Trial Outcomes & Findings for Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (NCT NCT03836612)

Last Updated: 2023-01-18

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

95055 participants

Primary outcome timeframe

Measured over five years - 2014 to 2018 inclusive

Results posted on

2023-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	19011	76044
Overall Study COMPLETED	19011	76044
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	People With Inflammatory Bowel Disease (Cases) n=19011 Participants Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice	People Without Inflammatory Bowel Disease (Controls) n=76044 Participants Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period No intervention: Observation of routine clinical practice	Total n=95055 Participants Total of all reporting groups
Age, Customized 18-29	2276 Participants n=19011 Participants	9416 Participants n=76044 Participants	11692 Participants n=95055 Participants
Age, Customized 30-39	3036 Participants n=19011 Participants	11931 Participants n=76044 Participants	14967 Participants n=95055 Participants
Age, Customized 40-49	3379 Participants n=19011 Participants	13593 Participants n=76044 Participants	16972 Participants n=95055 Participants
Age, Customized 50-59	3560 Participants n=19011 Participants	14305 Participants n=76044 Participants	17865 Participants n=95055 Participants
Age, Customized 60-69	3235 Participants n=19011 Participants	12890 Participants n=76044 Participants	16125 Participants n=95055 Participants
Age, Customized 70-79	2278 Participants n=19011 Participants	8942 Participants n=76044 Participants	11220 Participants n=95055 Participants
Age, Customized 80+	1247 Participants n=19011 Participants	4967 Participants n=76044 Participants	6214 Participants n=95055 Participants
Sex: Female, Male Female	9968 Participants n=19011 Participants	39746 Participants n=76044 Participants	49714 Participants n=95055 Participants
Sex: Female, Male Male	9043 Participants n=19011 Participants	36298 Participants n=76044 Participants	45341 Participants n=95055 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	19011 participants n=19011 Participants	76044 participants n=76044 Participants	95055 participants n=95055 Participants
BMI Underweight (≤18.5)	7229 Participants n=19011 Participants	24690 Participants n=76044 Participants	31919 Participants n=95055 Participants
BMI Normal weight (18.5-25)	639 Participants n=19011 Participants	1814 Participants n=76044 Participants	2453 Participants n=95055 Participants
BMI Overweight (25-30)	5824 Participants n=19011 Participants	23707 Participants n=76044 Participants	29531 Participants n=95055 Participants
BMI Obese (≥30)	3775 Participants n=19011 Participants	17379 Participants n=76044 Participants	21154 Participants n=95055 Participants
BMI Not recorded	1544 Participants n=19011 Participants	8454 Participants n=76044 Participants	9998 Participants n=95055 Participants
Index of Multiple Deprivation (IMD) quintile 1 (most deprived)	2396 Participants n=19011 Participants	9933 Participants n=76044 Participants	12329 Participants n=95055 Participants
Index of Multiple Deprivation (IMD) quintile 2	2846 Participants n=19011 Participants	11514 Participants n=76044 Participants	14360 Participants n=95055 Participants
Index of Multiple Deprivation (IMD) quintile 3	3617 Participants n=19011 Participants	14720 Participants n=76044 Participants	18337 Participants n=95055 Participants
Index of Multiple Deprivation (IMD) quintile 4	4684 Participants n=19011 Participants	18137 Participants n=76044 Participants	22821 Participants n=95055 Participants
Index of Multiple Deprivation (IMD) quintile 5 (least deprived)	5117 Participants n=19011 Participants	20388 Participants n=76044 Participants	25505 Participants n=95055 Participants
Index of Multiple Deprivation (IMD) quintile Not recorded	351 Participants n=19011 Participants	1352 Participants n=76044 Participants	1703 Participants n=95055 Participants
Comorbidities - Type 2 diabetes	1665 Participants n=19011 Participants	6336 Participants n=76044 Participants	8001 Participants n=95055 Participants
Comorbidities - Hypertension	4249 Participants n=19011 Participants	17591 Participants n=76044 Participants	21840 Participants n=95055 Participants
Comorbidities - Atrial fibrillation	658 Participants n=19011 Participants	2336 Participants n=76044 Participants	2994 Participants n=95055 Participants
Comorbidities - Angina	606 Participants n=19011 Participants	2075 Participants n=76044 Participants	2681 Participants n=95055 Participants
Comorbidities - Myocardial infarction	481 Participants n=19011 Participants	1650 Participants n=76044 Participants	2131 Participants n=95055 Participants
Comorbidities - Stroke	387 Participants n=19011 Participants	1382 Participants n=76044 Participants	1769 Participants n=95055 Participants
Comorbidities - Heart failure	296 Participants n=19011 Participants	1062 Participants n=76044 Participants	1358 Participants n=95055 Participants
Comorbidities - Chronic liver disease	386 Participants n=19011 Participants	487 Participants n=76044 Participants	873 Participants n=95055 Participants
Comorbidities - Dementia	694 Participants n=19011 Participants	2786 Participants n=76044 Participants	3480 Participants n=95055 Participants
Comorbidities - Rheumatoid arthritis	281 Participants n=19011 Participants	706 Participants n=76044 Participants	987 Participants n=95055 Participants
Comorbidities - Asthma	3796 Participants n=19011 Participants	12924 Participants n=76044 Participants	16720 Participants n=95055 Participants
Comorbidities - Chronic Obstructive Pulmonary Disease (COPD)	982 Participants n=19011 Participants	2990 Participants n=76044 Participants	3972 Participants n=95055 Participants
Use of systemic therapy	4183 Participants n=19011 Participants	700 Participants n=76044 Participants	4883 Participants n=95055 Participants

PRIMARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: Subset of people diagnosed with IBD having 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.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=7557 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=30228 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Prevalence of Anxiety Episodes (Crohn's Disease)	262 Participants	892 Participants	—	—

PRIMARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: Subset of people diagnosed with IBD having Ulcerative Colitis

Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=11454 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=45816 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Prevalence of Anxiety Episodes (Ulcerative Colitis)	341 Participants	1221 Participants	—	—

PRIMARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: Subset of people diagnosed with IBD having 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

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=7557 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=30228 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Prevalence of Depressive Episodes (Crohn's Disease)	431 Participants	1233 Participants	—	—

PRIMARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: Subset of people diagnosed with IBD having Ulcerative Colitis

Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=11454 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=45816 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Prevalence of Depressive Episodes (Ulcerative Colitis)	507 Participants	1666 Participants	—	—

PRIMARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: Subset of people diagnosed with IBD having Crohn's disease

Compare the prevalence of depressive disorder in people with and without Crohn's disease.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=7557 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=30228 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Number of People With Depressive Disorder in People With and Without Crohn's Disease	1322 Participants	3911 Participants	—	—

PRIMARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: Subset of people diagnosed with IBD having Ulcerative colitis

Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=11454 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=45816 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Number of People With Depressive Disorder in People With and Without Ulcerative Colitis	1627 Participants	5676 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=11360 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=45440 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis Any common infection	5111 Participants	17403 Participants	—	—
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis Gastrointestinal infection	510 Participants	1365 Participants	—	—
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis Viral infection	2544 Participants	8510 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=7469 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=29876 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease Any common infection	3470 Participants	11227 Participants	—	—
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease Gastrointestinal infection	395 Participants	841 Participants	—	—
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease Viral infection	1797 Participants	5917 Participants	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=11360 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=45440 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis URTI	2118 Participants	7143 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Pneumonia	100 Participants	288 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Acute Bronchitis	1754 Participants	5554 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Influenza	234 Participants	856 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Skin infections	1654 Participants	5268 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Genital infection	246 Participants	874 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis UTI	733 Participants	2631 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis GI infection subset	121 Participants	198 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Herpes Simplex infection	106 Participants	352 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis Herpes Zoster infection	309 Participants	839 Participants	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=7469 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=29876 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.	People With Crohn's Disease People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD 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.
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease URTI	1475 Participants	5002 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Pneumonia	59 Participants	136 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Acute Bronchitis	1059 Participants	3211 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Influenza	158 Participants	621 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Skin infections	1201 Participants	3294 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Genital infection	219 Participants	665 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease UTI	473 Participants	1568 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease GI infection subset	76 Participants	130 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Herpes Simplex infection	109 Participants	253 Participants	—	—
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease Herpes Zoster infection	237 Participants	491 Participants	—	—

SECONDARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD

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.

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=19011 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=11454 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.	People With Crohn's Disease n=7557 Participants People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD n=76044 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.
Healthcare Resource Utilization - Primary Care Visits	6.41 Visits per person per year Interval 6.39 to 6.44	6.18 Visits per person per year Interval 6.15 to 6.2	6.78 Visits per person per year Interval 6.75 to 6.82	4.49 Visits per person per year Interval 4.48 to 4.5

SECONDARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=19011 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=11454 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.	People With Crohn's Disease n=7557 Participants People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD n=76044 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.
Healthcare Resource Utilization - Secondary Care Emergency Attendances	0.455 Attendances per person per year Interval 0.449 to 0.461	0.396 Attendances per person per year Interval 0.389 to 0.403	0.546 Attendances per person per year Interval 0.536 to 0.557	0.259 Attendances per person per year Interval 0.257 to 0.262

SECONDARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=19011 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=11454 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.	People With Crohn's Disease n=7557 Participants People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD n=76044 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.
Healthcare Resource Utilization - Fitness for Work Notes	0.311 Notes issued per person per year Interval 0.306 to 0.316	0.270 Notes issued per person per year Interval 0.265 to 0.276	0.378 Notes issued per person per year Interval 0.368 to 0.386	0.215 Notes issued per person per year Interval 0.213 to 0.217

SECONDARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=19011 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=11454 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.	People With Crohn's Disease n=7557 Participants People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD n=76044 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.
Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)	1.328 Prescriptions per person per year Interval 1.317 to 1.338	1.218 Prescriptions per person per year Interval 1.205 to 1.23	1.495 Prescriptions per person per year Interval 1.478 to 1.512	1.046 Prescriptions per person per year Interval 1.041 to 1.05

SECONDARY outcome

Timeframe: Measured over five years - 2014 to 2018 inclusive

Population: The arm/Groups titled people with ulcerative colitis and people with Crohn's disease are subsets of the arm/Group titled people with IBD

Outcome measures

Outcome measures
Measure	People With Crohn's Disease (Cases) n=19011 Participants People aged ≥18, registered with a GP practice contributing to the Oxford-Royal College of General Practitioners Research and Surveillance Centre database (RCGP RSC) between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without Crohn's Disease (Controls) n=11454 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.	People With Crohn's Disease n=7557 Participants People aged ≥18, registered with a GP practice contributing to the RCGP RSC between 1 January 2014 and 1 January 2019 with an existing or incident diagnosis of Crohn's disease.	People Without IBD n=76044 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.
Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications	0.219 Prescriptions per person per year Interval 0.214 to 0.223	0.189 Prescriptions per person per year Interval 0.183 to 0.194	0.264 Prescriptions per person per year Interval 0.257 to 0.272	0.166 Prescriptions per person per year Interval 0.164 to 0.168

Adverse Events

People With Inflammatory Bowel Disease (Cases)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

People Without Inflammatory Bowel Disease (Controls)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Peter Irving

St Thomas' Hospital, London

Phone: 020 7188 7188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place