Epidemiology, Treatment Patterns, and Healthcare Resource Utilization in Pediatric Patients Under 18 Years of Age With Inflammatory Bowel Diseases in Korea: A Claims Database Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
研究概览
简要总结
The purpose of this study is:
- to find out out the number of children who develop crohn's disease (CD) and ulcerative colitis (UC) each year and are living with the disease and to see how this differs by age groups.
- to understand how children of different age groups are treated over time and how their treatment changes as they grow.
- to assess how often children use healthcare services and how much this costs for different age groups over several years.
CD and UC are long-term diseases that cause inflammation in intestine (part of digestive system) and develop ulcers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with at least two outpatient or one inpatient diagnosis codes for the same disease type (either CD or UC) using international classification of diseases, tenth revision (ICD-10) codes (K
- •X for CD and K
- •X for UC) recorded as primary or the first secondary diagnosis, and the codes for rare and intractable disease registration program (V130 for CD, V131 for UC) during the index period
- •Participants who received at least one prescription for conventional pediatric inflammatory bowel disease (IBD)-related medications (for example, 5-aminosalicylic acids [5-ASAs], exclusive enteral nutrition [EENs], corticosteroids, immunomodulators, or biologic drugs) during the index period
排除标准
- •- No specific exclusion criteria are defined in this study
研究组 & 干预措施
Group 1: Newly and Previously Diagnosed Pediatric Inflammatory Bowel Disease (IBD) Participants
Participants, who have been either newly diagnosed or previously diagnosed with Crohn's disease (CD) or Ulcerative colitis (UC) will be enrolled. Data will be analyzed for epidemiology, baseline demographics and clinical characteristics, health care resource utilization profiles, and associated costs. Only newly diagnosed participants will be included in the analysis of longitudinal treatment patterns and incidence estimation. Only data available per routine clinical practice will be used in this study and will be de-identified and extracted from the health insurance review and assessment (HIRA) database.
结局指标
主要结局
Crude and Age-Adjusted Annual Incidence in Pediatric Crohn's Disease (CD)
时间窗: During the index period (2012 to 2023; up to 12 years)
The crude and age-adjusted annual incidence CD will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
Crude and Age-Adjusted Annual Incidence in Pediatric Ulcerative Colitis (UC)
时间窗: During the index period (2012 to 2023; up to 12 years)
The crude and age-adjusted annual incidence UC will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
Crude and Age-Adjusted Annual Prevalence in Pediatric CD
时间窗: During the index period (2012 to 2023; up to 12 years)
The crude and age-adjusted annual prevalence CD will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
Crude and Age-Adjusted Annual Prevalence in Pediatric UC
时间窗: During the index period (2012 to 2023; up to 12 years)
The crude and age-adjusted annual prevalence UC will be calculated in each calendar year. Annual incidence and the prevalence in the year of interest will be estimated using the number of newly diagnosed participants and the number of participants with the diagnosis within the corresponding year, respectively.
Incidence of CD by Age-Stratified Groups
时间窗: During the index period (2012 to 2023; up to 12 years)
Incidence of CD stratified by age-specific subgroups (0 to less than \[\<\] 6 years old, 6 to \<10 years old, and 10 to \<18 years old) will be reported.
Incidence of UC by Age-Stratified Groups
时间窗: During the index period (2012 to 2023; up to 12 years)
Incidence of UC stratified by age-specific subgroups (0 to \<6 years old, 6 to \<10 years old, and 10 to \<18 years old) will be reported.
Prevalence of CD by Age-Stratified Groups
时间窗: During the index period (2012 to 2023; up to 12 years)
Prevalence of CD stratified by age-specific subgroups (0 to \<6 years old, 6 to \<10 years old, and 10 to \<18 years old) will be reported.
Prevalence of UC by Age-Stratified Groups
时间窗: During the index period (2012 to 2023; up to 12 years)
Prevalence of UC stratified by age-specific subgroups (0 to \<6 years old, 6 to \<10 years old, and 10 to \<18 years old) will be reported.
Percentage of Participants Whose Primary Diagnosis Switched Between CD and UC
时间窗: During the index period (2012 to 2023; up to 12 years)
Percentage of participants whose primary diagnosis switched at least once between CD and UC during the follow-up period will be reported.
Initial Treatment Types by Age-Stratified Group
时间窗: From index date to follow-up (Up to 13 years)
Initial treatment types by age-stratified groups (0 to \<6 years old, 6 to \<10 years old, and 10 to \<18 years old on the index date) will be reported.
Subsequent Treatment Sequences by Age-Stratified Group
时间窗: From index date to follow-up (Up to 13 years)
Subsequent treatment sequences by age-stratified groups (0 to \<6 years old, 6 to \<10 years old, and 10 to \<18 years old on the index date) will be reported.
Cumulative Persistence Rates for Biologic Drugs
时间窗: From index date to follow-up (Up to 13 years)
Cumulative persistence rates for biologic drugs is defined as continuous use of the same biologic drug without a pre-defined biologic free interval (that is, 90 days or more) between prescription claims.
Time to Discontinuation
时间窗: From index date to follow-up (Up to 13 years)
Discontinuation (non-persistence) will be defined as experiencing one of the following cases: stop: a case where biologic drug was prescribed with a gap of greater than or equal to (\>=) 90 days from the discontinuation date of the previous prescription OR no further biologic drug was prescribed until the end of study period from the discontinuation date of the index drug; switch: a case where a different biologic drug was prescribed after the initial drug; re-initiation: a case where the same biologic drug was prescribed again after \>=90 days.
Number of Hospitalizations
时间窗: From index date to follow-up (Up to 13 years)
Number of hospitalizations both overall and by age groups will be reported.
Length of Hospitalization
时间窗: From index date to follow-up (Up to 13 years)
Length of hospitalization both overall and by age groups will be reported.
Number of Emergency Department (ED) Visit
时间窗: From index date to follow-up (Up to 13 years)
Number of ED visits both overall and by age groups will be reported.
Number of Outpatient Visits
时间窗: From index date to follow-up (Up to 13 years)
Number of outpatient visits both overall and by age groups will be reported.
Number of Inflammatory Bowel Disease (IBD) Related Surgeries
时间窗: From index date to follow-up (Up to 13 years)
Number of IBD related surgeries both overall and by age groups will be reported.
Number of Inpatient and Outpatient Visits to Non-Gastroenterology (GI) Departments
时间窗: From index date to follow-up (Up to 13 years)
Number of inpatient and outpatient visits to non-GI departments both overall and by age groups will be reported.
Medical Costs
时间窗: From index date to follow-up (Up to 13 years)
Medical costs including inpatient, outpatient and pharmacy costs, both overall and by age groups, will be reported.
次要结局
未报告次要终点