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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

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ClinicalTrials.gov Identifier: NCT04011761
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Huiying Liang, Guangzhou Women and Children's Medical Center

Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 8, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • Hospital revisit [ Time Frame: The next 3 months after the initial visit ]
    Within 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 visit [ Time Frame: The next 3 months after the initial visit ]
    be performed each month to collect the information on hospitalization.
  • Average total outpatient cost [ Time Frame: The next 3 months after the initial visit ]
    be performed each month to collect the information on the amount of money spending on healthcare.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 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. [ Time Frame: The next 3 months after the initial visit ]
  • Counseling time spent with each patient [ Time Frame: The next 3 months after the initial visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Outpatients Encountered in Three Specialty Clinics, i.e. Respirology, Gastroenterology, and Genito-urology
Intervention  ICMJE Other: expert 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.
Study Arms  ICMJE
  • Active Comparator: Experimental Arm
    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.
    Intervention: Other: expert arbitration over discordant diagnoses made by AI diagnostic system and human doctors, respectively
  • No Intervention: Control Arm
    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 control arm will receive treatment prescribed by pediatricians.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019)
10000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Huiying Liang, PhD +86-20-3885-7692 lianghuiying@hotmail.com
Contact: Kuanrong Li, PhD +86-20-33857716 lik@gwcmc.org
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011761
Other Study ID Numbers  ICMJE aiwcmc
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Huiying Liang, Guangzhou Women and Children's Medical Center
Study Sponsor  ICMJE Guangzhou Women and Children's Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Guangzhou Women and Children's Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP