ChiCTR2400093883 版本V1.0 版本创建时间2024/12/13 09:07:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400093883 

最近更新日期：

Date of Last Refreshed on：

 2024-12-13 09:06:49 

注册时间：

Date of Registration：

 2024-12-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

AI Versus Human-Generated Multiple-Choice Questions for Medical Education: A Cohort Study in a High-Stakes Examination

Public title：

AI Versus Human-Generated Multiple-Choice Questions for Medical Education: A Cohort Study in a High-Stakes Examination

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Assessing the Non-Inferiority of AI-Generated Multiple-Choice Questions in Medical Education: A Comparative Study of ChatGPT-4 and Human-Authored Items

Scientific title：

Assessing the Non-Inferiority of AI-Generated Multiple-Choice Questions in Medical Education: A Comparative Study of ChatGPT-4 and Human-Authored Items

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Alex KK Law 

研究负责人：

Alex KK Law 

Applicant：

Alex KK Law 

Study leader：

Alex KK Law 

申请注册联系人电话：

Applicant telephone：

 +852 6301 6191

研究负责人电话：

Study leader's
telephone：

+852 6301 6191

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 alexlaw@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 alexlaw@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

The Accident and Emergency Medicine Academic Unit (AEMAU), The Chinese University of Hong Kong (CUHK) 2nd Floor, Main Clinical Block and Trauma Centre Prince of Wales Hospital Shatin, Hong Kong

研究负责人通讯地址：

The Accident and Emergency Medicine Academic Unit (AEMAU), The Chinese University of Hong Kong (CUHK) 2nd Floor, Main Clinical Block and Trauma Centre Prince of Wales Hospital Shatin, Hong Kong

Applicant address：

The Accident and Emergency Medicine Academic Unit (AEMAU), The Chinese University of Hong Kong (CUHK) 2nd Floor, Main Clinical Block and Trauma Centre Prince of Wales Hospital Shatin, Hong Kong

Study leader's address：

The Accident and Emergency Medicine Academic Unit (AEMAU), The Chinese University of Hong Kong (CUHK) 2nd Floor, Main Clinical Block and Trauma Centre Prince of Wales Hospital Shatin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong

Applicant's institution：

Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong

研究负责人所在单位：

Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong

Affiliation of the Leader：

Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024.320

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-08-20 00:00:00

伦理委员会联系人：

Amy Li

Contact Name of the ethic committee：

Amy Li

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

Primary sponsor's address：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

Institution
hospital：

The Chinese University of Hong Kong

Address：

University Road, Sha Tin District, Hong Kong Special Administrative Region, China

经费或物资来源：

No funding

Source(s) of funding：

No funding

研究疾病：

Medical Education  

Target disease：

Medical Education

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

The aim of the study is to determine the efficacy and quality of ChatGPT-4 in generating multiple-choice questions (MCQs) for medical education, by comparing these AI-generated MCQs against those crafted by human experts to establish non-inferiority in terms of educational value, candidate performance, and item analysis metrics.  

Objectives of Study：

The aim of the study is to determine the efficacy and quality of ChatGPT-4 in generating multiple-choice questions (MCQs) for medical education, by comparing these AI-generated MCQs against those crafted by human experts to establish non-inferiority in terms of educational value, candidate performance, and item analysis metrics.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

All Emergency Medical doctors who applied for the Primary Examination on Emergency Medicine (PEEM, organised by HK College of Emergency Medicine) examination.

Inclusion criteria

All Emergency Medical doctors who applied for the Primary Examination on Emergency Medicine (PEEM, organised by HK College of Emergency Medicine) examination.

排除标准：

1. Incomplete Participation 2. Trainees who withdraw consent

Exclusion criteria：

1. Incomplete Participation 2. Trainees who withdraw consent

研究实施时间：

Study execute time：

从 From 2024-08-20 00:00:00至 To 2024-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-20 00:00:00 至 To 2024-10-31 00:00:00

干预措施：

Interventions：

组别：

AI MCQ

样本量：

 40

Group：

AI MCQ

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

组别：

Human MCQ

样本量：

 40

Group：

Human MCQ

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

MCQ performance

指标类型：

主要指标

Outcome：

MCQ performance

Type：

Primary indicator

测量时间点：

End of MCQ test

测量方法：

Comparison of MCQ performance of AI and Human generated MCQ by difficult index and discrimination index

Measure time point of outcome：

End of MCQ test

Measure method：

Comparison of MCQ performance of AI and Human generated MCQ by difficult index and discrimination index

指标中文名：

MCQ production time

指标类型：

次要指标

Outcome：

MCQ production time

Type：

Secondary indicator

测量时间点：

End of MCQ test

测量方法：

Production time in term of person-hour required by the AI and human generated MCQ

Measure time point of outcome：

End of MCQ test

Measure method：

Production time in term of person-hour required by the AI and human generated MCQ

指标中文名：

MCQ quality

指标类型：

次要指标

Outcome：

MCQ quality

Type：

Secondary indicator

测量时间点：

End of MCQ test

测量方法：

item writing flaws, inaccuracy, and irrelevance as judged by experts

Measure time point of outcome：

End of MCQ test

Measure method：

item writing flaws, inaccuracy, and irrelevance as judged by experts

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 34 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

https://data.mendeley.com/datasets/n44nxxfymw/1

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://data.mendeley.com/datasets/n44nxxfymw/1

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

N/A

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-12-13 09:06:49