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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000042881
Receipt No. R000048705
Scientific Title The efficacy of AI-driven differential diagnosis list for physicians to generate a correct diagnostic hypothesis: an open-label randomized controlled study
Date of disclosure of the study information 2021/01/01
Last modified on 2021/02/22

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Basic information
Public title The efficacy of AI-driven differential diagnosis list for physicians to generate a correct diagnostic hypothesis: an open-label randomized controlled study
Acronym The efficacy of AI-driven differential diagnosis list for physicians to generate a correct diagnostic hypothesis: an open-label randomized controlled study
Scientific Title The efficacy of AI-driven differential diagnosis list for physicians to generate a correct diagnostic hypothesis: an open-label randomized controlled study
Scientific Title:Acronym The efficacy of AI-driven differential diagnosis list for physicians to generate a correct diagnostic hypothesis: an open-label randomized controlled study
Region
Japan

Condition
Condition Diseases in general internal medicine
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify the effects of the list of AI-driven differential diagnoses on the diagnostic accuracy of physicians
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prevalence that the list of differential diagnoses made by physicians include the accurate diagnosis
Key secondary outcomes The association between the accuracy of the physician's diagnosis and sex, the degree of trust in AI, whether the list of AI-driven differential diagnosis includes the accurate diagnosis or not.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Participants are required to develop up to three differential diagnoses for 16 clinical scenarios (which are chosen from real cases). Participants develop up to three differential diagnoses within two minutes by reading the documentation of patient history written by the AI-driven automated history taking system with an AI-driven list of differential diagnoses (included 10 diseases)
Interventions/Control_2 Participants are required to develop up to three differential diagnoses for 16 clinical scenarios (which are chosen from real cases). Participants develop up to three differential diagnoses within two minutes by reading the documentation of patient history written by the AI-driven automated history taking system without an AI-driven list of differential diagnoses
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
24 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Junior residents (postgraduate year 1 or 2) working at Dokkyo Medical University Hospital and physicians working at the Department of Diagnostic and Generalist Medicine in Dokkyo Medical University Hospital
Key exclusion criteria no consent for participating in this study
Target sample size 22

Research contact person
Name of lead principal investigator
1st name YUKINORI
Middle name
Last name HARADA
Organization Nagano Chuo Hospital
Division name Internal Medicine
Zip code 380-0814
Address 1570 Nishitsuruga-machi, Nagano-city
TEL 026-234-3211
Email yuki.gym23@gmail.com

Public contact
Name of contact person
1st name YUKINORI
Middle name
Last name HARADA
Organization Nagano Chuo Hospital
Division name Internal Medicine
Zip code 380-0814
Address 1570 Nishitsuruga-machi, Nagano-city
TEL 026-234-3211
Homepage URL
Email yuki.gym23@gmail.com

Sponsor
Institute Nagano Chuo Hospital
Institute
Department

Funding Source
Organization Nagano Chuo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Diagnostic and Generalist Medicine, Dokkyo Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee of Nagano Chuo Hospital
Address 1570 Nishitsuruga-machi, Nagano-city
Tel 026-234-3211
Email a-uehara@healthcoop-nagano.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/1660-4601/18/4/2086/htm
Number of participants that the trial has enrolled 22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2020 Year 12 Month 07 Day
Date of IRB
2020 Year 12 Month 18 Day
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2021 Year 01 Month 15 Day
Date of closure to data entry
2021 Year 01 Month 15 Day
Date trial data considered complete
2021 Year 01 Month 15 Day
Date analysis concluded
2021 Year 02 Month 22 Day

Other
Other related information

Management information
Registered date
2020 Year 12 Month 31 Day
Last modified on
2021 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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