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| Name | Class |
|---|---|
| Crohn's and Colitis Foundation | OTHER |
| University of Alabama at Birmingham | OTHER |
| Duke University | OTHER |
| Patient-Centered Outcomes Research Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-TNF - no intervention | Patients who are new users of anti-TNF therapy |
| |
| Corticosteroids - no intervention | Patients initiating corticosteroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | There is no intervention |
|
| 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 |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| James D Lewis, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31100456 | Derived | 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. |
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This is a retrospective cohort study of Medicaid and Medicare beneficiaries with Inflammatory Bowel Disease (IBD) in the United States using administrative data. Medicaid data were from 2001-2005 and Medicare data were from 2006-2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-TNF - no Intervention | Patients who are new users of anti-TNF therapy No intervention: There is no intervention |
| FG001 | Corticosteroids - no Intervention | Patients initiating corticosteroids No intervention: There is no intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-TNF - no Intervention | Patients who are new users of anti-TNF therapy No intervention: There is no intervention |
| BG001 | Corticosteroids - no Intervention | Patients initiating corticosteroids No intervention: There is no intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients treated with corticosteroids (CS) within the prior year and subsequently received either additional CS therapy meeting the definition of prolonged CS use or newly initiated anti-TNF therapy were included in the study. | Posted | Number | events per 1000 person-years | See Outcome Measure Description above |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anti-TNF - no Intervention | Patients who are new users of anti-TNF therapy No intervention: There is no intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Lewis | University of Pennsylvania | 215-573-5137 | lewisjd@upenn.edu |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
New users of anti-TNF therapy defined as ≥ 1 dispensing for an anti-TNF drug with ≥1 filled CS prescription and no dispensing for any anti-TNF medication in the 12 months preceding the first anti-TNF dispensing. |
| OG001 | Steroids | Prolonged users of steroids defined as either >3000 mg of prednisone (or equivalent) or >600 mg of budesonide divided between ≥2 prescriptions within 12 months and absence of any anti-TNF therapy during the same 12 months. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Corticosteroids - no Intervention | Patients initiating corticosteroids No intervention: There is no intervention | 0 | 0 | 0 | 0 |
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| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |