Patient information leaflets for medicines: using consumer testing to determine the most effective design

Patient Education and Counseling 43 (2001) 147±159

Patient information lea¯ets for medicines: using consumer testing to determine the most effective design David Dickinsona,*, D.K. Raynorb, Mark Dumanc,1 a

b

Consumation, 53 Hosack Road, London SW17 7QW, UK Division of Academic Pharmacy Practice, School of Healthcare Studies, University of Leeds, Leeds, UK c Health and Relationships, BBC Education, London, UK Received 10 November 1999; received in revised form 9 June 2000; accepted 2 July 2000

Abstract Comprehensive medicine information lea¯ets for patients are now mandatory across the European Union. In 1997, the European Commission (EC) proposed a prescriptive `model' for the lea¯ets and a method for consumer testing. This exploratory study compared consumers' ability to use a lea¯et based on the EC model lea¯et and an alternative lea¯et based on best practice in information design (Mark II). The lea¯ets were tested in two matched groups of 20 consumers, who were required to ®nd, and understand, 15 pieces of information in the lea¯ets. The target that each question should be answered correctly by 16 out of 20 consumers, was achieved for three of the 15 points in the EC lea¯et, compared with eight in the Mark II lea¯et. Open questioning con®rmed the problems with the EC lea¯et, including a failure to understand key concepts about medicine interactions and contraindications. This research demonstrates the bene®ts of consumer testing, ensuring that lea¯ets are patient-orientated. A rigid model lea¯et would prevent these bene®ts from being utilised. # 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Patient education; Evaluation; Information lea¯ets; Drug labelling; Package inserts

1. Introduction Until the mid 1980s, most medicines in UK were supplied without any printed information for the patient, apart from the medicine label. In 1987, a pharmaceutical industry working group proposed that lea¯ets should be developed by manufacturers, and guidelines were produced [1]. The guidelines were based on the notion that lea¯ets should be succinct, * Corresponding author. Tel.: ‡44-208-673-4403; fax: ‡44-208-355-7811. E-mail address: [email protected] (D. Dickinson). 1 Present address: Commercial Director, EncycloMedica, London, UK.

intelligible and of uniform design. They were based on the work of Gibbs et al., who produced and tested a series of lea¯ets based on an A5 design (with a summary on one side and more detailed information on the other) [2]. Their research showed that the lea¯ets, which were handed to the patient by the doctor or pharmacist, resulted in a small but signi®cant increase in patients' knowledge, and satisfaction with treatment. The new style lea¯ets based on this design started to appear in 1989, supplied as package inserts. In some continental European countries, there was more of a tradition of medicine information lea¯ets as package inserts, but they tended to be more technical in nature [3]. For example, Belgian and Swiss lea¯ets were longer and written in a less patient-friendly style

0738-3991/01/$ ± see front matter # 2001 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 7 3 8 - 3 9 9 1 ( 0 0 ) 0 0 1 5 6 - 7

148

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

than those in UK [4]. In USA in the 1970s, early attempts to legislate for patient information lea¯ets were shelved in favour of private sector initiatives. However, limited government requirements for leaflets for a small number of drugs were introduced [5]. In the mid 1990s, a government-led initiative set a target for 75% of patients with new medicines to get useful and easy to understand lea¯ets by 2000. These lea¯ets will be mandatory for selected drugs with particular risks [6]. In Australia, legislation was enacted in 1993, which required all new drugs to be accompanied by a patient information lea¯et (`Consumer medicines information'). Guidelines were commissioned for writing and testing the lea¯ets [7]. 1.1. EC directive 92/27 In 1992, a European Union Directive (EU 92/27) [8] was published which required that all medicines should be accompanied by a comprehensive information lea¯et for the patient, produced by the manufacturer. The Directive required much more detailed lea¯ets than had been used before in UK. Each lea¯et had to contain all the information in the Summary of Product Characteristics (previously known as the Data Sheet), and be written ``in clear and understandable terms for the patient''. The Directive came fully into effect across the European Union in January 1999, after a 5 year phasing-in period. In UK, the law was planned to be implemented through the Patient Pack Initiative, with the lea¯ets supplied as package inserts [9]. 1.2. Testing of patient information lea¯ets There is little research describing the ef®cacy of detailed lea¯ets delivered as package inserts in UK; previous work was generally carried out on lea¯ets handed to patients, and much shorter than those required by the Directive. Work in Belgium looked at package insert lea¯ets and showed that more than two-thirds of patients read the insert and satisfaction with the lea¯ets was high [10]. Research in US published in 1981, on a number of package inserts (summarised by Ley [11]), showed that most patients read the lea¯et and their knowledge was increased. Vander Stichele has noted the need for evaluation of the impact of the insert on the patient [4] and Blenkinsopp et al. said that involving consumers

should be an essential part of the development of information for patients [12]. However, a study in 1995 found that only a quarter of pharmaceutical companies producing patient lea¯ets for over-thecounter medicines had formal testing procedures [13]. Testing of health-related lea¯ets for patients has tended to focus on readability formulae [1]. These estimate a `reading age' needed to read a lea¯et and are based on word and sentence length. They have signi®cant limitations [14,15], and take no account taken of layout, typeface, motivation of reader or delivery method. It is worth noting that a lea¯et written backwards will have the same score as when written forwards. Writers need to aim for audience acceptance, rather than a favourable reading score, and there is no substitute for testing on the intended audience [1]. 1.3. EC guideline on readability In 1996, the EC produced a draft Guideline on readability, for manufacturers to follow when developing labels and lea¯ets [16]. This included a `model' lea¯et which detailed the structure and wording of the information. A later draft also included a process for testing the ``readability'' of the lea¯ets. The testing process was based on that pioneered by the Communication Research Institute of Australia (under the term ``diagnostic testing'') and was integral to the development of consumer medicines information in Australia [17]. The method involves interviewing potential users, and aims to evaluate two aspects of the document under test:  can they find information in the leaflet quickly and easily;  having found it, can they understand and act upon it appropriately? It is not a controlled method and is not designed to be conducted on a representative sample. We have adopted the term `consumer testing' to describe this process. The testing is designed to be used repeatedly, i.e. after revision of the lea¯et (which should address any problems highlighted in the testing), the lea¯et should be re-tested, until 80% of consumers can use the lea¯et successfully. The aim of this study was to test the EC's draft proposals for a model lea¯et, and compare this with a lea¯et developed using best practice in design. The

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

consumer testing was conducted according to the process included in the draft Guideline itself. 2. Method Two alternative designs of a lea¯et for Burofen (a ®ctitious brand of over-the-counter ibuprofen) were produced. One lea¯et was constructed according to the model in the European Commission draft guidelines (EC lea¯et; see Fig. 1). The other lea¯et was edited and designed using principles of best practice in information design (Mark II lea¯et; Fig. 2). Both were derived from a hypothetical Summary of Product Characteristics. Each lea¯et was tested for effectiveness in a series of individual interviews with separate, age matched, groups of 20 older consumers. The interviews used a structured questionnaire, according to the European Commission's consumer testing guidelines (Appendix A). 2.1. Principles used to redesign the lea¯et The EC lea¯et was produced in the A4 format recommended in the Guideline, using 10 point type, with 29 of the possible 37 proposed headings included. The Mark II lea¯et was slightly larger than A5 in size and had seven numbered sections, with short, simple headings, to help consumers navigate through the lea¯et. Section headings re¯ected the chronological sequence in which people would approach taking the medicine (e.g. `Before you take Burofen', `While you take Burofen') and this allowed us to group related items together. This contrasts with the 29 numbered headings in the EC lea¯et (e.g. `When should you only use Burofen after consultation with your physician?', `What needs to be taken into consideration for children or the elderly?). The Mark II lea¯et was written and designed according to best practice in information and design [17]. However, to allow direct comparison, we also used 10 point type in the Mark II lea¯et. The `box' used in this lea¯et is of open design, which highlights the information without encouraging readers to skip it (as closed boxes sometimes do). We also made extensive use of bullet points and broken paragraphs, which are much more successful in hooking attention than solid text. Jargon was removed as far as possible, and

149

we reworded several sections to make them more userfriendly. We did this as far as possible for both lea¯ets, but some text in the model lea¯et was compulsory and this was left unchanged in the EC lea¯et. The design principles used to develop the Mark II lea¯et are summarised in Table 1. 2.2. Consumer testing process The EC lea¯et was shown individually to 20 older people, all English speakers, who lived independently at home. The exercise was repeated for the Mark II lea¯et with 20 different subjects. Ages ranged from 55 to 85 years and the groups were matched with respect to age and sex. Interviewing was carried out in a senior citizens' lunch club. The people interviewed  took and were responsible for taking their own medication;  understood the nature of the research;  if they used reading glasses, had the glasses with them. A structured questionnaire (Appendix A) probed the interviewee's understanding of 15 key points from the lea¯et (see Table 2). The methodology is that proposed in the European Commission's draft Guideline on testing, where the aim is for 16 out of 20 subjects tested to be able to both ®nd the information and put it accurately in their own words. Each consumer was interviewed individually and after being handed the lea¯et, they were asked two questions about each of the 15 key points. The ®rst question tested whether the interviewee could locate the relevant information. This was followed by a second question: ``Can you tell me what it says, in your own words?'' There were rigorous requirements for the awarding of a ``right'' answer. Thus, each point generated two possible correct responses: one for successfully locating the information, and the second for interpreting it correctly. We also recorded any general comments, solicited by open questions. 3. Results 3.1. Consumer testing process The EC Guideline sets a target that each question should be answered correctly by 16 out of 20 users.

150

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

Fig. 1. The Burofen lea¯et, produced in line with the model lea¯et proposed by the European Commission (EC lea¯et).

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

Fig. 1. ( Continued ).

151

152

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

Fig. 2. The Burofen lea¯et, produced in line with best practice in information design (Mark II lea¯et).

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

153

Fig. 2. ( Continued ).

Table 2 shows that this was achieved for 3 of the 15 points of information in the EC lea¯et, compared with 8 in the Mark II lea¯et. None of the 20 respondents questioned about the EC lea¯et answered all the questions correctly and only one respondent scored

26 from a possible 30. Of the 20 consumers questioned about the Mark II lea¯et, four scored a perfect 30 and 10 scored 26 or more out of 30. Particular dif®culties for people using the EC lea¯et were encountered for 8 of the 15 points, mostly

154

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

Table 1 Design principles applied to the Mark II lea¯et Signposting Short, easy-to-read section headings help consumers navigate their way through a leaflet Sections of a leaflet should echo the sequence in which people would approach the task concerned Numbering encourages people to read through a whole leaflet in sequence, but is still clear if people `dip' into the leaflet (also adopted in the EC leaflet) Boxes with a special open design highlight information, without encouraging readers to skip it (as closed boxes sometimes do) Order of information Grouping together related items is helpful to the lay reader Bullet points and broken paragraphs are more successful in attracting attention than solid text Jargon and sentence length Jargon should be replaced with lay language Sentences should usually contain just one message or concept

relating to information about drug purpose, taking other medicines, and information relating to warnings, precautions and contra-indications. These were grouped differently in the Mark II lea¯et, and generally appear to have been easier for people to understand. The Mark II lea¯et generated a different pattern of responses to the EC lea¯et. People using the EC model found information more easily than they gave correct answers. Table 2 shows that the responses to each of the two questions for each point on the Mark II lea¯et are more closely aligned. This suggests that with the Mark II lea¯et, people who found the information, more often got the answer right; suggesting it was easier to understand. 3.2. Open questions In their answers to open questions, the balance of feedback for both lea¯ets was positive, but the EC lea¯et attracted more negative comments. Similar numbers in both groups said that the lea¯ets were comprehensive or covered everything. A minority of users said that the EC lea¯et was too long. Consumers using the Mark II lea¯et expressed a liking for its tone and its clear layout and design, which was barely mentioned by users of the EC lea¯et. People using the EC lea¯et more often expressed fears about possible side effects of the medicine. The tone of the comments about the two lea¯ets differed, with `pretty good' or `quite good' more often used of the EC lea¯et. The Mark II lea¯et more often attracted

descriptions such as `very good' or `best' and in one case `interesting'. The comments that follow were selected to re¯ect the quality of the feeling of users of both lea¯ets. 3.3. The EC lea¯et The EC lea¯et was reasonably well-liked by signi®cant numbers of consumers: Quite a good lea¯et Ð explains everything. (EC Patient T) Many interviewees liked lea¯ets because they helped them (and/or others) to take more responsibility for medication: Wonderful, tells you all about doses and what to give the children Ð it's responsible. (EC Patient S) However, some praise was half-hearted, with complaints that the EC model lea¯et was over-long: Lea¯et is too lengthy. Condensation, if possible, would be good. (EC Patient B) Some people are not so well-educated Ð by the time they get to the last bit they've forgotten the ®rst bit. (EC Patient G) Most concern was around clarity: Some sections could be explained a bit simpler . . . it's a bit confusing how long you should take it [section 16]. (EC Patient A) Side-effects emerged as a priority, with eight respondents expressing concern: Mine are suppositories and have just had lea¯ets [included in the pack]. I think it's important,

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

155

Table 2 The 15 questions asked and number of subjects who answered correctly Question 1

Using the leaflet, can you tell me what this medicine is used for?

2

Does the leaflet tell you about when you should take the medicine?

3

Are there any instructions in the leaflet that are especially for people with asthma?

4

Does the leaflet tell you whether children can take the medicine?

5

Does the leaflet tell you what to do if you have stomach ulcers?

6

According to the leaflet, what's the biggest dose of this medicine that an adult should take in 24 hours?

7

Looking at the leaflet, does it say what to do if you accidentally took too much medicine?

8

Suppose you've been taking this medicine for a week & you're not getting any better. Does the leaflet tell you what to do?

9

Is there any advice in this leaflet for young women who are pregnant, who may be pregnant or who are trying for a baby?

10

Does the leaflet tell you how to store the medicine?

11

Suppose you started to get a rash while you were taking the medicine. Does the leaflet tell you what to do?

12

Does the leaflet say if there are other medicines that you shouldn't take with this one?

13

Are there any instructions in the leaflet that are specially for elder people?

14

Suppose you had kidney problems. Is there any advice in the leaflet that would tell you what to do?

15

Does the leaflet tell you about what to do if you forget to take the medicine? a

EC leaflet

Mark II leaflet

Located

19

19

Understood Located Understood Located Understood Located Understood Located Understood Located

9 16 9 12 4 19a 17 19a 16 18

14 16 14 17 12 20a 20 18a 18 18a

Understood Located Understood Located

14 18 8 12

18 16 10 16

Understood Located

9 18a

15 20a

Understood Located Understood Located

18 20 14 19

20 17a 17 16

Understood Located Understood Located Understood Located

14 14 2 16 9 19

14 19a 16 20a 18 19a

Understood Located Understood

7 20 15

17 16 15

Questions which reached the target of 16/20 respondents who correctly found and understood the information.

especially with the side effects you get with some of these drugs. (EC Patient Q) 3.4. Mark II lea¯et Slightly more of the 20 users of the Mark II lea¯et than the EC model users praised the lea¯et, and the Mark II users did so in stronger terms. No, I can't fault it in any way. I would understand if I read this. One of the best ones I've seen, it covers so many things. (MII Patient N)

Clarity from good design and layout was mentioned with approval by eight respondents using the Mark II lea¯et. It's all worked out and explained to you. It's easy to read Ð some of the lea¯ets you get are hard. (MII Patient F) Clear data about side effects reinforced wariness about taking the medicine in three consumers. It's all in very simple language, but it may well put [people] off . . . there's so much adverse information. (MII Patient P)

156

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

Others thought side-effects should be even more clearly ¯agged. I still think it's all wrong Ð things you shouldn't do ought to be at the top written in red Ð because older people will take more notice of them. (MII Patient R) Red was not used because of the risk to colour-blind patients: for them (and for everyone else) black on white provides a clearer contrast. There was praise from people who have become reluctant connoisseurs of other lea¯ets, for both clarity and tone of the Mark II lea¯et. Very easy to follow compared to some of them. If they were all like this there would be no problems. It's very clear. (MII Patient O) It's the honesty of it Ð it doesn't hide anything Ð it doesn't frighten you but at the same time it warns you. That's a good thing, I've never seen that on any other lea¯ets. (MII Patient H) 4. Discussion Medicines are the major mode of treatment in healthcare and, therefore, the patient's role as an informed partner is vital. There is no doubt that the information provided to patients for this purpose must be tested for effectiveness [18]. Previous work showed that many current medicine information lea¯ets for patients are dif®cult to read and to understand for the elderly [19]. This work was a small exploratory study which was designed to use the Commission's own consumer testing method, which does not use a randomly selected representative sample of consumers. However, it does show the potential of consumer testing to identify faults in the effectiveness of written information. Compulsory wording and model lea¯ets, as seen in the draft EC guidelines, inhibit the process of revision which is the great strength of consumer testing. The promotion of consumer testing along with the rigid model lea¯et in the proposed Guideline was not a coherent policy. If regulators apply guidelines strictly, then much of the bene®ts of consumer testing will be lost. The research was presented to the European Commission and this contributed to a change in policy. The substantive Guideline, issued in September 1998, allows deviation from the

model lea¯et if this is supported by consumer testing [20]. 4.1. Problems with the EC lea¯et The readability Guideline sets a target that each question should be answered correctly by 16 out of 20 users. The EC lea¯et was a long way from achieving this, whereas the Mark II lea¯et only failed to reach this level for 7 of the 15 points of information. For 5 of these, they were only 1 or 2 marks below this standard. The problems associated with the EC lea¯et appear to relate to it being too long, too unwieldy and too wordy for consumers to use easily. Responses to the open questions con®rmed that  The order of items prescribed by the Directive was not always helpful.  Compulsory sections of wording need to be more user-friendly, or allowed to be ``translated'' into user-friendly language.  Multi-section format (37 possible headings) caused problems in locating and understanding and contributed to its length.  Use of questions in headings led to overlong and complex headings e.g. ``When should you only use Burofen after consultation with your physician?''  Most of these points have been addressed in the substantive Guideline document. 4.2. Problems with the Mark II lea¯et Although the Mark II lea¯et achieved higher scores across a broader range of questions, two particular points continued to cause problems; instructions for people with asthma and what to do for accidental overdose. This information will be revised accordingly, and the Mark II lea¯et will be re-tested. By learning from consumer testing and incorporating improvements like these, lea¯et writers can build up a series of solutions for problem areas of information. 4.3. Cultural and visual issues Two key issues not directly addressed in this study are cultural differences between EU Member States and secondly the need for a legible print size. It is clear that worldwide, the different cultural contexts

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

157

Table 3 Practice implications Well designed patient information can contribute to responsible medicine taking by improving patients' ability to find and understand information about their medicines In common with the drugs to which they refer, medicine information leaflets must be tested to prove their effectiveness Consumer testing of patient information is a convenient and powerful tool for identifying problem areas and improving consumers' ability to use the information

in which healthcare providers and patients ®nd themselves, are important factors to take into account when devising education strategies [21]. There is anecdotal evidence that this applies regionally also, and that the populations of different Member States have different approaches to medicine-taking. If true, this is a strong argument for diversity in information provision rather than one set of universal guidelines applied to all. Combining consumer testing with a more ¯exible approach could be the way to address different needs in different European Countries while retaining consistency across the European Union. This approach is consistent with the European Guideline on readability, but other European guidelines require lea¯ets to be identical across the Union [22]. A problem which remains with the substantive Guideline is the issue of print size. The Royal National Institute for the Blind in UK suggest a minimum type size of 12 point for normal use [23], whereas the Guideline suggests a minimum size which is approximately 8 point. For people with major reading dif®culties, a large print version (at least 14 points) or audio version should be available [24]. 5. Practice implications It is welcome that the European Commission has recognised the importance of medicines information for patients by making the supply of such patientoriented lea¯ets mandatory. Lea¯ets with the appropriate tone, length, and design can do much to aid responsible medicine-taking. Industry, regulators and prescribers can help by ensuring that the wording and ordering of information is from the patient's point of view. This work shows that consumer testing is a useful tool for obtaining this viewpoint, and identifying solutions in problem areas (see Table 3).

The original draft of the European Guideline on lea¯et readability, with its rigidly de®ned model leaflet, was not ¯exible enough to bene®t fully from the power of consumer testing. Compulsory wording or structures inhibit the process of revision, which is the great strength of consumer testing. The subsequent substantive Guideline, which recognises that con¯ict and provides more ¯exibility, is a step forward. Other changes, notably the move from 37 to 5 headings are also welcome. The Guideline should contribute to an increase in the responsible management of medicines by patients and positive consumer attitudes towards medicinetaking. However, there remains an in-built tension even between a non-mandatory model lea¯et and consumer testing which, by its nature, can lead to signi®cant deviation from the model lea¯et. It remains to be seen how this tension is handled by the regulators. In particular, the requirements for centralised licensing (through the European Medicines Evaluation Agency) include the use of identical lea¯et content across Member States, with language as the only difference. This leaves no scope to deal with different cultures of medicine taking, which could be identi®ed by consumer testing in the countries concerned. Acknowledgements Thanks are due to the graphic designer, Suzy Gallina, and researcher Christine McLauchlan, and to the patients who took part. This work was commissioned by a UK working group, Promoting Excellence in Consumer Medicines Information (PECMI) which represents those involved in information design, the pharmaceutical industry, academia and consumer groups. Three bodies helped fund the research: the Association of the British Pharmaceutical Industry (ABPI), the Proprietary Association of Great Britain (PAGB), and the King's Fund.

158

Appendix A

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

D. Dickinson et al. / Patient Education and Counseling 43 (2001) 147±159

References [1] Raynor DK. The in¯uence of written information on patient knowledge and adherence to treatment. In: Myers L, Midence K, editors. Adherence to treatment in medical conditions. London: Harwood Academic, 1998. [2] Gibbs S, Waters WE, George CF. Communicating information to patients about medicines. J R Soc Med 1990;83: 292±7. [3] Baudrihaye N. Assessment of the current situation in Europe and the way forward. In: Mann RD, editor. Patient information in medicine. Carnforth, UK: Parthenon, 1991. [4] Vander Stichele RH, Bogaert MG. European legislation and research projects regarding patient education for medication. Drug Inform J 1995;29:285±90. [5] Nightingale SL. Written patient information on prescription drugs. Int J Technol Assess Health Care 1995;11:399± 409. [6] Rheinstein PH, McGinnis TJ, Nightingale SL. The patient information and education initiative. Am Fam Physician 1995;52:2377±82. [7] Dowling H. Consumer product information Ð where to from here? Aust J Hosp Pharm 1996;26:293±8. [8] Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package lea¯ets (OJ No. L 113 of 30.4.1992, p. 8). [9] Anon. Patient pack prescribing and the provision of patient information lea¯ets. Drug Ther Bull 1995;33:86±8. [10] Vander Stichele RH, Van Haecht CH, Braem MD, Bogaert MG. Attitude of the public towards technical package inserts for medication information in Belgium. Ann Pharmacother 1991;25:1002±6. [11] Ley P. Communicating with patients. London: Croom Helm, 1988.

159

[12] Blenkinsopp A, Bashford J, Dickinson D. Health professionals need to identify how much information patients want. Br Med J 1998;317:413. [13] Bradley B, McClusker E, Scott E, Li Wan Po A. Patient information lea¯ets on over-the-counter medicines: the manufacturers perspective. J Clin Pharm Ther 1995;20: 37±40. [14] Meade CD, Smith CF. Readability formulas: cautions and criteria. Patient Educ Couns 1991;17:153±8. [15] Beaver K, Luker K. Readability of patient information booklets for women with breast cancer. Patient Educ Couns 1997;31:95±102. [16] Anon. European drug lea¯ets: new test rules drafted. Patient i 1998;17:1 and 6. [17] Sless D, Wiseman R. Writing about medicines for people. 2nd ed. Canberra: Australian Government Publishing Service, 1997. [18] Coulter A. Evidence based patient information. Br Med J 1998;317:225±6. [19] Bandesha G, Raynor DK, Teale C. Preliminary investigation of patient information lea¯ets as package inserts. Int J Pharm Pract 1996;4:246±8. [20] European Commission, Directorate-General III. A guideline on the readability of the label and package lea¯et of medicinal products for human use. Brussels: European Commission, 1998. [21] Herbert CP. The relevance of cultural diversity to patient education. Patient Educ Couns 1997;31:93±944. [22] European Commission, Directorate-General III. A guideline on the packaging information of medical products for human use authorised by the community. Brussels: European Commission, 1997. [23] Royal National Institute for the Blind. See it right: new approaches to information for blind and partially sighted people. London: RNIB, 1993. [24] Raynor DK, Yerassimou N. Medicine information Ð leaving blind people behind? Br Med J 1997;315:268.