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«HEALTH PSYCHOLOGY Series Editors: Sheila Payne and Sandra Horn Di an ne Be rr y ion at ce nic cti mu Pra om and h C ory alt The He Health ...»

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Finally, it was noted that few of the materials actively promoted shared decision making (Coulter et al., 1998). Similar findings to this were reported by Meredith et al. (1995) who examined 25 leaflets, and contrasted the 96 Health communication information given with the information wanted by 5361 patients. They reported that much of the information had considerable shortcomings.

Specifically, it lacked uniformity in form and content, topics of relevance to patients were limited, terminology was often poor and the patients’ experiences were often at variance with what their doctors had told them.

More recently, Brown et al. (2004) carried out a study in 12 ophthalmology departments in the West Midlands, UK, to assess the extent to which the provision of PILs before cataract surgery provide patients with enough information to give adequately informed consent. The leaflets were scored according to the information that they provided on diagnosis, prognosis, treatment options, costs to patient, details about the procedure, its purpose, likely benefits, how to prepare for it, what to expect during and after the operation, and common as well as serious complications that might occur.

Readability was also assessed. Brown et al found that all the leaflets provided information on diagnosis, lifestyle changes required post-operatively and cost to patient. However, only five units had leaflets that mentioned the risks involved in cataract surgery. The other areas of information were covered in between 50 and 75 per cent of leaflets. The average readability score of the leaflets was also high. In line with this, White et al. (2004) found that nearly half of the leaflets about hayfever that were available in GP surgeries and community pharmacies in South-East England, did not show the date of publication, and one-third of those that did were more than five years old.

Fewer than half contained information on the full range of management and treatment options, and all had readability scores requiring at least secondary school education. In addition, the researchers found that no leaflets at all were available in 30 per cent of the community pharmacies and 23 per cent of the GP practices they surveyed.

On the basis of their study’s findings, Coulter et al. (1998, p. xi) made the

following recommendations in relation to producing PILs:

♦ involve patients throughout the development process ♦ involve a wide range of clinical experts ♦ be specific about the purpose of information and the target audience ♦ consider information needs of minority groups ♦ review clinical research evidence and use systematic review ♦ plan how materials can support shared decision making ♦ consider cost and feasibility when selecting media ♦ develop a strategy for distribution ♦ evaluate materials and how they are used ♦ publicise availability.

In terms of the actual content of the materials, they recommended that,

developers should:

♦ use patient questions as a starting point ♦ ensure that common concerns and misconceptions are addressed Health promotion and the wider public 97 ♦ refer to all relevant treatment or management options ♦ include honest information about risks and benefits ♦ include quantitative information where possible ♦ include checklists and questions to ask the doctor, and sources of further information ♦ use non-alarmist, non-patronising language in an active voice ♦ use structured and concise text with good illustrations ♦ include references and publication date.

(p. xi) Many of Coulter et al’s recommendations are in line with those of a number of other researchers and practitioners (e.g. Kitching, 1990; Newton et al., 1998; Raynor, 1998; Wright, 1998). In general, there is a consensus of opinion that the extent to which prose is comprehended is determined largely by the complexity of the sentences and the familiarity of the vocabulary.

Thus, when producing written information materials, technical terms should be replaced by everyday counterparts, non-essential information should be eliminated, word and sentence length should be reduced, language structures should be simplified and information reordered to enhance coherence. Kenny et al. (1998) recommended that all new Patient Information Leaflets should declare an objective score of readability using a standard formula. In relation to this, Albert and Chadwick (1992) suggested that leaflets should not exceed a readability age of 12. However, in aiming for simplicity, authors have to be careful that leaflets do not end up becoming overly patronizing.

In addition, as Newton et al. (1998) pointed out, to be meaningful, the leaflet content must relate to the reader’s existing knowledge. One way of doing this is to use appropriate analogies and concrete examples. In terms of design and layout, materials should incorporate clear headings and use of bullet points, plenty of white space, and the font should be clear and at least 12 point size. Finally, in order to be believed, the clinical content of a leaflet should be correct, balanced, unbiased and developed independently of commercial interests. Overall, there is now clear advice from a variety of sources on ‘how to write a good leaflet’ with respect to style, language, layout, print size, readability, diagrams, colour and numeracy. This includes a number of articles and publications that review the evidence for this advice (e.g. Centre for Health Quality Improvement, 1997; Kenny et al., 1998; Newton et al., 1998).

As a general principle, Wright (1998) has suggested that information design needs to be reader based rather than text based (see also Schriver, 1997). Wright emphasized that it is essential to carry out a thorough evaluation of any materials that are produced, and that the process must be intimately involved with the development of the materials (rather than a separate process that is tagged on at the end). In a similar vein, Mayberry and Mayberry (1996) proposed that the scientific evaluation of patient 98 Health communication information must include tests of both readability and comprehension, as well as of the long-term effects of the material. Wright (1998) argued that evaluation requires more than just showing the material to a few people and asking them if they like it or find it helpful. One reason is that people may ‘like’ leaflets that do not actually lead to good understanding or retention.

A study by Livingstone et al. (1993), for instance, found that 90 per cent of 312 people evaluating a leaflet about cystic fibrosis said that they found it easy to understand but, nevertheless, more than one-third gave the wrong answer when asked about the likelihood that they might have the cystic fibrosis gene. Thus, Wright (1998) recommended that performance-based criteria are needed when evaluating materials. In terms of medicine information leaflets, for example, some specific criteria could be that a certain percentage of people (e.g. 70 per cent) can locate relevant dosage information within a specified time (e.g. 20 seconds), that 80 per cent of readers can demonstrate correct understanding for responding to a hypothetical scenario, and that, say, 90 per cent of readers can identify the circumstances in which the medicine should be taken. More broadly, Sless (2001) has noted that setting performance benchmarks for written information for patients involves establishing technical, social, physical, aesthetic and usability criteria. Clearly, therefore, such evaluations need to be well planned and rigorously carried out.

Medicine information leaflets Written patient information is probably most associated with the distribution of medicines. Medicine information leaflets (often referred to as Patient Package Inserts in Europe) are now routinely provided with the majority of prescribed and over-the-counter medicines in many countries in the western world. In the USA, the growing availability of medicine information leaflets followed a Federal mandate which stated that by the year 2000 useful information must be delivered to 75 per cent of patients receiving new prescriptions. The intention was that this would rise to 95 per cent by 2006 (US Department of Health and Human Services, 1996). The Federal Drug Administration (FDA) steering committee recommended that all information provided to the public must be scientifically accurate, unbiased, easily understood and comprehensive enough to be useful to patients (Marwick, 1997). The preferred route for delivering the information in the USA has been through computer-generated leaflets from community pharmacies. Unfortunately, a survey commissioned by the FDA (Traynor,

2002) found that, although 89 per cent of newly filled prescriptions came with written information for consumers, much of the information was incomplete and of limited use to patients. Using predetermined criteria, a panel of 16 pharmacy professionals found that 51 per cent or fewer of the leaflets provided adequate information about contra-indications to the prescribed drug. In addition, no more than 53 per cent of the leaflets provided Health promotion and the wider public 99 sufficient warning of adverse events, and 45 per cent or fewer described important precautions patients should take when using drugs.

Following this, the FDA (2006) have recently revised their guidelines for prescription drug information. In addition to improved graphical specifications, the new format requires the insertion of a new highlights section that gives immediate access to the most important information about medicine risks and benefits, a table of contents and the date of initial product approval.

The aim is to give patients and healthcare professionals clear and concise prescription information in order to manage the risks of medicine use and reduce medical errors.

Likewise, in Australia, legislation was introduced in 1993 which required all new medicines to be accompanied by information leaflets (referred to as ‘consumer medicines information’). Information in the leaflet has to be consistent with the information in the drug’s Data Sheet, although not all of the information in the Data Sheet has to be included in the leaflet. As in the USA, the preferred route for delivery of the medicines information has been through computer-generated leaflets in community pharmacies (Raynor, 2001). In order to exert control over the quality of leaflets, guidelines were commissioned for writing and testing leaflets (Dowling, 1996; Sless, 2001).

The guidelines specify, for example, that any literate patient should be able to find at least 90 per cent of what he or she is looking for in the leaflet and should be able to understand 90 per cent of what they find. Sless (2001) noted that the guidelines had been used to develop over 800 consumer medicines information leaflets to date, covering most major therapeutic classes of prescription medicine.

In some European countries, medicines information leaflets have been available for some time. This is particularly the case in The Netherlands, Sweden, France and Germany, although the content and method of distribution varies. The general tradition, however, has been to incorporate leaflets as package inserts, rather than to generate them on line in community pharmacies. In many cases, the content of the leaflets is fairly technical (Dickinson et al. 2001). In an attempt to increase the availability of materials, and to ensure a degree of consistency, the European Commission issued a Directive in 1992 (European Commission, 1992), which required that all medicines supplied to patients should be accompanied by a comprehensive information leaflet which must include a list of all side effects referred to in the medicine’s Summary of Product Characteristics (previously known as Data Sheet), in a form that is understandable to the patient. The Directive came fully into effect in Europe in 1999, following a phasing-in period. It was implemented in the UK through the development of a patient pack dispensing system (that is, the incorporation of patient package inserts).

In 1996 the European Commission (EC) produced a Draft Guideline on assessing readability (together with a model leaflet) to be used by manufacturers when producing leaflets. The recommended method was based on that used in Australia (Sless and Wiseman, 1994) and involved interviews 100 Health communication with potential users to ascertain whether they could find specified key information in the leaflet quickly and easily, and whether they could understand and act upon it. It was recommended that the leaflet would be deemed to be satisfactory if more than 80 per cent of consumers could use it successfully according to these two criteria.

Dickinson et al. (2001) carried out an empirical study to evaluate the EC’s proposals for producing PILs. They compared people’s ability to use two specially constructed leaflets that were based on either the EC model leaflet or on recognized best practice in information design. Their test involved requiring participants to find and understand 15 key pieces of information in each leaflet (e.g. when the medicine should be taken, how it should be stored and what to do if too much is taken). The results showed that performance was worse with the EC model leaflet; the criterion that 80 per cent of readers should be able to locate and understand the requested information was only reached for 3 of the 15 items, compared with 8 for the leaflet that was based on best practice in information design. Subsequent interviews with the participants confirmed many of the difficulties with the EC leaflet, including the fact that many of readers did not understand the information that they were given about drug interactions and contraindications for use.

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