Clinical trial NCT02316678: Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
Official title: Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Inflammatory Bowel Diseases
Crohn's Disease
Keywords: Patient Preference
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
name: University of Alabama at Birmingham
name: Duke University
name: Patient-Centered Outcomes Research Institute
First posted: 2014-12-15
Enrollment: 9573
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will use Medicare data from 2006-2011. Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or coritcosteroids as defined below. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

Brief summary: The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.

Detailed description: The investigators will conduct a comparative effectiveness study among Medicare Parts A, B, and D beneficiaries with inflammatory bowel disease. The investigators will compare the incidence of severe infection, bowel resection surgery, and death among new users of anti-tumor necrosis factor therapies and corticosteroids. The investigators will compute propensity scores to describe the propensity for treatment with anti-tumor necrosis factor drugs compared to corticosteroids, and will match corticosteroids and anti-tumor necrosis factor drug treated patients on the propensity score. Cox regression will be employed to assess the hazard ratio for each of the outcomes.

Eligibility criteria: Inclusion Criteria:

1. Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or corticosteroids. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

Exclusion Criteria:

1. Diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy.
2. Less than 6 months of follow-up time within the data source prior to initiation of the therapy.
3. Diagnosis of cancer in the 6 months prior to initiation of the study medication.
4. Initiation of anti-TNF therapies within the first 6 months following surgery.
5. Patients who are in managed care plans (Medicare Part C).

Primary outcomes:
measure: Mortality Rate
timeFrame: See Outcome Measure Description above
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James D Lewis, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bewtra M, Reed SD, Johnson FR, Scott FI, Gilroy E, Sandler RS, Chen W, Lewis JD. Variation Among Patients With Crohn's Disease in Benefit vs Risk Preferences and Remission Time Equivalents. Clin Gastroenterol Hepatol. 2020 Feb;18(2):406-414.e7. doi: 10.1016/j.cgh.2019.05.010. Epub 2019 May 14.