Cargando…
An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling
OBJECTIVE: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using t...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8492593/ https://www.ncbi.nlm.nih.gov/pubmed/34341945 http://dx.doi.org/10.1007/s43441-021-00325-5 |
_version_ | 1784578946672623616 |
---|---|
author | Jacobson, Kara L. Faughnan, Juliette Myers, Laurie Dubost, Amy Courtade, Lisa von Lutcken, Scott McCrary Sisk, Christine Gregory, Suzanne Cunningham, Anita Gunther, Cathryn Wolf, Michael S. |
author_facet | Jacobson, Kara L. Faughnan, Juliette Myers, Laurie Dubost, Amy Courtade, Lisa von Lutcken, Scott McCrary Sisk, Christine Gregory, Suzanne Cunningham, Anita Gunther, Cathryn Wolf, Michael S. |
author_sort | Jacobson, Kara L. |
collection | PubMed |
description | OBJECTIVE: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using the Patient Package Insert (PPI) for bezlotoxumab (ZINPLAVA™, Merck & Co., Inc., Kenilworth, NJ, USA) as an example. METHODS: We used a mixed-model, iterative approach consisting of three phases: (1) content development; (2) focus group testing; and (3) comprehension testing. Content development was based on evidence-based health literacy principles and conducted through a collaborative partnership between industry and academia professionals. The PPI was then tested in four focus groups, two in Atlanta and two in Chicago, with an emphasis on collecting feedback from respondents with limited health literacy, evaluated using the Newest Vital Sign (NVS) health literacy assessment tool. Subsequent comprehension testing included patients with C. diff, caregivers, and general population members, with a pre-defined target sample of 25% with limited health literacy identified through two health literacy assessment tools: the Single Item Literacy Screener and the NVS. RESULTS: Content development of the bezlotoxumab PPI occurred in May 2015. In June 2015, focus group respondents (n = 34) provided generally favorable feedback, with insights revolving around organization and usability; language and comprehension; and volume of information. Comprehension testing of the revised PPI resulted in average comprehension scores of 96% for the overall population (n = 59), 90% for individuals presenting with limited health literacy (n = 14), and 97% for those with adequate health literacy (n = 45). This PPI development approach was similarly effective for subsequent products across diverse therapeutic areas, with comprehension scores ≥ 86% for all participants (n = 1197). CONCLUSION: This methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-021-00325-5. |
format | Online Article Text |
id | pubmed-8492593 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-84925932021-10-15 An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling Jacobson, Kara L. Faughnan, Juliette Myers, Laurie Dubost, Amy Courtade, Lisa von Lutcken, Scott McCrary Sisk, Christine Gregory, Suzanne Cunningham, Anita Gunther, Cathryn Wolf, Michael S. Ther Innov Regul Sci Original Research OBJECTIVE: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using the Patient Package Insert (PPI) for bezlotoxumab (ZINPLAVA™, Merck & Co., Inc., Kenilworth, NJ, USA) as an example. METHODS: We used a mixed-model, iterative approach consisting of three phases: (1) content development; (2) focus group testing; and (3) comprehension testing. Content development was based on evidence-based health literacy principles and conducted through a collaborative partnership between industry and academia professionals. The PPI was then tested in four focus groups, two in Atlanta and two in Chicago, with an emphasis on collecting feedback from respondents with limited health literacy, evaluated using the Newest Vital Sign (NVS) health literacy assessment tool. Subsequent comprehension testing included patients with C. diff, caregivers, and general population members, with a pre-defined target sample of 25% with limited health literacy identified through two health literacy assessment tools: the Single Item Literacy Screener and the NVS. RESULTS: Content development of the bezlotoxumab PPI occurred in May 2015. In June 2015, focus group respondents (n = 34) provided generally favorable feedback, with insights revolving around organization and usability; language and comprehension; and volume of information. Comprehension testing of the revised PPI resulted in average comprehension scores of 96% for the overall population (n = 59), 90% for individuals presenting with limited health literacy (n = 14), and 97% for those with adequate health literacy (n = 45). This PPI development approach was similarly effective for subsequent products across diverse therapeutic areas, with comprehension scores ≥ 86% for all participants (n = 1197). CONCLUSION: This methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-021-00325-5. Springer International Publishing 2021-08-02 2021 /pmc/articles/PMC8492593/ /pubmed/34341945 http://dx.doi.org/10.1007/s43441-021-00325-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Research Jacobson, Kara L. Faughnan, Juliette Myers, Laurie Dubost, Amy Courtade, Lisa von Lutcken, Scott McCrary Sisk, Christine Gregory, Suzanne Cunningham, Anita Gunther, Cathryn Wolf, Michael S. An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling |
title | An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling |
title_full | An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling |
title_fullStr | An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling |
title_full_unstemmed | An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling |
title_short | An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling |
title_sort | innovative health literacy approach designed to improve patient understanding of medication labeling |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8492593/ https://www.ncbi.nlm.nih.gov/pubmed/34341945 http://dx.doi.org/10.1007/s43441-021-00325-5 |
work_keys_str_mv | AT jacobsonkaral aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT faughnanjuliette aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT myerslaurie aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT dubostamy aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT courtadelisa aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT vonlutckenscott aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT mccrarysiskchristine aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT gregorysuzanne aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT cunninghamanita aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT gunthercathryn aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT wolfmichaels aninnovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT jacobsonkaral innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT faughnanjuliette innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT myerslaurie innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT dubostamy innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT courtadelisa innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT vonlutckenscott innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT mccrarysiskchristine innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT gregorysuzanne innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT cunninghamanita innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT gunthercathryn innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling AT wolfmichaels innovativehealthliteracyapproachdesignedtoimprovepatientunderstandingofmedicationlabeling |