Incidence of Psychological Comorbidities in Paediatric and Young Adults With Inflammatory Bowel Disease, and the Impacts on Quality-of-life, Disease Severity and Resource Utilisation: A Population-based Cohort Study in the United Kingdom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,469
- 试验地点
- 1
- 主要终点
- Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
研究概览
简要总结
This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years diagnosed with Inflammatory Bowel Disease (IBD) and the impacts of mental health conditions in those diagnosed with IBD.
详细描述
This study will use routinely electronic medical record (EMR) data from primary care practices within the Optimum Patient Care Research Database (OPCRD).
Stream 1 primary objective is to compare the prevalence and cumulative incidence of mental health conditions in children, adolescents and young adults (aged 5-25 years) with a diagnosis of Inflammatory Bowel Disease (IBD), compared to matched population controls without a diagnosis of IBD. The secondary objective is to determine the severity of mental health outcomes in those with and without a diagnosis of IBD.
Stream 2 primary objective is to determine the impact of mental health conditions in children, adolescents and young adults (aged 5-25 years) diagnosed with IBD on quality-of-life indicators, such as records for absence from work or school, unemployment, sleep disturbance and substance abuse.
The secondary objectives are to compare indicators of IBD severity, such as medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including underweight or growth retardation,and healthcare resource utilisation.These impacts and indicators will be assessed using participants that have been diagnosed with IBD, comparing those with the presence of a mental health condition to those without a mental health condition.
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
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 5 years and 25 years
- •Registration with a general practices (GP) contributing routinely collected electronic healthcare data to the Optimum Patient Care Research Database (OPCRD) for more than 6 months during the follow up period
- •A recorded diagnosis of IBD in the clinical record (cases)
排除标准
- 未提供
结局指标
主要结局
Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
时间窗: 5 years
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
Stream 1: Relative Risk of Any Mental Health Condition
时间窗: Retrospective data assessed from 2010-2020, up to 10 years
Calculated using Cox proportional hazards models using matched controls as the reference group. Adjusted for age, sex, socioeconomic status, ethnicity, and other common chronic childhood conditions.
Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)
时间窗: 5 years of follow-up.
Bowel symptoms consist of abdominal pain, bloating, discomfort and diarrhoea. Relative risk in participants with mental health conditions compared with those without mental health (MH) conditions. Calculated using negative binomial regression.
Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)
时间窗: 5 years of follow-up.
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.
Stream 2: Relative Risk of Low Mood (Emotional Function)
时间窗: 5 years of follow-up.
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
次要结局
- Stream 1: Lifetime Risk of Developing a Mental Health Condition(Retrospective data assessed from 2010-2020, up to 10 years)
- Stream 2: Relative Risk of Increased Primary Care Utilisation(5 years of follow-up.)
- Stream 2: Relative Risk of Increased Hospital Admissions(5 years of follow-up.)