Abstract
BackgroundThe package leaflet included in the packaging of all medicinal products plays an important role in the transmission of medicine-related information to patients. Therefore, in 2009, the European Commission published readability guidelines to try to ensure that the information contained in the package leaflet is understood by patients.ObjectiveThe main objective of this study was to calculate and compare the readability levels and length (number of words) of the package leaflets for biological medicines in 2007, 2010, and 2013.MethodsThe sample of this study included 36 biological medicine package leaflets that were downloaded from the European Medicines Agency website in three different years: 2007, 2010, and 2013. The readability of the selected package leaflets was obtained using the following readability formulas: SMOG grade, Flesch-Kincaid grade level, and Szigriszt’s perspicuity index. The length (number of words) of the package leaflets was also measured. Afterwards, the relationship between these quantitative variables (three readability indexes and length) and categorical (or qualitative) variables were analyzed. The categorical variables were the year when the package leaflet was downloaded, the package leaflet section, type of medicine, year of authorization of biological medicine, and marketing authorization holder.ResultsThe readability values of all the package leaflets exceeded the sixth-grade reading level, which is the recommended value for health-related written materials. No statistically significant differences were found between the three years of study in the readability indexes, although differences were observed in the case of the length (P=.002), which increased over the study period. When the relationship between readability indexes and length and the other variables was analyzed, statistically significant differences were found between package leaflet sections (P<.001) and between the groups of medicine only with regard to the length over the three studied years (P=.002 in 2007, P=.007 in 2010, P=.009 in 2013). Linear correlation was observed between the readability indexes (SMOG grade and Flesch-Kincaid grade level: r2=.92; SMOG grade and Szigriszt’s perspicuity index: r2=.81; Flesch-Kincaid grade level and Szigriszt’s perspicuity index: r2=.95), but not between the readability indexes and the length (length and SMOG grade: r2=.05; length and Flesch-Kincaid grade level: r2=.03; length and Szigriszt’s perspicuity index: r2=.02).ConclusionsThere was no improvement in the readability of the package leaflets studied between 2007 and 2013 despite the European Commission’s 2009 guideline on the readability of package leaflets. The results obtained from the different readability formulas coincided from a qualitative point of view. Efforts to improve the readability of package leaflets for biological medicines are required to promote the understandability and accessibility of this online health information by patients and thereby contribute to the appropriate use of medicines and medicine safety.
Highlights
Today, health care professionals are no longer the only source of information for patients on matters related to health because the new information and communication technologies have increased the capacity of patients to seek information independently [1-3]
No statistically significant differences were found in the readability values between the three years (P=.40 in SMOG grade, P=.22 in Flesch-Kincaid grade level, P=.20 in Szigriszt perspicuity index), but differences emerged in terms of the length (P=.002), with the length of the package leaflets increasing over the 6-year period (Figure 1)
Most studies to date have shown that the materials targeted at patients are written with readability levels that make it difficult for the materials to be understood by most people
Summary
Health care professionals are no longer the only source of information for patients on matters related to health because the new information and communication technologies have increased the capacity of patients to seek information independently [1-3]. That is why patient education is growing in importance; in particular, written health-related materials available on the Internet [4], such as package leaflets provided by manufacturers. On the basis of this concept, health literacy is defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions” [6]. The capacity of the individual is an important aspect in the definition of health literacy, referring to both innate and acquired skills [7]. Health literacy plays an important role in the evaluation of the online health information [8]. The package leaflet included in the packaging of all medicinal products plays an important role in the transmission of medicine-related information to patients. In 2009, the European Commission published readability guidelines to try to ensure that the information contained in the package leaflet is understood by patients
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