«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 ...»
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,
♦ 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.