ChiCTR2300078274 版本V1.0 版本创建时间2023/12/03 18:43:33 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：

 ChiCTR2300078274 

最近更新日期：

Date of Last Refreshed on：

 2023-12-03 18:43:22 

注册时间：

Date of Registration：

 2023-12-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

在全膝关节置换术中使用ChatGPT辅助进行术前知情同意:一项探索性随机临床试验

Public title：

Use of Chatgpt for Informed Consent in Total Knee Arthroplasty: an Exploratory Randomized Clinical Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

在全膝关节置换术中使用ChatGPT辅助进行术前知情同意:一项探索性随机临床试验

Scientific title：

Use of Chatgpt for Informed Consent in Total Knee Arthroplasty: an Exploratory Randomized Clinical Trial

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：

甘文奕 

研究负责人：

郑小飞 

Applicant：

Wenyi Gan 

Study leader：

Xiaofei Zheng 

申请注册联系人电话：

Applicant telephone：

 +86 130 7685 5735

研究负责人电话：

Study leader's
telephone：

+86 138 8990 4898

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：

 494414224@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 zhengxiaofei12@163.com

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：

广东省广州市天河区黄埔大道西601号

研究负责人通讯地址：

广东省广州市天河区黄埔大道西601号

Applicant address：

601 Huangpu Avenue West, Tianhe District, Guangzhou, Guangdong

Study leader's address：

601 Huangpu Avenue West, Tianhe District, Guangzhou, Guangdong

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：

暨南大学

Applicant's institution：

Jinan University

研究负责人所在单位：

暨南大学附属第一医院

Affiliation of the Leader：

The First Hospital of Jinan University

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：

 KY-2023-193

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：

暨南大学附属第一医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of The First Affiliated Hospital of Jinan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-03 00:00:00

伦理委员会联系人：

郭军

Contact Name of the ethic committee：

Jun Guo

伦理委员会联系地址：

广东省广州市天河区黄埔大道西601号

Contact Address of the ethic committee：

601 Huangpu Avenue West, Tianhe District, Guangzhou, Guangdong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3868 8066

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：

暨南大学附属第一医院

Primary sponsor：

The First Hospital of Jinan University

研究实施负责（组长）单位地址：

广东省广州市天河区黄埔大道西601号

Primary sponsor's address：

601 Huangpu Avenue West, Tianhe District, Guangzhou, Guangdong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

暨南大学附属第一医院

具体地址：

天河区黄埔大道西601号

Institution
hospital：

The First Hospital of Jinan University

Address：

601 Huangpu Avenue West, Tianhe District

经费或物资来源：

暨南大学附属第一医院

Source(s) of funding：

The First Affiliated Hospital of Jinan University

研究疾病：

膝骨关节炎  

Target disease：

Knee osteoarthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探究在签署“手术知情同意书”时使用ChatGPT辅助能否更好的缓解患者在住院期间的焦虑、提高患者对手术的认知和提升患者的住院满意度。  

Objectives of Study：

To determine if the use of ChatGPT when signing the "informed consent for surgery" can better alleviate patients' anxiety during hospitalisation, improve patients' understanding of surgery, and increase patients' hospital satisfaction.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）年龄在45-80岁之间的患者。 （2）符合膝关节骨关节炎（knee osteoarthritis, KOA）的诊断标准,即满足主诉为“近1个月内反复的膝关节疼痛”合并以下条件中的2条：站立位或负重位的X线片显示关节间隙狭窄、软骨下骨硬化和(或)囊性变、关节边缘出现骨赘；晨僵时间一般小于30分钟；主动活动时偶尔感觉有骨摩擦音(感)。 （3）术前站立位下肢全长X光片评估Kellgren-Lawrence(KL)分级为IV级，满足TKA手术适应症。 （4）患者就诊能够享用“职工医疗保险”或者“居民医疗保险”。 （5）进行关于手术知情同意书签署的谈话过程需要有至少一位年龄小于50岁的家庭成员共同参与。

Inclusion criteria

(1) Individuals aged 45 to 80 years. (2) Meet the diagnostic criteria for knee osteoarthritis (KOA), that is, have "recurrent knee pain within the past month" as the primary complaint and two of the following conditions: X-rays taken in a standing or weight-bearing position reveal joint space stenosis, subchondral osteosclerosis, and/or cystic change, as well as the presence of osteophytes at the joint margin; The average duration of morning stiffness is less than 30 minutes; Actively occasionally experience a bony fricative sound (sensation). (3) Kellgren-Lawrence(KL) grade IV for preoperative full-length standing lower extremity X-ray assessment satisfies TKA surgery indications. Patients may be covered by "employee medical insurance" or "resident medical insurance." (5) At least one family member under the age of 50 must be present during the signature of the informed assent for surgery.

排除标准：

（1）有精神障碍或精神疾病患者。 （2）主诉出现髋部或腰背部疼痛，曾行全髋关节置换术、膝关节侧副韧带重建术。曾行胫骨近端或股骨远端截骨术病史。 （3）体重指数BMI大于30kg/m2。 （4）行TKA术前下肢肌肉力量检查为三级或三级以下或坐轮椅时间大于三个月。 （5）既往病史中出现影响下肢力量的疾病，如脊髓灰质炎后遗症、帕金森等。或者患有影响主观认知功能的疾病，如阿尔兹海默症、脑萎缩等。 （6）诊断为夏科氏关节病或下肢外翻畸形或严重内翻畸形（大于30°）或下肢出现10°以上的关节外畸形。 （7）住院期间出现无菌性假体松动、假体周围骨折、假体周围感染和（或）手术切口不愈合（或坏死）等术后并发症。

Exclusion criteria：

(1) Mental disorder or mental ailment patients. (2) Hip or low back discomfort was the chief complaint, and total hip replacement or knee collateral ligament reconstruction had been performed. Osteotomy of the proximal tibia or distal femur. (3) A body mass index in excess of 30 kg/m2. (4) The lower limb muscle strength test prior to TKA was grade III or less, or the patient spent more than three months in a wheelchair. (5) Diseases with a history of influencing lower limb strength, such as poliomyelitis sequelae, Parkinson's disease, etc. Or suffer from subjective cognitive-function-impairing maladies, such as Alzheimer's disease, brain atrophy, etc. (6) Charcot's joint disease or lower extremity valgus malformation or severe varus malformation (greater than 30°) or lower extremity external articular malformation (greater than 10°) diagnosis. (7)During hospitalisation, seven postoperative complications including aseptic displacement of prosthesis, periprosthesis fracture, periprosthesis infection, and/or nonunion (or necrosis) of surgical incision occurred.

研究实施时间：

Study execute time：

从 From 2023-04-26 00:00:00至 To 2023-09-11 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-04-26 00:00:00 至 To 2023-08-30 00:00:00

干预措施：

Interventions：

组别：

传统手术前医患交谈模式

样本量：

 30

Group：

Traditional doctor-patient discussion prior to surgical procedure

Sample size：

干预措施：

本科室用于与将进行TKA的患者术前谈话的资料是“TKA宣传手册和典型病例”，其中内容包含对手术过程、假体类型、本科室典型病例、近期随访和远期随访。面对分配至该组的患者，主刀医生首先根据患者的体格检查结果和影像学检查结果介绍患者目前的病情和选择TKA手术的必要性，其次结合术前谈话资料对TKA手术的过程和术后病情的转归进行科普和预测，最后主刀医生根据患者及家属实时提出的问题进行口头解答，直到患者及家属对治疗方案没有疑问后指导患者签署“手术知情同意书”。

干预措施代码：

Intervention：

The Department uses the "TKA Brochure and Typical Cases" for pre-operative consultations with TKA patients. This brochure contains information on the procedure, the type of prosthesis, the typical case in the department, and the recent and long-term follow-up. The surgeon first introduced the patient's current condition and the necessity of TKA surgery based on the results of the patient's physical examination and imaging examination; secondly, he popularised and predicted the process of TKA surgery and the prognosis of the postoperative condition based on the preoperative interview data; and thirdly, he orally answered the questions raised by the patients and their family members. The patient is instructed to submit the "informed consent for surgery" form until he and his family have no questions about the treatment plan.

Intervention code：

组别：

ChatGPT辅助下手术前医患交谈模式

样本量：

 30

Group：

ChatGPT facilitated doctor-patient communication prior to surgical procedure

Sample size：

干预措施：

面对分配至该组的患者，主刀医生首先介绍患者目前的病情、选择TKA手术的必要性。接着结合术前谈话资料描述TKA手术的过程和术后病情的转归，到这一步为止与对照组一致。然后主刀医生向患者及家属介绍什么是ChatGPT，并将患者及家属所提出的问题经过文本编辑输入至ChatGPT4.0中。最后主刀医生解释ChatGPT回答的内容并结合自己的临床经验对ChatGPT的回答进行补充。直到患者及家属对治疗方案没有疑问后指导患者签署“手术知情同意书”。

干预措施代码：

Intervention：

The surgeon introduced the patient's current condition and the need for TKA surgery to the patients assigned to this group. Then, in conjunction with the preoperative interview information, the course of TKA surgery and postoperative outcomes were described, which were comparable to those of the control group. The surgeon then introduces ChatGPT to the patient and family and uses text editing to input the patient's queries into ChatGPT4.0. The surgeon then explained the content of ChatGPT's answers and supplemented them based on his own clinical experience. The patient is instructed to submit the "informed consent for surgery" form until he and his family have no questions about the proposed treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

 暨南大学附属第一医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Hospital of Jinan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

医院焦虑抑郁量表

指标类型：

主要指标

Outcome：

Hospital anxiety and depression scale

Type：

Primary indicator

测量时间点：

入院当天、手术前一天晚上（签署手术知情同意书后）和术后第五天

测量方法：

量表

Measure time point of outcome：

The day of admission, the night before surgery (after signing the informed consent form) and the fifth day after surgery

Measure method：

Scale

指标中文名：

术前焦虑量表

指标类型：

主要指标

Outcome：

Perioperative Anxiety Scale-7

Type：

Primary indicator

测量时间点：

入院当天、手术前一天晚上（签署手术知情同意书后）和术后第五天

测量方法：

量表

Measure time point of outcome：

The day of admission, the night before surgery (after signing the informed consent form) and the fifth day after surgery

Measure method：

Scale

指标中文名：

焦虑视觉模拟量表

指标类型：

主要指标

Outcome：

Visual analog scale for anxiety

Type：

Primary indicator

测量时间点：

入院当天、手术前一天晚上（签署手术知情同意书后）和术后第五天

测量方法：

量表

Measure time point of outcome：

The day of admission, the night before surgery (after signing the informed consent form) and the fifth day after surgery

Measure method：

Scale

指标中文名：

西安大略和麦克马斯特大学骨关节炎指数

指标类型：

次要指标

Outcome：

Western Ontario and McMaster Universities Osteoarthritis Index

Type：

Secondary indicator

测量时间点：

观测时间点为入院当天和术后第五天

测量方法：

量表

Measure time point of outcome：

The observation time points were the day of admission and the fifth day after surgery

Measure method：

Scale

指标中文名：

疼痛视觉模拟评分

指标类型：

次要指标

Outcome：

Visual analogue scale for pain

Type：

Secondary indicator

测量时间点：

观测时间点为入院当天和术后第五天

测量方法：

量表

Measure time point of outcome：

The observation time points were the day of admission and the fifth day after surgery

Measure method：

Scale

指标中文名：

一个问题的满意度问卷

指标类型：

主要指标

Outcome：

Single Item Overall Patient Satisfaction Questionnaire

Type：

Primary indicator

测量时间点：

测试的时间点为患者出院当天

测量方法：

量表

Measure time point of outcome：

The time point of the test was the day of the patient's discharge

Measure method：

Scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 45 岁 years
最大 Max age 80 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）：

随机方法采用的是信封法。先使用随机数产生器产生60个随机数，根据大小进行排列，将从大到小排序的前30个数字后面写上“传统手术前医患交谈模式”组，后30个数字后面写上“ChatGPT辅助下手术前医患交谈模式”组。将信封交给研究小组之外的一名护士储存保管，并且在患者住院后的第二天抽取其中一个信封，将该名患者的分组结果告知项目执行人甲和乙。

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

The random method is envelope method. First, a random number generator was used to generate 60 random numbers, which were sorted according to their size. After the first 30 numbers in the order from largest to smallest, write "Traditional doctor-patient conversation mode before surgery" group, and after the last 30 numbers write "Doctor-patient conversation mode before surgery assisted by ChatGPT" group. The envelopes were given to a nurse outside the study group for storage, and one of the envelopes was extracted on the second day after the patient's admission and the results of that patient's grouping were communicated to project managers A and B.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

项目执行人甲、与患者进行签署手术知情同意书时进行术前谈话的主刀医生们和参与本次研究的患者知道分组。为了排除人为偏见带来的系统误差，本研究对患者的主管医生们、负责指导患者术后康复的康复治疗师丙和收集研究所需要数据的医生实行盲法。

Blinding：

The group status was known to project executor A, the surgeons who had a preoperative interview with the patients when they signed the informed consent for surgery, and the patients who participated in this study. In order to eliminate systematic errors caused by human bias, the study blinded the doctors in charge of the patients, the rehabilitation therapist C who was responsible for guiding the patients' postoperative rehabilitation, and the doctors who collected the data needed for the study.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

临床试验公共管理平台ResMan（http://www.medresman.org.cn/login.aspx）

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

ResMan (http://www.medresman.org.cn/login.aspx)

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：

使用SPSS 23.0（SPSS，芝加哥，伊利诺伊州，美国）软件包分析数据。 使用Mann-Whitney U检验分析非参数数据，分析两组之间客观和半客观测量的差异。 两位专家进行的半客观评估之间的一致性水平是由科恩的K系数估算的。 P <0.05被认为是显着的。

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

Data were analyzed using the SPSS 23.0 (SPSS, Chicago, Illisnois, USA) software package. Differences in the objective and semi-objective measurements between the two groups were analyzed using the Mann-Whitney U test for non-parametric data. The level of agreement between the semi-objective assessments made by the two experts was estimated by Cohen's K co-efficient. P < 0.05 was considered significant.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-12-03 18:43:22