Clinical trial NCT04011761: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Outpatients Encountered in Three Specialty Clinics, i.e. Respirology, Gastroenterology, and Genito-urology
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 10000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital revisit
timeFrame: The next 3 months after the initial visit
measure: Hospitalization in the next 3 months after the initial visit
timeFrame: The next 3 months after the initial visit
measure: Average total outpatient cost
timeFrame: The next 3 months after the initial visit
Secondary outcomes:
measure: 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.
timeFrame: The next 3 months after the initial visit
measure: Counseling time spent with each patient
timeFrame: The next 3 months after the initial visit
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
References: