Redesigning printed educational materials for primary care physicians: design improvements increase usability

Background Printed educational materials (PEMs) are a frequently used tool to disseminate clinical information and attempt to change behavior within primary care. However, their effect on clinician behavior is limited. In this study, we explored how PEMs can be redesigned to better meet the needs of primary care physicians (PCPs) and whether usability and selection can be increased when design principles and user preferences are used. Methods We redesigned a publicly available PEM using physician preferences, design principles, and graphic designer support. We invited PCPs to select their preferred document between the redesigned and original versions in a discrete choice experiment, followed by an assessment of usability with the System Usability Scale and a think aloud process. We conducted this study in both a controlled and opportunistic setting to determine whether usability testing results vary by study location. Think aloud data was thematically analyzed, and results were interpreted using the Technology Acceptance Model. Results One hundred and eighty four PCPs participated in the discrete choice experiment at the 2014 Family Medicine Forum, a large Canadian conference for family physicians. Of these, 87.7 % preferred the redesigned version. Follow-up interviews were held with a randomly selected group of seven participants. We repeated this in a controlled setting in Toronto, Canada, with a set of 14 participants. Using the System Usability Scale, we found that usability scores were significantly increased with the redesign (p < 0.001). We also found that when PCPs were given the choice between the two versions, they selected the redesigned version as their preferred PEM more often than the original (p < 0.001). Results did not appear to differ between the opportunistic and controlled setting. We used the results of the think aloud process to add to a list of end user preferences developed in a previous study. Conclusions We found that redesigning a PEM with user preferences and design principles can improve its usability and result in the PEM being selected more often than the original. We feel this finding supports the involvement of the user, application of design principles, and the assistance of a graphic designer in the development of PEMs. Electronic supplementary material The online version of this article (doi:10.1186/s13012-015-0339-5) contains supplementary material, which is available to authorized users.

T herapeutics Letter #49 (Jul-Sept 2003) concluded that "Statins provide a cardiovascular and total mortality benefit for patients with clinically evident occlusive vascular disease (secondary prevention)" and Letter #77 (Mar-Apr 2010) concluded that "Statins do not have a net health benefit in primary prevention populations", because they reduce coronary heart disease (CHD) serious adverse events (SAEs), but have no effect on total SAEs. This suggests that there are unidentified SAEs caused by statins that counterbalance the reduction in CHD SAEs. Concerns about SAEs related to HMG-CoA reductase inhibitors (statins) were first raised in 2001, when cerivastatin was withdrawn from the market after being linked to over 100 deaths from muscle damage occurring at a rate much higher than other statins. 1 This Letter examines proven and associated harms with statin use. Proven harms are those that have been established in systematic reviews or randomized controlled trials (RCTs); associated harms are those identified from observational studies, case series and case reports.

How do statins work?
Statins inhibit the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase at an early stage of the mevalonate pathway. Cholesterol is generated by this pathway, but so are a number of other products with a pivotal role in bodily functions, such as coenzyme Q10, heme A, isoprenylated proteins, sex steroids, corticosteroids, bile acids, and vitamin D. 1 Statins reduce plasma cholesterol by inhibiting HMG-CoA reductase in the liver, but also inhibit this enzyme in tissues throughout the body.

Why aren't the harms of statins more commonly acknowledged?
First, most of the literature on statins has focused on the benefits. As a result awareness of statin harms is low 2 , and many specialists propound that statin harms are very unusual. 3 Second, the reported incidence of common statin effects, such as muscle pain and weakening, is low in randomized trials but higher in studies of real world use. 1,4 To some extent this is explained by use of a 'run-in period' in some statin RCTs when all patients are exposed to the drug prior to randomization and only those tolerating the drug are randomized. 5 16 and the 2013 RCT demonstrating that simvastatin significantly attenuates cardiorespiratory fitness as compared to placebo in overweight and obese patients. 17 (See Table 2).

Associated statin harms Third level evidence: Observational studies
The magnitude of statin harms has also been estimaed in large observational studies (see Table 3).

Fourth level evidence: Case series and case reports
A longer and growing list of harms is supported by case series and case reports. These are documented and referenced in the detailed analysis by Golomb and Evans and include peripheral neuropathy, The Therapeutics Letter presents critically appraised summary evidence primarily from controlled drug trials. Such evidence applies to patients similar to those involved in the trials, and may not be generalizable to every patient. We are committed to evaluate the effectiveness of our educational activities using the PharmaCare/PharmaNet databases without identifying individual physicians, pharmacies or patients. The Therapeutics Initiative is funded by the BC Ministry of Health through a grant to the University of BC. The Therapeutics Initiative provides evidence-based advice about drug therapy, and is not responsible for formulating or adjudicating provincial drug policies.

Muscle symptoms, the commonest statin adverse effect
Patients taking statins can experience muscle pain, aches, soreness, weakness or fatigue, but these symptoms also occur in people not taking statins. 4 An approach to dealing with patients with statin related muscle symptoms is provided by Fernandez et al. 26 It is important to appreciate that falls in the elderly could be due to statin adverse effects on muscle. The incidence of muscle symptoms is low in RCTs 4 but higher in observational studies. 27 Muscle symptoms interfering with exercise and inhibition of cardiorespiratory fitness 17 are problematic because regular exercise is the best way for patients to prevent adverse cardiovascular events. 28 Minor muscle damage may be very prevalent as low level ultrastructural muscle damage was detectable in muscle biopsies from 10 of 14 patients taking statins with no muscle symptoms. 29 Greater damage was seen in patients with muscle symptoms, whether or not the creatine kinase was elevated, and whether treatment was continuing or had been stopped for varying lengths of time. This suggests that the damage is not readily reversible. 30

Clinical Implications
Statins work by inhibiting a critical enzymatic pathway and thus have many potential effects in addition to the reduction of serum cholesterol. The full spectrum of statin related harms and their magnitude is still largely uncertain. However, from this analysis it is clear that the magnitude of statin harms is greater with high doses than with low doses and that the added benefits of high doses is unlikely to exceed the magnitude of the harms in most if not all clinical settings. 14 Even for lower doses the magnitude of harms appears to be in the range of 1-2%, a range similar to the benefits of statins for primary prevention. Physicians must be vigilant in order to detect statin adverse effects as many of them are subtle. When statins interfere with exercise, the benefits of exercise are undermined.

Conclusions
• The action of statins to reduce many compounds in addition to cholesterol is problematic. • Harms with statins are often subtle, usually dose related, sometimes serious and require vigilance to detect. • The magnitude of most statins harms remains uncertain at this time.
• It is essential to weigh the potential benefits and the potential harms in all patients taking or being considered for statin therapy.