Acute Stress Disorder, Adjustment Disorders, Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Behavioral Disorder, Bipolar Disorder, Body Image Disorder, Depressive Episode, Eating Disorders, Inflammatory Bowel Diseases, Parasuicide, Post-traumatic Stress Disorder, Psychological Disorder, Recurrent Depressive Disorder, Schizophrenia, Self Harm, Sleep Disturbance, Suicide, Attempted
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Observational analysis of usual care only.
Sponsors
Optimum Patient Care
Momentum Data
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
• None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stream 2: Relative Risk of Low Mood (Emotional Function) | 5 years of follow-up. | Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression. |
| Stream 1: Relative Risk of Any Mental Health Condition | 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) | 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) | 5 years of follow-up. | Relative risk in participants with mental health conditions compared with those without MH conditions. Calculated using Cox regression. |
| Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | 5 years | Cumulative incidence (percentage of participants in each arm who developed any mental health condition) was calculated using Kaplan-Meier analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stream 2: Relative Risk of Increased Primary Care Utilisation | 5 years of follow-up. | Relative risk of increased primary care visits in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression. |
| Stream 2: Relative Risk of Increased Hospital Admissions | 5 years of follow-up. | Relative risk of increased hospital admissions in participants with mental health conditions compared with those without MH conditions. Calculated using negative binomial regression. |
| Stream 1: Lifetime Risk of Developing a Mental Health Condition | Retrospective data assessed from 2010-2020, up to 10 years | Probability of developing a mental health condition by age 25 years.Estimated using modified Cox regression models |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IBD Cases All incident cases of Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and IBD Unclassified in children, adolescents and young adults up to their 25th birthday. Cases will be defined based on an algorithm using diagnostic codes from the electronic medical record (EMR).
No specific intervention: Observational analysis of usual care only. | 3,898 |
| Matched Controls People without a diagnosis in their electronic medical record (ERM) of Inflammatory Bowel Disease, matched on age group, sex, ethnicity (consistent with UK census categories: White, Asian, Black, Mixed, Other), index of multiple deprivation based on postcode, and by practice where numbers allow.
No specific intervention: Observational analysis of usual care only. | 15,571 |
| Total | 19,469 |
Baseline characteristics
| Characteristic | IBD Cases | Matched Controls | Total |
|---|---|---|---|
| Age, Continuous | 19 years | 19 years | 19 years |
| Age, Customized Age subgroup 12-17 years | 1178 Participants | 4684 Participants | 5862 Participants |
| Age, Customized Age subgroup 18-25 years | 2356 Participants | 9421 Participants | 11777 Participants |
| Age, Customized Age subgroup 5-11 years | 364 Participants | 1466 Participants | 1830 Participants |
| Deprivation quintile 1 (most deprived) | 243 Participants | 1019 Participants | 1262 Participants |
| Deprivation quintile 2 | 749 Participants | 2973 Participants | 3722 Participants |
| Deprivation quintile 3 | 1172 Participants | 4623 Participants | 5795 Participants |
| Deprivation quintile 4 | 1193 Participants | 4811 Participants | 6004 Participants |
| Deprivation quintile 5 (least deprived) | 209 Participants | 847 Participants | 1056 Participants |
| Deprivation quintile Missing | 332 Participants | 1298 Participants | 1630 Participants |
| Race/Ethnicity, Customized Asian or Asian British | 276 Participants | 1000 Participants | 1276 Participants |
| Race/Ethnicity, Customized Black or Black British | 35 Participants | 176 Participants | 211 Participants |
| Race/Ethnicity, Customized Missing | 1218 Participants | 5472 Participants | 6690 Participants |
| Race/Ethnicity, Customized Mixed | 50 Participants | 136 Participants | 186 Participants |
| Race/Ethnicity, Customized Not stated | 183 Participants | 703 Participants | 886 Participants |
| Race/Ethnicity, Customized Other | 173 Participants | 548 Participants | 721 Participants |
| Race/Ethnicity, Customized White | 1963 Participants | 7536 Participants | 9499 Participants |
| Sex: Female, Male Female | 1819 Participants | 7262 Participants | 9081 Participants |
| Sex: Female, Male Male | 2079 Participants | 8309 Participants | 10388 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Participants with a pre-existing diagnosis of mental health were excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IBD Cases | Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | 12.0 percentage of participants |
| Matched Controls | Stream 1: Percentage of Participants Who Developed Any Mental Health Condition | 9.4 percentage of participants |
Primary
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
Population: Participants with a pre-existing diagnosis of mental health were excluded
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IBD Cases | Stream 1: Relative Risk of Any Mental Health Condition | 299 Participants |
| Matched Controls | Stream 1: Relative Risk of Any Mental Health Condition | 811 Participants |
95% CI: [1.12, 1.46]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IBD Cases | Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | 148 Participants |
| Matched Controls | Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator) | 473 Participants |
95% CI: [1.33, 2.52]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IBD Cases | Stream 2: Relative Risk of Low Mood (Emotional Function) | 63 Participants |
| Matched Controls | Stream 2: Relative Risk of Low Mood (Emotional Function) | 119 Participants |
95% CI: [1.76, 4.43]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IBD Cases | Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | 26 Participants |
| Matched Controls | Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator) | 83 Participants |
95% CI: [1.02, 2.62]
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IBD Cases | Stream 1: Lifetime Risk of Developing a Mental Health Condition | 31.1 percentage of participants analyzed |
| Matched Controls | Stream 1: Lifetime Risk of Developing a Mental Health Condition | 25.1 percentage of participants analyzed |
Secondary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IBD Cases | Stream 2: Relative Risk of Increased Hospital Admissions | 339 Count of general hospital admissions |
| Matched Controls | Stream 2: Relative Risk of Increased Hospital Admissions | 1295 Count of general hospital admissions |
95% CI: [1.29, 2.75]
Secondary
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IBD Cases | Stream 2: Relative Risk of Increased Primary Care Utilisation | 12881 Count of prinary care interactions |
| Matched Controls | Stream 2: Relative Risk of Increased Primary Care Utilisation | 58153 Count of prinary care interactions |
95% CI: [1.12, 1.58]