Today is 2020-07-15

Incidence and surgeries for developmental dysplasia of the hip-- Surveillance of hip screening in Taiwan using Health and Welfare Data Science Center, Ministry of Health and Welfare (HWDC, MOHW) databank
download

注册号:

Registration number:

ChiCTR2000032887 

最近更新日期:

Date of Last Refreshed on:

2020-05-14 

注册时间:

Date of Registration:

2020-05-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

台灣髖關節發育不良發生率及手術率–以衛生福利部衛生福利資料科 學中心資料庫進行嬰兒髖關節篩檢成效的長期監督 

Public title:

Incidence and surgeries for developmental dysplasia of the hip-- Surveillance of hip screening in Taiwan using Health and Welfare Data Science Center, Ministry of Health and Welfare (HWDC, MOHW) databank 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

台灣髖關節發育不良發生率及手術率–以衛生福利部衛生福利資料科 學中心資料庫進行嬰兒髖關節篩檢成效的長期監督 

Scientific title:

Incidence and surgeries for developmental dysplasia of the hip-- Surveillance of hip screening in Taiwan using Health and Welfare Data Science Center, Ministry of Health and Welfare (HWDC, MOHW) databank 

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:

張嘉獻 

研究负责人:

張嘉獻 

Applicant:

CHANG, CHIA-HSIEH 

Study leader:

CHANG, CHIA-HSIEH 

申请注册联系人电话:

Applicant telephone:

+886 9 75365974 

研究负责人电话:

Study leader's telephone:

+886 9 75365974 

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:

chiahchang@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

chiahchang@gmail.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:

中國臺灣桃園市龜山區復興街5號 

研究负责人通讯地址:

中國臺灣桃園市龜山區復興街5號 

Applicant address:

5 Fushing Street, Guishan District, Taoyuan, Taiwan, China 

Study leader's address:

5 Fushing Street, Guishan District, Taoyuan, Taiwan, China 

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:

兒童骨科 

Applicant's institution:

Pediatric orthopedics 

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:

201600345B0C502 

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:

長庚醫療財團法人人體試驗倫理委員會 

Name of the ethic committee:

Chang Gung Medical Foundation Institutional Review Board 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-10 

伦理委员会联系人:

謝燦堂 

Contact Name of the ethic committee:

Tsang-Tang Hsieh 

伦理委员会联系地址:

中國臺灣台北市敦化北路199號 

Contact Address of the ethic committee:

199 Tunghwa Road North, Taipei, Taiwan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

林口長庚兒童骨科 

Primary sponsor:

Orthopedic department, Linkou Chang Gung Memorial Hospital  

研究实施负责(组长)单位地址:

中國臺灣桃園市龜山區復興街5號 

Primary sponsor's address:

5 Fushing Street, Guishan District, Taoyuan, Taiwan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

臺灣

市(区县):

桃園龜山區

Country:

China

Province:

Taiwan

City:

Kueishan, Taoyuan

单位(医院):

林口長庚醫院

具体地址:

333桃園市龜山區復興街5號

Institution
hospital:

Linkou Chang Gung Memorial Hospital

Address:

5 Fushing Street, Kueishan, Taoyuan

经费或物资来源:

自籌 

Source(s) of funding:

Self-raised 

研究疾病:

先天髖發育不良 

Target disease:

DDH 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

調查 DDH 發病率、早期診斷率、晚期診斷率、手術發生率及大手術百分比,以此監控台灣髖關節篩檢之品質。  

Objectives of Study:

The purposes of this study are to survey incidence of early and late diagnosis and surgical rate for DDH.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

從衛生福利部衛生福利資料科學中心數據資料庫檢索 1999- 2014 全民健保處方及治療明細檔-門急診與全民健保處方及治療明細檔-西醫住院,納入研究對象的條件為(1)曾以 ICD-9 (754.3 或 754.7)為主診斷,以此進行三次或更多之門診治療 (2) 以 ICD-9 (754.3 或 754.7)為主診斷進行之手術。  

Inclusion criteria

The scrambled H_NHI_OPDTE and H_NHI_IPDTE files from 1999 to 2014 will be retrieved from the Health and Welfare Data Science Center, Ministry of Health and Welfare (HWDC, MOHW) databank. Children with three or more sequential ICD-9 diagnosis codes (754.3x or 754.7x) in the outpatient claim file or DDH-related surgeries are studied. 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2020-05-07To 2021-04-30 

干预措施:

Interventions:

组别:

手術組

样本量:

1400

Group:

surgery group

Sample size:

干预措施:

手術

干预措施代码:

Intervention:

surgery

Intervention code:

组别:

門診組

样本量:

3500

Group:

OPD group

Sample size:

干预措施:

門診看診

干预措施代码:

Intervention:

OPD

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

臺灣 

市(区县):

桃園 

Country:

China 

Province:

Taiwan 

City:

Taoyuan 

单位(医院):

林口長庚醫院 

单位级别:

醫療中心 

Institution
hospital:

Linkou Chang Gung Memorial Hospital  

Level of the institution:

Medical center 

测量指标:

Outcomes:

指标中文名:

DDH手術發生率

指标类型:

主要指标 

Outcome:

incidence of surgeries for DDH

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大手術百分比

指标类型:

主要指标 

Outcome:

percentage of major surgeries

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

早期診斷率

指标类型:

主要指标 

Outcome:

the ratio of early diagnosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

晚期診斷率

指标类型:

主要指标 

Outcome:

the ratio of late diagnosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NO

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 5 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):

此為健保資料庫巨量資料回溯分析研究

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

This is a retrospective analysis of the big data in the health insurance database

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

采用网络平台 (中國臨床試驗中心)

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

http://www.chictr.org.cn

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:

电子采集和管理系统(Electronic Data Capture, EDC)

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

ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-14
return list