Dataset Information

Readability assessment of package leaflets of biosimilars.

ABSTRACT:

Objectives

To assess the degree of readability and the length of the package leaflets of biosimilars.

Setting

The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website.

Participants

The study sample included the package leaflets written in English of all the biosimilars that were authorised by the EMA on 31 August 2017, and whose content was available via the internet on that date (n=35).

Design

This was a cross-sectional analytical study. The readability of the package leaflets of all biosimilars authorised by the EMA in August 2017 was determined applying the Flesch and Flesch-Kincaid formulas. The influence of the following variables on the readability and length was also analysed: package leaflet section, type of biosimilar, date of first authorisation of the biosimilar and type of medicine.

Results

A considerable variation of the package leaflets length was found (3154±803). The readability of all the package leaflets overtook the recommended value for health-related written materials taking into account Flesch-Kincaid Index, and none of the package leaflets were easy to understand according to the Flesch Index. Statistically significant differences (p<0.05) were observed between the sections of package leaflets in readability indices and length. The most difficult sections to understand were those related with the therapeutic indication of medicine and the possible side effects.

Conclusions

Package leaflets for authorised biosimilars may not fulfil the function for which they were designed. The competent organisations could be informed about the possible negative effect on the use of this type of medicines.

SUBMITTER: Pinero-Lopez MA

PROVIDER: S-EPMC6340469 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Readability assessment of package leaflets of biosimilars.

Piñero-López María Ángeles MÁ Figueiredo-Escribá Carlos C Modamio Pilar P Lastra Cecilia F CF Mariño Eduardo L EL

BMJ open 20190117 1

<h4>Objectives</h4>To assess the degree of readability and the length of the package leaflets of biosimilars.<h4>Setting</h4>The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website.<h4>Participants</h4>The study sample included the package leaflets written in English of all the biosimilars that were authorised by the EMA on 31 August 2017, and whose content was available via the internet on that date (n=35).<h4>Design</h4>This was a cross-sectional analytic ...[more]

PMID: 30659042

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Project description:BackgroundCurrent German and EU package leaflets (PLs) do not distinguish to what extent listed side effects are indeed side effects caused by drug intake or instead symptoms that occur regardless of drug use. We recently showed that most health professionals misinterpret the frequencies of listed side effects as solely caused by the drug. The present study investigated whether (1) these misinterpretations also prevail among laypeople and (2) alternative PLs reduce these misinterpretations.MethodsIn March 2017, 397 out of 400 laypeople approached completed an online survey. They were randomized to one of four PL formats: three alternative PLs (drug facts box with/without reading instruction, narrative format with numbers) and one standard PL. Each PL listed four side effects for a fictitious drug: two were presented as occurring more often, one as equally often, and one as less often with drug intake. The alternative formats (interventions) included information on frequencies with and without drug intake and included a statement on the causal relation. The standard PL (control) only included information on frequency ranges with drug intake. Questions were asked on general occurrence and causality of side effects.ResultsParticipants randomized to the standard PL were unable to answer questions on causality. For side effects occurring more often (equally; less often) with drug intake, only 1.9% to 2.8% (equally: 1.9%; less often: 1.9%) provided correct responses about the causal nature of side effects, compared to 55.0% to 81.9% (equally: 23.8% to 70.5%; less often: 21.0% to 43.2%) of participants who received alternative PLs. It remains unclear whether one alternative format is superior to the others.ConclusionIn conclusion, information on the frequency of side effects in current package leaflets is misleading. Comparative presentation of frequencies for side effects with and without drug intake including statements on the causal relation significantly improves understanding.

Project description:BackgroundIn the era of new information and communication technologies, the Internet is being increasingly accessed for health-related information. Indeed, recently published patient surveys of people with autoimmune disorders confirmed that the Internet was reported as one of the most important health information sources. Wikipedia, a free online encyclopedia launched in 2001, is generally one of the most visited websites worldwide and is often consulted for health-related information.ObjectiveThe main objective of this investigation was to quantitatively assess whether the Wikipedia pages related to autoimmune disorders can be easily accessed by patients and their families, in terms of readability.MethodsWe obtained and downloaded a list of autoimmune disorders from the American Autoimmune Related Diseases Association (AARDA) website. We analyzed Wikipedia articles for their overall level of readability with 6 different quantitative readability scales: (1) the Flesch Reading Ease, (2) the Gunning Fog Index, (3) the Coleman-Liau Index, (4) the Flesch-Kincaid Grade Level, (5) the Automated Readability Index (ARI), and (6) the Simple Measure of Gobbledygook (SMOG). Further, we investigated the correlation between readability and clinical, pathological, and epidemiological parameters. Moreover, each Wikipedia analysis was assessed according to its content, breaking down the readability indices by main topic of each part (namely, pathogenesis, treatment, diagnosis, and prognosis plus a section containing paragraphs not falling into any of the previous categories).ResultsWe retrieved 134 diseases from the AARDA website. The Flesch Reading Ease yielded a mean score of 24.34 (SD 10.73), indicating that the sites were very difficult to read and best understood by university graduates, while mean Gunning Fog Index and ARI scores were 16.87 (SD 2.03) and 14.06 (SD 2.12), respectively. The Coleman-Liau Index and the Flesch-Kincaid Grade Level yielded mean scores of 14.48 (SD 1.57) and 14.86 (1.95), respectively, while the mean SMOG score was 15.38 (SD 1.37). All the readability indices confirmed that the sites were suitable for a university graduate reading level. We found no correlation between readability and clinical, pathological, and epidemiological parameters. Differences among the different sections of the Wikipedia pages were statistically significant.ConclusionsWikipedia pages related to autoimmune disorders are characterized by a low level of readability. The onus is, therefore, on physicians and health authorities to improve the health literacy skills of patients and their families and to create, together with patients themselves, disease-specific readable sites, disseminating highly accessible health-related online information, in terms of both clarity and conciseness.

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Project description:ImportanceInformed consent is a fundamental element of research ethics. The COVID-19 vaccine trials are high profile trials that have enrolled more than 100 000 participants. Consent documents must be succinct and understandable to ensure informed voluntary participation.ObjectiveTo assess how well informed consent documents of the COVID-19 vaccine trials achieve the ideal of being succinct and understandable, and to create a shorter, more readable document.Design, setting, and participantsThis quality improvement study collected and analyzed the informed consent documents used in 4 COVID-19 vaccine phase III randomized clinical trials to quantitatively assess readability and length and, based on this analysis, created a measurably more accessible informed consent document. Analysis was conducted from October 2020 to January 2021.Main outcomes and measuresThe main outcomes were number of words (measured as word count), time-to-read (measured at reading speeds of 175-300 words per minute), language complexity (measured using Flesch-Kincaid Grade Level assessment), and readability (measured using Flesch Reading Ease Score). Secondary outcomes included clarity of how the placebo group could access the vaccine if it is proven safe and effective. The study also examined the length and readability of an improved consent document.ResultsThe 4 informed consent documents were a mean (range) of 8333 (7821 to 9340) words long, with a mean (range) 35 (32.6 to 38.9) minutes to read at 240 words per minute. All documents exceeded grade 9 language complexity and scored lower than 60 in the formal reading ease metric, which constitutes difficult. Only 1 document specified that participants in the placebo group might receive vaccine. It was possible to write a document in fewer than 3000 words with a grade 7 to 8 reading level and a formal readability score that was not difficult.Conclusions and relevanceThese findings suggest that existing COVID-19 vaccine informed consent documents were too long, difficult to read, and exceeded grade 9 in language complexity. It was possible to create a shorter, more readable informed consent document for these trials.

Project description:Background: From time to time, neuroimaging research findings receive press coverage and attention by the general public. Scientific articles therefore should be written in a readable manner to facilitate knowledge translation and dissemination. However, no published readability report on neuroimaging articles like those published in education, medical and marketing journals is available. As a start, this study therefore aimed to evaluate the readability of the most-cited neuroimaging articles. Methods: The 100 most-cited articles in neuroimaging identified in a recent study by Kim et al. (2016) were evaluated. Headings, mathematical equations, tables, figures, footnotes, appendices, and reference lists were trimmed from the articles. The rest was processed for number of characters, words and sentences. Five readability indices that indicate the school grade appropriate for that reading difficulty (Automated Readability Index, Coleman-Liau Index, Flesch-Kincaid Grade Level, Gunning Fog index and Simple Measure of Gobbledygook index) were computed. An average reading grade level (AGL) was calculated by taking the mean of these five indices. The Flesch Reading Ease (FRE) score was also computed. The readability of the trimmed abstracts and full texts was evaluated against number of authors, country of corresponding author, total citation count, normalized citation count, article type, publication year, impact factor of the year published and type of journal. Results: Mean AGL ± standard deviation (SD) of the trimmed abstracts and full texts were 17.15 ± 2.81 (college graduate level) and 14.22 ± 1.66 (college level) respectively. Mean FRE score ± SD of the abstracts and full texts were 15.70 ± 14.11 (college graduate level) and 32.11 ± 8.56 (college level) respectively. Both items indicated that the full texts were significantly more readable than the abstracts (p < 0.001). Abstract readability was not associated with any factors under investigation. ANCOVAs showed that review/meta-analysis (mean AGL ± SD: 16.0 ± 1.4) and higher impact factor significantly associated with lower readability of the trimmed full texts surveyed. Conclusion: Concerning the 100 most-cited articles in neuroimaging, the full text appears to be more readable than the abstracts. Experimental articles and methodology papers were more readable than reviews/meta-analyses. Articles published in journals with higher impact factors were less readable.

Dataset Information

Readability assessment of package leaflets of biosimilars.

Objectives

Setting

Participants

Design

Results

Conclusions

Publications

Readability assessment of package leaflets of biosimilars.

Similar Datasets

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