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Assessing the Readability and Quality of Patient or Caregiver Fact Sheets for COVID-19 Therapeutics with Emergency Use Authorization by the Food and Drug Administration

Aside from remdesivir, US Food and Drug Administration approved drug to treat coronavirus disease 2019 (COVID-19), FDA authorized emergency use of drug products known as EUA due to unavailability of treatments for different circumstances1. We conducted this study to determine fact sheet readability and quality of FDA-approved and EUA non-vaccine drugs or biologicals (therapeutics) to treat COVID-19. Design In a cross-sectional study, we identified facts sheets with 1 or more issuances using Google and the terms fact sheet and <therapeutic name> and FDA EUA website for fact sheets for patients, parents, or caregivers on 1/17/22 and 3/2/221. Similarities in quality and readability between fact sheets allowed grouping by therapeutic. Two investigators independently selected eligible English-language fact sheets on FDA-approved drugs and EUAs for COVID-19 treatment. Primary outcomes were readability and quality. We used 7 readability tests including Flesch-Kincaid reading ease index (FKRE) [ranges from 0 to 100 where higher scores correspond to reading ease]. Lower grades correspond to easier readability with Flesch-Kincaid grade (FKG) level (ranges from grades 0 to 18 [college graduate], Gunning-Fog (GF) score (ranges from grades 0 to 20 [college graduate]), Coleman-Liau index (CLI) [ranges from grade 4 to college graduate] , automated readability index (ARI) [ranging from grades 5 to 22 (college graduate)], New Dale-Chall Readability (NDCR) [ranges from grade 4 to college graduate], and simple measure of gobbledygook (SMOG) [ranges from grade 3 to college graduate]. Secondary outcomes were word, syllable, and sentence counts. Agreement between investigators was good (80%) in rating 2 fact sheets for quality using the 16-item DISCERN instrument2 with Likert-responses (minimum 1, maximum 5) where the total is 80 and lowest is 16, corresponding to low-quality information ; another investigator rated the remainder. Items on the DISCERN assess the transparency of authorship information and relevance of treatment options to patients as described previously2. Results We found 18 fact sheets that described 6 (37.5%) anti-viral (4 for remdesivir and 1 each molnupiravir and nirmatrelvir/ritonavir), 9 (43.8%) SARS-CoV-2-targeting monoclonal antibody (1 for bamlanivimab/etesevimab, 3 for casirivimab/imdevimab, and 2 each for sotrovimab, tixagevimab/cilgavimab, and 1 for bebtelovimab) and 3 (21.4%) immune modulator (1 each tocilizumab, baricitinib, and convalescent plasma) information. Table 1 shows the median FKG, GF, CLI, ARI, NDCR, and SMOG reading levels above sixth-grade and quality was fair. Conclusions Although of fair quality, the reading grade level of fact sheets intended for patients, parents, or caregivers for COVID-19 therapeutics was high, reflecting a need for FDA officials to enforce readable resources from drug manufacturers.

COVID-19 ; therapeutics ; readability ; quality

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