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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| University of Surrey | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with inflammatory bowel disease | Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period |
| |
| Controls | Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observation of routine clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Anxiety Episodes (Crohn's Disease) | 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. | Measured over five years - 2014 to 2018 inclusive |
| Prevalence of Anxiety Episodes (Ulcerative Colitis) | Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode | Measured over five years - 2014 to 2018 inclusive |
| Prevalence of Depressive Episodes (Crohn's Disease) | Compare the prevalence of depressive episodes in people with and without Crohn's disease. Number of people with at least one depressive episode | Measured over five years - 2014 to 2018 inclusive |
| Prevalence of Depressive Episodes (Ulcerative Colitis) | Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode. | Measured over five years - 2014 to 2018 inclusive |
| Number of People With Depressive Disorder in People With and Without Crohn's Disease | Compare the prevalence of depressive disorder in people with and without Crohn's disease. | Measured over five years - 2014 to 2018 inclusive |
| Number of People With Depressive Disorder in People With and Without Ulcerative Colitis | Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Resource Utilization - Primary Care Visits | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | Measured over five years - 2014 to 2018 inclusive |
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Inclusion Criteria:
Exclusion Criteria:
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All individuals with an existing or incident diagnosis of UC or CD during the study period (2013-2018), defined by the presence of at least one disease-specific diagnostic code will be eligible for inclusion in the IBD cohort. Controls will matched people without IBD matched on age, gender and primary care practice.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McGovern, MD | Momentum Data Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Data Ltd | London | WC1X 8QT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32943436 | Derived | Irving P, Barrett K, Tang D, Nijher M, de Lusignan S. Common infections, mental health problems and healthcare use in people with inflammatory bowel disease: a cohort study protocol. Evid Based Ment Health. 2021 May;24(2):82-87. doi: 10.1136/ebmental-2020-300167. Epub 2020 Sep 17. |
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Individual patient data (IPD) is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
As above
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Inflammatory Bowel Disease (Cases) | Adults (18+) with inflammatory bowel disease registered with a contributing General Practitioner (GP) practice during the study period No intervention: Observation of routine clinical practice |
| FG001 | People Without Inflammatory Bowel Disease (Controls) | Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | People With Inflammatory Bowel Disease (Cases) | Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice |
| BG001 | People Without Inflammatory Bowel Disease (Controls) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of Anxiety Episodes (Crohn's Disease) | 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. | Subset of people diagnosed with IBD having Crohn's disease | Posted | Count of Participants | Participants | Measured over five years - 2014 to 2018 inclusive |
|
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Death, serious adverse events and other (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People With Inflammatory Bowel Disease (Cases) | Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Peter Irving | St Thomas' Hospital, London | 020 7188 7188 | peter.irving@gstt.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2018 | Feb 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Measured over five years - 2014 to 2018 inclusive |
| Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis | Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection. | Measured over 5 years - 2014 to 2018 inclusive |
| Number of People With at Least One Infection Event in Those With and Without Crohn's Disease | Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection. | Measured over 5 years - 2014 to 2019 inclusive |
| Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis | 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 | Measured over 5 years - 2014 to 2019 inclusive |
| Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease | 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 | Measured over 5 years - 2014 to 2019 inclusive |
| Healthcare Resource Utilization - Secondary Care Emergency Attendances |
Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. |
| Measured over five years - 2014 to 2018 inclusive |
| Healthcare Resource Utilization - Fitness for Work Notes | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | Measured over five years - 2014 to 2018 inclusive |
| Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs) | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | Measured over five years - 2014 to 2018 inclusive |
| Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | Measured over five years - 2014 to 2018 inclusive |
Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Count of Participants | Participants |
|
| Index of Multiple Deprivation (IMD) quintile | Count of Participants | Participants |
|
| Comorbidities - Type 2 diabetes | Count of Participants | Participants |
|
| Comorbidities - Hypertension | Count of Participants | Participants |
|
| Comorbidities - Atrial fibrillation | Count of Participants | Participants |
|
| Comorbidities - Angina | Count of Participants | Participants |
|
| Comorbidities - Myocardial infarction | Count of Participants | Participants |
|
| Comorbidities - Stroke | Count of Participants | Participants |
|
| Comorbidities - Heart failure | Count of Participants | Participants |
|
| Comorbidities - Chronic liver disease | Count of Participants | Participants |
|
| Comorbidities - Dementia | Count of Participants | Participants |
|
| Comorbidities - Rheumatoid arthritis | Count of Participants | Participants |
|
| Comorbidities - Asthma | Count of Participants | Participants |
|
| Comorbidities - Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Use of systemic therapy | Count of Participants | Participants |
|
People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 without a history of IBD and matched with an individual with IBD. |
|
|
| Primary | Prevalence of Anxiety Episodes (Ulcerative Colitis) | Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode | Subset of people diagnosed with IBD having Ulcerative Colitis | Posted | Count of Participants | Participants | Measured over five years - 2014 to 2018 inclusive |
|
|
|
| Primary | Prevalence of Depressive Episodes (Crohn's Disease) | Compare the prevalence of depressive episodes in people with and without Crohn's disease. Number of people with at least one depressive episode | Subset of people diagnosed with IBD having Crohn's disease | Posted | Count of Participants | Participants | Measured over five years - 2014 to 2018 inclusive |
|
|
|
| Primary | Prevalence of Depressive Episodes (Ulcerative Colitis) | Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode. | Subset of people diagnosed with IBD having Ulcerative Colitis | Posted | Count of Participants | Participants | Measured over five years - 2014 to 2018 inclusive |
|
|
|
| Primary | Number of People With Depressive Disorder in People With and Without Crohn's Disease | Compare the prevalence of depressive disorder in people with and without Crohn's disease. | Subset of people diagnosed with IBD having Crohn's disease | Posted | Count of Participants | Participants | Measured over five years - 2014 to 2018 inclusive |
|
|
|
| Primary | Number of People With Depressive Disorder in People With and Without Ulcerative Colitis | Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis. | Subset of people diagnosed with IBD having Ulcerative colitis | Posted | Count of Participants | Participants | Measured over five years - 2014 to 2018 inclusive |
|
|
|
| Primary | Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis | Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection. | Posted | Count of Participants | Participants | Measured over 5 years - 2014 to 2018 inclusive |
|
|
|
| Primary | Number of People With at Least One Infection Event in Those With and Without Crohn's Disease | Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection. | Posted | Count of Participants | Participants | Measured over 5 years - 2014 to 2019 inclusive |
|
|
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| Primary | Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis | 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 | Posted | Count of Participants | Participants | Measured over 5 years - 2014 to 2019 inclusive |
|
|
|
| Secondary | Healthcare Resource Utilization - Primary Care Visits | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD | Posted | Number | 95% Confidence Interval | Visits per person per year | Measured over five years - 2014 to 2018 inclusive |
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|
| Secondary | Healthcare Resource Utilization - Secondary Care Emergency Attendances | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD | Posted | Number | 95% Confidence Interval | Attendances per person per year | Measured over five years - 2014 to 2018 inclusive |
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| Secondary | Healthcare Resource Utilization - Fitness for Work Notes | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD | Posted | Number | 95% Confidence Interval | Notes issued per person per year | Measured over five years - 2014 to 2018 inclusive |
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|
|
| Secondary | Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs) | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD | Posted | Number | 95% Confidence Interval | Prescriptions per person per year | Measured over five years - 2014 to 2018 inclusive |
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| Secondary | Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications | Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness. | The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD | Posted | Number | 95% Confidence Interval | Prescriptions per person per year | Measured over five years - 2014 to 2018 inclusive |
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| Primary | Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease | 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 | Posted | Count of Participants | Participants | Measured over 5 years - 2014 to 2019 inclusive |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | People Without Inflammatory Bowel Disease (Controls) | Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice | 0 | 0 | 0 | 0 | 0 | 0 |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |
| Overweight (25-30) |
|
| Obese (≥30) |
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| Not recorded |
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| 3 |
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| 4 |
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| 5 (least deprived) |
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| Not recorded |
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| Viral infection |
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| Viral infection |
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| Acute Bronchitis |
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| Influenza |
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| Skin infections |
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| Genital infection |
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| UTI |
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| GI infection subset |
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| Herpes Simplex infection |
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| Herpes Zoster infection |
|
| Acute Bronchitis |
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| Influenza |
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| Skin infections |
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| Genital infection |
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| UTI |
|
| GI infection subset |
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| Herpes Simplex infection |
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| Herpes Zoster infection |
|