Coronary heart disease (CHD) is a chronic illness that is best managed when positive health behaviors become integrated into long-term lifestyle habits [1]. Secondary prevention of CHD involves risk factor reduction through control of health behaviors such as diet, physical activity, smoking and medication adherence using a coordinated approach and referrals to health professionals [2, 3]. Modification of risk factors such as blood cholesterol, blood pressure (BP), physical inactivity, smoking, overweight, diabetes and depression can reduce cardiovascular events, the need for coronary revascularisation and improve quality of life (QOL) [4]. However, strategies are needed to motivate patients to consistently follow multidimensional treatment regimens [1].

Although attendance at cardiac rehabilitation (CR) programs is widely recommended [5, 6] there is significant under-use of facility-based programs in Australia [7, 8] and internationally [9–11]. Despite clear short-term benefits for attendees, large groups of patients are not accessing, which presents an opportunity and challenge to improve CHD care [10]. Although many authors have suggested the need for development of alternative models, these have not yet been widely described or implemented. One pilot study investigated secondary prevention of CHD using a 'modular' approach [12]. For the study, a metropolitan cardiac rehabilitation program was offered as individual components, or modules, based on patient need rather than an all-or-nothing exercise-based approach. Although only 26 subjects participated, the study demonstrated enhanced completion rates and cost effectiveness. The pilot study was an important step from standard cardiac rehabilitation however, modules were still conducted in a group environment and were based on education without formal goal setting and follow-up and no patient information leaflets were provided. Results of the pilot study suggest that development and evaluation of more detailed unique risk factor modules may enhance long-term outcomes.

The development of patient resources based on multidimensional behavior modification techniques may enhance compliance with long-term risk factor interventions [13]. Techniques include goal setting, choice and offering a wide range of individually-tailored services [6]. For chronic disease, change needs to be conceptualised in a positive light to reduce anxiety rather than focusing on negative aspects of making a change [1]. Setting of mutually-agreed and realistic goals with clear time-frames enhances active patient orientation and motivation which facilitates behavior change [1, 14]. The inclusion of a confidence rating for goal achievement may improve the health professional's insight into a patient's motivation to change [1].

Offering choice, in situations where there are several management options, based on individual need and preference is a further method of enhancing active patient orientation [15]. It is also suggested that options offered as a menu of strategies are more successful because it encourages each patient's task to be one of "choosing rather than refuting" [1]. Providing choice allows different people to respond to health professionals in different ways based on each persons needs at different times. We have chosen the term 'guided self-choice' to describe this model which creates a collaborative encounter, which is similar to the spirit of behavior counseling [16].

Facilitation of collaborative relationships, shared decision-making and communication of expectations in a supportive environment helps motivate behavior change and contribute to the disease management process [17, 18]. Formation of collaborative relationships decreases patient anxiety and dissatisfaction that is often related to uncertainty and lack of information, explanation and feedback [19]. Studies have demonstrated that encouraging patients to participate in treatment decisions improves health status, QOL [20, 21], satisfaction, compliance and treatment outcomes [22]. More specifically, patients with a higher degree of active orientation are more likely to comply with treatment recommendations for BP [18], diabetes and physical activity [23].

Although provision of effective education is an essential component of healthcare [24], patients tend to forget approximately half the information provided [25]. Providing supplementary written information increases patients' knowledge of disease [26–28] and reduces distress [29] and decisional conflict [30] because it reinforces verbal instructions and serves as a home resource [31]. Effective patient information must be evidence-based, clearly presented and most importantly, involve patients throughout the process of development [32–34]. Information materials should succinctly deal with the relevant messages [31] be written in active voice with personalised messages and use simple terminology [14, 31, 35]. Layout should be clear, simple and consistent [14, 35] and use subheadings to allow patients to efficiently sift through the information [17, 31].

Various studies have tested patient education materials including those for drug information [36, 37], prostate cancer [38], asthma [39], cardiac catheterization [40] and about general practice [41]. Two studies have highlighted the importance of devoting considerable effort to the development of educational materials and including patients throughout the entire process [42, 43]. Both studies used a progressive approach and demonstrated that if a leaflet is written at an easily readable level and in collaboration with patients, knowledge is increased. The objectives of this study were to develop and evaluate a series of cardiac risk factor modules and corresponding information leaflets for secondary prevention of CHD.

This study describes the development and testing of a new series of CHD risk factor modules and corresponding information leaflets for patients. From the literature and input from consumers and health professionals, it was determined that cholesterol-lowering would be a mandatory module and remaining risk factors (BP management, physical inactivity and smoking cessation) would be optional modules. A menu of management options was developed and adapted for each of the risk factors to facilitate active choice rather than encourage refuting and scrutinising that often occurs if options are presented one by one [1].

Development of the risk factor modules was achieved by interview with health professionals and a systematic review of management options available in the local area. After identifying four consistent management options, each was then tailored for the four chosen risk factors. The management options included choices where the patient could take a more passive role and choices where the patient could take a more independent and active role in their health-care (self-help). Therefore, the choices within each module were designed to facilitate a successful outcome, or risk factor reduction, for a diverse range of personality types and for patients at different stages since their original heart event.

The information needs expressed by patients in phase two compared favourably with the suggestions given in published guidelines [17], for example, the need for specific and honest information, a concise design and the availability of treatment options. We addressed both process and content guidelines by involving patients and health professionals, reviewing clinical evidence and evaluating the leaflets. Therefore, this study provides an extension from published guidelines, documents the specific information needs of patients with CHD risk factors and highlights the importance of identifying patient needs using interview, as suggested by previous researchers [48].

When tested for quality, all four newly developed module information leaflets scored ratings greater than 'moderate' level on the DISCERN instrument. The leaflets were designed to provide basic information about the risk factor rather than comprehensive information about heart disease. All leaflets scored highly on items relating to treatment options, sources of additional information and support for shared decision-making. This finding confirms the pre-defined intention of the developed resources, particularly in terms of shared decision making.

When assessed for readability, the majority of leaflets scored in the 'fairly easy to read' Flesch category. The mean Flesch reading ease score for the leaflets was 75, indicating that 80% of the general population would be expected to understand it [35]. Many of the polysyllabic words (eg, blood cholesterol) appeared repetitively in the leaflets and hence the Flesch score probably underestimated reading ease. Importantly, studies comparing readability and knowledge, found that a leaflets reading ease was associated with a significant increase in knowledge [36, 41].

The blood cholesterol leaflet scored the lowest readability, probably because the word 'cholesterol' was repeated nine times in the 100 word sample assessed. The word 'cholesterol' represents a four syllable word which would have adversely affected the Flesch score. Previous authors have criticised the use of readability formulas because they disregard patients' familiarity with certain words [39]. Importantly, when interviewed, no participants with high cholesterol identified the 'cholesterol' as a term they did not understand. A similar scenario existed for the physical activity leaflet. While the readability score is a useful objective method of assessing written education material, the scores do not consider patient motivation, visual attractiveness and conceptual background of the reader. Therefore, the score, as suggested by previous authors [49], was only used as one element for consideration when developing the written material.

When assessed for suitability, all leaflets scored in the category representing 'superior' suitability [57]. Each leaflet scored similarly because each followed the same basic style and layout and the SAM is weighted fairly heavily in terms of these aspects. The main deficiency in each of the information leaflets was the reading level score. To achieve the maximum score the reading level had to be of grade 5 or less. As described previously it is likely that the module information leaflets scored greater reading age then grade five due to the repetitive use of polysyllabic words such as "cholesterol" and "physical activity".

Compared to the newly developed module leaflets, the existing CR information leaflets scored poorly on all assessment tools. The CR leaflets were not dated, did not provide sources of additional information, presented an unbalanced view where only treatment was offered and they did not support shared decision making. Also, the CR leaflets were written in complex language and passive voice within minimal personalisation. These findings highlight the importance of involving patients throughout the process of development and demonstrate the superiority of the newly developed module information leaflets.

High scores for content and relevance suggest that people with relevant CHD risk factors found them useful and easy to comprehend. Overall, the cholesterol management leaflet tended to score slightly lower which may reflect the different nature of this module. Being a mandatory module, management choices were restricted. In contrast, the modules for BP, physical activity and smoking all had extensive information about treatment choices. The leaflets tended to score lowest on the section related to information about CHD but highest on the section about treatment choices. This finding reflects the aim of the leaflets which was to focus on flexibility and choice rather than to provide didactic information.

There are various strengths and weaknesses of the progressive approach used in this study. We have documented a clinically practical method for developing and testing patient information materials that involved patients and health professionals throughout. However, only a small number of participants were involved for each phase and most did not have severe CHD. As only four key risk factors were chosen for development into modules and corresponding leaflets, future research could investigate modules and leaflets for all modifiable CHD risk factors. Also, as the leaflets were only compared to the existing information leaflet from one cardiac rehabilitation program, comparison of the leaflets with patient information from a diverse range of cardiac rehabilitation programs would be beneficial.

Using a three phase approach including qualitative and quantitative research methods, a series of risk factor modules and corresponding information leaflets have been developed and tested. Importantly, this study describes a readily applicable systematic process for designing and validating written patient information. This study also documents the unique perspective of persons with CHD risk factors. The leaflets are now considered suitable for use in further studies to test the effectiveness of a modular approach to secondary prevention of CHD and are expected to contribute to shared-decision making, patient empowerment and active patient participation.