William J Sheehan1, Ian M Paul2, David T Mauger3, James N Moy4, Stanley J Szefler5, Daniel J Jackson6, Anne M Fitzpatrick7, Michael D Cabana8, Ronina Covar9, Rachel G Robison10, Wanda Phipatanakul11. 1. Boston Children's Hospital, Division of Allergy and Immunology, Harvard Medical School, Boston, MA, United States of America; Children's National Hospital, Division of Allergy and Immunology, George Washington University School of Medicine and Health Sciences, Washington DC, United States of America. 2. Penn State College of Medicine, Department of Pediatrics, Hershey, PA, United States of America. 3. Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA, United States of America. 4. Stroger Hospital of Cook County, Department of Pediatrics, Rush University Medical Center, Chicago, IL, United States of America. 5. Children's Hospital Colorado, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, United States of America. 6. University of Wisconsin School of Medicine and Public Health, Section of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Madison, WI, United States of America. 7. Emory University, Department of Pediatrics, Atlanta, GA, United States of America. 8. University of California, San Francisco, Department of Pediatrics, San Francisco, CA, United States of America. 9. National Jewish Health, Department of Pediatrics, Denver, CO, United States of America. 10. Ann and Robert H. Lurie Children's Hospital of Chicago, Division of Allergy and Immunology, Chicago, IL, United States of America. 11. Boston Children's Hospital, Division of Allergy and Immunology, Harvard Medical School, Boston, MA, United States of America. Electronic address: wanda.phipatanakul@childrens.harvard.edu.
Abstract
BACKGROUND/AIMS: When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications. METHODS: To prospectively evaluate associations between acetaminophen use and asthma in 300 children aged 1-5 years, we conducted a double blind, randomized, controlled trial where parents administered blinded forms of either acetaminophen or ibuprofen as needed to their children over a 48 week period. Written and verbal instructions encouraged the exclusive use of the blinded study medication and discouraged OTC use. Adherence was determined by evaluating the frequency of use of per-protocol blinded study medication compared to off-protocol use of OTC medications. RESULTS: 4195 doses of acetaminophen or ibuprofen were received by children during the study which included 3664 doses (87.3%) of blinded study medication adhering to the protocol and 531 doses (12.7%) of OTC products deviating from the protocol with better adherence among those randomized to ibuprofen as compared to acetaminophen (89.5% vs. 85.5% of doses, p < 0.01). Individually, 227 participants (75.7%) remained fully adherent by not receiving any OTC medications. Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication. CONCLUSION: This parallel study demonstrated greater than 85% of acetaminophen or ibuprofen doses were blinded study medications adhering to the protocol while less than 15% were OTC deviations from the protocol. This successfully implemented study design provides a template to comparatively evaluate these and other OTC medications.
BACKGROUND/AIMS: When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications. METHODS: To prospectively evaluate associations between acetaminophen use and asthma in 300 children aged 1-5 years, we conducted a double blind, randomized, controlled trial where parents administered blinded forms of either acetaminophen or ibuprofen as needed to their children over a 48 week period. Written and verbal instructions encouraged the exclusive use of the blinded study medication and discouraged OTC use. Adherence was determined by evaluating the frequency of use of per-protocol blinded study medication compared to off-protocol use of OTC medications. RESULTS: 4195 doses of acetaminophen or ibuprofen were received by children during the study which included 3664 doses (87.3%) of blinded study medication adhering to the protocol and 531 doses (12.7%) of OTC products deviating from the protocol with better adherence among those randomized to ibuprofen as compared to acetaminophen (89.5% vs. 85.5% of doses, p < 0.01). Individually, 227 participants (75.7%) remained fully adherent by not receiving any OTC medications. Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication. CONCLUSION: This parallel study demonstrated greater than 85% of acetaminophen or ibuprofen doses were blinded study medications adhering to the protocol while less than 15% were OTC deviations from the protocol. This successfully implemented study design provides a template to comparatively evaluate these and other OTC medications.
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