UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042881
Receipt number 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 08:55:19

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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 or person

Institute

Nagano Chuo Hospital

Institute

Department

Personal name



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

Value
https://center6.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