Evidence map›Paper›PMID 34341945›Full record

ArticleTherapeutic innovation & regulatory science2021

An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling.

Kara L Jacobson, Juliette Faughnan, Laurie Myers, Amy Dubost, Lisa Courtade, Scott von Lutcken, Christine McCrary Sisk, Suzanne Gregory, Anita Cunningham, Cathryn Gunther and 1 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Kara L JacobsonRollins School of Public Health of Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA. kljacob@emory.edu.
Juliette FaughnanSommer Consulting, Langhorne, PA, USA.
Laurie MyersMerck & Co., Inc., Kenilworth, NJ, USA.
Amy DubostMerck & Co., Inc., Kenilworth, NJ, USA.
Lisa CourtadeMerck & Co., Inc., Kenilworth, NJ, USA.
Scott von LutckenMerck & Co., Inc., Kenilworth, NJ, USA.
Christine McCrary SiskMerck & Co., Inc., Kenilworth, NJ, USA.
Suzanne GregoryMerck & Co., Inc., Kenilworth, NJ, USA.
Anita CunninghamMerck & Co., Inc., Kenilworth, NJ, USA.
Cathryn GuntherMerck & Co., Inc., Kenilworth, NJ, USA.
Michael S WolfFeinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USEmory University · USNew Jersey City University · USNorthwestern University · US

Funding

Research Design, Data, and Analytics CoreP30DK092949 · NIDDK · UNIVERSITY OF CHICAGO · PI Ronald T. Ackermann, MARSHALL H CHIN · 2011 to 2026
$10.0M
NIDDK NIH HHS P30 DK092949
6 · The paper itself

Abstract

objectiveLimited 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.

methodsWe 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.

resultsContent 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).

conclusionThis methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy.

Indexed as

Health LiteracyDrug LabelingHumansLanguageHealth literacyLabeling comprehensionMedGuidePatient labelingPatient package insertPatient understanding

Identifiers

PMID34341945
PMCPMC8492593
OpenAlexW3188726302

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.