Quality and readability of drug fact sheets for FDA-approved and emergency use authorised drug products for COVID-19 treatment: an observational study.

Abstract

Objectives: To determine the quality of drug manufacturers' fact sheets for patients for COVID-19 therapeutics for baricitinib, convalescent plasma, anakinra, molnupiravir, nirmatrelvir/ritonavir, remdesivir, tocilizumab and vilobelimab, and fact sheet readability.

Design: Cross-sectional document analysis.

Setting: Fact sheets on COVID-19 drugs approved by the US Food and Drug Administration from 2020 to 2023.

Primary and secondary outcome measures: Quality assessments with the 16-item DISCERN tool scored 16-80 points and 36-item Ensuring Quality of Information for Patients (EQIP) tool scored 0-36, where lower scores indicate low-quality information. We assessed readability with Flesch-Kincaid Reading Ease (ranges from 0 to 100 where higher scores correspond to reading ease). Higher grades indicated hard-to-read information: Flesch-Kincaid grade level (ranges from grades 0 to 18 (college graduate)), Gunning-Fog score (ranges from grades 0 to 20 (college graduate)), Coleman-Liau index (ranges from grade 4 to college graduate), automated readability index (ranging from grades 5 to 22 (college graduate)), Dale-Chall Readability (ranges from grade 4 to college graduate) and simple measure of gobbledygook (ranges from grade 3 to college graduate). Secondary outcomes were word, syllable and sentence counts. We reported percentages and the median (IQR).

Results: We found 18 fact sheets that described 11 (63.5%) anti-virals (remdesivir (n=4), molnupiravir (n=4) and nirmatrelvir/ritonavir (n=3)) and 7 (37.5%) immune modulators (tocilizumab (n=2), baricitinib (n=2), convalescent plasma (n=1), anakinra (n=1) and vilobelimab (n=1)). DISCERN (median (IQR)) reliability was 4 (IQR 3-4) and 5 (1-5), while DISCERN treatment information was 3 (1-5) and 5 (1-5) for anti-virals and immune modulators, respectively. EQIP (median (IQR)) content was 12 (11-13) and 11 (11-13), identification of information was 4 (3-4) and 3 (3-3) and structure was 9 (8-9) and 9 (9-9) for anti-virals and immune modulators, respectively. Overall, fact sheets had median readability grade levels that ranged from 6.2 to 12.4. Anti-viral and immune modulator fact sheets had median readability grade levels from 6.1 to 12.5. Median (IQR) word, >4 syllable words and sentence counts were 1646.5 (1318.3-1934.8), 25.0 (21.3-29.8) and 118.0 (92.0-152.5) overall; 1758.00 (1200.0-2181.0), 23.0 (15.0-27.0) and 134.0 (82.0-185.0) for anti-virals; and 1461.0 (1341.0-1776.0), 29.0 (23.0-46.0) and 107.0 (105.0-122.0) for immune modulators, respectively.

Conclusions: Although of fair quality, the fact sheet reading level was high, and the transparency of sources used was low. Regulatory officials should enforce readable resources from drug manufacturers to guide patients' decision-making surrounding COVID-19 therapeutics.