Hemorrhage, Gastrointestinal, Kidney Diseases, Myocardial Infarction, Stroke
Conditions
Brief summary
The Purpose of this study is to examine whether evidence of channeling exists by analyzing within a cohort of participants with first prescriptions of single-ingredient paracetamol or ibuprofen (or both) whether participants with paracetamol were more likely to have an ibuprofen-related contraindication.
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in up-to-standard practices (practices that have been qualified for research purposes by the Clinical Practice Research Datalink \[CPRD\] administrators) in the CPRD * Received a first prescription for paracetamol or a first prescription for ibuprofen in 2012 * Were age 18 or older in the date of their qualifying prescription in 2012
Exclusion criteria
* Who received a prescription for paracetamol or ibuprofen in the 6 months prior to their qualifying prescription in 2012 * Who received a prescription for any acetaminophen- or ibuprofen-containing combination products in the 6 months prior to the qualifying prescription in 2012
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Channeling as Measured by an Odds-ratio Different From 1.0 for Contraindications to Ibuprofen Comparing Paracetamol and Ibuprofen Groups | up to 7 months | Participants receiving first prescriptions of single-ingredient paracetamol or ibuprofen will be assessed to analyze whether participants with paracetamol were more likely to have had an ibuprofen-related contraindication than participants with ibuprofen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Propensity Score Model | up to 7 months | The potential to control for channeling bias will be examined. It will also assess whether there will be sufficient overlap in propensity scores to allow for adequate adjustment to control for bias due to channeling. The propensity score is the estimated probability of receiving a treatment (paracetamol), based on the available data, ranges from 0 to 1. The higher the score, the more likely to be treated with paracetamol. |
| Extent of Bias as Measured by an Odds-ratio Different From 1.0 for the Covariate Indicating Exposure to Paracetamol or Ibuprofen in the Negative Control Outcome Models | up to 7 months | Relative risks for paracetamol versus ibuprofen for the 31 negative control outcomes should be 1.0 if there is no bias. A series of models with increasing numbers of covariates will be fit to measure the extent to which covariates can diminish the impact of bias. |
Countries
United States
Outcome results
None listed