Perianal Fistula (PAF) Validation and Burden of Illness Study

Perianal Fistula Procedure Validation, Matched Case Control, and Patient Journey Study

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease; Perianal Fistula; Crohns Disease
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 3032

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Oakville, Ontario, Canada, L6H 0J8
      • Takeda Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with CD with and without CPAF will be observed retrospectively in this study.

Description

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.

Exclusion Criteria for Objective 2:

1. Missing demographics at index date (sex, age, neighbourhood income quintile, LHIN).
2. Death during 5-year analysis period.
3. Ontario Health Insurance Plan (OHIP) coverage is terminated during the follow-up example if the participant moves to another province.
4. Meeting the case definition during the lookback period.
5. Cases for whom a matched control cannot be found.

Exclusion Criteria for Objective 3:

1. Missing demographics at index date (sex, age, neighbourhood income quintile, LHIN).
2. Death during 5-year analysis period.
3. OHIP coverage is terminated during the 5-year analysis period example if the participant moves to another province.
4. Meeting the case definition during the lookback period.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CD Participants with CPAF - The Ottawa Hospital (TOH); Participants diagnosed with Complex Perianal Fistula (CPAF) from the Ottawa Hospital (TOH) were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).	Other: No intervention; This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.
CD Participants without CPAF (ICES database); Participants diagnosed with CD and without CPAF from Institute for Clinical Evaluative Sciences (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).	Other: No intervention; This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.
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).	Other: No intervention; This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the date of CD diagnosis up to the index date (approximately 5 years)
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.	From the index date up to end of study (approximately 5 years post-index)
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.	From the index date up to end of study (approximately 5 years post-index)
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.	From the index date up to 5 years post-index
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.	From the index date up to 5 years post-index

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Inflammatory Bowel Diseases; Fistula; Crohn Disease; Rectal Fistula
• Other Study ID Numbers: IBD-5009; U1111-1233-6312 (Other Identifier: World health organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No