Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Conditions
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Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn's Disease

Intervention / Treatment
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* Other: No intervention


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anti-TNF - no intervention<br>Patients who are new users of anti-TNF therapy | Other: No intervention<br>* There is no intervention<br>|
| Corticosteroids - no intervention<br>Patients initiating corticosteroids | Other: No intervention<br>* There is no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Incidence of death per 1000 person-years Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD. | See Outcome Measure Description above | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Preference