Seizure 1999; 8: 35 –37
Article No. seiz.1998.0220, available online at http://www.idealibrary.com on
Readability of patient information leaflets on antiepileptic drugs in the UK I.C.K. Wong
School of Pharmacy, University of Bradford, Bradford BD7 1DP, UK Correspondence to: Dr Ian Wong, Department of Pharmacy Practice, School of Pharmacy, University of Bradford, Bradford BD7 1DP, UK
The Audit Commission in the UK recommends that patient information leaflets (PILs) should be audited by health professionals using a formal readability test. However, no such study on antiepileptic drugs (AEDs) has been identified in a Medline search. The aim of this study was to audit the readability of PILs prepared for marketed proprietary AEDs in the UK. Twelve PILs were compared with six antiepileptic drug articles from medical journals and six headline articles from UK newspapers. The Gunning Fog index and the Flesch Reading Ease index were calculated for each PIL and article. The results of the Gunning Fog index and the Flesch Reading Ease score were compared using the Kruskal–Wallis non-parametric test. PILs were shown to have a statistically significant lower mean reading age than the medical articles and newspapers (P < 0.001). The Gunning Fog index and Flesch Reading Ease score showed that PILs had a mean reading age of 8.8 and mean readability score of 69, respectively. In conclusion, the PILs prepared for proprietary antiepileptic drugs in the UK are suitable for the reading age of the general adult population. Key words: antiepileptic drugs; patient information leaflets; readability.
Introduction Patients who receive patient information leaflets (PILs) generally have improved awareness of medication use, are more likely to be completely satisfied with their treatment, know the name of their medicine, and are more aware of the possible adverse drug reactions1–4 . PILs have also been shown to improve compliance of short-term antibiotic treatment4 , although for the treatment of chronic conditions, the evidence for improving compliance is debatable5, 6 . Since January 1994, the European Community Directive 92/27/EEC has come into force in the UK. All new medicinal products are required to have PILs and the existing products should include PILs according to the Medicines Control Agency (MCA) timetable. The MCA expects the manufacturers to use plain English to produce the PILs. At the moment, no formal readability test is used by the MCA to assess the PILs (MCA, personal communication, 1998). Bradley et al.7 demonstrated that the mean reading age (14.8 years) of the PILs on over-the-counter medicines were well above the mean reading age (9 years) of the general adult population in the UK. They concluded that these PILs might be too difficult for the intended audience. 1059–1311/99/010035 + 03
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It is very important for patients with epilepsy to acquire clear information on AEDs. Clear information can improve compliance and identify adverse drug reaction. The clinical guidelines for treatment of epilepsy also recognize this important message8 . Good PILs should be able to assist the patients in achieving this goal. The Audit Commission in the UK recommends that PILs should be audited by health professionals using a formal readability test9 . However, no such study on AEDs has been identified in a Medline search. As a result, this study was conducted.
Materials and methods Twelve PILs on proprietary AEDs were obtained. Six antiepileptic drug articles were obtained from the British Medical Journal, Epilepsia, Epilepsy Research, The Lancet, Neurology and Seizure10–15 . Six headline articles were obtained from the Daily Mail, the Express, the Guardian, the Independent, the Sun and the Times newspapers16–21 . The Gunning Fog test22 and the Flesch Reading Ease index23 were applied to the above PILs and articles to assess readability. c 1999 British Epilepsy Association
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I.C.K. Wong
Procedures for the Gunning Fog test 1. Choose a group of 100 words that end with a fullstop from the following: (a) the ‘How to take your medicine’ section (or equivalent section) of each PIL; (b) the first few paragraphs of each antiepileptic drug article; and (c) the first few paragraphs of each newspaper article.
where W = average number of syllables per hundred words, and S = average number of words in a sentence. This test was performed by Microsoft Word 97 SR-1. The Flesch Reading Ease index provides numeric representation of reading difficulty ranging from zero (extremely difficult) to 100 (extremely easy). To ensure that most of the population is able to understand; the written material should have an index of around 60–70. The results of the Gunning Fog test and the Flesch Reading Ease score were then analysed using the Kruskal–Wallis non-parametric test. This analysis was performed using SPSS for Window V7.5.
Results Then divide the total number of words in the passage by the number of sentences. This gives the average sentence length of the passage. 2. Count the number of words of three syllables or more per 100 words. Do not count words: (a) that are capitalized (chemical and drug names were classified as capitalized words in this study); (b) that are combinations of short easy words (like ‘bookkeeper’ and ‘butterfly’); and (c) that are verb forms made of three syllables by adding ‘-ed’ or ‘-es’ (like ‘created’ or ‘trespasses’). Divide the exact number of three-syllable words by the exact number of words in the passage. This gives the percentage of hard words in the passage. 3. To obtain the Fog Score, add the average sentence length to the percentage of hard words. Multiply by 0.4. The final number is approximately the number of years of education (not counting kindergarten) needed to understand the writing sample easily, quickly and completely. To ensure that most of the population is able to understand; the written material should have an index of around 12 (equivalent to an average score of lead stories in the tabloid press).
Procedures for the Flesch Reading Ease index Use the same passage selected for the Gunning Fog test and apply the following formula: Reading Ease score = 206.835 − 0.846W − 1.015S
PILs were more readable than the scientific articles and newspapers. The Flesch Reading Ease index and the Gunning Fog test results showed that PILs had a mean readability score of 69 and reading age of 8.8, respectively. The results of the Flesch and Gunning Fog test are shown in Table 1.
Table 1: Results of the Flesch and Gunning Fog tests. Flesch Reading Gunning Fog Index Ease score AED articles in medical journals Epilepsy Research 22.9 13.6 BMJ 35.7 14.8 Seizure 22.9 15.4 Neurology 0 16.4 Epilepsia 22.1 17.6 Lancet 24.7 18.7 Mean (95% CI) 21.4 (9.2–33.6) 16.1 (14.1–18.0) Headline articles in the UK newspapers Guardian 57.8 11.5 Express 52.8 12.1 Sun 55.9 12.5 Daily Mail 47.2 12.8 Independent 49.4 13.9 Times 50 14.1 Mean (95% CI) 52.2 (47.9–56.5) 12.8 (11.8–13.9) Patient information leaflets on antiepileptic drugs in the UK Tegretol 85.8 6.4 Zarontin 67.2 7.0 Neurontin 63.7 7.9 Diamox 59.6 8.6 Epilim 67.4 8.7 Sabril 60.7 8.8 Lamictal 83.5 9.1 Epanutin 68.9 9.4 Topamax 71.6 9.7 Mysoline 68.0 9.8 Rivotril 65.3 10.2 Frisium 65.9 10.3 Mean (95% CI) 69.0 (63.8–69.0) 8.8 (8.05–9.6) Recommended for general adult population 60–70 12 The 95% confidence intervals (CI) of the mean of the Flesch Reading Ease score and the Gunning Fog index do not overlap between PILs, medical articles and newspaper articles and Kruskal–Wallis P < 0.001.
Readability of patient information leaflets
Discussion It is very encouraging to find that all the PILs are actually within the recommended reading age. They all have been shown to have a lower reading age than the UK newspapers. Furthermore, the mean Gunning Fog test result suggests that the mean reading age of the PILs (8.8 years) is similar to the UK adult population (9 years). It suggests that these PILs are suitable for the UK adult population. When compared with other studies, these PILs show a lower reading age than other studies7, 24, 25 . One of the reasons may be that patients with epilepsy are perceived to be mentally impaired. The manufacturers make special efforts to simplify the PILs for AEDs. Assessing the PILs is not a simple task. Although readability scores are well known in general education and have been used to assess a range of health-related material; they take no account of grammar, content or the ability of the readers7, 26 . Consequently, whether the readers can understand or not remains unknown. Despite the above problems, readability tests provide an objective comparison of texts across different styles of writing. They can also ensure the texts do not have too many long words or sentences. At least in theory, the text will be easier to read and remember. The Audit Commission in England recommends the use of the Gunning Fog test to examine the PILs9 in order to improve communication between health professionals and patients. Furthermore, the MCA is also considering using formal readability tests for the assessment of new PILs in the future (MCA, personal communication). Conclusions The PILs for antiepileptic drugs in the UK are more readable than the newspapers and scientific articles. They are suitable for the reading age of the general adult population in the UK. Acknowledgements I thank Dr Stephen Chan (Lloyds Chemist) and Miss Joanna Cosby (David Lewis Centre for Epilepsy) for providing patient information leaflets. Conflict of interest: my previous post at the David Lewis Centre was funded by Glaxo-Wellcome. References 1. }Morris, L. A., Mazis, M. and Gordon, E. A survey of the effects of oral contraceptive patient information. Journal of the American Medical Association 1977; 238: 2504–2508.
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