Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95,055
- 试验地点
- 1
- 主要终点
- Prevalence of Anxiety Episodes (Ulcerative Colitis)
研究概览
简要总结
Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both conditions are treated with medications which suppress the immune system. It is not known whether this increases the risk for infections and cancers in these conditions. It is also recognised by healthcare professionals that these conditions cause a considerable amount of psychological distress. However, this has never been measured in a large population sample.
This study will investigate any associations with treatment and new onset infections and cancer. They will also examine the relationship between IBD and common mental health problems (specifically, depression and anxiety) and the impact that these have on the healthcare use (including number of general practitioner [GP] appointments, hospital attendances, and medication prescriptions. Combined, these studies should provide a better understanding of the impact of IBD on affected people and provide evidence to support the correct allocation of healthcare resources.
详细描述
Objective We aim to provide an accurate and contemporary measurement of the current healthcare resource utilisation in people with inflammatory bowel disease (IBD); namely ulcerative colitis (UC) and Crohn's disease (CD). We also aim to provide estimates of infection incidence in this population and the prevalence of common mental health conditions.
Method We will identify UC and CD using algorithms validated for accurately identifying these conditions from primary care records in the United Kingdom (UK). We will identify a prevalent cohort of adults with IBD with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network over the last decade. We will identify a matched cohort of people without IBD; matched on age, gender and primary care practice. Across these cohorts we will compare healthcare resource utilisation (primary care attendances, number of primary care prescriptions for antidepressant and anxiolytic medications, number of primary care prescriptions for medications used in IBD, recorded secondary care attendances, and issue of statements of fitness for work), incident infections (any common infection, any viral infection, or any gastrointestinal infection), and common mental health conditions (depression and anxiety).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥18 years over the study period
- •Registered with a contributing primary care practice for any duration during the study period
排除标准
- •IBD not classifiable or of a type other than UC or Crohn's disease
结局指标
主要结局
Prevalence of Anxiety Episodes (Ulcerative Colitis)
时间窗: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode
Prevalence of Depressive Episodes (Ulcerative Colitis)
时间窗: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode.
Number of People With Depressive Disorder in People With and Without Ulcerative Colitis
时间窗: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease
时间窗: Measured over 5 years - 2014 to 2019 inclusive
Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis
时间窗: Measured over 5 years - 2014 to 2018 inclusive
Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Prevalence of Anxiety Episodes (Crohn's Disease)
时间窗: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of anxiety episodes in people with and without Crohn's disease. Number of people with at least one anxiety episode in people.
Prevalence of Depressive Episodes (Crohn's Disease)
时间窗: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive episodes in people with and without Crohn's disease. Number of people with at least one depressive episode
Number of People With Depressive Disorder in People With and Without Crohn's Disease
时间窗: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive disorder in people with and without Crohn's disease.
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis
时间窗: Measured over 5 years - 2014 to 2019 inclusive
Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease
时间窗: Measured over 5 years - 2014 to 2019 inclusive
Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
次要结局
- Healthcare Resource Utilization - Secondary Care Emergency Attendances(Measured over five years - 2014 to 2018 inclusive)
- Healthcare Resource Utilization - Fitness for Work Notes(Measured over five years - 2014 to 2018 inclusive)
- Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)(Measured over five years - 2014 to 2018 inclusive)
- Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications(Measured over five years - 2014 to 2018 inclusive)
- Healthcare Resource Utilization - Primary Care Visits(Measured over five years - 2014 to 2018 inclusive)