Readability of medicinal package leaflets: a systematic review

Abstract

OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use.METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords “Readability and Package Leaflet” and “Readability and Package Insert” in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded.RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions.CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

Attitudes towards sales and use of over-the-counter drugs in Sweden in a reregulated pharmacy market: a population-based study

“…Collecting sufficient and adequate information for safe self-care is a responsibility for each individual, but several obstacles exist. Previous research has reported that patient information leaflets often are difficult to understand, [31] and that reading leaflets with additional information regarding potential interactions and side effects does not contribute to safe use (avoiding interacting agents) of analgesics. [32] The level of health literacy has not been established in the general Swedish population.…”

Knowledge translation strategies for dissemination with a focus on healthcare recipients: an overview of systematic reviews

“…Of the 44 SRs, 24 included both experimental and quasi-experimental designs [3, 5, 7, 9, 11, 12, 20, 21, 25, 27-30, 32-34, 36, 38, 41, 42, 49, 51, 53, 54], ten only included randomized controlled trials [18,23,24,26,35,43,47,48,50,52], and ten included both quantitative and qualitative research [10,19,22,31,37,39,40,[44][45][46]. Seventeen SRs included only patients or caregivers [7,9,10,20,24,31,32,34,35,37,39,40,43,44,49,50,53], and the remaining 27 also included providers. Twenty SRs were informed by, or based on, a theory or framework [3,7,9,11,12,18,21,25,27,29,…”

“…For written information that does not require the internet, concerns were raised about motivation and awareness [29,49], health literacy [40,53], and comprehension and understanding [29,40]. Other possible barriers that should be considered are the reliability and trustworthiness of the information [29], personal needs [49], and text complexity and design [40].…”

Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets: a cross-sectional descriptive study

“…3,4,6 These scales are easy to apply and often present high response rates (84-91%) and completion rates (70-85%). 4,7 Another advantage is that 20-item questionnaires in which responses are assessed using a Likert scale can be completed fast: in less than five minutes if the questionnaire is simple. Lastly, these tools give rise to good internal consistency, reliability and construct validity.…”

“…6 Tools using Likert scales for these purposes have also not been reported for Portuguese package leaflets. 4 Pires et al found that sociodemographic characteristics explained Portuguese users' opinions of package leaflets: lower socioeconomic status or higher frequency of taking medicines positively influenced participants' overall opinion and/or perception regarding package leaflets. 5 Worryingly, previous studies detected that package leaflets of authorized medicines were too complex, and were difficult to understand and use, thus confirming that even approved package leaflets need to be optimized.…”