A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications

Completed

• Conditions: Stroke; Myocardial Infarction; Hemorrhage, Gastrointestinal; Kidney Diseases

• Registration Number: NCT02830178
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144337

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.