| 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 | Participants with a pre-existing diagnosis of mental health were excluded | Posted | | Number | 95% Confidence Interval | percentage of participants | | 5 years | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00012.0(10.5 to 13.4)
- OG0019.4(8.7 to 10.1)
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| 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. | Participants with a pre-existing diagnosis of mental health were excluded | Posted | | Count of Participants | | Participants | | Retrospective data assessed from 2010-2020, up to 10 years | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Matched Controls (Reference Group) | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years of follow-up. | | | | ID | Title | Description |
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| OG000 | IBD Cases With Mental Health Condition | A subset of the IBD cases comprising of those participants with the presence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. | | OG001 | IBD Cases Without Mental Health Condition (Reference Group) | A subset of the IBD cases comprising of those participants with the absence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years of follow-up. | | | | ID | Title | Description |
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| OG000 | IBD Cases With Mental Health Condition | A subset of the IBD cases comprising of those participants with the presence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. | | OG001 | IBD Cases Without Mental Health Condition (Reference Group) | A subset of the IBD cases comprising of those participants with the absence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. |
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| 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. | | Posted | | Count of Participants | | Participants | | 5 years of follow-up. | | | | ID | Title | Description |
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| OG000 | IBD Cases With Mental Health Condition | A subset of the IBD cases comprising of those participants with the presence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. | | OG001 | IBD Cases Without Mental Health Condition (Reference Group) | A subset of the IBD cases comprising of those participants with the absence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. |
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| 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 | | Posted | | Number | | percentage of participants analyzed | | Retrospective data assessed from 2010-2020, up to 10 years | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Number | | Count of prinary care interactions | | 5 years of follow-up. | | | | ID | Title | Description |
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| OG000 | IBD Cases With Mental Health Condition | A subset of the IBD cases comprising of those participants with the presence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. | | OG001 | IBD Cases Without Mental Health Condition (Reference Group) | A subset of the IBD cases comprising of those participants with the absence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. |
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| 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. | | Posted | | Number | | Count of general hospital admissions | | 5 years of follow-up. | | | | ID | Title | Description |
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| OG000 | IBD Cases With Mental Health Condition | A subset of the IBD cases comprising of those participants with the presence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. | | OG001 | IBD Cases Without Mental Health Condition (Reference Group) | A subset of the IBD cases comprising of those participants with the absence of a mental health condition at the same date as their IBD diagnosis. Mental health defined by the diagnosis of any of depression (recurrent depressive disorder or depressive episode), non-phobia-related anxiety disorder (AD), eating disorders, body image disorder, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, schizophrenia, bipolar disorder or post-traumatic stress disorder No specific intervention: Observational analysis of usual care only. |
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