019-11-01
Completion date
2021-04-30
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Outpatients Encountered in Three Specialty Clinics, i.e. Respirology, Gastroenterology, and Genito-urology

Brief summary

We have recently developed an artificial intelligence (AI) framework to diagnose common pediatric diseases. This randomized controlled clinical trial aims to investigate the effects of expert arbitration on clinical outcomes in the situation where the AI-based diagnosis differs from the diagnosis made by pediatricians.

Detailed description

Based on the historical clinical data of more than 1 million pediatric outpatients in the Guangzhou Women and Children's Medical Center, an AI diagnostic framework has recently been developed for common pediatric diseases \[Liang H et al. evaluation and accurate diagnosis of pediatric disease using artificial intelligence. Nat Med. 2019;25(3):433-8\]. This AI framework utilizes predefined schema to extract informative clinical data from free text and reaches clinical diagnoses by hypothetico-deductive reasoning. In internal validation, the AI system showed accuracy rates ranging from 0.85 for gastrointestinal disease to 0.98 for neuropsychiatric disorders, suggesting that it might be a promising assisting diagnostic tool in clinical practice. However, there is a lack of evidence-based strategy on how to handle the scenarios where the AI-based diagnosis and the diagnosis made by pediatricians are discordant. It is legitimate to assume that diseases with discordant diagnoses present more similar clinical features; in this case it is necessary to introduce an extra arbitrator for differential and decisive diagnosis. Therefore, we conduct this randomized controlled trial to: 1) compare the accuracy of the two diagnostic modes in a real-world clinical setting where the AI-based diagnosis and the diagnosis made by pediatricians are discordant by introducing an expert arbitrator; and 2) look further into the change of clinical outcomes (hospital revisit and hospitalization in the next 3 months after initial visit; average total outpatient cost) due to introduction of the expert arbitrator. Please note that although the aforementioned AI framework was designed for diagnosis of a wide range of diseases, this clinical trial is limited to outpatients encountered in three specialty clinics, i.e. respirology, gastroenterology, and genito-urology. The reason for this selection is that the discordant diagnoses are assumed to be more common for these two specialties according to the internal validation result.

Interventions

OTHERexpert arbitration over discordant diagnoses made by AI diagnostic system and human doctors, respectively

Each participant receives two diagnoses: one from the AI diagnostic system and the other from pediatricians, and the two diagnoses are discordant. Participants in the experimental arm will be referred to an expert arbitrator for differential and decisive diagnosis and will receive treatment prescribed by the expert arbitrator.

Sponsors

Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

parallel assignment

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Outpatients who visits the respirology clinics or the gastroenterology clinics during the recruitment period. 2. Written informed consent is provided by parents/guardians

Exclusion criteria

1\. Patients with any conditions that require immediate diagnosis and treatment.

Design outcomes

Primary

MeasureTime frameDescription
Hospital revisitThe next 3 months after the initial visitWithin the first 3 months after the initial visit, active follow-up via phone call will be performed each month to collect the information on hospital revisit.
Hospitalization in the next 3 months after the initial visitThe next 3 months after the initial visitbe performed each month to collect the information on hospitalization.
Average total outpatient costThe next 3 months after the initial visitbe performed each month to collect the information on the amount of money spending on healthcare.

Secondary

MeasureTime frame
Accuracy rate of AI-based diagnosis and accuracy rate of the diagnoses made by pediatricians, using the diagnoses made by the expert arbitrator as the decisive diagnoses.The next 3 months after the initial visit
Counseling time spent with each patientThe next 3 months after the initial visit

Countries

China

Contacts

Primary ContactHuiying Liang, PhD
lianghuiying@hotmail.com+86-20-3885-7692
Backup ContactKuanrong Li, PhD
lik@gwcmc.org+86-20-33857716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026