Dataset Information

Usability of FDA-approved medication guides.

ABSTRACT:

Background

Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use.

Objective

To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy.

Design

Assessments of suitability and readability of 185 medication guides, and a sub-study examining change in suitability and readability from 2006 to 2010 among 32 of the medication guides (Study 1); 'open book' comprehension assessment of medication guides (Study 2).

Setting

Two general internal medicine clinics in Chicago, IL.

Patients

Four hundred and forty-nine adults seeking primary care services, ages 18-85.

Measurements

For Study 1, the Suitability Assessment of Materials (SAM) and Lexile score for readability. For Study 2, a tailored comprehension assessment of content found in three representative medication guides.

Results

The 185 analyzed medication guides were on average 1923 words (SD?=?1022), with a mean reading level of 10-11th grade. Only one medication guide was deemed suitable in SAM analyses. None provided summaries or reviews, or framed the context first, while very few were rated as having made the purpose evident (8 %), or limited the scope of content (22 %). For Study 2, participants' comprehension of medication guides was poor (M?=?52.7 % correct responses, SD?=?22.6). In multivariable analysis, low and marginal literacy were independently associated with poorer understanding (??=?-14.3, 95 % CI -18.0 - -10.6, p?ConclusionCurrent medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.

SUBMITTER: Wolf MS

PROVIDER: S-EPMC3509312 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Publications

Usability of FDA-approved medication guides.

Wolf Michael S MS King Jennifer J Wilson Elizabeth A H EA Curtis Laura M LM Bailey Stacy Cooper SC Duhig James J Russell Allison A Bergeron Ashley A Daly Amanda A Parker Ruth M RM Davis Terry C TC Shrank William H WH Lambert Bruce B

Journal of general internal medicine 20120508 12

<h4>Background</h4>Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use.<h4>Objective</h4>To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy.<h4>Design</h4>Assessments of suitability and readability of 185 medication guide ...[more]

PMID: 22566170

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Project description:The inability of the adult human heart to regenerate lost or damaged myocardial tissue has created one of the most pressing public health dilemmas due to the devastating impact of heart failure. Our group and others have outlined several regulators of cardiomyocyte mitosis that may impact the regenerative capacity of the adult myocardium in mammals. Recently, we reported that the transcription factors Meis1 and Hoxb13 regulate postnatal cardiomyocyte cell cycle arrest, where concomitant deletion of both genes induced cardiomyocyte proliferation and myocardial regeneration following ischemic injury. These studies suggest that pharmacological targeting Meis1 and Hoxb13 transcriptional activity could be a viable path towards heart regeneration. Therefore, we performed an in-silico screen to identify FDA-approved drugs that can inhibit Meis1 and Hoxb13 transcriptional activity based on the published crystal structure of Meis1 and Hoxb13 bound to DNA. Our screen yielded several candidates based on binding profiles to either Meis1 DNA binding domain, Hoxb13 DNA binding domain, or the interface between Meis1 and Hoxb13, as well as safety and side effect profiles. Out of the shortlist of top hits, paromomycin and neomycin induced proliferation of neonatal rat ventricular myocytes in vitro and displayed dose-dependent inhibition of Meis1 and Hoxb13 transcriptional activity by luciferase assay, and disruption of DNA binding by EMSA. X-ray crystal structure revealed that both paromomycin and neomycin bind to Meis1 near the Hoxb13 interaction site where they interact with 3 out of the 5 Meis1 amino acids that participate in DNA-binding. The crystal structure also demonstrates that both drugs bind at the interface of Meis1 homodimer, therefore placing one of the Meis1 monomers in a position incompatible with DNA-binding. Importantly, administration of paromomycin-neomycin combination by intraperitoneal injection in mice induced cardiomyocyte proliferation, improved left ventricular (LV) systolic function and decreased scar formation in two models of ischemic reperfusion injury in mice. Finally, dual intravenous administration of the paromomycin-neomycin combination in Yorkshire pigs following cardiac ischemia/reperfusion injury induced cardiomyocyte proliferation, improved LV systolic function, and decreased scar formation. Collectively, we identified paromomycin and neomycin as FDA-approved drugs with therapeutic potential for induction of heart regeneration in humans.

Dataset Information

Usability of FDA-approved medication guides.

Background

Objective

Design

Setting

Patients

Measurements

Results

Publications

Usability of FDA-approved medication guides.

Similar Datasets

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