Crohns Disease, Inflammatory Bowel Disease, Perianal Fistula
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
Detailed description
This is a retrospective follow-up observational study of participants with CD with and without complex perianal fistula (CPAF) from January 2002 to March 2017. The study will verify the potential of using procedure codes to reliably identify participants with CPAF in Validation Study (Objective 1), compare Crohn's participants with CPAF (cases) to matched participants without CPAF (controls) to determine the disease burden and healthcare resource utilization of Crohn's related CPAF in Ontario, and will describe the participant's journey among Crohn's participants following the first diagnosis of CPAF (Objective 3). The study will enroll approximately 600 participants (300 participants with CPAF and 300 participants without CPAF). All participants will be enrolled in 2 observation groups: * CD Participants with/without CPAF (ICES data) * CD Participants with CPAF - The Ottawa Hospital (TOH) The data will be collected through Ontario health administrative data. Participants will be observed retrospectively who were diagnosed with CD with and without fistula between index period: April 2002 and July 2013. Participants will be followed up retrospectively from the index period (that is onset of CPAF) to the end of study (Objective 2), and for 5 years following the (Objective 3) index date defined as onset of CPAF will be selected based on the first time they meet the first code in the case definition identified in Objective 1 between April 1, 2005 to March 31, 2012. The overall time for data collection in this study will be approximately 7 months.
Interventions
OTHERNo intervention
This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.
Sponsors
Takeda
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
for Objective 1: 1. Inclusion in the TOH reference database. 2. Aged 18-105 inclusive at date of index. 3. Participant can be linked between TOH reference database to the Institute for Clinical Evaluative Sciences (ICES) databases based on health card number. 4. Incident inclusion in the Ontario Crohn's and Colitis Cohort (OCCC) between April 1, 2002 to July 1, 2013. 5. Incident diagnosis of CPAF in TOH database between April 1, 2004 to July 1, 2015. Inclusion Criteria for Objective 2: 1. Participants were incident in the OCCC from April 1, 2002 to March 31, 2012. 2. The case meets the PAF case definition identified in Objective 1 in the selection period (April 1, 2005 to March 31, 2012). 3. Aged 18-105 inclusive at date of index. Inclusion Criteria for Objective 3: 1. Inclusion in the OCCC at or prior to index visit with a diagnosis of Crohn's disease. 2. The case meets the CPAF case definition identified in Objective 1 in the selection period. 3. Have to have 5 years of follow-up. 4. Aged 18-105 inclusive at date of index.
Exclusion criteria
for Objective 1: 1. Missing demographics at index date (sex, age, Local Health Integration Network (LHIN), income quintile) in all databases. 2. Death date in the ICES data prior to TOH CPAF incidence date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | From the date of CD diagnosis up to the index date (approximately 5 years) | Index date first time participant meets case definition(diagnosis of CD with CPAF in index period).Participants divided as:2 diagnosis/imaging codes(IC),2 codes must be in 2 year(yr) period of each other;3 diagnosis/IC/intervention code/EUA+seton;3 diagnosis/IC/intervention code/EUA+seton,diagnosis/IC requirements are satisfied,codes must be in 2yr period of each other;2 diagnosis/IC;3 diagnosis/IC,3 codes must be in 2yr period of each other;3 diagnosis/IC;diagnosis/IC+(EUA+Seton);diagnosis/IC+(EUA+Seton),2 codes must be in 2yr period of each other;3 diagnosis /IC+intervention code 4 codes must be in 2 yr period of each other;2 IC/intervention code/diagnosis code/EUA+seton;2 IC/intervention code/diagnosis code/EUA+seton,IC requirements are satisfied, codes must be in 2yr period of each other;2 diagnosis/IC+intervention code;3 diagnosis/IC+intervention code;2 diagnosis/IC+intervention code,3 codes must be in 2yr period of each other;diagnosis/imaging/intervention codes;diagnosis/IC. |
| Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | From the index date up to end of study (approximately 5 years post-index) | Impact of total disease burden on participants CD with and without CPAF was measured as total cost and cost by sector which included general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, dialysis, cancer, and radiation, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. |
| Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | From the index date up to end of study (approximately 5 years post-index) | Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. |
| Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | From the index date up to 5 years post-index | Impact of total disease burden on participants CD with CPAF was based on three procedures which included total cost, total cost (without ODB) and cost by sector i.e. general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, Dialysis, Cancer, and Radiation, non-hospital based residential care, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention. |
| Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | From the index date up to 5 years post-index | Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention. |
Countries
Canada
Participant flow
Recruitment details
Data from participants were collected for this retrospective observational study at a single investigative site in Canada from 2 July 2019 to 31 December 2019.
Pre-assignment details
Participants with a diagnosis of Crohn's disease (CD) with and without Complex Perianal Fistula (CPAF) were enrolled from The Ottawa Hospital (TOH) and Institute for Clinical Evaluative Sciences (ICES) database and were observed retrospectively in this study.
Participants by arm
| Arm | Count |
|---|---|
| CD Participants With CPAF - TOH Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). | 549 |
| CD Participants Without CPAF (ICES Database) Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). | 1,902 |
| CD Participants With CPAF (ICES Database) Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). | 581 |
| Total | 3,032 |
Baseline characteristics
| Characteristic | CD Participants Without CPAF (ICES Database) | CD Participants With CPAF (ICES Database) | Total | CD Participants With CPAF - TOH |
|---|---|---|---|---|
| Age, Continuous | 31.83 years | 33.09 years | 34.34 years | 38.12 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Canada | 1902 Participants | 581 Participants | 3032 Participants | 549 Participants |
| Sex: Female, Male Female | 903 Participants | 279 Participants | 1486 Participants | 304 Participants |
| Sex: Female, Male Male | 999 Participants | 302 Participants | 1546 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 549 | 0 / 1,902 | 0 / 581 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database
Index date first time participant meets case definition(diagnosis of CD with CPAF in index period).Participants divided as:2 diagnosis/imaging codes(IC),2 codes must be in 2 year(yr) period of each other;3 diagnosis/IC/intervention code/EUA+seton;3 diagnosis/IC/intervention code/EUA+seton,diagnosis/IC requirements are satisfied,codes must be in 2yr period of each other;2 diagnosis/IC;3 diagnosis/IC,3 codes must be in 2yr period of each other;3 diagnosis/IC;diagnosis/IC+(EUA+Seton);diagnosis/IC+(EUA+Seton),2 codes must be in 2yr period of each other;3 diagnosis /IC+intervention code 4 codes must be in 2 yr period of each other;2 IC/intervention code/diagnosis code/EUA+seton;2 IC/intervention code/diagnosis code/EUA+seton,IC requirements are satisfied, codes must be in 2yr period of each other;2 diagnosis/IC+intervention code;3 diagnosis/IC+intervention code;2 diagnosis/IC+intervention code,3 codes must be in 2yr period of each other;diagnosis/imaging/intervention codes;diagnosis/IC.
Time frame: From the date of CD diagnosis up to the index date (approximately 5 years)
Population: All participants identified from TOH with and without CPAF were included in the analysis. Participants could meet more than more case definition.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 2 Diagnosis/IC, in a 2 Year Period of Each Other | 120 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 3 Diagnosis/ IC/ Intervention Code/EUA+seton | 120 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 3 Diagnosis/ IC/ Intervention/EUA+seton, Diagnosis/ IC Requirements are Satisfied | 127 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 2 Diagnosis/ IC | 127 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 3 Diagnosis/ IC, 3 Codes Must be in 2 Year Period of Each Other | 88 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 3 Diagnosis/ IC | 97 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any Diagnosis/ IC + (EUA+ Seton) | 83 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any Diagnosis/ IC + (EUA+Seton), in a 2 Year Period of Each Other | 78 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 3 Diagnosis/IC + Intervention Code, 4 Codes Must be in 2 Year Period of Each Other | 66 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 2 IC Intervention Code/ Diagnosis Code/EUA+Seton | 127 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 2 Imaging/Intervention/ Diagnosis Code/EUA+seton, If Imaging Code Requirements Are Satisfied | 127 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 2 Diagnosis/ IC + Intervention Code | 69 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 3 Diagnosis/ IC + an Intervention Code | 67 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any 2 Diagnosis/ IC + Intervention Code, 3 Codes Must be in 2 Year Period of Each Other | 69 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any Diagnosis/ IC / Intervention Codes | 146 Participants |
| CD Participants With CPAF - TOH | Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database | Any Diagnosis/ IC | 146 Participants |
Primary
Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF
Impact of total disease burden on participants CD with and without CPAF was measured as total cost and cost by sector which included general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, dialysis, cancer, and radiation, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period.
Time frame: From the index date up to end of study (approximately 5 years post-index)
Population: All participants who were eligible as cases (CD Participants with CPAF) and controls (CD Participants without CPAF) from the ICES database were used in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: General Physicians (GP) | 1192.63 canadian dollars | Standard Deviation 2936.3 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Dialysis, Cancer, and Radiation | 64.61 canadian dollars | Standard Deviation 949.45 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: All physician OHIP | 8029.55 canadian dollars | Standard Deviation 6818.29 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Non-hospital Based Residential Care | 182.73 canadian dollars | Standard Deviation 2797.46 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Total Cost (Without ODB) | 22866.85 canadian dollars | Standard Deviation 37256.27 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Emergency Department (ED) | 1421.81 canadian dollars | Standard Deviation 2167.73 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Home Care Services | 900.90 canadian dollars | Standard Deviation 14925.27 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: ODB | 9917.46 canadian dollars | Standard Deviation 32562.86 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Specialist | 5978.09 canadian dollars | Standard Deviation 5317.74 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Hospital Outpatient Clinics | 3177.37 canadian dollars | Standard Deviation 3632.82 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Hospital Admissions | 7586.89 canadian dollars | Standard Deviation 23760.92 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Same Day Surgery (SDS) | 1500.39 canadian dollars | Standard Deviation 1504.51 |
| CD Participants With CPAF - TOH | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Total Cost | 32781.12 canadian dollars | Standard Deviation 52124.77 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Same Day Surgery (SDS) | 2935.31 canadian dollars | Standard Deviation 2270.25 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Total Cost | 62375.54 canadian dollars | Standard Deviation 70332.9 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Total Cost (Without ODB) | 36486.07 canadian dollars | Standard Deviation 42218.43 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: General Physicians (GP) | 1275.58 canadian dollars | Standard Deviation 1974.01 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Specialist | 8075.60 canadian dollars | Standard Deviation 5777.89 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: All physician OHIP | 10368.04 canadian dollars | Standard Deviation 6969.59 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Home Care Services | 4142.01 canadian dollars | Standard Deviation 12246.05 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Hospital Admissions | 11079.55 canadian dollars | Standard Deviation 24994.66 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Dialysis, Cancer, and Radiation | 275.93 canadian dollars | Standard Deviation 4181.82 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Non-hospital Based Residential Care | 217.79 canadian dollars | Standard Deviation 2781.88 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Emergency Department (ED) | 1807.10 canadian dollars | Standard Deviation 2658.28 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: ODB | 25889.50 canadian dollars | Standard Deviation 52074.97 |
| CD Participants With CPAF (ICES Database) | Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF | Cost by Sector: Hospital Outpatient Clinics | 5660.54 canadian dollars | Standard Deviation 5234.69 |
Primary
Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database
Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period.
Time frame: From the index date up to end of study (approximately 5 years post-index)
Population: All participants who were eligible as cases (CD Participants with CPAF) and controls (CD Participants without CPAF) from the ICES database were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPAF - TOH | Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | Number of ED Visits | 4.26 visits | Standard Deviation 6.28 |
| CD Participants With CPAF - TOH | Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | Number of Hospitalizations | 0.95 visits | Standard Deviation 1.74 |
| CD Participants With CPAF - TOH | Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | Number of Outpatient Visits | 8.57 visits | Standard Deviation 9.81 |
| CD Participants With CPAF (ICES Database) | Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | Number of ED Visits | 5.57 visits | Standard Deviation 8.09 |
| CD Participants With CPAF (ICES Database) | Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | Number of Hospitalizations | 1.38 visits | Standard Deviation 2 |
| CD Participants With CPAF (ICES Database) | Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database | Number of Outpatient Visits | 15.18 visits | Standard Deviation 14.07 |
Primary
Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database
Impact of total disease burden on participants CD with CPAF was based on three procedures which included total cost, total cost (without ODB) and cost by sector i.e. general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, Dialysis, Cancer, and Radiation, non-hospital based residential care, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention.
Time frame: From the index date up to 5 years post-index
Population: All participants who were eligible as cases (CD Participants with CPAF) CPAF from the ICES database were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Hospital Outpatient Clinics | 4482.35 canadian dollars | Standard Deviation 4128.71 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Non-Hospital Based Residential Care | 293.11 canadian dollars | Standard Deviation 3402.11 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Home Care Services | 1231.69 canadian dollars | Standard Deviation 3596.56 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: GP | 1144.88 canadian dollars | Standard Deviation 1762.59 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Dialysis, Cancer, and Radiation | 212.03 canadian dollars | Standard Deviation 2312.88 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Hospital Admissions | 7615.50 canadian dollars | Standard Deviation 14938.04 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Total Cost | 45982.45 canadian dollars | Standard Deviation 51581.52 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Total Cost (Without ODB) | 26799.65 canadian dollars | Standard Deviation 26777.44 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: ODB | 19182.85 canadian dollars | Standard Deviation 42673.84 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Specialist | 7128.15 canadian dollars | Standard Deviation 5772.59 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: SDS | 2007.24 canadian dollars | Standard Deviation 2090.86 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Emergency department (ED) | 1664.22 canadian dollars | Standard Deviation 2355.68 |
| CD Participants With CPAF - TOH | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: All physician OHIP | 9293.98 canadian dollars | Standard Deviation 6771.63 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Hospital Admissions | 9623.01 canadian dollars | Standard Deviation 18429.69 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Total Cost | 65430.16 canadian dollars | Standard Deviation 68268.35 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Total Cost (Without ODB) | 36992.93 canadian dollars | Standard Deviation 33981.36 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: GP | 1218.24 canadian dollars | Standard Deviation 1583.95 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Specialist | 8019.46 canadian dollars | Standard Deviation 4884.16 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: All physician OHIP | 10240.95 canadian dollars | Standard Deviation 5951.3 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Home Care Services | 5217.44 canadian dollars | Standard Deviation 14078.41 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Dialysis, Cancer, and Radiation | 350.46 canadian dollars | Standard Deviation 5383.99 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Non-Hospital Based Residential Care | 185.89 canadian dollars | Standard Deviation 2393.87 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Emergency department (ED) | 1657.65 canadian dollars | Standard Deviation 1966.21 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: ODB | 28437.24 canadian dollars | Standard Deviation 55455.37 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Hospital Outpatient Clinics | 6202.11 canadian dollars | Standard Deviation 5617.27 |
| CD Participants With CPAF (ICES Database) | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: SDS | 3515.43 canadian dollars | Standard Deviation 2132.19 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Non-Hospital Based Residential Care | 0.00 canadian dollars | Standard Deviation 0 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Specialist | 14610.30 canadian dollars | Standard Deviation 8173.77 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Hospital Outpatient Clinics | 8713.70 canadian dollars | Standard Deviation 6348.41 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Emergency department (ED) | 3962.38 canadian dollars | Standard Deviation 6285.67 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: GP | 2588.51 canadian dollars | Standard Deviation 4379.07 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Total Cost | 142034.86 canadian dollars | Standard Deviation 119455.5 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: ODB | 47708.86 canadian dollars | Standard Deviation 69074.61 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Hospital Admissions | 45353.59 canadian dollars | Standard Deviation 66413.97 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Home Care Services | 13860.7 canadian dollars | Standard Deviation 21997.79 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Total Cost (Without ODB) | 94326 canadian dollars | Standard Deviation 100709.22 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: Dialysis, Cancer, and Radiation | 66.78 canadian dollars | Standard Deviation 406.23 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: All physician OHIP | 18302.27 canadian dollars | Standard Deviation 10416.85 |
| Advanced Intervention | Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database | Cost by Sector: SDS | 4066.57 canadian dollars | Standard Deviation 2424.82 |
Primary
Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF
Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention.
Time frame: From the index date up to 5 years post-index
Population: All participants who were eligible as cases (CD Participants with CPAF) CPAF from the ICES database were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD Participants With CPAF - TOH | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of Hospitalizations | 1.06 visits | Standard Deviation 1.54 |
| CD Participants With CPAF - TOH | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of ED Visits | 5.29 visits | Standard Deviation 7.74 |
| CD Participants With CPAF - TOH | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of Outpatient Visits | 12.11 visits | Standard Deviation 11.31 |
| CD Participants With CPAF (ICES Database) | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of Hospitalizations | 1.37 visits | Standard Deviation 1.84 |
| CD Participants With CPAF (ICES Database) | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of ED Visits | 5.11 visits | Standard Deviation 5.79 |
| CD Participants With CPAF (ICES Database) | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of Outpatient Visits | 16.57 visits | Standard Deviation 15.04 |
| Advanced Intervention | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of ED Visits | 11.22 visits | Standard Deviation 18.46 |
| Advanced Intervention | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of Outpatient Visits | 23.24 visits | Standard Deviation 16.82 |
| Advanced Intervention | Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF | Number of Hospitalizations | 3.57 visits | Standard Deviation 3.79 |