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.
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.
Study Type
OBSERVATIONAL
Enrollment
19,469
Observational analysis of usual care only.
Momentum Data Ltd
London, United Kingdom
Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis
Time frame: 5 years
Stream 1: Relative Risk of Any Mental Health Condition
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.
Time frame: Retrospective data assessed from 2010-2020, up to 10 years
Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)
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.
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression.
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Low Mood (Emotional Function)
Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
Stream 1: Lifetime Risk of Developing a Mental Health Condition
Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models
Time frame: Retrospective data assessed from 2010-2020, up to 10 years
Stream 2: Relative Risk of Increased Primary Care Utilisation
Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
Stream 2: Relative Risk of Increased Hospital Admissions
Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression.
Time frame: 5 years of follow-up.
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