Construction and Validation of a "Risk-Intervention-Recurrence" Model for Traditional Chinese Medicine in the Treatment of Chronic Rhinosinusitis Based on Multi-Center Electronic Medical Records Machine Learning and CT Radiomics

注册号:

Registration number:

ITMCTR2025000049

最近更新日期:

Date of Last Refreshed on:

2025-01-09

注册时间:

Date of Registration:

2025-01-09

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于多中心电子病历机器学习与CT影像组学的慢性鼻窦炎中医药诊疗“风险-干预-复发”模型的构建与验证

Public title:

Construction and Validation of a "Risk-Intervention-Recurrence" Model for Traditional Chinese Medicine in the Treatment of Chronic Rhinosinusitis Based on Multi-Center Electronic Medical Records Machine Learning and CT Radiomics

注册题目简写:

基于多中心电子病历机器学习与CT影像组学的慢性鼻窦炎中医药诊疗“风险-干预-复发”模型

English Acronym:

"Risk-Intervention-Recurrence" Model for Traditional Chinese Medicine in the Treatment of Chronic Rhinosinusitis Based on Multi-Center Electronic Medical Records Machine Learning and CT Radiomics

研究课题的正式科学名称:

基于多中心电子病历机器学习与CT影像组学的慢性鼻窦炎中医药诊疗“风险-干预-复发”模型的构建与验证

Scientific title:

Construction and Validation of a "Risk-Intervention-Recurrence" Model for Traditional Chinese Medicine in the Treatment of Chronic Rhinosinusitis Based on Multi-Center Electronic Medical Records Machine Learning and CT Radiomics

研究课题的正式科学名称简写:

基于多中心电子病历机器学习与CT影像组学的慢性鼻窦炎中医药诊疗“风险-干预-复发”模型

Scientific title acronym:

"Risk-Intervention-Recurrence" Model for Traditional Chinese Medicine in the Treatment of Chronic Rhinosinusitis Based on Multi-Center Electronic Medical Records Machine Learning and CT Radiomics

研究课题代号(代码):

Study subject ID:

川财社[2023]169号(CJX2024004)

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:

傅勤为

研究负责人:

张勤修

Applicant:

Fu Qin-Wei

Study leader:

Zhang Qin-Xiu

申请注册联系人电话:

Applicant telephone:

17702856801

研究负责人电话:

Study leader's telephone:

18980880173

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:

fuq13@mcmaster.ca

研究负责人电子邮件:

Study leader's E-mail:

zhqinxiu@163.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

http://www.sctcm120.com/

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

http://www.sctcm120.com/ksysxqy.htm?id=657f34505925428698a7c42b92fbd901

申请注册联系人通讯地址:

四川省成都市金牛区十二桥路39号成都中医药大学附属医院

研究负责人通讯地址:

四川省成都市金牛区十二桥路39号成都中医药大学附属医院

Applicant address:

Hospital of Chengdu University of Traditional Chinese Medicine 39 12 Qiao Road Jinniu District Chengdu City Sichuan Province

Study leader's address:

Hospital of Chengdu University of Traditional Chinese Medicine 39 12 Qiao Road Jinniu District Chengdu City Sichuan Province

申请注册联系人邮政编码:

Applicant postcode:

610075

研究负责人邮政编码:

Study leader's postcode:

610075

申请人所在单位:

成都中医药大学附属医院

Applicant's institution:

Hospital of Chengdu University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024KL-179

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

成都中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/11/8 0:00:00

伦理委员会联系人:

马喜桃

Contact Name of the ethic committee:

Ma Xitao

伦理委员会联系地址:

四川省成都市金牛区十二桥路39号成都中医药大学附属医院

Contact Address of the ethic committee:

Hospital of Chengdu University of Traditional Chinese Medicine 39 12 Qiao Road Jinniu District Chengdu City Sichuan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

028-87783142

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ethicscd@126.com

研究实施负责(组长)单位:

成都中医药大学附属医院

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

四川省成都市金牛区十二桥路39号成都中医药大学附属医院

Primary sponsor's address:

Hospital of Chengdu University of Traditional Chinese Medicine 39 12 Qiao Road Jinniu District Chengdu City Sichuan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都中医药大学附属医院

具体地址:

四川省成都市金牛区十二桥路39号成都中医药大学附属医院

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

Hospital of Chengdu University of Traditional Chinese Medicine 39 12 Qiao Road Jinniu District Chengdu City Sichuan Province

经费或物资来源:

川财社[2023]169号(CJX2024004)

Source(s) of funding:

Sichuan Caishe [2023]169 (CJX2024004)

研究疾病:

慢性鼻窦炎

研究疾病代码:

J32

Target disease:

Chronic Rhinosinusitis

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

其它

Others

研究目的:

本研究的主要目标是回顾性地基于电子病历(Electronic Medical Records, EMR)中的多维数据和CT影像组学(Radiomics)技术,构建并验证一个适用于慢性鼻窦炎的“风险-干预-复发”诊疗模型。通过该模型,能够预测CRS患者的发病情况、疾病类型(如伴鼻息肉型、嗜酸性粒细胞型等)、疾病特征(具有某些特殊解剖或临床特征的慢性鼻窦炎)以及术后复发风险,同时通过中医药诊疗模型为个性化的中医药治疗方案提供科学依据,进而提高治疗效果,减少复发率。

Objectives of Study:

The main objective of this study was to retrospectively construct and validate a risk-intervention-relapse diagnosis and treatment model for chronic sinusitis based on multidimensional data from Electronic Medical Records (EMR) and Radiomics techniques. Through this model the pathogenesis disease type (such as nasal polyp type eosinophilic type etc.) disease characteristics (chronic sinusitis with some special anatomical or clinical characteristics) and postoperative recurrence risk of patients with CRS can be predicted. Meanwhile the TCM diagnosis and treatment model can provide scientific basis for personalized TCM treatment plans thus improving treatment effects. Reduce recurrence rate.

药物成份或治疗方案详述:

本研究为横断面观察性研究,不涉及特别规定的药物成份或治疗方案,受试者按照各中心临床路径接受中医或中西医结合常规干预。

Description for medicine or protocol of treatment in detail:

This study is a cross-sectional observational study which does not involve specially prescribed drug ingredients or treatment regiments. Participants received conventional intervention of traditional Chinese medicine or integrated Chinese and Western medicine according to the clinical pathways of each center.

纳入标准:

①符合慢性鼻窦炎诊断标准的患者。 ②已接受或计划接受手术治疗的住院患者。 ③数据完整,包括电子病历、CT影像数据、病理报告和治疗记录。

Inclusion criteria

① Patients who meet the diagnostic criteria for chronic sinusitis. ② Hospitalized patients who have received or plan to receive surgical treatment. ③ Complete data including electronic medical records CT image data pathology reports and treatment records.

排除标准:

①影像数据不完整或质量不符合分析要求的患者。 ②术前一个月内使用了系统性糖皮质激素的患者。 ③有严重合并症或其他影响研究结果的疾病的患者。 ④无法完成随访或数据记录不全的患者。

Exclusion criteria:

① Patients whose image data is incomplete or the quality does not meet the analysis requirements. ② Patients who used systemic glucocorticoids within one month before surgery. ③ Patients with severe comorbidities or other diseases that affected the study results. ④ Patients who were unable to complete follow-up or whose data were not fully recorded.

研究实施时间:

Study execute time:

From 2025-02-01

To      2025-08-01

征募观察对象时间:

Recruiting time:

From 2025-02-01

To      2025-08-01

干预措施:

Interventions:

组别:

本研究为横断面观察性研究,不涉及分组及干预

样本量:

1500

Group:

This study is a cross-sectional observational study without grouping or intervention

Sample size:

干预措施:

本研究为横断面观察性研究,不涉及分组及干预

干预措施代码:

本研究为横断面观察性研究,不涉及分组及干预

Intervention:

This study is a cross-sectional observational study without grouping or intervention

Intervention code:

样本总量 Total sample size : 1500

研究实施地点:

Countries of recruitment
and research settings:

国家:

中华人民共和国

省(直辖市):

河南省

市(区县):

三门峡市

Country:

People's Republic of China

Province:

Henan Province

City:

Sanmenxia City

单位(医院):

三门峡市中医院

单位级别:

三级甲等医院

Institution/hospital:

Sanmenxia Hospital of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都市妇女儿童中心医院

单位级别:

三级甲等医院

Institution/hospital:

Chengdu Women and Children's Central Hospital

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都市龙泉驿区中医医院

单位级别:

三级甲等医院

Institution/hospital:

Chengdu Longquanyi District Hospital of Traditional Chinese medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

乐山市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Leshan City

单位(医院):

乐山市中医医院

单位级别:

三级甲等医院

Institution/hospital:

Leshan Hospital of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都市郫都区中医医院

单位级别:

三级甲等医院

Institution/hospital:

Chengdu Pidu District Hospital of Traditional Chinese medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

河南省

市(区县):

郑州市

Country:

People's Republic of China

Province:

Henan Province

City:

Zhengzhou City

单位(医院):

河南中医药大学第二附属医院

单位级别:

三级甲等医院

Institution/hospital:

The Second Affiliated Hospital of Henan University of Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都市中西医结合医院

单位级别:

三级甲等医院

Institution/hospital:

Chengdu Hospital of Integrated Chinese and Western Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都市眉山区中医医院

单位级别:

三级甲等医院

Institution/hospital:

Chengdu Meishan District Hospital of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

广东省

市(区县):

广州市

Country:

People's Republic of China

Province:

Guangdong Province

City:

Guangzhou City

单位(医院):

广州中医药大学第一附属医院

单位级别:

三级甲等医院

Institution/hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都中医药大学附属医院

单位级别:

三级甲等医院

Institution/hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

山东省

市(区县):

济南市

Country:

People's Republic of China

Province:

Shandong Province

City:

Jinan City

单位(医院):

山东中医药大学附属医院

单位级别:

三级甲等医院

Institution/hospital:

Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

广东省

市(区县):

深圳市

Country:

People's Republic of China

Province:

Guangdong Province

City:

Shenzhen City

单位(医院):

深圳市宝安区中医医院

单位级别:

三级甲等医院

Institution/hospital:

Shenzhen Baoan District Hospital of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

山西省

市(区县):

太原市

Country:

People's Republic of China

Province:

Shanxi Province

City:

Taiyuan City

单位(医院):

山西省中医院

单位级别:

三级甲等医院

Institution/hospital:

Shanxi Hospital of Traditional Chinese Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

四川省

市(区县):

成都市

Country:

People's Republic of China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

四川省中西医结合医院

单位级别:

三级甲等医院

Institution/hospital:

Sichuan Hospital of Integrated Chinese and Western Medicine

Level of the institution:

Class III Class A hospital

国家:

中华人民共和国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

People's Republic of China

Province:

Guizhou Province

City:

Guiyang City

单位(医院):

贵州中医药大学第一附属医院

单位级别:

三级甲等医院

Institution/hospital:

The First Affiliated Hospital of Guizhou University of Chinese Medicine

Level of the institution:

Class III Class A hospital

测量指标:

Outcomes:

指标中文名:

入院首次胸片检查结果

指标类型:

主要指标

Outcome:

Initial Chest X-ray Findings at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

主诉本病相关病情主要复发次数

指标类型:

主要指标

Outcome:

Number of Major Recurrences of the Primary Complaint

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院主要耳/咽喉/头/颈部体征

指标类型:

主要指标

Outcome:

Main Ear/Throat/Head/Neck Signs at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

药物过敏情况

指标类型:

主要指标

Outcome:

Drug Allergy Status

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院体格检查结果

指标类型:

附加指标

Outcome:

Physical Examination Findings at Admission

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

特殊临床特征

指标类型:

附加指标

Outcome:

Special Clinical Features

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院首次鼻窦CT检查影像

指标类型:

主要指标

Outcome:

Initial Sinus CT Imaging Findings

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

术前准备天数

指标类型:

主要指标

Outcome:

Days of Preoperative Preparation

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

入院首次鼻部症状VAS评分

指标类型:

主要指标

Outcome:

Initial Nasal Symptom VAS Score at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术切除区大小占病灶百分比

指标类型:

主要指标

Outcome:

Percentage of Surgical Resection Area Relative to Lesion Size

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

女性月经情况

指标类型:

主要指标

Outcome:

Menstrual History (for Female Patients)

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

耳鼻咽喉专科检查情况

指标类型:

主要指标

Outcome:

ENT Specialist Examination Findings

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

吸烟史

指标类型:

主要指标

Outcome:

Smoking History

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

食物过敏史

指标类型:

附加指标

Outcome:

History of Food Allergies

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

年龄

指标类型:

附加指标

Outcome:

Age

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

中医主病诊断

指标类型:

主要指标

Outcome:

Primary TCM Diagnosis

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间医院感染情况

指标类型:

主要指标

Outcome:

Hospital-Acquired Infection During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

民族

指标类型:

主要指标

Outcome:

Ethnicity

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间相关中医主证变化情况

指标类型:

主要指标

Outcome:

Changes in Primary TCM Syndromes During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

药物过敏史

指标类型:

主要指标

Outcome:

History of Drug Allergies

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

发病节气

指标类型:

主要指标

Outcome:

Season of Onset

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

主诉本病相关病情本次加重时间

指标类型:

附加指标

Outcome:

Time of Recent Exacerbation of Primary Complaint

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术名称

指标类型:

主要指标

Outcome:

Name of Surgery Performed During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

职业

指标类型:

附加指标

Outcome:

Occupation

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院主要其它全身体征

指标类型:

主要指标

Outcome:

Main Systemic Signs at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

剂型

指标类型:

主要指标

Outcome:

Dosage Form

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

血型RH分型

指标类型:

主要指标

Outcome:

Blood Type and RH Typing

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院首次实验室检验结果

指标类型:

主要指标

Outcome:

Initial Laboratory Test Results at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院首次LUND-MACKAY CT评分

指标类型:

主要指标

Outcome:

Initial Lund-Mackay CT Score at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院主要鼻部症状

指标类型:

附加指标

Outcome:

Main Nasal Symptoms at Admission

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术预防性应用抗菌药物剂量

指标类型:

主要指标

Outcome:

Dosage of Preventive Antibiotics During Surgery

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

住院期间手术切除区大小

指标类型:

主要指标

Outcome:

Size of Surgical Resection Area During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

住院期间输液反应

指标类型:

主要指标

Outcome:

Infusion Reactions During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

婚姻状况

指标类型:

主要指标

Outcome:

Marital Status

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院主要鼻部体征

指标类型:

主要指标

Outcome:

Main Nasal Signs at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间相关中医主病是否治愈/好转或未愈

指标类型:

主要指标

Outcome:

Outcome of Primary TCM Diagnosis During Hospitalization (Cured/Improved/Not Resolved)

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

中药药味

指标类型:

主要指标

Outcome:

Chinese Herbal Medicine Ingredients

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术持续时间

指标类型:

主要指标

Outcome:

Duration of Surgery During Hospitalization

Type:

Primary indicator

测量时间点:

手术后

测量方法:

根据病历信息记录

Measure time point of outcome:

postoperation

Measure method:

Record according to medical record information

指标中文名:

入院首次心电图检查结果

指标类型:

主要指标

Outcome:

Initial ECG Findings at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间其它治疗操作名称

指标类型:

主要指标

Outcome:

Other Treatment Procedures Performed During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

中医主证诊断

指标类型:

主要指标

Outcome:

Primary TCM Syndrome Diagnosis

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

饮酒史

指标类型:

附加指标

Outcome:

Alcohol Consumption History

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

鼻腔活检病理报告

指标类型:

附加指标

Outcome:

Nasal Biopsy Pathology Report

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院首次鼻息肉DAVOS评分

指标类型:

主要指标

Outcome:

Initial Nasal Polyp DAVOS Score at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

入院主要其它全身症状

指标类型:

附加指标

Outcome:

Main Systemic Symptoms at Admission

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

其它中医治疗措施

指标类型:

主要指标

Outcome:

Other TCM Treatment Measures

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

住院期间使用各西药剂量

指标类型:

主要指标

Outcome:

Dosage of Each Western Medication Used During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

住院期间手术切口愈合等级

指标类型:

主要指标

Outcome:

Surgical Incision Healing Grade During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

家族遗传病史

指标类型:

附加指标

Outcome:

Family History of Genetic Diseases

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

西医其他疾病诊断

指标类型:

附加指标

Outcome:

Western Medicine Diagnosis of Other Conditions

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

性别

指标类型:

主要指标

Outcome:

Gender

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

出生地

指标类型:

主要指标

Outcome:

Place of Birth

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

慢性鼻窦炎发病类型

指标类型:

附加指标

Outcome:

Type of Chronic Rhinosinusitis Onset

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

血型

指标类型:

主要指标

Outcome:

Blood Type

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术是否预防性应用抗菌药物

指标类型:

主要指标

Outcome:

Preventive Use of Antibiotics During Surgery

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

住院期间手术是否预防性应用抗菌药物

指标类型:

主要指标

Outcome:

Preventive Use of Antibiotics During Surgery

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

籍贯

指标类型:

附加指标

Outcome:

Place of Origin

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

非本病及相关疾病既往疾病史

指标类型:

附加指标

Outcome:

Past Medical History Unrelated to This Condition

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间使用西药名称

指标类型:

主要指标

Outcome:

Western Medications Used During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

入院首次鼻窦CT检查结果

指标类型:

主要指标

Outcome:

Initial Sinus CT Findings at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间抗菌药物使用情况

指标类型:

主要指标

Outcome:

Antibiotic Usage During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

主诉本病相关病情初发时间

指标类型:

附加指标

Outcome:

Onset Time of Primary Complaint Related to This Condition

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术风险评分

指标类型:

主要指标

Outcome:

Surgical Risk Score During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

出院日期

指标类型:

主要指标

Outcome:

Discharge Date

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

入院主要耳/咽喉/头/颈部症状

指标类型:

附加指标

Outcome:

Main Ear/Throat/Head/Neck Symptoms at Admission

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

西医主病诊断

指标类型:

主要指标

Outcome:

Primary Diagnosis of Western Medicine

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

住院期间手术是否联合应用抗菌药物

指标类型:

主要指标

Outcome:

Use of Antibiotics in Combination During Surgery

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

特殊解剖特征

指标类型:

主要指标

Outcome:

Special Anatomical Features

Type:

Primary indicator

测量时间点:

手术后

测量方法:

根据病历信息记录

Measure time point of outcome:

postoperation

Measure method:

Record according to medical record information

指标中文名:

门诊中医诊断

指标类型:

附加指标

Outcome:

Outpatient TCM Diagnosis

Type:

Additional indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

方剂名称

指标类型:

主要指标

Outcome:

Prescription Name

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

住院期间输血情况

指标类型:

主要指标

Outcome:

Blood Transfusion During Hospitalization

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

剂量

指标类型:

主要指标

Outcome:

Dosage

Type:

Primary indicator

测量时间点:

出院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At discharge

Measure method:

Record according to medical record information

指标中文名:

入院中医证素

指标类型:

主要指标

Outcome:

TCM Syndrome Elements at Admission

Type:

Primary indicator

测量时间点:

入院时

测量方法:

根据病历信息记录

Measure time point of outcome:

At admission

Measure method:

Record according to medical record information

指标中文名:

手术持续时间

指标类型:

主要指标

Outcome:

Duration of Surgery

Type:

Primary indicator

测量时间点:

手术后

测量方法:

根据病历信息记录

Measure time point of outcome:

postoperation

Measure method:

Record according to medical record information

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不涉及标本

组织:

不涉及组织

Sample Name:

No specimen involved

Tissue:

No tissue involved

人体标本去向

其它

说明

不涉及人体标本

Fate of sample 

Others

Note:

No human specimens involved

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 0
Min age years
最大 120
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究为横断面观察性研究,不涉及随机。

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

This study is a cross-sectional observational study and will not involve randomization.

盲法:

本研究为横断面观察性研究,不涉及盲法。

Blinding:

This study is a cross-sectional observational study and will not involve blinding.

是否共享原始数据:

IPD sharing:

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):

原始数据可在研究完成后向研究负责人张勤修教授(zhqinxiu@163.com)邮件正式申请获取,所有申请需经由成都中医药大学附属医院伦理委员会与研究负责人审核同意。

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

The original data can be obtained by formal application via email to study leader Professor Zhang Qinxiu (zhqinxiu@163.com) after the study is completed. All applications should be approved by the Ethics Committee of Affiliated Hospital of Chengdu University of Traditional Chinese Medicine and the study leader.

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:

所有研究数据将通过标准化的电子病历系统进行收集和管理,并严格遵守患者隐私保护规定,确保数据的安全和准确性。 研究过程中需要严格遵循数据保护法,确保患者隐私安全。所有数据在使用前将进行去标识化处理,确保个人隐私不被泄露。此外,研究团队需定期召开会议,确保研究进展顺利,并及时解决出现的问题。 确保所有研究数据的完整性和可追溯性,以支持后续的数据分析和研究验证。数据管理制度将确保数据从收集到分析的全过程都符合高标准的科学规范。 所有数据采集和录入将由经过培训的专业人员完成,确保数据的准确性和一致性。数据录入人员将定期接受培训,并严格遵守数据管理制度。 建立双重核对制度,确保数据在录入和处理过程中的准确性。数据管理团队将定期对数据进行核对和审核,确保每一项数据都准确无误。

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

All study data will be collected and managed through a standardized electronic medical record system with strict compliance with patient privacy protection regulations to ensure data security and accuracy. Data protection laws are strictly observed during the research process to ensure patient privacy. All data will be de-identified before use to ensure that personal privacy is not disclosed. In addition the research team needs to hold regular meetings to ensure that the research is progressing smoothly and that problems arise in a timely manner. Ensure the integrity and traceability of all study data to support subsequent data analysis and study validation. The data management system will ensure that the whole process of data collection and analysis meets high scientific standards. All data collection and entry will be done by trained professionals to ensure data accuracy and consistency. Data entry personnel will receive regular training and strictly follow the data management system. Establish a double check system to ensure the accuracy of data entry and processing. The data management team will check and review the data on a regular basis to ensure that everything is accurate.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

将在完成后于权威期刊发表并及时更新相关信息。

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

Will be published in authoritative journals after completion and timely update the relevant information.

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